(108 days)
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.
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.
The provided text describes the Reza Band and Reflux Band, external upper esophageal sphincter (UES) compression devices, and their substantial equivalence to a predicate device for the reduction of laryngopharyngeal reflux (LPR) symptoms. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting detailed acceptance criteria and studies in the format requested.
Therefore, the available information is insufficient to fully complete the requested table and details regarding acceptance criteria and performance data as per your prompt. However, I can extract what is explicitly stated in the document.
Here's a summary of the available information and an explanation of what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in terms of numerical thresholds for outcomes. Instead, it mentions various tests performed and concludes substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Performance: | |
| Electrical Safety (IEC 60601-1 compliance) | Tested to IEC 60601-1 (Compliance implies meeting the safety standards) |
| Electromagnetic Compatibility (IEC 60601-1-2 compliance) | Tested to IEC 60601-1-2 (Compliance implies meeting the EMC standards) |
| Software Functionality (Software Verification and Validation) | Software Verification and Validation performed (Successful completion implies software functions as intended) |
| Manometer Accuracy (Bench Testing) | Bench Testing for Manometer Accuracy performed (Successful completion implies manometer provides accurate pressure readings) |
| Device Stability (Shelf Life Testing) | Shelf Life Testing performed (Successful completion implies device maintains its properties over its designated shelf life) |
| Clinical Performance: | |
| Usability for OTC use | Usability testing performed (Successful usability suggests users can properly operate the device without medical supervision) |
| User Comprehension of LPR symptoms (Reflux Symptom Index - RSI) | Comprehension testing of a tool commonly used for the population with LPR symptoms is the Reflux Symptom Index (RSI) (Successful comprehension suggests users can understand and report their symptoms using the common tool, supporting proper self-assessment and device usage in an OTC setting, and presumably demonstrating the device's ability to reduce symptoms as measured by this index). The document mentions "comprehension testing of a tool" which implies testing if users can understand symptoms measurement, not necessarily a direct measure of device effectiveness via RSI reduction in a clinical trial. However, the overall conclusion of "substantial equivalence" and "can be used safely and effectively as OTC devices" suggests that the clinical tests supported the device's ability to reduce LPR symptoms. |
Missing Information:
The document does not provide specific numerical acceptance criteria (e.g., "RSI score reduction by X points" or "accuracy of manometer within +/- Y mmHg"). The "Reported Device Performance" column above is based on the implication of successfully performing the tests mentioned, rather than specific quantitative results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated for either usability testing or comprehension testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. For non-clinical tests like electrical safety or bench testing, "ground truth" is typically established by engineering standards and measurement equipment. For clinical/usability tests, the "experts" or evaluators are not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This type of study is not relevant to the device described (an external UES compression device) which is not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable to the device described as it is a physical, user-operated device, not a standalone algorithm. The "software" mentioned for the Reflux Band (an app) supports device fitting, not a standalone diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For non-clinical tests (IEC standards, bench testing, shelf life): Ground truth is typically derived from established engineering and safety standards, validated measurement equipment, and defined material properties.
- For usability and comprehension testing: Ground truth would likely be based on expert observation of user interaction, user feedback, and pre-defined criteria for successful task completion or correct understanding. The mention of the Reflux Symptom Index (RSI) suggests that symptom reduction, as reported by patients using this validated tool, would be a key outcome for efficacy (though the text only mentions comprehension of the tool, not direct efficacy results). However, specific details on how "ground truth" for efficacy was established for substantial equivalence are not provided in this summary.
8. The sample size for the training set:
This device is not an AI/machine learning model that typically relies on a "training set" in the computational sense. Therefore, this concept is not applicable to the information provided.
9. How the ground truth for the training set was established:
As mentioned above, the concept of a "training set" with associated ground truth is not applicable to this physical device submission.
Conclusion based on provided text:
The provided document is a 510(k) summary focused on demonstrating "substantial equivalence" of the Reza Band and Reflux Band to a predicate device (Reza Band, DEN130046). It lists various non-clinical and clinical tests performed, but it does not provide the detailed quantitative acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or adjudication methods that would typically be found in a comprehensive study report. The intent of a 510(k) summary is to summarize findings that support a claim of substantial equivalence for regulatory purposes, rather than being a full scientific publication of detailed study results.
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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 (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, LLCW175 N11081 Stonewood DriveGermantown, WI 53022Phone: (262) 345-5553Fax: (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 olderto reduce the symptoms of laryngopharyngeal reflux (LPR) disease byreducing the regurgitation of stomach contents from passing throughthe upper esophageal sphincter. The devices are worn by the userwhile sleeping. |
| Comparison toPredicate Device: | The intended use is substantially equivalent to the predicate device.The Reflux Band brand was added and the word "patient" waschanged to "people" and "user" to reflect the proposed over thecounter (OTC) application. |
| The components for the Reza Band and the Reflux Band are identicalexcept for the added electronics in the SmartCushion of the RefluxBand. The method of applying external pressure at the cricoid, deviceapplication, use life, shelf life, user population, biocompatibility,mechanical strength, materials and standards compliance are identicalor substantially equivalent. | |
| Non-ClinicalPerformance Data: | Non-Clinical performance data to support substantial equivalenceincluded:• Testing to IEC 60601-1• Testing to IEC 60601-1-2• Software Verification and Validation• Bench Testing for Manometer Accuracy• Shelf Life Testing |
| ClinicalPerformance Data: | Clinical performance testing to support substantial equivalenceincluded:• Usability testing• Comprehension testing of a tool commonly used for thepopulation with LPR symptoms is the Reflux SymptomIndex (RSI). |
| Conclusion ofClinical and Non-Clinical Data: | Based on the results of Clinical and Non-Clinical data, the Reflux Bandand Reza Band devices are substantially equivalent to the predicate(DEN130046), and can be used safely and effectively as OTCdevices. |
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§ 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.