80 FR 63671 - Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 203 (October 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 203 (October 21, 2015)
| Page Range | 63671-63674 | |
| FR Document | 2015-26658 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Rules and Regulations] [Pages 63671-63674] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26658] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2015-N-3387] Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective October 21, 2015. The classification was applicable on November 26, 2014. FOR FURTHER INFORMATION CONTACT: Shawn Forrest, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1326, Silver Spring, MD 20993-0002, 301-796-5554. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112- 144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. On November 6, 2013, HeartFlow, Inc. submitted a request for classification of the FFRCT v.1.4 under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1). In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the [[Page 63672]] establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on November 26, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 870.1415. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a coronary vascular physiologic simulation software device will need to comply with the special controls named in this final order. The device is assigned the generic name coronary vascular physiologic simulation software device, and it is identified as a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician. FDA has identified the following risks to health associated with this type of device, as well as the mitigation measures required to mitigate these risks, in table 1. Table 1--Coronary Vascular Physiologic Simulation Software Device Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ False negative results improperly Software verification, indicating diseased vessel as low validation, and hazard probability for significant disease leads analysis. to delay of further evaluation/treatment. Non-clinical performance testing. False positive results improperly Clinical testing. indicating diseased vessel as high probability for significant disease leads to incorrect patient management. Delayed delivery of results leading to Consistency (repeatability/ delay of further evaluation/treatment. reproducibility) evaluation. Labeling. Failure to properly interpret device Human factors testing. results leads to incorrect patient Labeling. management. ------------------------------------------------------------------------ FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:Adequate software verification and validation based on comprehensive hazard analysis with identification of appropriate mitigations, must be performed including: [cir] Full characterization of the technical parameters of the software, including any proprietary algorithm(s) used to model the vascular anatomy; [ssquf] Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications; [cir] Adequate consideration of privacy and security issues in the system design; and [ssquf] Adequate mitigation of the impact of failure of any subsystem components (e.g., signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures. Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement. Clinical data supporting the proposed intended use must be provided, including the following: [cir] Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner; [cir] Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (e.g., from literature analysis); [cir] Statistical performance of the device within clinical risk strata (e.g., age, relevant comorbidities, disease stability) must be reported; [cir] The dataset must be adequately representative of the intended use population for the device (e.g., patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified; [cir] Statistical methods must consider the predefined endpoints; [ssquf] Estimates of probabilities of incorrect results must be provided for each endpoint; [ssquf] Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification; [ssquf] The report must provide appropriate confidence intervals for each performance metric; [cir] Sensitivity and specificity must be characterized across the range of available measurements; [cir] Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements; [cir] Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and [cir] If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation and it must be justified as to how it was determined and clinically validated. Adequate validation must be performed and controls implemented to characterize and ensure consistency (i.e., repeatability and reproducibility) of measurement outputs; [cir] Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified; [cir] Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (i.e., repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment; [ssquf] Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device; and [ssquf] The factors (e.g., medical imaging data set, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data. Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on [[Page 63673]] measurements require significant user intervention. Device labeling must be provided that adequately describes the following: [cir] The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended; [cir] Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements; [cir] Key assumptions made in the calculation and determination of simulated measurements; [cir] The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data; [cir] A detailed description of the patients studied in the clinical validation (e.g., age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study (e.g., scanner representation, calcium scores, use of beta-blockers or nitrates); and [cir] Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results. A coronary vascular physiologic simulation software device is not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109, Prescription devices). Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the coronary vascular physiologic simulation software device they intend to market. II. Environmental Impact, No Significant Impact The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485. IV. Reference The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov. 1. DEN130045: De Novo Request from HeartFlow, Inc., dated November 1, 2013. List of Subjects in 21 CFR Part 870 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows: PART 870--CARDIOVASCULAR DEVICES 0 1. The authority citation for 21 CFR part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 0 2. Add Sec. 870.1415 to subpart B to read as follows: Sec. 870.1415 Coronary vascular physiologic simulation software device. (a) Identification. A coronary vascular physiologic simulation software device is a prescription device that provides simulated functional assessment of blood flow in the coronary vascular system using data extracted from medical device imaging to solve algorithms and yield simulated metrics of physiologic information (e.g., blood flow, coronary flow reserve, fractional flow reserve, myocardial perfusion). A coronary vascular physiologic simulation software device is intended to generate results for use and review by a qualified clinician. (b) Classification. Class II (special controls). The special controls for this device are: (1) Adequate software verification and validation based on comprehensive hazard analysis, with identification of appropriate mitigations, must be performed, including: (i) Full characterization of the technical parameters of the software, including: (A) Any proprietary algorithm(s) used to model the vascular anatomy; and (B) Adequate description of the expected impact of all applicable image acquisition hardware features and characteristics on performance and any associated minimum specifications; (ii) Adequate consideration of privacy and security issues in the system design; and (iii) Adequate mitigation of the impact of failure of any subsystem components (e.g., signal detection and analysis, data storage, system communications and cybersecurity) with respect to incorrect patient reports and operator failures. (2) Adequate non-clinical performance testing must be provided to demonstrate the validity of computational modeling methods for flow measurement; and (3) Clinical data supporting the proposed intended use must be provided, including the following: (i) Output measure(s) must be compared to a clinically acceptable method and must adequately represent the simulated measure(s) the device provides in an accurate and reproducible manner; (ii) Clinical utility of the device measurement accuracy must be demonstrated by comparison to that of other available diagnostic tests (e.g., from literature analysis); [[Page 63674]] (iii) Statistical performance of the device within clinical risk strata (e.g., age, relevant comorbidities, disease stability) must be reported; (iv) The dataset must be adequately representative of the intended use population for the device (e.g., patients, range of vessel sizes, imaging device models). Any selection criteria or limitations of the samples must be fully described and justified; (v) Statistical methods must consider the predefined endpoints: (A) Estimates of probabilities of incorrect results must be provided for each endpoint, (B) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification, and (C) The report must provide appropriate confidence intervals for each performance metric; (vi) Sensitivity and specificity must be characterized across the range of available measurements; (vii) Agreement of the simulated measure(s) with clinically acceptable measure(s) must be assessed across the full range of measurements; (viii) Comparison of the measurement performance must be provided across the range of intended image acquisition hardware; and (ix) If the device uses a cutoff threshold or operates across a spectrum of disease, it must be established prior to validation, and it must be justified as to how it was determined and clinically validated; (4) Adequate validation must be performed and controls implemented to characterize and ensure consistency (i.e., repeatability and reproducibility) of measurement outputs: (i) Acceptable incoming image quality control measures and the resulting image rejection rate for the clinical data must be specified, and (ii) Data must be provided within the clinical validation study or using equivalent datasets demonstrating the consistency (i.e., repeatability and reproducibility) of the output that is representative of the range of data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment; (A) Testing must be performed using multiple operators meeting planned qualification criteria and using the procedure that will be implemented in the production use of the device, and (B) The factors (e.g., medical imaging dataset, operator) must be identified regarding which were held constant and which were varied during the evaluation, and a description must be provided for the computations and statistical analyses used to evaluate the data; (5) Human factors evaluation and validation must be provided to demonstrate adequate performance of the user interface to allow for users to accurately measure intended parameters, particularly where parameter settings that have impact on measurements require significant user intervention; and (6) Device labeling must be provided that adequately describes the following: (i) The device's intended use, including the type of imaging data used, what the device measures and outputs to the user, whether the measure is qualitative or quantitative, the clinical indications for which it is to be used, and the specific population for which the device use is intended; (ii) Appropriate warnings specifying the intended patient population, identifying anatomy and image acquisition factors that may impact measurement results, and providing cautionary guidance for interpretation of the provided measurements; (iii) Key assumptions made in the calculation and determination of simulated measurements; (iv) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance. Per-vessel clinical performance, including where applicable localized performance according to vessel and segment, must be included as well as a characterization of the measurement error across the expected range of measurement for key parameters based on the clinical data; (v) A detailed description of the patients studied in the clinical validation (e.g., age, gender, race or ethnicity, clinical stability, current treatment regimen) as well as procedural details of the clinical study (e.g., scanner representation, calcium scores, use of beta-blockers or nitrates); and (vi) Where significant human interface is necessary for accurate analysis, adequately detailed description of the analysis procedure using the device and any data features that could affect accuracy of results. Dated: October 14, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-26658 Filed 10-20-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations 63671
E. Effective Date and Congressional DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as
Notification HUMAN SERVICES amended by section 607 of the Food and
Drug Administration Safety and
31. This regulation is effective Food and Drug Administration Innovation Act (Pub. L. 112–144),
December 21, 2015. The Commission provides two procedures by which a
has determined, with concurrence of the 21 CFR Part 870 person may request FDA to classify a
Administrator of the Office of device under the criteria set forth in
[Docket No. FDA–2015–N–3387]
Information and Regulatory Affairs of section 513(a)(1). Under the first
OMB, that this rule is not a ‘‘major rule’’ Medical Devices; Cardiovascular procedure, the person submits a
as defined in section 251 of the Small Devices; Classification of the Coronary premarket notification under section
Business Regulatory Enforcement Vascular Physiologic Simulation 510(k) of the FD&C Act for a device that
Fairness Act of 1996.41 This rule is Software Device has not previously been classified and,
being submitted to the Senate, House, within 30 days of receiving an order
and Government Accountability Office. AGENCY: Food and Drug Administration, classifying the device into class III
HHS. under section 513(f)(1) of the FD&C Act,
List of Subjects in 18 CFR Part 11 ACTION: Final order. the person requests a classification
Electric power, Reporting and under section 513(f)(2). Under the
SUMMARY: The Food and Drug
recordkeeping requirements. second procedure, rather than first
Administration (FDA) is classifying the
submitting a premarket notification
By the Commission. coronary vascular physiologic
under section 510(k) of the FD&C Act
simulation software device into class II
Issued: October 15, 2015. and then a request for classification
(special controls). The special controls
Kimberly D. Bose, under the first procedure, the person
that will apply to the device are
determines that there is no legally
Secretary. identified in this order and will be part
marketed device upon which to base a
In consideration of the foregoing, the of the codified language for the coronary
determination of substantial
Commission amends part 11, chapter I, vascular physiologic simulation
equivalence and requests a classification
title 18, Code of Federal Regulations, as software device’s classification. The
under section 513(f)(2) of the FD&C Act.
Agency is classifying the device into
follows: If the person submits a request to
class II (special controls) in order to
classify the device under this second
PART 11—ANNUAL CHARGES UNDER provide a reasonable assurance of safety
procedure, FDA may decline to
PART I OF THE FEDERAL POWER ACT and effectiveness of the device.
undertake the classification request if
DATES: This order is effective October
FDA identifies a legally marketed device
■ 1. The authority citation for part 11 21, 2015. The classification was that could provide a reasonable basis for
continues to read as follows: applicable on November 26, 2014. review of substantial equivalence with
FOR FURTHER INFORMATION CONTACT: the device or if FDA determines that the
Authority: 16 U.S.C. 792–828c; 42 U.S.C. Shawn Forrest, Center for Devices and
7101–7352.
device submitted is not of ‘‘low-
Radiological Health, Food and Drug moderate risk’’ or that general controls
■ 2. Revise § 11.1(c)(5) to read as Administration, 10903 New Hampshire would be inadequate to control the risks
follows: Ave., Bldg. 66, Rm. 1326, Silver Spring, and special controls to mitigate the risks
MD 20993–0002, 301–796–5554. cannot be developed.
§ 11.1 Costs of administration. SUPPLEMENTARY INFORMATION: In response to a request to classify a
* * * * * I. Background device under either procedure provided
by section 513(f)(2) of the FD&C Act,
(c) * * * In accordance with section 513(f)(1) of FDA will classify the device by written
(5) For unconstructed projects, the the Federal Food, Drug, and Cosmetic order within 120 days. This
assessments begin on the date by which Act (the FD&C Act) (21 U.S.C. classification will be the initial
the licensee or exemptee is required to 360c(f)(1)), devices that were not in classification of the device.
commence project construction, or as commercial distribution before May 28, On November 6, 2013, HeartFlow, Inc.
that deadline may be extended, but in 1976 (the date of enactment of the submitted a request for classification of
no case longer than four years after the Medical Device Amendments of 1976), the FFRCT v.1.4 under section 513(f)(2)
issuance date of the license or generally referred to as postamendments of the FD&C Act. The manufacturer
exemption. For constructed projects, the devices, are classified automatically by recommended that the device be
assessments begin on the effective date statute into class III without any FDA classified into class II (Ref. 1).
of the license or exemption, except for rulemaking process. These devices In accordance with section 513(f)(2) of
any new capacity authorized therein. remain in class III and require the FD&C Act, FDA reviewed the
The assessments for new authorized premarket approval, unless and until request in order to classify the device
capacity at licensed or exempted the device is classified or reclassified under the criteria for classification set
into class I or II, or FDA issues an order forth in section 513(a)(1). FDA classifies
projects begin on the date by which the
finding the device to be substantially devices into class II if general controls
licensee or exemptee is required to
equivalent, in accordance with section by themselves are insufficient to
commence construction of the new
513(i) of the FD&C Act, to a predicate provide reasonable assurance of safety
capacity. In the event that assessments
device that does not require premarket and effectiveness, but there is sufficient
begin during a fiscal year, the charges
approval. The Agency determines information to establish special controls
tkelley on DSK3SPTVN1PROD with RULES
will be prorated.
whether new devices are substantially to provide reasonable assurance of the
* * * * * equivalent to predicate devices by safety and effectiveness of the device for
[FR Doc. 2015–26726 Filed 10–20–15; 8:45 am] means of premarket notification its intended use. After review of the
BILLING CODE 6717–01–P procedures in section 510(k) of the information submitted in the request,
FD&C Act (21 U.S.C. 360(k)) and part FDA determined that the device can be
41 5 U.S.C. 804(2) (2012). 807 (21 CFR part 807) of the regulations. classified into class II with the
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![63674 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Rules and Regulations
(iii) Statistical performance of the evaluation, and a description must be DEPARTMENT OF HOMELAND
device within clinical risk strata (e.g., provided for the computations and SECURITY
age, relevant comorbidities, disease statistical analyses used to evaluate the
stability) must be reported; data; Coast Guard
(iv) The dataset must be adequately (5) Human factors evaluation and
representative of the intended use validation must be provided to 33 CFR Parts 100, 117, 147, and 165
population for the device (e.g., patients, demonstrate adequate performance of [USCG–2015–0242]
range of vessel sizes, imaging device the user interface to allow for users to
models). Any selection criteria or accurately measure intended Quarterly Listings; Safety Zones,
limitations of the samples must be fully parameters, particularly where Security Zones, Special Local
described and justified; parameter settings that have impact on Regulations, Drawbridge Operation
(v) Statistical methods must consider measurements require significant user Regulations and Regulated Navigation
the predefined endpoints: intervention; and Areas
(A) Estimates of probabilities of
incorrect results must be provided for (6) Device labeling must be provided AGENCY: Coast Guard, DHS.
each endpoint, that adequately describes the following: ACTION: Notice of expired temporary
(B) Where multiple samples from the (i) The device’s intended use, rules issued.
same patient are used, statistical including the type of imaging data used,
analysis must not assume statistical what the device measures and outputs SUMMARY: This document provides
independence without adequate to the user, whether the measure is notice of substantive rules issued by the
justification, and qualitative or quantitative, the clinical Coast Guard that were made temporarily
(C) The report must provide indications for which it is to be used, effective between January 2015 and
appropriate confidence intervals for and the specific population for which March 2015 but expired before they
each performance metric; the device use is intended; could be published in the Federal
(vi) Sensitivity and specificity must Register. This notice lists temporary
be characterized across the range of (ii) Appropriate warnings specifying safety zones, security zones, special
available measurements; the intended patient population, local regulations, drawbridge operation
(vii) Agreement of the simulated identifying anatomy and image regulations and regulated navigation
measure(s) with clinically acceptable acquisition factors that may impact areas, all of limited duration and for
measure(s) must be assessed across the measurement results, and providing which timely publication in the Federal
full range of measurements; cautionary guidance for interpretation of Register was not possible.
(viii) Comparison of the measurement the provided measurements;
DATES: This document lists temporary
performance must be provided across (iii) Key assumptions made in the Coast Guard rules that became effective
the range of intended image acquisition calculation and determination of between January 2015 and March 2015
hardware; and simulated measurements; and were terminated before they could
(ix) If the device uses a cutoff (iv) The measurement performance of be published in the Federal Register.
threshold or operates across a spectrum the device for all presented parameters, ADDRESSES: Temporary rules listed in
of disease, it must be established prior with appropriate confidence intervals, this document may be viewed online,
to validation, and it must be justified as and the supporting evidence for this under their respective docket numbers,
to how it was determined and clinically performance. Per-vessel clinical using the Federal eRulemaking Portal at
validated; performance, including where http://www.regulations.gov.
(4) Adequate validation must be
applicable localized performance FOR FURTHER INFORMATION CONTACT: For
performed and controls implemented to
according to vessel and segment, must questions on this notice contact Yeoman
characterize and ensure consistency
be included as well as a characterization First Class Maria Fiorella Villanueva,
(i.e., repeatability and reproducibility)
of the measurement error across the Office of Regulations and
of measurement outputs:
expected range of measurement for key Administrative Law, telephone (202)
(i) Acceptable incoming image quality
parameters based on the clinical data; 372–3862.
control measures and the resulting
image rejection rate for the clinical data (v) A detailed description of the SUPPLEMENTARY INFORMATION: Coast
must be specified, and patients studied in the clinical Guard District Commanders and
(ii) Data must be provided within the validation (e.g., age, gender, race or Captains of the Port (COTP) must be
clinical validation study or using ethnicity, clinical stability, current immediately responsive to the safety
equivalent datasets demonstrating the treatment regimen) as well as and security needs within their
consistency (i.e., repeatability and procedural details of the clinical study jurisdiction; therefore, District
reproducibility) of the output that is (e.g., scanner representation, calcium Commanders and COTPs have been
representative of the range of data scores, use of beta-blockers or nitrates); delegated the authority to issue certain
quality likely to be encountered in the and local regulations. Safety zones may be
intended use population and relevant (vi) Where significant human established for safety or environmental
use conditions in the intended use interface is necessary for accurate purposes. A safety zone may be
environment; analysis, adequately detailed stationary and described by fixed limits
(A) Testing must be performed using description of the analysis procedure or it may be described as a zone around
multiple operators meeting planned using the device and any data features a vessel in motion. Security zones limit
qualification criteria and using the that could affect accuracy of results. access to prevent injury or damage to
tkelley on DSK3SPTVN1PROD with RULES
procedure that will be implemented in vessels, ports, or waterfront facilities.
Dated: October 14, 2015. Special local regulations are issued to
the production use of the device, and
(B) The factors (e.g., medical imaging Leslie Kux, enhance the safety of participants and
dataset, operator) must be identified Associate Commissioner for Policy. spectators at regattas and other marine
regarding which were held constant and [FR Doc. 2015–26658 Filed 10–20–15; 8:45 am] events. Drawbridge operation
which were varied during the BILLING CODE 4164–01–P regulations authorize changes to
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Document Created: 2018-02-27 08:54:03
Document Modified: 2018-02-27 08:54:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective October 21, 2015. The classification was applicable on November 26, 2014. | |
| Contact | Shawn Forrest, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1326, Silver Spring, MD 20993-0002, 301-796-5554. | |
| FR Citation | 80 FR 63671 |
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