82 FR 34850 - Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 143 (July 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 143 (July 27, 2017)
| Page Range | 34850-34852 | |
| FR Document | 2017-15786 |
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)] [Rules and Regulations] [Pages 34850-34852] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15786] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2017-N-1916] Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter 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 balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective July 27, 2017. The classification was applicable on June 11, 2012. FOR FURTHER INFORMATION CONTACT: Nicole Ibrahim, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1232, Silver Spring, MD, 20993-0002, 301-796-5171, [email protected]. 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 [[Page 34851]] 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, also known as De Novo classification, 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 shall classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on December 3, 2008, classifying the NuCLEUS-X Percutaneous Transluminal Valvuloplasty Catheter into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On December 23, 2008, NuMED, Inc. submitted a request for classification of the NuCLEUS-X Percutaneous Transluminal Valvuloplasty Catheter under section 513(f)(2) of the FD&C Act. 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 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 June 11, 2012, 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 870.1255. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a balloon aortic valvuloplasty catheter will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name balloon aortic valvuloplasty catheter, and it is identified as a catheter with a balloon at the distal end of the shaft that is intended to treat stenosis in the aortic valve when the balloon is expanded. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1: Table 1--Balloon Aortic Valvuloplasty Catheter Risks and Mitigation Measures ---------------------------------------------------------------------------------------------------------------- Identified risks Mitigation measures ---------------------------------------------------------------------------------------------------------------- Adverse tissue reaction.................... Biocompatibility testing. Labeling. Infection.................................. Sterility. Shelf life testing. User error................................. Labeling. Valve leaflet perforation.................. Non-clinical performance evaluation. In Vivo evaluation. Labeling. Perforation of vascular or cardiac tissue.. Non-clinical performance evaluation. In Vivo evaluation. Labeling. Procedural complications, including Non-clinical performance evaluation. bleeding, cardiac tamponade, calcium In Vivo evaluation. embolic events, valvular regurgitation, Labeling. and death. Balloon burst.............................. Non-clinical performance evaluation. In Vivo evaluation. Labeling. [[Page 34852]] Inability for balloon deflation............ Non-clinical performance evaluation. In Vivo evaluation. Increased balloon inflation and deflation Non-clinical performance evaluation. times. In Vivo evaluation. Labeling. Inability to steer towards valve of Non-clinical performance evaluation. interest. In Vivo evaluation. ---------------------------------------------------------------------------------------------------------------- FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. Balloon aortic valvuloplasty catheters are 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), 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 (510(k)), prior to marketing the device, which contains information about the balloon aortic valvuloplasty catheter they intend to market. II. Analysis of Environmental Impact We have 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. 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 part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 870.1255 to subpart B to read as follows: Sec. 870.1255 Balloon aortic valvuloplasty catheter. (a) Identification. A balloon aortic valvuloplasty catheter is a catheter with a balloon at the distal end of the shaft, which is intended to treat stenosis in the aortic valve when the balloon is expanded. (b) Classification. Class II (special controls). The special controls for this device are: (1) The device must be demonstrated to be biocompatible. (2) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components. (3) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use, including device delivery, inflation, deflation, and removal. (4) In vivo evaluation of the device must demonstrate device performance, including the ability of the device to treat aortic stenosis. (5) Labeling must include a detailed summary of the device-related and procedure-related complications pertinent to the use of the device. Dated: July 21, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15786 Filed 7-26-17; 8:45 am] BILLING CODE 4164-01-P
![34850 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
requirements. Persons who intend to use with either qualitative or statement: ‘‘This product is not
market this type of device must submit quantitative assays. intended to replace manufacturer
to FDA a premarket notification (b) Classification. Class II (special controls provided with the device.’’
(510(k)), prior to marketing the device, controls). The special controls for this (iii) A limiting statement that reads
which contains information about the device are: ‘‘Quality control materials should be
assayed quality control material for (1) Premarket notification used in accordance with local, state,
clinical microbiology assays they intend submissions must include detailed federal regulations, and accreditation
to market. device description documentation and requirements.’’
information concerning the composition Dated: July 24, 2017.
II. Analysis of Environmental Impact of the quality control material, Anna K. Abram,
We have determined under 21 CFR including, as appropriate:
25.34(b) that this action is of a type that Deputy Commissioner for Policy, Planning,
(i) Analyte concentration;
Legislation, and Analysis.
does not individually or cumulatively (ii) Expected values;
have a significant effect on the human (iii) Analyte source; [FR Doc. 2017–15858 Filed 7–26–17; 8:45 am]
environment. Therefore, neither an (iv) Base matrix; BILLING CODE 4164–01–P
environmental assessment nor an (v) Added components;
environmental impact statement is (vi) Safety and handling information;
required. and DEPARTMENT OF HEALTH AND
(vii) Detailed instructions for use. HUMAN SERVICES
III. Paperwork Reduction Act of 1995 (2) Premarket notification
This final order establishes special submissions must include detailed Food and Drug Administration
controls that refer to previously documentation, including line data as
approved collections of information well as detailed study protocols and a 21 CFR Part 870
found in other FDA regulations. These statistical analysis plan used to establish [Docket No. FDA–2017–N–1916]
collections of information are subject to performance, including:
review by the Office of Management and (i) Description of the process for value Medical Devices; Cardiovascular
Budget (OMB) under the Paperwork assignment and validation. Devices; Classification of the Balloon
Reduction Act of 1995 (44 U.S.C. 3501– (ii) Description of the protocol(s) used Aortic Valvuloplasty Catheter
3520). The collections of information in to establish stability. AGENCY: Food and Drug Administration,
part 807, subpart E, regarding premarket (iii) Line data establishing precision/
HHS.
notification submissions have been reproducibility.
(iv) Where applicable, assessment of ACTION: Final order.
approved under OMB control number
0910–0120, and the collections of matrix effects and any significant SUMMARY: The Food and Drug
information in 21 CFR parts 801 and differences between the quality control Administration (FDA, Agency, or we) is
809, regarding labeling have been material and typical patient samples in classifying the balloon aortic
approved under OMB control number terms of conditions known to cause valvuloplasty catheter into class II
0910–0485. analytical error or affect assay (special controls). The special controls
performance. that will apply to the device are
List of Subjects in 21 CFR Part 866 (v) Where applicable, identify or identified in this order and will be part
Biologics, Laboratories, Medical define traceability or relationship to a of the codified language for the balloon
devices. domestic or international standard aortic valvuloplasty catheter’s
Therefore, under the Federal Food, reference material and/or method. classification. The Agency is classifying
Drug, and Cosmetic Act and under (vi) Where applicable, detailed the device into class II (special controls)
authority delegated to the Commissioner documentation related to studies for to provide a reasonable assurance of
of Food and Drugs, 21 CFR part 866 is surrogate controls. safety and effectiveness of the device.
amended as follows: (3) Premarket notification
DATES: This order is effective July 27,
submissions must include an adequate
PART 866—IMMUNOLOGY AND mitigation (e.g., real-time stability 2017. The classification was applicable
MICROBIOLOGY DEVICES program) to the risk of false results due on June 11, 2012.
to potential modifications to the assays FOR FURTHER INFORMATION CONTACT:
■ 1. The authority citation for part 866 specified in the device’s 21 CFR 809.10 Nicole Ibrahim, Center for Devices and
is revised to read as follows: compliant labeling. Radiological Health, Food and Drug
Authority: 21 U.S.C. 351, 360, 360c, 360e, (4) Your 21 CFR 809.10 compliant Administration, 10903 New Hampshire
360j, 360l, 371. labeling must include the following: Ave., Bldg. 66, Rm. 1232, Silver Spring,
■ 2. Add § 866.3920 to subpart D to read (i) The intended use of your 21 CFR MD, 20993–0002, 301–796–5171,
as follows: 809.10(a)(2) and (b)(2) compliant nicole.ibrahim@fda.hhs.gov.
labeling must include the following: SUPPLEMENTARY INFORMATION:
§ 866.3920 Assayed quality control (A) Assayed control material
material for clinical microbiology assays. I. Background
analyte(s);
(a) Identification. An assayed quality (B) Whether the material is intended In accordance with section 513(f)(1) of
control material for clinical for quantitative or qualitative assays; the Federal Food, Drug, and Cosmetic
microbiology assays is a device (C) Stating if the material is a Act (the FD&C Act) (21 U.S.C.
mstockstill on DSK30JT082PROD with RULES
indicated for use in a test system to surrogate control; and 360c(f)(1)), devices that were not in
estimate test precision or to detect (D) The system(s), instrument(s), or commercial distribution before May 28,
systematic analytical deviations that test(s) for which the quality control 1976 (the date of enactment of the
may arise from reagent or analytical material is intended. Medical Device Amendments of 1976),
instrument variation. This type of (ii) The intended use in your 21 CFR generally referred to as postamendments
device consists of single or multiple 809.10(a)(2) and (b)(2) compliant devices, are classified automatically by
microbiological analytes intended for labeling must include the following statute into class III without any FDA
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![34852 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
TABLE 1—BALLOON AORTIC VALVULOPLASTY CATHETER RISKS AND MITIGATION MEASURES—Continued
Identified risks Mitigation measures
Inability for balloon deflation ................................................................................................................ Non-clinical performance evaluation.
In Vivo evaluation.
Increased balloon inflation and deflation times ................................................................................... Non-clinical performance evaluation.
In Vivo evaluation.
Labeling.
Inability to steer towards valve of interest ........................................................................................... Non-clinical performance evaluation.
In Vivo evaluation.
FDA believes that special controls, in notification submissions, have been Dated: July 21, 2017.
combination with the general controls, approved under OMB control number Anna K. Abram,
address these risks to health and 0910–0120, and the collections of Deputy Commissioner for Policy, Planning,
provide reasonable assurance of safety information in 21 CFR part 801, Legislation, and Analysis.
and effectiveness. regarding labeling have been approved [FR Doc. 2017–15786 Filed 7–26–17; 8:45 am]
Balloon aortic valvuloplasty catheters under OMB control number 0910–0485. BILLING CODE 4164–01–P
are not safe for use except under the
List of Subjects in 21 CFR Part 870
supervision of a practitioner licensed by
law to direct the use of the device. As Medical devices. DEPARTMENT OF STATE
such, the device is a prescription device Therefore, under the Federal Food,
and must satisfy prescription labeling Drug, and Cosmetic Act and under 22 CFR Part 147
requirements (see 21 CFR 801.109, authority delegated to the Commissioner
[Public Notice: 10027]
Prescription devices). of Food and Drugs, 21 CFR part 870 is
Section 510(m) of the FD&C Act amended as follows: RIN 1400–AE42
provides that FDA may exempt a class
II device from the premarket notification PART 870—CARDIOVASCULAR Electronic and Information Technology
requirements under section 510(k), if DEVICES
AGENCY: Department of State.
FDA determines that premarket
notification is not necessary to provide ■ 1. The authority citation for part 870 ACTION: Final rule.
reasonable assurance of the safety and continues to read as follows:
SUMMARY: This rule provides a
effectiveness of the device. For this type Authority: 21 U.S.C. 351, 360, 360c, 360e, correction to a hyperlink included in
of device, FDA has determined that 360j, 360l, 371. the Section 508 implementing rule for
premarket notification is necessary to ■ 2. Add § 870.1255 to subpart B to read the Department of State (the
provide reasonable assurance of the as follows: Department). The hyperlink takes the
safety and effectiveness of the device. reader to a form that can be used by an
Therefore, this device type is not § 870.1255 Balloon aortic valvuloplasty
employee or a member of the public to
exempt from premarket notification catheter.
report accessibility issues to the
requirements. Persons who intend to (a) Identification. A balloon aortic Department, regarding its electronic and
market this type of device must submit valvuloplasty catheter is a catheter with information technology.
to FDA a premarket notification a balloon at the distal end of the shaft,
DATES: This rule is effective on August
(510(k)), prior to marketing the device, which is intended to treat stenosis in
28, 2017.
which contains information about the the aortic valve when the balloon is
expanded. FOR FURTHER INFORMATION CONTACT:
balloon aortic valvuloplasty catheter
they intend to market. (b) Classification. Class II (special Alice Kottmyer, Attorney-Adviser, 202–
controls). The special controls for this 647–2318, kottmyeram@state.gov.
II. Analysis of Environmental Impact device are: SUPPLEMENTARY INFORMATION: Section
We have determined under 21 CFR (1) The device must be demonstrated 508 requires that when Federal
25.34(b) that this action is of a type that to be biocompatible. departments and agencies develop,
does not individually or cumulatively (2) Sterility and shelf life testing must procure, maintain, or use electronic and
have a significant effect on the human demonstrate the sterility of patient- information technology, they shall
environment. Therefore, neither an contacting components and the shelf life ensure that the electronic and
environmental assessment nor an of these components. information technology is accessible to
environmental impact statement is (3) Non-clinical performance individuals with disabilities. The
required. evaluation must demonstrate that the Department’s implementing regulations,
device performs as intended under in 22 CFR part 147, were published in
III. Paperwork Reduction Act of 1995 anticipated conditions of use, including 2016. Due to a re-configuration of Web
This final order establishes special device delivery, inflation, deflation, and site assets within the Department, the
controls that refer to previously removal. hyperlink included in § 147.7(c) for the
approved collections of information (4) In vivo evaluation of the device DS–4282 (Discrimination Complaint
mstockstill on DSK30JT082PROD with RULES
found in other FDA regulations. These must demonstrate device performance, Form), is no longer valid. This
collections of information are subject to including the ability of the device to rulemaking corrects the link.
review by the Office of Management and treat aortic stenosis. The Department is preparing a more
Budget (OMB) under the Paperwork (5) Labeling must include a detailed comprehensive update to Part 147,
Reduction Act of 1995 (44 U.S.C. 3501– summary of the device-related and which will align its rule with the final
3520). The collections of information in procedure-related complications rule published by the Access Board (see
part 807, subpart E, regarding premarket pertinent to the use of the device. 82 FR 5790); and to parts 142 and 144
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Document Created: 2017-07-27 02:07:09
Document Modified: 2017-07-27 02:07:09
| 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 July 27, 2017. The classification was applicable on June 11, 2012. | |
| Contact | Nicole Ibrahim, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1232, Silver Spring, MD, 20993-0002, 301-796-5171, [email protected] | |
| FR Citation | 82 FR 34850 |
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