(203 days)
The Sanuthera's Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms.
The target population is primarily the adult population over 18 years of age.
Sanuthera's Serenity is a device utilizing sound therapy as a means to mitigate the symptoms associated with tinnitus. The Serenity device works as a plug-in device to the uDirect2 bridge device, manufactured by a hearing- aid company Unitron and can be customized to a patient's tinnitus profile and then adjusted to his/her preference to play a number of sounds aimed at obscuring the ringing in the patient's ear and/or re-train patients to avoid focusing on the ringing, essentially “habituating” them away from the disease.
The process of providing tinnitus therapy occur a number of ways although the most popular are Tinnitus Retraining Therapy (TRT) and Tinnitus Masking (TM). In either case, the patient is provided with the Serenity device which is custom programmed. The patient is then taken through a process of multiple protocols to set filter and volume parameters via an onboard processing unit and an onboard digital band pass filter to slowly assist in the habituation to the tinnitus.
Associated Accessories:
• The Software that is utilized by an audiologist to customize, per patient's preference during the device fitting process, the sounds aimed at obscuring the ringing in the patient's ear and/or re-train patients to avoid focusing on the ringing.
• The Unitron's commercially available neck-worn uDirect2 bridge device with Unitron's Moxi Kiss Behind-the-Ear family hearing aids (K130494).
• The battery charger to simultaneously charge in parallel the batteries of the Serenity and the uDirect2 bridge device.
The provided text is a 510(k) premarket notification for a Tinnitus Masker device (Serenity). This type of document is submitted to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.
Crucially, a 510(k) submission for a Class II device like a Tinnitus Masker, especially one cleared through substantial equivalence to a previously marketed device, often relies on demonstrating technological equivalence and safety and effectiveness through non-clinical performance data and comparison to the predicate, rather than new, extensive clinical studies with specific statistical acceptance criteria for a novel AI algorithm.
The document states:
- "The Serenity Tinnitus Masking Device did not conduct any performance testing on animals."
- "The Serenity Tinnitus Masking Device did not conduct any clinical testing."
It mentions "Software Verification and Validation Testing" but does not provide specific performance metrics, acceptance criteria, or a study design for a clinical performance study as would be typical for an AI-powered diagnostic device. The "performance data" section primarily discusses biocompatibility and software validation in general terms.
Therefore, many of the typical questions for AI acceptance criteria and studies (like sample size, number of experts, adjudication, MRMC studies, effect size, training set details) are not applicable to this specific 510(k) submission, as it does not rely on a clinical study demonstrating AI performance against a ground truth.
Based on the provided text, I cannot fill out the requested table and details because the device is a Tinnitus Masker, not an AI diagnostic device, and its 510(k) clearance is based on substantial equivalence to a predicate device, without new clinical performance studies.
However, I can extract the relevant information regarding the type of data presented and the basis for its clearance:
Summary of Acceptance Criteria and Study Information as Pertains to this 510(k) Submission (which is not an AI-driven device requiring clinical performance metrics):
Given that the device is a Tinnitus Masker – a sound therapy device – and not an AI diagnostic tool, the typical "acceptance criteria" for AI performance metrics (e.g., sensitivity, specificity, AUC) and associated studies (clinical trials comparing AI-assisted vs. unassisted performance) are not present in this document. The "proof" of the device meeting criteria relies on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and safety considerations.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance/Compliance |
|---|---|---|
| Safety - Biocompatibility | Device materials do not present significant patient contact for the main unit (worn over clothing). Ear-level devices (Unitron's Moxi Kiss BTE Family hearing aids) utilize materials evaluated per ISO 10993-1:2000/AC2010. | Serenity device (and neck-worn bridge) do not have significant patient contact and thus no biocompatibility concerns. Ear-level devices' biocompatible properties were evaluated via cytotoxicity, sensitization, and irritation tests according to ISO 10993-1. |
| Safety - Sound Output | Max output limited to 85 dBA SPL, corresponding to 8 hours daily use, per OSHA regulations to prevent permanent hearing damage. Device should never be used at uncomfortable levels. | The device's volume can be set to a level that could lead to permanent hearing damage if used for prolonged periods (consistent with OSHA warnings). Hearing healthcare professionals are expected to advise on maximum daily use time. This is a warning rather than a performance metric, indicating awareness of potential risk and instructional mitigation. |
| Software Verification & Validation | Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "minor" level of concern. | Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance. (No specific performance metrics for the software's sound generation). |
| Technological Equivalence (to Predicate) | Underlying principle of sound enrichment to defocus attention from tinnitus; offers sound/noise filtering, volume control, maximum output volume, maximum output frequency (10,000 Hz). Usage of complex (non-noise) sounds is consistent with scientific principles. Adjustments provide customized amplification based on hearing loss for each ear. | Device operates on the same core principles and possesses the same fundamental technological elements (sound/noise filtering, volume control, max output volume/frequency) as the predicate (Unitron Tinnitus Masker Feature, K130494). Differences in sound/noise source (complex sound vs. noise) deemed not to raise new safety/efficacy issues. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data is presented in this 510(k) submission for performance evaluation. The device clearance relies on demonstrating substantial equivalence to a predicate based on existing technological and safety profiles, and non-clinical testing (biocompatibility, software validation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No test set with ground truth established by experts is mentioned, as there were no clinical studies for performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set requiring expert adjudication is mentioned.
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:
- Not Applicable. This is not an AI diagnostic device, and no MRMC study was conducted or required for this type of 510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI diagnostic algorithm. The device's "standalone" function is to generate sound, which is then customized and used by a healthcare professional as part of a patient's management program.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As no clinical performance study was conducted, there was no ground truth established for performance evaluation. The "ground truth" for the device's function is its ability to produce sounds according to specifications, which is verified through software and hardware testing, not clinical outcomes data in this submission.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/machine learning model that requires a "training set" in the conventional sense. The "training" that occurs is the programming of the device by a healthcare professional according to a patient's individual needs.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2015
Sanuthera, Inc. Mr. Jeffery DiGiovanni President 340 West State Street, Unit 45 Athens, Ohio 45701
Re: K150014 Trade/Device Name: Serenity Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: June 22, 2015 Received: June 25, 2015
Dear Mr. DiGiovanni:
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.
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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indication for Use Summary
| 510(k) Number (if known): | K150014 |
|---|---|
| Device Name: | Serenity |
Indications For Use:
The Sanuthera's Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms.
The target population is primarily the adult population over 18 years of age.
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section 5: 510k) Summary
The Summary of Safety and Effectiveness information on the Sanuthers, Inc. Serenity is being submitted in accordance of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be execised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or forth.
SUBMITTER I.
| Applicant: | Sanuthera, Inc.340 West State StreetUnit 45Athens, Ohio 45701 |
|---|---|
| Telephone: | 740-591-1410 |
| Facsimile: | 928-396-9094 |
| Contact: | Jeffery DiGiovanni |
| Date Prepared: | December 29, 2014 |
II. DEVICE
| Name: | Serenity |
|---|---|
| Common Name: | Tinnitus Masking Device |
| Classification Name: | Tinnitus Masker, 21 CFR §874.3400 |
| Regulatory Class: | Class II |
| Product Code: | KLW |
III. PREDICATE DEVICE
| Predicate: | Unitron Tinnitus Masker Feature, K130494, with market clearance date ofMay 7, 2013 |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------- |
IV. DEVICE DESCRIPTION
| Description: | Sanuthera's Serenity is a device utilizing sound therapy as a means to mitigate the symptoms associated with tinnitus. The Serenity device works as a plug-in device to the uDirect2 bridge device, manufactured by a hearing- aid company Unitron and can be customized to a patient's tinnitus profile and then adjusted to his/her preference to play a number of sounds aimed at obscuring the ringing in the patient's ear and/or re-train patients to avoid focusing on the ringing, essentially “habituating” them away from the disease. |
|---|---|
| The process of providing tinnitus therapy occur a number of ways although the most popular are Tinnitus Retraining Therapy (TRT) and Tinnitus Masking (TM). In either case, the patient is provided with the Serenity device which is custom programmed. The patient is then taken through a process of multiple protocols to set filter and volume parameters via an onboard processing unit and an onboard digital band pass filter to slowly assist in the habituation to the tinnitus. |
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IV. DEVICE DESCRIPTION, continue
| Associated Accessories: | The following are part of the Serenity system: |
|---|---|
| • The Software that is utilized by an audiologist to customize, perpatient's preference during the device fitting process, the soundsaimed at obscuring the ringing in the patient's ear and/or re-train | |
| patients to avoid focusing on the ringing. | |
| The Unitron's commercially available neck-worn uDirect2 bridge●device with Unitron's Moxi Kiss Behind-the-Ear family hearing aids(K130494). | |
| • The battery charger to simultaneously charge in parallel the batteriesof the Serenity and the uDirect2 bridge device. |
v. INDICATION FOR USE
| Indication For Use: | The Sanuthera's Serenity device is indicated to provide a mean of soundenrichment therapy that is programmed by a hearing health care professionalfamiliar with diagnosis and management of tinnitus as part of a personalizedtinnitus management program to provide temporary relief from the tinnitussymptoms.The target population is primarily the adult population over 18 years of age. |
|---|---|
| --------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
VI. COMPARISION OF TECHNOLOGICAL CHARACTERISTIC WITH PREDICATE DEVICE
| Substantial EquivalencyInformation: | The underlying principle of sound enrichment is to provide supplementaryacoustic stimulation which can help defocus attention from tinnitus and avoidnegative reactions for both the subject and predicate device. The process ofproviding tinnitus therapy occur a number of ways although the most popularare Tinnitus Retraining Therapy (TRT) and Tinnitus Masking (TM). Thepatient is then taken through a process of multiple protocols to set filter andvolume parameters via an onboard processing unit and an onboard digitalband pass filter to slowly assist in the habituation to the tinnitus. The Serenityand predicate device are based on the following technological elements:• Sound / Noise Filtering: Allows the spectral manipulation of thesounds to a narrow band (frequency tuning) to occur at the time offitting.• Volume Control: Can be adjusted with volume control by end user,but limited by the hearing aid.• Maximum Output Volume: Limited by hearing aid's Maximum PowerOutput (MPO).• Maximum Output Frequency: 10,000 Hz |
|---|---|
| ----------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Substantial EquivalencyInformation: | The following technological differences exist between the Serenity and predicate device: |
|---|---|
| Sound / Noise source: The Serenity and predicate device generated broad band complex sound and noise, respectively, at all frequencies across the frequency response. The frequency response is limited by hearing output (~10kHz). The usage of complex (non-noise) sounds that has been built into each sound utilized within the Serenity is consistent with scientific principles of effective sound therapy and does not raise any new issues of safety or efficacy. Sound / Noise level and shape: The “hearing loss” may vary from ear to ear the adjustments made provide customized amplification of the audio stream received by each hearing aid (frequency- and input-dependent output levels) shall be independent and according hearing loss as established in the hearing-aid fitting activity. Serenity device is determined for both ears simultaneously the custom levels are set for each ear hearing aid even in the case of asymmetrical hearing loss. Noise level and shape determined for both ears simultaneously. |
VII. PERFORMACE DATA
| Biocompatibility: | The Sanuthera Serenity device works as a plug-in device to a commerciallyavailable neck-worn bridge device and transmits the audio sounds through theneck-worn device which wirelessly transmits the sounds to ear-level devices.The Serenity device or commercially available neck-worn bridge device doesnot have significant patient contact as the devices are typically worn over thepatient clothing. Therefore, the Serenity device does not present anybiocompatibility concerns.The ear-level devices specifically utilized with the Sanuthera Serenity devicesare the Unitron's Moxi Kiss Behind-The-Ear (BTE) Family hearing aids. Thehearing aids are intended to be worn on or in the ear on a daily basis with atypical duration of 8 – 12 hours continuously. The biocompatible propertiesof the materials utilized in the Unitron's Moxi Kiss BTE Family hearing aidswere evaluated for the duration and type of contact as specified in ISO 10993-1:2000/AC2010 – Biological Evaluation of Medical Devices. The battery oftesting include the following tests: |
|---|---|
| ------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Software Verificationand Validation Testing: | The software verification and validation testing were conducted anddocumentation was provided as recommended by FDA's Guidance forIndustry and Staff, "Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices." The software for the SerenityTinnitus Masking Device was considered as a "minor" level of concern, since afailure or latent flaw in the software could not directly result in a serious injuryor death to the patient or operator or lead to delay in delivery of appropriatemedical care that would likely lead to a minor injury. |
|---|---|
| Animal Studies: | The Serenity Tinnitus Masking Device did not conduct any performancetesting on animals. |
| Clinical Studies: | The Serenity Tinnitus Masking Device did not conduct any clinical testing. |
| Risk and Warning forSafe Use: | The Sanuthera's Serenity tinnitus masking device, being coupled to the uDirectwhich sends the sounds wirelessly to the hearing aids, is limited to the settingsin the hearing aid's Maximum Power Output. According to OSHAregulations, the volume of the Serenity's tinnitus masker can be set to a levelwhich could lead to permanent hearing damage when used for a prolongedperiod of time. Should the tinnitus masker be set to such a level in yourhearing aid, your hearing healthcare professional will advise you of themaximum amount of time per day you should use the tinnitus masker. Thetinnitus masker should never be used at uncomfortable levels.According to OSHA (Occupational Safety & Health Administration, U.S.Department of Labor) regulations, the maximum output of the tinnitus maskerfeature can be set to a level that can lead to permanent hearing loss. Themaximum limit is 85 dBA SPL which corresponds to 8 hours daily use. |
CONCLUSION VII.
| Conclusion: | Based upon similar indications of use and technology characteristics it isconcluded the Sanuthera's Serenity to be substantially equivalent to K130494,Unitron Tinnitus Masking feature. |
|---|---|
| ------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.