The TinniLogic Mobile Tinnitus Management Device is indicated for use in the temporary relief of tinnitus symptoms. The device is a player to play customized sounds and display professional counseling or education 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.

Device Description

The TinniLogic Mobile Tinnitus Management Device is a sound player which is designed to assist the qualified healthcare professional in delivering customized sound therapies and professional counseling or education to the patient for treatment. The TinniLogic Mobile Tinnitus Management Device provides idiopathic tinnitus sound treatment based upon sound stimulation during sleeping or waking hours. The TinniLogic Mobile Tinnitus Management Device uses amplitude modulated (SAM) tinnitus pitch matched sounds, narrow-band noise centered at the tinnitus frequency. broad-band noise, pure tone, white noise, natural sounds, and combination of these sounds. The subject device consists of a tablet, a specialized headset, a charger and a charger cable.

AI/ML Overview

The provided text is a 510(k) Summary for the "TinniLogic Mobile Tinnitus Management Device." This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria based on a clinical study for a novel device.

The document explicitly states: "No clinical study is included in this submission."

Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria from the provided text in the way you've requested. The "device performance" reported here is strictly in the context of non-clinical safety/electrical tests and comparison of technical specifications to predicate devices.

However, I can extract information related to the device's technical specifications and how its performance was assessed in a non-clinical context, which serves a similar purpose in a 510(k) submission (demonstrating equivalence rather than novel efficacy).

Here's the information that can be extracted, framed within the limitations of the provided document:

Acceptance Criteria and Device Performance (Based on 510(k) Equivalence)

The TinniLogic Mobile Tinnitus Management Device (K163094) did not undergo a clinical study to establish novel acceptance criteria. Instead, its acceptance for market clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing and comparison of technical characteristics. The "performance" in this context refers to its technical specifications matching or being similar to those of the predicate devices, and its compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.

1. Table of Acceptance Criteria (from predicate comparison) and Reported Device Performance

Parameter	Acceptance Criteria (based on predicate device range/standards)	Reported Device Performance (TinniLogic)
Regulatory Information
Product Code	KLW (matching predicates)	KLW
Regulation Number	21 CFR 874.3400 (matching predicates)	21 CFR 874.3400
Technical Characteristics
Maximum Sound Loudness Output	85 dB SPL - 92 dB SPL (range of predicates)	90 dB SPL
Sound Output Frequency	100Hz-16KHz (Predicate 1) to 1KHz-14KHz (Predicate 2)	50Hz~15KHz
Electrical Safety Standard	IEC 60601-1 (matching predicates)	IEC 60601-1
EMC Standard	IEC 60601-1-2 (matching predicates)	IEC 60601-1-2
Other Output Performance	Device calibration and maximum output remain valid in various settings of three possible volume controls (demonstrated by testing)	Confirmed through output performance testing

Note: The "acceptance criteria" in this table are inferred from the demonstrated substantial equivalence to the predicate devices. The device's technical specifications fall within the range or align with the standards met by the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set: Not applicable. No clinical test set or patient data was used for evaluating performance as no clinical study was conducted.
Data Provenance: Not applicable for clinical data. Non-clinical test data would be from laboratory testing conducted presumably at the manufacturer's facilities in China (Jiangsu BetterLife Medical Co., Ltd.).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No clinical ground truth was established, as no clinical study was conducted.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a sound player for tinnitus management; it does not involve an algorithm requiring standalone performance evaluation in the context of diagnostic AI. Its performance is related to its sound output characteristics and electrical safety.

7. The Type of Ground Truth Used

Not applicable for clinical ground truth. For non-clinical testing (electrical safety, EMC, output performance), the "ground truth" would be the applicable international standards (IEC 60601-1, IEC 60601-1-2) and the technical specifications of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a sound player and does not use machine learning in a way that would require a "training set" in the context of AI/algorithms generating medical insights.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set was used.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 17, 2017

Jiangsu Betterlife Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K163094

Trade/Device Name: TinniLogic Mobile Tinnitus Management Device Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: April 14, 2017 Received: April 17, 2017

Dear Diana Hong:

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 of medical devicerelated 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 2017.05.17 13:21:17 -04'00'

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)

Device Name

Mobile Tinnitus Management Device

Models:BTG-A5/ BTG-A6/ BTG-B5/ BTG-B6/ BTG-C5/ BTG-C6

Indications for Use (Describe)

The TimiLogic Mobile Timitus Management Device is indicated for use in the temporary relice of timitus symptoms. The device is a plaver to play customized sounds and display professional counseling or education 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.

Type of Use (Select one or both, as applicable)

	Form Designed to Meet ATBCB/ADA Guidelines
	Form Designed to Meet WCAG 2.0 Guidelines

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163094

1. Date of Preparation: 4/14/2017
1. Sponsor Identification

Jiangsu BetterLife Medical Co., Ltd.

No. 11 Si Hai Road, Changshu Economic and Technological Development Park, Jiangsu Province, 215513, China.

Establishment Registration Number: 3010197022

Contact Person: Mr. Hongwei Xu Position: Management Representative Tel: +86-512-52269378 Fax: +86-512-52269366 Email: jerry.xu(@goblm.com.cn

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Subject Device

Trade Name: TinniLogic Mobile Tinnitus Management Device Common Name: Tinnitus Masker Models: BTG-A5, BTG-A6, BTG-B5, BTG-B6, BTG-C5 and BTG-C6

Regulatory Information

Classification Name: Tinnitus Masker; Classification: II; Product Code: KLW; Regulation Number: 21CFR 874.3400 Review Panel: Ear Nose& Throat;

Indications for Use

Device Description

The TinniLogic Mobile Tinnitus Management Device is a sound player which is designed to assist the qualified healthcare professional in delivering customized sound therapies and professional counseling or education to the patient for treatment. The TinniLogic Mobile Tinnitus Management Device provides idiopathic timitus sound treatment based upon sound stimulation during sleeping or waking hours. The TinniLogic Mobile Tinnitus Management Device uses amplitude modulated (SAM) timitus pitch matched sounds, narrow-band noise centered at the tinnitus frequency. broad-band noise, pure tone, white noise, natural sounds, and combination of these sounds.

The subject device consists of a tablet, a specialized headset, a charger and a charger cable.

Identification of Predicate Devices ર .

Predicate Device 1 510(k) Number: K140845 Product Name: LEVO Tinnitus Masking Software Device

Predicate Device 2 510(k) Number: K111293 Product Name: SoundCure™ Serenade™ Tinnitus Management System

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Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

IEC 60601-1-2: 2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
A IEC 60601-1:2005+A1:2012 Medical electrical equipment- Part 1: General requirements for basic safety, and essential performance, including the US National Differences
A Output performance testing including the testing of Maximum output, harmonic distortion and Output frequency; additionally, the output performance testing is conducted to demonstrate that the device calibration and the maximum output reamin valid in various settings of three possible volume controls.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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7. Substantially Equivalent (SE) Comparison

Item	Subject Device	Predicate Device 1K140845	Predicate Device 2K111293
Product Code	KLW	KLW	KLW
Regulation Number	21 CFR 874.3400	21CFR 874.3400	21 CFR 874.3400
Indications for Use	The TinniLogic Mobile TinnitusManagement Device is indicatedfor use in the temporary relief oftinnitus symptoms. The device is aplayer to play customized soundsand display professionalcounseling or education to relievepatients suffering from tinnitus andcan be used in a tinnitusmanagement program. The targetpopulation is adults (18 years orolder). This is a medical deviceand should only be used with theadvice of a physician, audiologistor other hearing healthcareprofessional.	The Levo System isindicated for use in thetemporary relief oftinnitus symptoms. Thedevice is a tool togenerate customizedsounds to relieve patientssuffering from tinnitusand can be used in atinnitus managementprogram. The targetpopulation is adults (18years or older).This is a medical deviceand should only be usedwith the advice of aphysician, audiologist orother hearing healthcareprofessional.	The SoundCure SerenadeTinnitus Treatment System isindicated for use in thetemporary relief of tinnitussymptoms. The device is a toolto generate customized soundsto relieve patients sufferingfrom tinnitus and can be usedin a tinnitus managementprogram. The targetpopulation is adults (18 yearsor older). This is a medicaldevice and should only beused with the advice of aphysician, audiologist or otherhearing healthcareprofessional.
Components	TinniLogic Mobile TinnitusManagement Devicewith software pre-installedEarphonesAccessories (adaptor, power cable,USB cable)	Levo Manager softwaresupplied pre-installed oniPad or iPad AirLevo Patient softwaresupplied pre-installed oniPod touchEar budsAccessories (standardApple charger withApple device)	Serenade Treatment Software(to be used with user'scommercially availablecomputer)Serenade patient device withsoftware pre-installedEarphonesAccessories (power supply,power cord, USB cable)
Sounds	Sounds customized to the patientby qualified healthcareprofessional.The subject device just onlydisplays the following sounds and	Sounds customized to thepatient by qualifiedhealth care professional.From 1 to ten (10)combinations of thefollowing sounds:	Sounds customized to thepatient by qualified health careprofessional. Individualpatient selectable from thefollowing sounds:Sinusoidal amplitude

	the combination of them:Sinusoidal amplitude modulated(SAM) tinnitus pitch matchedsoundsNarrow-band noise centered at thetinnitus frequencyBroad-band noisesPure toneWhite noisesNatural soundsRelax sounds	Pure ToneWhite NoisesNarrow Band Noises(bandwidth selectable byHCP)Includes the ability tocreate sinusoidalamplitude modulated(SAM) tones.	modulated (SAM) tones (S-Tones) (choice of 2 predefinedby HCP)White NoisesBand Noises
Data Logging	Data logging of patient use.	Data logging of patientuse.	Data logging of patient use.
Volume Control	Individual volume control per earof the application software;Physical volume controls	Individual volumecontrol per ear of theapplication software;Physical volume controls	Individual volume control perear of the application software;Physical volume controls
Maximum SoundLoudness Output	90 dB SPL	85 dB SPL	92 dB SPL
SoundOutputFrequency	50Hz~15KHz	100Hz- 16KHz	1 KHz to 14 KHz
Power	Rechargeable lithium-Ion (Li-Ion)Battery, external power supplywith power cord for recharging	Rechargeable lithium-Ion(Li-Ion) Battery, externalpower supply with powercord for recharging.(Battery and chargerprovided by Apple forApple devices)	Rechargeable lithium-Ion(Li-Ion) Battery, externalpower supply with power cordfor recharging.
Communication	USB cable and/or Wireless	Wireless	USB cable
Patientcontactmaterial	Earphones	Earphones	Earphones
Electrical Safety	IEC 60601-1	IEC 60601-1	IEC 60601-1
EMC	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2

Table 1 Comparison of Technology Characteristics

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The subject device is as safe and effective as the two predicate devices. The subject device has the similar indications for use, technological characteristics as its predicate devices. The subject device and predicate devices have the same target population and audio player functions.

of the subject device are The Maximum sound loudness output and Output sound frequency of similar as those of the predicate devices. This minor difference on output performance will not raise new problem on the safety and effectiveness of the subject device. The output performance he subject device have been conducted to demonstrate that the device calibration and the um output reamin valid in various settings of three possible volume controls.

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8. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 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.