[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Rules and Regulations]
[Pages 46192-46194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2015-N-2525]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the External Upper Esophageal Sphincter Compression Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
external upper esophageal sphincter (UES) compression 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 external UES compression 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 4, 2015. The classification was 
applicable on March 6, 2015.

FOR FURTHER INFORMATION CONTACT: Sunny Park, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2432, Silver Spring, MD, 20993-0002, 301-796-7059, 
[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 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), 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.

[[Page 46193]]

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 22, 2013, Somna Therapeutics, LLC, submitted a request for 
classification of the REZA BAND UES Assist 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 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 March 6, 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 874.5900.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for an external 
UES compression device will need to comply with the special controls 
named in this final order. The device is assigned the generic name 
external UES compression device, and it is identified as a prescription 
device used to apply external pressure on the cricoid cartilage for the 
purpose of reducing the symptoms of laryngopharyngeal reflux disease.
    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--External UES Compression Device Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation method
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility assessment.
Risk of overcompression................  Clinical study.
                                         Labeling.
                                         Technical specifications.
Device misuse/incorrect fitting/         Technical specifications.
 malfunctions.                           Clinical study.
                                         Labeling.
                                         Performance testing (mechanical
                                          integrity and shelf life
                                          testing).
------------------------------------------------------------------------

    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:
    1. The patient contacting components must be demonstrated to be 
biocompatible.
    2. Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be demonstrated:
    a. Mechanical integrity testing (e.g., tensile strength testing, 
fatigue testing) and
    b. shelf life testing
    3. The technical specifications must include pressure measurement 
accuracy to characterize device performance.
    4. Clinical performance testing must document any adverse events 
observed during clinical use, and demonstrate that the device performs 
as intended under anticipated conditions of use.
    5. Labeling must include the following:
    a. Appropriate warnings and precautions.
    b. A detailed summary of the clinical testing pertinent to use of 
the device including a detailed summary of the device-related 
complications or adverse events.
    c. Detailed instructions on how to fit the device to the patient.
    d. Instructions for reprocessing of any reusable components.
    6. Patient labeling must be provided and must include:
    a. Relevant warnings, precautions, and adverse effects/
complications.
    b. Information on how to correctly wear the device.
    c. The potential risks and benefits associated with the use of the 
device.
    d. Alternative treatments.
    e. Reprocessing instructions.
    The external UES compression device is a prescription device 
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 
external UES compression 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 21 
CFR 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.


[[Page 46194]]


1. DEN130046: De Novo Request per 513(f)(2) from Somna Therapeutics, 
LLC, dated November 11, 2013.

List of Subjects in 21 CFR Part 874

    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 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for 21 CFR part 874 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  874.5900 to subpart F to read as follows:


Sec.  874.5900  External upper esophageal sphincter compression device.

    (a) Identification. An external upper esophageal sphincter 
compression device is a prescription device used to apply external 
pressure on the cricoid cartilage for the purpose of reducing the 
symptoms of laryngopharyngeal reflux disease.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient contacting components must be demonstrated to be 
biocompatible.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use. The 
following performance characteristics must be demonstrated:
    (i) Mechanical integrity testing (e.g., tensile strength testing, 
fatigue testing) and
    (ii) Shelf life testing.
    (3) The technical specifications must include pressure measurement 
accuracy to characterize device performance.
    (4) Clinical performance testing must document any adverse events 
observed during clinical use, and demonstrate that the device performs 
as intended under anticipated conditions of use.
    (5) Labeling must include the following:
    (i) Appropriate warnings and precautions,
    (ii) A detailed summary of the clinical testing pertinent to use of 
the device including a detailed summary of the device-related 
complications or adverse events,
    (iii) Detailed instructions on how to fit the device to the 
patient, and
    (iv) Instructions for reprocessing of any reusable components.
    (6) Patient labeling must be provided and must include:
    (i) Relevant warnings, precautions, and adverse effects/
complications,
    (ii) Information on how to correctly wear the device,
    (iii) The potential risks and benefits associated with the use of 
the device,
    (iv) Alternative treatments, and
    (v) Reprocessing instructions.

    Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19074 Filed 8-3-15; 8:45 am]
 BILLING CODE 4164-01-P