(269 days)
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 12 and older.
Sonu is a non-invasive, over the counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu uses acoustic resonance therapy to achieve its therapeutic effect. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers (hardware), a USB-C Charging Cable (hardware), and a smartphone application (Sonu iOS App) (software) that connects to the Sonu Band. Sonu is indicated for individuals, aged 12 years old and above.
The provided text is related to an FDA 510(k) clearance for the Sonu device, which is an external mechanical stimulator for the relief of nasal congestion. The clearance is specifically for expanding the indications for use to include the pediatric population aged 12-21 years old.
However, the document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., "device must achieve X accuracy"). Instead, it presents clinical study results and concludes that the device is substantially equivalent to its predicate. The "reported device performance" in this context refers to the outcomes of the clinical study, which are used to support this substantial equivalence.
Here's the information extracted and structured based on your request, with an emphasis on what's explicitly stated and what is inferred from the available text:
Acceptance Criteria and Device Performance
Since explicit, quantitative acceptance criteria are not provided in the document, the "acceptance criteria" are inferred from the demonstrated clinical improvement needed to support substantial equivalence for the expanded pediatric population. The device's performance is reported as the statistically significant improvement in the Total Nasal Symptom Score (TNSS) and its nasal congestion sub-score.
| Acceptance Criteria (Inferred from Study Success) | Reported Device Performance |
|---|---|
| Statistical evidence of improvement in nasal congestion for pediatric patients (12-21 years old). | Mean change in Total Nasal Symptom Score (TNSS): -2.42 for 12 to <16 year old group -3.03 for 16 to <22 year old group -2.74 overall for both groups |
| Mean change in nasal congestion sub-score: -0.70 for 12 to <16 year old group -0.81 for 16 to <22 year old group -0.76 overall for both groups | |
| No adverse events reported. | No adverse events were reported in both groups. |
Additional Study Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: 31 subjects (15 for 12 to <16 years old, 16 for 16 to <22 years old).
- Data Provenance: Not explicitly stated, but the study was described as an "interventional study," suggesting prospective data collection. The country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study uses patient-reported scores (TNSS and nasal congestion sub-score) as outcome measures, which are subjective assessments by the subjects themselves rather than an expert-established "ground truth" in the traditional sense (like expert review of imaging).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the study did not involve expert adjudication for establishing a ground truth.
-
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study design is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images) and comparing performance with and without AI assistance. The Sonu device is a therapeutic device, and the clinical study focuses on treatment effectiveness.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Sonu device itself is the standalone therapeutic device; its performance is measured by its direct effect on patient symptoms. The study evaluates the device's therapeutic effect directly in subjects. While there is a "Sonu iOS App" (software), its function is to control the device, and the effectiveness is tied to the complete system, not just the software in isolation in a diagnostic context. Therefore, a "standalone" algorithm-only performance study in the typical diagnostic AI sense was not performed or relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or primary outcome measures) used for the clinical study consisted of patient-reported outcomes data, specifically the Total Nasal Symptom Score (TNSS) and its nasal congestion sub-score. These are subjective measures of symptom severity reported by the subjects themselves.
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The sample size for the training set:
- This information is not applicable and not provided. The clinical study described is an interventional study to assess the device's therapeutic effect, not a study to train a machine learning algorithm. The software component (Sonu iOS App) indicates "software development and testing was executed in compliance with IEC 62304," but this refers to software validation, not algorithm training data.
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How the ground truth for the training set was established:
- This information is not applicable as there was no explicit "training set" for a machine learning algorithm described in the clinical study.
FDA 510(k) Clearance Letter - Sonu Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 24, 2025
Sound Health Systems, Inc.
℅ Pierre Bounaud
Principal Consultant
Rqm+
2251 San Diego Avenue
Suite B-257
San Diego, California 92110
Re: K242214
Trade/Device Name: Sonu
Regulation Number: 21 CFR 874.6010
Regulation Name: External Mechanical Stimulator For The Relief Of Congestion
Regulatory Class: Class II
Product Code: QZC
Dated: March 25, 2025
Received: March 25, 2025
Dear Pierre Bounaud:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Page 2
K242214 - Pierre Bounaud
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K242214 - Pierre Bounaud
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D.
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242214
Device Name
Sonu
Indications for Use (Describe)
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 12 and older.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
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Page 5
Sonu 510(k) SUMMARY
DATE PREPARED
April 24, 2025
MANUFACTURER AND 510(k) OWNER
Sound Health Systems, Inc.
650B Fremont Avenue #363
Los Altos, CA 94024, USA
Official Contact: Dr. Parameswaran Gopi, CEO
REPRESENTATIVE/CONSULTANT
Pierre Bounaud, Ph.D.
Allison Komiyama, Ph.D., RAC
RQM+
Email: pbounaud@rqmplus.com, akomiyama@rqmplus.com
DEVICE INFORMATION
Proprietary Name/Trade Name: Sonu
Common Name: External mechanical stimulator for the relief of congestion
Regulation Number: 21 CFR 874.6010
Class: II
Product Code: QZC
Premarket Review: Division of Dental and ENT Devices (DHT1B)
Review Panel: Ear Nose & Throat
PREDICATE DEVICE IDENTIFICATION
The Sonu is substantially equivalent to the following predicate:
| De Novo Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| DEN230045 | Sonu / Sound Health Systems, Inc. | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
Sonu is a non-invasive, over the counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu uses acoustic resonance therapy to achieve its therapeutic effect. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers (hardware), a USB-C Charging Cable (hardware), and a smartphone application (Sonu iOS App) (software) that connects to the Sonu Band. Sonu is indicated for individuals, aged 12 years old and above.
The purpose of this premarket submission is to expand the indications for use to the pediatric population, aged 12-21 years old.
Page 6
INDICATIONS FOR USE
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 12 and older.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Sound Health Systems, Inc. believes that the Sonu is substantially equivalent to the predicate device based on the information summarized here:
The subject device has the same intended use as the primary predicate, i.e., an external mechanical stimulator for the relief of congestion in home settings. The subject device is the same device as the primary predicate, i.e., it has the same design, dimensions, materials, and technological characteristics.
The main difference is the intended patient population. While the primary predicate is intended for adults only, the subject device now also includes pediatric population, 12 to 21 years old. We believe that this difference does not raise new/different questions of safety or effectiveness compared to the predicate device, as supported by clinical data.
SUMMARY OF NON-CLINICAL TESTING
The Sonu iOS App was updated for the added intended population. Software development and testing was executed in compliance with IEC 62304, FDA's software guidance Content of Premarket Submissions for Device Software Functions, and FDA's cybersecurity guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Usability testing was also conducted to assess OTC use in the new intended population per FDA's guidance Applying Human Factors and Usability Engineering to Medical Devices.
SUMMARY OF CLINICAL TESTING
To demonstrate the substantial equivalence of the Sonu for the treatment of pediatric patients with moderate to severe nasal congestion due to allergic and non-allergic rhinitis, a single-arm, non-randomized, interventional study of 31 subjects suffering from nasal congestion for ≥1 month was conducted in two groups - 12 to <16 years of age (N=15) and 16 to <22 years of age (N=16). Results showed the mean change in Total Nasal Symptom Score (TNSS) was -2.42 for the 12 to <16 year old group and -3.03 for the 16- to < 22 year old group; overall change for both groups was -2.74. Results also showed the mean change in nasal congestion sub-score was -0.70 in the 12 to <16 year old group and -0.81 in the 16 to < 22 year old group; overall change for both groups was -0.76. No adverse events were reported in both groups.
CONCLUSION
Based on the clinical data and software testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The expanded indications for use and the same technological characteristics for the proposed Sonu are assessed to be substantially equivalent to the predicate device.
N/A