(108 days)
No
The document describes a mechanical device that applies external pressure and an associated app for fitting, but there is no mention of AI or ML being used for diagnosis, treatment, or device operation.
Yes
The device is intended to "reduce the symptoms of laryngopharyngeal reflux (LPR) disease" by applying pressure to the upper esophageal sphincter, which falls under the definition of a therapeutic purpose (treatment or alleviation of a disease or its symptoms).
No
The device is described as a treatment for LPR symptoms by reducing the regurgitation of stomach contents, not for diagnosing the condition.
No
The device description explicitly mentions hardware components like a cushion, comfort band, frame, comfort dial, clasp, and electronics incorporated into a "SmartCushion" for the Reflux Band, and accessories like an External Manometer and Pressure Sensor for the Reza Band. While an app is used for fitting the Reflux Band, the core function and components are physical.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Reza Band and Reflux Band are external, non-invasive devices worn around the neck. Their function is to apply external pressure to the cricoid cartilage region to reduce the regurgitation of stomach contents.
- Lack of Sample Analysis: The device does not analyze any biological samples from the user. It operates purely through mechanical pressure application.
Therefore, the description clearly indicates a physical, external medical device for symptom management, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / 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.
Product codes
PKA
Device Description
The Reza Band and Reflux Band are proposed for over the counter (OTC) use. 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. 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. 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. The components of the Reflux Band and Reflux Band are identical of a Cushion, Comfort Band, Frame, Comfort Dial and Clasp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper Esophageal Sphincter (UES)
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
User while sleeping / Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical performance data to support substantial equivalence included:
- Testing to IEC 60601-1
- Testing to IEC 60601-1-2
- Software Verification and Validation
- Bench Testing for Manometer Accuracy
- Shelf Life Testing
Clinical performance testing to support substantial equivalence included:
- Usability testing
- Comprehension testing of a tool commonly used for the population with LPR symptoms is the Reflux Symptom Index (RSI).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
W175 N11081 Stonewood Drive
Germantown, WI 53022
Phone: (262) 345-5553
Fax: (262) 345-5618 |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
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.
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.
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.
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
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. |
| Comparison to
Predicate Device: | The intended use is substantially equivalent to the predicate device.
The Reflux Band brand was added and the word "patient" was
changed to "people" and "user" to reflect the proposed over the
counter (OTC) application. |
| | The components for the Reza Band and the Reflux Band are identical
except for the added electronics in the SmartCushion of the Reflux
Band. The method of applying external pressure at the cricoid, device
application, use life, shelf life, user population, biocompatibility,
mechanical strength, materials and standards compliance are identical
or substantially equivalent. |
| Non-Clinical
Performance Data: | Non-Clinical performance data to support substantial equivalence
included:
• Testing to IEC 60601-1
• Testing to IEC 60601-1-2
• Software Verification and Validation
• Bench Testing for Manometer Accuracy
• Shelf Life Testing |
| Clinical
Performance Data: | Clinical performance testing to support substantial equivalence
included:
• Usability testing
• Comprehension testing of a tool commonly used for the
population with LPR symptoms is the Reflux Symptom
Index (RSI). |
| Conclusion of
Clinical and Non-
Clinical Data: | Based on the results of Clinical and Non-Clinical data, the Reflux Band
and Reza Band devices are substantially equivalent to the predicate
(DEN130046), and can be used safely and effectively as OTC
devices. |
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