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.
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.
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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, LLC<br>W175 N11081 Stonewood Drive<br>Germantown, WI 53022<br>Phone: (262) 345-5553<br>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.<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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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
