Reza Band, Reflux Band

K173934 · Somna Therapeutics, LLC · PKA · Apr 13, 2018 · Ear, Nose, Throat

Device Facts

• Record ID: K173934
• Device Name: Reza Band, Reflux Band
• Applicant: Somna Therapeutics, LLC
• Product Code: PKA · Ear, Nose, Throat
• Decision Date: Apr 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.5900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Reza Band and the Reflux Band are for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The devices are worn by the user while sleeping.

Device Story

Non-invasive, wearable device for LPR symptom reduction; worn around neck during sleep. Applies 20-30 mmHg external pressure at cricoid cartilage to increase UES luminal pressure; prevents stomach contents from reaching larynx/pharynx/lungs. Reflux Band uses SmartCushion electronics to interface with iOS/Android mobile app for pressure fitting; Reza Band uses external manometer/pressure sensor accessories for fitting. Operated by user (OTC). Output is physical compression; app provides feedback for correct pressure application. Benefits patient by reducing reflux symptoms.

Clinical Evidence

Clinical performance data included usability testing and comprehension testing of the Reflux Symptom Index (RSI) tool for the LPR population. No clinical efficacy trials were required as the device is substantially equivalent to the predicate.

Technological Characteristics

External UES compression device. Components: cushion, comfort band, frame, comfort dial, clasp. SmartCushion includes integrated electronics for mobile app connectivity. Pressure range: 20-30 mmHg. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for people 18 years and older to reduce symptoms of laryngopharyngeal reflux (LPR) disease by reducing regurgitation of stomach contents through the upper esophageal sphincter. Worn during sleep.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the External UES Compression Device is subject to the following special controls:

*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.

Predicate Devices

• Reza Band® Upper Esophageal Sphincter (UES) Assist Device (DEN130046)

Submission Summary (Full Text)

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April 13, 2018

Somna Therapeutics, L.L.C. James Miller VP, Product Development & Regulatory Affairs W175 N11081 Stonewood Dr. Germantown, WI 53022

Re: K173934

Trade/Device Name: Reza Band, Reflux Band Regulation Number: 21 CFR 874.5900 Regulation Name: External Upper Esophageal Sphincter (UES) Compression Device Regulatory Class: Class II Product Code: PKA Dated: March 14, 2018 Received: March 16, 2018

Dear James Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K173934

Device Name Reza Band, Reflux Band

Indications for Use (Describe)

The Reza Band and the Reflux Band are for people 18 years and older to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The devices are worn by the user while sleeping.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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## K173934 – 510(k) Summary

510(k) Summary for the Reflux Band™ and Reza Band® provided in accordance with 21 CFR 807.92

| 510(k) Owner: | Somna Therapeutics, LLC<br>W175 N11081 Stonewood Drive<br>Germantown, WI 53022<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Contact Person: | James Miller |
| Date of Summary Preparation: | December 21, 2017 |
| Device Common Name: | External upper esophageal sphincter (UES) compression device |
| Device Trade/ Proprietary Name: | Reflux Band™, Reza Band® |
| Classification Name: | External upper esophageal sphincter (UES) compression device (21 CFR 874.5900, Product Code PKA) |
| Predicate Device: | Reza Band® Upper Esophageal Sphincter (UES) Assist Device (DEN130046) |
| Device Description: | The Reza Band and Reflux Band are proposed for over the counter (OTC) use.<br><br>The proposed devices are non-invasive and non-sterile worn by the user while sleeping. As with the predicate device (Reza Band), the proposed Reza Band and Reflux Band were designed as a treatment for LPR symptoms.<br><br>The mode of operation of these devices is to provide slight external pressure, typically in a range of 20-30 mmHg, at the cricoid cartilage region. This external pressure increases the luminal pressure within the upper esophageal sphincter (UES). It has been shown that when the UES is subjected to the increased external pressure, it reduces stomach contents from coming up into the larynx, pharynx and lungs.<br><br>The user positions the device around their neck. For the Reflux Band, the user uses an application (App) installed on an iOS or Android mobile device to fit the Reflux Band to the desired externally applied pressure. The electronics of the Reflux Band have been incorporated into its cushion (SmartCushion) so that the Reflux Band can interact with the App. For the Reza Band, the user utilizes the accessories External Manometer and Pressure Sensor to properly fit the device. A typical range is also 20-30mmHg of applied pressure.<br><br>The components of the Reflux Band and Reflux Band are identical |
| | of a Cushion, Comfort Band, Frame, Comfort Dial and Clasp. |
| Intended Use: | The Reza Band and the Reflux Band are for people 18 years and older<br>to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by<br>reducing the regurgitation of stomach contents from passing through<br>the upper esophageal sphincter. The devices are worn by the user<br>while sleeping. |
| Comparison to<br>Predicate Device: | The intended use is substantially equivalent to the predicate device.<br>The Reflux Band brand was added and the word "patient" was<br>changed to "people" and "user" to reflect the proposed over the<br>counter (OTC) application. |
| | The components for the Reza Band and the Reflux Band are identical<br>except for the added electronics in the SmartCushion of the Reflux<br>Band. The method of applying external pressure at the cricoid, device<br>application, use life, shelf life, user population, biocompatibility,<br>mechanical strength, materials and standards compliance are identical<br>or substantially equivalent. |
| Non-Clinical<br>Performance Data: | Non-Clinical performance data to support substantial equivalence<br>included:<br>• Testing to IEC 60601-1<br>• Testing to IEC 60601-1-2<br>• Software Verification and Validation<br>• Bench Testing for Manometer Accuracy<br>• Shelf Life Testing |
| Clinical<br>Performance Data: | Clinical performance testing to support substantial equivalence<br>included:<br>• Usability testing<br>• Comprehension testing of a tool commonly used for the<br>population with LPR symptoms is the Reflux Symptom<br>Index (RSI). |
| Conclusion of<br>Clinical and Non-<br>Clinical Data: | Based on the results of Clinical and Non-Clinical data, the Reflux Band<br>and Reza Band devices are substantially equivalent to the predicate<br>(DEN130046), and can be used safely and effectively as OTC<br>devices. |

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