80 FR 49895 - Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 159 (August 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 159 (August 18, 2015)
| Page Range | 49895-49897 | |
| FR Document | 2015-20317 |
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)] [Rules and Regulations] [Pages 49895-49897] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20317] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2015-N-2723] Medical Devices; Cardiovascular Devices; Classification of the Esophageal Thermal Regulation Device AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation 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 esophageal thermal regulation 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 August 18, 2015. The classification was applicable on June 23, 2015. FOR FURTHER INFORMATION CONTACT: Lydia Glaw, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1102, Silver Spring, MD 20993-0002, 301-796-1456, Lydia.glaw@fda.hhs.gov. 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), the person requests a classification under section 513(f)(2) of the FD&C Act. 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 May 8, 2014, Advanced Cooling Therapy, LLC, submitted a request for classification of the Esophageal Cooling Device 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 could be classified into class II with the [[Page 49896]] 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 23, 2015, 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 870.5910. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an esophageal thermal regulation device will need to comply with the special controls named in this final order. The device is assigned the generic name esophageal thermal regulation device, and it is identified as a prescription device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature. FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in table 1. Table 1--Esophageal Thermal Regulation Device Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risk Mitigation measure ------------------------------------------------------------------------ Adverse tissue reaction................... Biocompatibility testing. Gastric distension........................ Non-clinical performance evaluation. Labeling. Injury to the esophagus................... Non-clinical performance evaluation. Animal testing. Labeling. Harmful hypo/hyperthermia................. Non-clinical performance evaluation. Animal testing. Labeling. Injury to the trachea..................... Labeling. ------------------------------------------------------------------------ FDA believes that the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:The patient contacting materials must be demonstrated to be biocompatible. Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: [cir] Mechanical integrity testing; [cir] Testing to determine temperature change rate(s); [cir] Testing to demonstrate compatibility with the indicated external controller; and [cir] Shelf life testing. Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use. Labeling must include the following: [cir] Detailed insertion instructions; [cir] Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction; [cir] The operating parameters, name, and model number of the indicated external controller; and [cir] The intended duration of use. Esophageal thermal regulation devices are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; 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, prior to marketing the device, which contains information about the esophageal thermal regulation device they intend to market. II. Environmental 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. DEN140018: De Novo Request per 513(f)(2) from Advanced Cooling Therapy, LLC, dated May 8, 2014. 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. 870.5910 to subpart F to read as follows: Sec. 870.5910 Esophageal thermal regulation device. (a) Identification. An esophageal thermal regulation device is a prescription device used to apply a specified temperature to the endoluminal surface of the esophagus via an external controller. This device may incorporate a mechanism for gastric decompression and suctioning. The device is used to regulate patient temperature. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting materials must be demonstrated to be biocompatible. (2) Non-clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use. The [[Page 49897]] following performance characteristics must be tested: (i) Mechanical integrity testing. (ii) Testing to determine temperature change rate(s). (iii) Testing to demonstrate compatibility with the indicated external controller. (iv) Shelf life testing. (3) Animal testing must demonstrate that the device does not cause esophageal injury and that body temperature remains within appropriate boundaries under anticipated conditions of use. (4) Labeling must include the following: (i) Detailed insertion instructions. (ii) Warning against attaching the device to unintended connections, such as external controllers for which the device is not indicated, or pressurized air outlets instead of vacuum outlets for those devices, including gastric suction. (iii) The operating parameters, name, and model number of the indicated external controller. (iv) The intended duration of use. Dated: August 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20317 Filed 8-17-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations 49895
These special conditions contain the DEPARTMENT OF HEALTH AND Section 513(f)(2) of the FD&C Act, as
additional safety standards that the HUMAN SERVICES amended by section 607 of the Food and
Administrator considers necessary to Drug Administration Safety and
establish a level of safety equivalent to Food and Drug Administration Innovation Act (Pub. L. 112–144),
that established by the existing provides two procedures by which a
airworthiness standards. 21 CFR Part 870 person may request FDA to classify a
[Docket No. FDA–2015–N–2723] device under the criteria set forth in
Applicability section 513(a)(1). Under the first
Medical Devices; Cardiovascular procedure, the person submits a
As discussed above, these special premarket notification under section
Devices; Classification of the
conditions apply to Gulfstream Model 510(k) of the FD&C Act for a device that
Esophageal Thermal Regulation
GVII–G500 airplanes. Should has not previously been classified and,
Device
Gulfstream apply later for a change to within 30 days of receiving an order
the type certificate to include another AGENCY: Food and Drug Administration, classifying the device into class III
model incorporating the same or similar HHS. under section 513(f)(1), the person
novel or unusual design feature, these ACTION: Final order. requests a classification under section
special conditions would apply to that 513(f)(2) of the FD&C Act. Under the
SUMMARY: The Food and Drug
model as well. second procedure, rather than first
Administration (FDA) is classifying the
submitting a premarket notification
Conclusion esophageal thermal regulation device
under section 510(k) of the FD&C Act
into class II (special controls). The
This action affects only certain novel and then a request for classification
special controls that will apply to the
or unusual design features on under the first procedure, the person
device are identified in this order and
Gulfstream Model GVII–G500 airplanes. determines that there is no legally
will be part of the codified language for
marketed device upon which to base a
It is not a rule of general applicability. the esophageal thermal regulation
determination of substantial
device’s classification. The Agency is
List of Subjects in 14 CFR Part 25 equivalence and requests a classification
classifying the device into class II
under section 513(f)(2) of the FD&C Act.
Aircraft, Aviation safety, Reporting (special controls) in order to provide a
If the person submits a request to
and recordkeeping requirements. reasonable assurance of safety and
classify the device under this second
effectiveness of the device.
The authority citation for these procedure, FDA may decline to
DATES: This order is effective August 18,
special conditions is as follows: undertake the classification request if
2015. The classification was applicable FDA identifies a legally marketed device
Authority: 49 U.S.C. 106(g), 40113, 44701, on June 23, 2015. that could provide a reasonable basis for
44702, 44704. FOR FURTHER INFORMATION CONTACT: review of substantial equivalence with
Lydia Glaw, Center for Devices and the device or if FDA determines that the
The Special Conditions Radiological Health, Food and Drug device submitted is not of ‘‘low-
Accordingly, pursuant to the Administration, 10903 New Hampshire moderate risk’’ or that general controls
Ave., Bldg. 66, Rm. 1102, Silver Spring, would be inadequate to control the risks
authority delegated to me by the
MD 20993–0002, 301–796–1456, and special controls to mitigate the risks
Administrator, the following special
Lydia.glaw@fda.hhs.gov. cannot be developed.
conditions are issued as part of the type
SUPPLEMENTARY INFORMATION: In response to a request to classify a
certification basis for Gulfstream Model
I. Background device under either procedure provided
GVII–G500 airplanes.
by section 513(f)(2) of the FD&C Act,
In addition to the requirements of In accordance with section 513(f)(1) of FDA will classify the device by written
§§ 25.143, 25.671, 25.672, and 25.1322, the Federal Food, Drug, and Cosmetic order within 120 days. This
when a flight condition exists where, Act (the FD&C Act) (21 U.S.C. classification will be the initial
without being commanded by the crew, 360c(f)(1)), devices that were not in classification of the device. On May 8,
control surfaces are coming so close to commercial distribution before May 28, 2014, Advanced Cooling Therapy, LLC,
their limits that return to the normal 1976 (the date of enactment of the submitted a request for classification of
flight envelope, or continuation of safe Medical Device Amendments of 1976), the Esophageal Cooling Device under
flight, or both, requires a specific crew generally referred to as postamendments section 513(f)(2) of the FD&C Act. The
action, a suitable flight-control-position devices, are classified automatically by manufacturer recommended that the
statute into class III without any FDA device be classified into class II (Ref. 1).
annunciation must be provided to the
rulemaking process. These devices In accordance with section 513(f)(2) of
crew, unless other existing indications
remain in class III and require the FD&C Act, FDA reviewed the
are found adequate or sufficient to premarket approval, unless and until request in order to classify the device
prompt that action. the device is classified or reclassified under the criteria for classification set
Note: The term ‘‘suitable’’ indicates an into class I or II, or FDA issues an order forth in section 513(a)(1). FDA classifies
appropriate balance between necessary finding the device to be substantially devices into class II if general controls
operation and nuisance factors. equivalent, in accordance with section by themselves are insufficient to
513(i) of the FD&C Act, to a predicate provide reasonable assurance of safety
Issued in Renton, Washington, on August device that does not require premarket and effectiveness, but there is sufficient
7, 2015. approval. The Agency determines
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information to establish special controls
Michael Kaszycki, whether new devices are substantially to provide reasonable assurance of the
Acting Manager, Transport Airplane equivalent to predicate devices by safety and effectiveness of the device for
Directorate, Aircraft Certification Service. means of premarket notification its intended use. After review of the
[FR Doc. 2015–20296 Filed 8–17–15; 8:45 am] procedures in section 510(k) of the information submitted in the request,
BILLING CODE 4910–13–P FD&C Act (21 U.S.C. 360(k)) and part FDA determined that the device could
807 (21 CFR part 807) of the regulations. be classified into class II with the
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![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations 49897
following performance characteristics these revisions is to eliminate the 1218–AC76) for this rulemaking.
must be tested: unnecessary codification of material in Because of security-related procedures,
(i) Mechanical integrity testing. the Code of Federal Regulations and submission by regular mail may result
(ii) Testing to determine temperature thus save the time and funds currently in significant delay. Please contact the
change rate(s). expended in publicizing State plan OSHA Docket Office for information
(iii) Testing to demonstrate revisions. The streamlining of OSHA about security procedures for making
compatibility with the indicated State plan regulations does not change submissions by hand delivery, express
external controller. the areas of coverage or any other delivery and messenger or courier
(iv) Shelf life testing. substantive components of any State service.
(3) Animal testing must demonstrate plan. It also does not affect the rights All comments, including any personal
that the device does not cause and responsibilities of the State plans, information you provide, are placed in
esophageal injury and that body or any employers or employees, except the public docket without change and
temperature remains within appropriate to eliminate the burden on State plan may be made available online at http://
boundaries under anticipated designees to keep paper copies of www.regulations.gov. Therefore, caution
conditions of use. approved State plans and plan should be taken in submitting personal
(4) Labeling must include the supplements in an office, and to submit information, such as Social Security
following: multiple copies of proposed State plan numbers and birth dates.
(i) Detailed insertion instructions. documents to OSHA. This document Docket: To read or download
(ii) Warning against attaching the also contains a request for comments for submissions in response to this Federal
device to unintended connections, such an Information Collection Request (ICR) Register document, go to docket number
as external controllers for which the under the Paperwork Reduction Act of OSHA–2014–0009, at http://
device is not indicated, or pressurized 1995 (PRA), which covers all collection www.regulations.gov. All submissions
air outlets instead of vacuum outlets for of information requirements in OSHA are listed in the http://
those devices, including gastric suction. State plan regulations. www.regulations.gov index: However,
(iii) The operating parameters, name, DATES: This direct final rule is effective some information (e.g., copyrighted
and model number of the indicated October 19, 2015. Comments and material) is not publicly available to
external controller. additional materials (including read or download through that Web
(iv) The intended duration of use. comments on the information-collection page. All submissions, including
Dated: August 12, 2015. (paperwork) determination described copyrighted material, are available for
Leslie Kux, under the section titled SUPPLEMENTARY inspection at the OSHA Docket Office.
INFORMATION of this document) must be Electronic copies of this Federal
Associate Commissioner for Policy.
submitted (post-marked, sent or Register document are available at
[FR Doc. 2015–20317 Filed 8–17–15; 8:45 am] http://www.regulations.gov. This
received) by September 17, 2015.
BILLING CODE 4164–01–P
ADDRESSES: You may submit comments,
document, as well as news releases and
identified by docket number OSHA– other relevant information, is available
2014–0009, or regulatory information at OSHA’s Web page at http://
DEPARTMENT OF LABOR number (RIN) 1218–AC76 by any of the www.osha.gov. A copy of the documents
following methods: referenced in this document may be
Occupational Safety and Health obtained from: Office of State Programs,
Administration Electronically: You may submit
comments and attachments Directorate of Cooperative and State
electronically at http:// Programs, Occupational Safety and
29 CFR Parts 1902, 1903, 1904, 1952, Health Administration, Room N3700,
1953, 1954, 1955, and 1956 www.regulations.gov, which is the
Federal eRulemaking Portal. Follow the 200 Constitution Avenue NW.,
[Docket No. OSHA–2014–0009] instructions on-line for making Washington, DC 20210, (202) 693–2244,
electronic submissions; or fax (202) 693–1671.
RIN 1218–AC76 Fax: If your submission, including FOR FURTHER INFORMATION CONTACT: For
attachments, does not exceed 10 pages, press inquiries: Francis Meilinger,
Streamlining of Provisions on State
you may fax them to the OSHA Docket OSHA Office of Communications, Room
Plans for Occupational Safety and
Office at (202) 693–1648; or N–3647, U.S. Department of Labor, 200
Health
U.S. mail, hand delivery, express Constitution Avenue NW., Washington,
AGENCY: Occupational Safety and Health mail, messenger or courier service: You DC 20210; telephone (202) 693–1999;
Administration (OSHA), Department of must submit your comments and email: meilinger.francis2@dol.gov.
Labor. attachments to the OSHA Docket Office, For general and technical
ACTION: Direct final rule. Docket No OSHA–2014–0009, U.S. information: Douglas J. Kalinowski,
Department of Labor, Room N–2625, Director, OSHA Directorate of
SUMMARY: This document primarily 200 Constitution Avenue NW., Cooperative and State Programs, Room
amends OSHA regulations to remove Washington, DC 20210; telephone (202) N–3700, U.S. Department of Labor, 200
the detailed descriptions of State plan 693–2350 (OSHA’s TTY number is (877) Constitution Avenue NW., Washington
coverage, purely historical data, and 889–5627). Deliveries (hand, express DC 20210; telephone: (202) 693–2200;
other unnecessarily codified mail, messenger and courier service) are email: kalinowski.doug@dol.gov.
information. In addition, this document accepted during the Department of SUPPLEMENTARY INFORMATION:
moves most of the general provisions of
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Labor’s and Docket Office’s normal
subpart A of part 1952 into part 1902, business hours, 8:15 a.m.–4:45 p.m., Background
where the general regulations on State EST. Section 18 of the Occupational Safety
plan criteria are found. It also amends Instructions for submitting comments: and Health Act of 1970 (the Act), 29
several other OSHA regulations to All submissions must include the U.S.C. 667, provides that States that
delete references to part 1952, which Docket Number (Docket No. OSHA– desire to assume responsibility for the
will no longer apply. The purpose of 2014–0009) or the RIN number (RIN development and enforcement of
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Document Created: 2015-12-15 12:04:39
Document Modified: 2015-12-15 12:04:39
| 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 August 18, 2015. The classification was applicable on June 23, 2015. | |
| Contact | Lydia Glaw, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1102, Silver Spring, MD 20993-0002, 301-796-1456, [email protected] | |
| FR Citation | 80 FR 49895 |
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