(110 days)
The SoundCure™ Serenade™ Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
The Serenade System is a personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus. The Serenade System is intended to provide relief from the debilitating effects of tinnitus through the use of a hand-held customized digital audio device (Serenade Patient Device) that generates sound therapy/masking. The Serenade System uses modulated tinnitus pitch matched tones (S-Tones) and narrow-band noise centered at the tinnitus frequency and provides broad-band noise. The Serenade System consists of the following components: Serenade Treatment Software, Earphones, Serenade Patient Device as well as the following Accessories: power supply, power cord and USB cable (provided separately).
Here's an analysis of the provided text regarding the SoundCure Serenade Tinnitus Treatment System's acceptance criteria and studies:
Summary of Acceptance Criteria and Study Details for the SoundCure Serenade Tinnitus Treatment System
Based on the provided 510(k) summary, the SoundCure Serenade Tinnitus Treatment System's acceptance criteria and supporting studies are primarily focused on demonstrating substantial equivalence to a predicate device and meeting established design specifications through non-clinical (bench) testing. There is no mention of clinical studies involving human participants to establish efficacy or direct performance metrics against specific acceptance criteria for a clinical outcome.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) relies heavily on substantial equivalence and non-clinical testing, the "acceptance criteria" are implied to be conformance with established engineering and safety standards, as well as demonstrating comparable technical characteristics to the predicate. Direct performance metrics for clinical efficacy are not reported in this document.
| Acceptance Criteria Category | Specific Criteria (Implied from testing) | Reported Device Performance |
|---|---|---|
| System Output Performance | Meeting established acoustic output specifications (e.g., max SPL, frequency response). | Met established specifications. |
| Environmental Durability | Maintaining function under specified operational and storage temperature/humidity. | Met established specifications. |
| Electrical Safety | Compliance with electrical safety standards (e.g., IEC60601-1). | Complied with applicable IEC60601-1 testing. |
| Electromagnetic Compatibility (EMC) | Compliance with EMC standards. | Passed EMC testing (implied by "Electrical Safety & Electromagnetic Compatibility"). |
| Hardware Functionality | Hardware performing as designed. | Verified as performing as designed. |
| Software Functionality | Software operating without errors and meeting design requirements. | Verified and validated as performing as designed. |
| Packaging Integrity | Packaging protecting the device during transport and storage. | Validated as suitable for intended purpose. |
| Battery Life | Meeting specified battery useful life. | Met established specifications. |
| Substantial Equivalence | Demonstrating similar indications for use, technological characteristics, and safety/effectiveness profile to predicate. | Determined by FDA to be substantially equivalent to the predicate device (GN Resound A/S Tinnitus Sound Generator Module K073636). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical test set for performance. The "test set" here refers to the actual device units subjected to non-clinical bench testing. The specific number of units tested for each "in-vitro bench study" (e.g., System Output, Environmental, etc.) is not explicitly stated in this summary.
- Data Provenance: The data is from in-vitro bench studies conducted by SoundCure, Inc. within the USA. It is retrospective in the sense that it evaluates manufactured devices against pre-defined specifications. There is no mention of data from human subjects or any country of origin for such data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the non-clinical test set was established by engineering specifications and industry standards, not by human experts adjudicating clinical outcomes or images. The "experts" would be the engineers and quality assurance personnel performing the tests and comparing results against established specifications.
4. Adjudication Method for the Test Set
Not applicable. This was engineering validation against objective specifications, not a subjective clinical assessment requiring adjudication among human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention any MRMC comparative effectiveness study or any other clinical study involving human readers or assessment of human improvement with or without AI assistance. The device is a "Tinnitus Masker" which generates sound, not an AI diagnostic tool that human readers would use in conjunction with.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone performance" typically applies to AI algorithms generating a diagnostic or predictive output. This device is a sound therapy system. Therefore, a "standalone" performance study in the AI sense is not relevant. The device's standalone performance was assessed through its non-clinical bench testing (e.g., sound output, safety, durability) to ensure it performs according to its design specifications.
7. The Type of Ground Truth Used
The "ground truth" for the testing performed was engineering specifications, industry standards (e.g., IEC60601-1 for safety), and design requirements. The device's components and overall system were tested to confirm they met these predefined technical and safety benchmarks. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this 510(k) submission.
8. The Sample Size for the Training Set
Not applicable. This device is a sound therapy system, not an AI or machine learning algorithm in the typical sense that would require a "training set" of data to learn from. The device generates customized sounds based on a patient's individual tinnitus frequency match which is determined by a healthcare professional, not by an algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm mentioned for this device.
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SoundCure, Inc.
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Name, Address, Phone and Fax Number of Applicant A.
SoundCure, Inc. 560 S. Winchester Blvd Suite 500 San Jose, CA 95128 Phone: (408) 938-5745 Fax: (408) 938-5746
B. Contact Person
Nancy Lincé, RAC Clinical and Regulatory Affairs Consultant (650) 759-6186 nlince@linceconsulting.com
Altemate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net
- C. Date Prepared
May 5, 2011
D. Device Name
| Trade Name: | SoundCure™ Serenade™ Tinnitus Treatment System |
|---|---|
| Common Name: | Tinnitus Masker |
| Classification Name: | Tinnitus Masker (21 CFR §874.3400, Product Code KLW) |
E. Predicate Devices
The SoundCure™ Serenade™ Tinnitus Treatment System is substantially equivalent to the GN Resound A/S Tinnitus Sound Generator Module cleared under K073636.
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F. Device Description
The Serenade System is a personalized sound therapy system designed specifically to evaluate a patient's tinnitus, to create customized audio stimulus, and to deliver and monitor/data log the audio stimulus. The Serenade System is intended to provide relief from the debilitating effects of tinnitus through the use of a hand-held customized digital audio device (Serenade Patient Device) that generates sound therapy/masking. The Serenade System uses modulated tinnitus pitch matched tones (S-Tones) and narrow-band noise centered at the tinnitus frequency and provides broad-band noise. The Serenade System consists of the following components: Serenade Treatment Software, Earphones, Serenade Patient Device as well as the following Accessories: power supply, power cord and USB cable (provided separately).
Indications For Use G.
The SoundCure Serenade Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).
This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
Technological Comparison H.
The Serenade System has similar features as compared to the predicate devices in the table below.
| Manufacturer | GN Resound A/S | SoundCure, Inc. | |
|---|---|---|---|
| Device Name | TSG Module | SoundCure™ Serenade™Tinnitus Treatment System | |
| 510(k) Number | K073636 | K111293 | |
| Indications for Use | The Tinnitus Sound GeneratorModule is a tool to generatesounds to be used in a tinnitusmanagement program torelieve patients suffering fromtinnitus. The target populationis primarily the adult populationover 18 years of age. Thisproduct may also be used withchildren 5 years of age orolder. | The SoundCure™Serenade™ TinnitusTreatment System is indicatedfor use in the temporary reliefof tinnitus symptoms. Thedevice is a tool to generatecustomized sounds to relievepatients suffering from tinnitusand can be used in a tinnitusmanagement program. Thetarget population is adults (18years or older). | |
| ManufacturerDevice Name | GN Resound A/STSG Module | SoundCure, Inc.SoundCure™ Serenade™Tinnitus Treatment System | |
| 510(k) Number | K073636 | K111293 | |
| The Tinnitus Sound Generatormodule is targeted forhealthcare professionals,which are treating patientssuffering from tinnitus, as wellas conventional hearingdisorders. The fitting of theTinnitus Sound generatormodule must be done byhearing professionalparticipating in a tinnitusmanagement program. | This is a medical device andshould only be used with theadvice of a physician,audiologist or other hearinghealthcare professional. | ||
| Mechanism ofAction | Uses noise that can beconfigured from broad band tonarrow band customized to thepatient. | Uses noise that can beconfigured from broad band tonarrow band, and pure tonescustomized to the patient | |
| Stimulus can be amplitudemodulated | Stimulus can be amplitudemodulated | ||
| Level of sound can be adjustedby a user volume control | Level of sound can beadjusted by a user volumecontrol | ||
| Independent volumeparameters per ear (inherentto ear specific device) | Independent volumeparameters per ear | ||
| Stimulus designed to beplaced in the background andignored | Stimulus designed to beplaced in the background andignored | ||
| Maximum OutputCharacteristics | Maximum output fixed at93dB SPLOutput Frequency Response:Cutoffs at 500-6000 Hz | Maximum output fixed at92dB SPLOutput FrequencyResponse: 1 kHz to 14 kHz | |
| Target Anatomy | Ear | Ear | |
| Design Features | Tinnitus Sound Generator withfrequency shapingEnvironmental Steering™ | Patient Device SoundGenerator with frequencyshaped soundsSleep Mode Timer (60 mintimer to shut-off when buttonis pressed) | |
| Amplitude modulation | Amplitude modulation | ||
| Manufacturer | GN Resound A/S | SoundCure, Inc. | |
| Device Name | TSG Module | SoundCure™ Serenade™Tinnitus Treatment System | |
| 510(k) Number | K073636 | K111293 | |
| Sounds customized to thepatient | Sounds customized to thepatient | ||
| Behind the Ear | Handheld device withearphones | ||
| 4 sound programs/tracks | 4 sound programs / tracks(memory for up to 8) | ||
| Data logging of patient use | Data logging of patient use | ||
| Independent volume controlper ear (inherent withindividual devices per ear) | Individual volume control perear | ||
| Patient ContactMaterials | Silicone domes in openconfiguration | Silicone earphones | |
| Power | Battery, Hearing Aid BatterySize 13 | Rechargeable Lithium-Ion (Li-Ion) Battery | |
| Serenade System also | |||
| includes an external power | |||
| supply (100-250VAC to 5V | |||
| DC) with power cord for | |||
| recharging | |||
| Meets ApplicableIEC60601-1 testing | Yes | Yes |
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Traditional 510(k) SoundCure™ Serenade™ Tinnitus Treatment System
SoundCure, Inc.
The subject Serenade Patient Device and predicate device are both battery-powered devices worn in the patient's ear. The Serenade Patient Device is equipped with a power supply to recharge the battery and replacement batteries are used with the predicate device. The subject Serenade Patient Device is a hand-held device with earphones while the predicate device is a behind the ear hearing aid style device. Both the subject and predicate device produce individually customizable sounds designed to provide relief to patients suffering from tinnitus. Both the subject and predicate device use software driven applications to allow the healthcare professional to perform the hearing evaluations and to program the devices to produce the customizable sounds.
The technological characteristics and principals of operation of the Serenade System are substantially equivalent to the named predicate device.
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l. Summary of Non-Clinical Data
The Serenade System performance characteristics were evaluated in the following in-vitro bench studies:
- · System Output Performance Testing
- · Operational and Storage Temperature and Humidity Testing
- Electrical Safety & Electromagnetic Compatibility Packaging Testing
- Hardware Verification
- · Software Verification and Validation
- · Packaging Validation Testing · Battery Useful Life
Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the Serenade System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the Serenade System is substantially equivalent to the named predicate.
J. Summary of Data
The Serenade System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, nonclinical testing was conducted to validate the performance of the device and ensure the Serenade System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the Serenade System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, depicted in a minimalist, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
SoundCure, Inc. c/o Ms. Nancy Lince Clinical and Regulatory Affairs Consultant 560 S. Winchester Blvd. Suite 500 San Jose, CA 95128
AUG 2 4 2011
Re: K111293
Trade/Device Name: Serenade Tinnitus Treatment System Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: July 13, 2011 Received: July 14, 2011
Dear Ms. Lince:
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.
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 acon). Existing major regulations affecting your device can be may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may found in the Oous of incements 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 that I Dri has Intact a and regulations administered by other Federal agencies. You must or any I edelul statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Fall 607); abonnig (21 CFR 803); good manufacturing practice requirements as set de nece relation adverse orients (2) CFR Part 820); and if applicable, the electronic forth in the quality by seller (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 11 you desire specific advice to: your conters offices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Concertor Devices and "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 r ou may oouall only generers, International and Consumer Assistance 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,
E. Feldman, M.D.
Malvina B. Eydelman, Mr Director Division of Opthalmic, Neurological, Ears, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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SoundCure, Inc.
Indications for Use Statement
510(k) Number (if known): K_111293
SoundCure™ Serenade™ Tinnitus Treatment System Device Name:
Indications for Use:
The SoundCure™ Serenade™ Tinnitus Treatment System is indicated for use in the temporary relief of tinnitus symptoms. The device is a tool to generate customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older).
This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
Prescription Use X OR
Over-The-Counter Use
(per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kim Mathews
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K111293
Appendix J, Page 1 of 1
§ 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.