(194 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a sound player delivering pre-defined sound therapies. There is no mention of algorithms that learn or adapt based on data.
Yes
The device is indicated for "temporary relief of tinnitus symptoms" and uses sound stimulation for "idiopathic tinnitus sound treatment," fitting the definition of a therapeutic device.
No
The device is described as a 'Tinnitus Management Device' that acts as a 'sound player' to provide 'temporary relief of tinnitus symptoms' and 'assist the qualified healthcare professional in delivering customized sound therapies and professional counseling or education to the patient for treatment.' It does not appear to diagnose tinnitus or other conditions.
No
The device description explicitly states that the subject device consists of a tablet, a specialized headset, a charger, and a charger cable, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The TinniLogic Mobile Tinnitus Management Device is a sound player and display device used to deliver sound therapy and educational content directly to the patient to manage tinnitus symptoms. It does not analyze any biological samples.
- Intended Use: The intended use is for the temporary relief of tinnitus symptoms through sound and information delivery, not for diagnosing or monitoring a medical condition through the analysis of in vitro specimens.
Therefore, the description clearly indicates a therapeutic and management device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
KLW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults (18 years or older)
Intended User / Care Setting
This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- IEC 60601-1:2005+A1:2012 Medical electrical equipment- Part 1: General requirements for basic safety, and essential performance, including the US National Differences
- 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.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract design featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
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
-
- Date of Preparation: 4/14/2017
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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
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 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
5
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.
-
- 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 1
K140845 | Predicate Device 2
K111293 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KLW | KLW | KLW |
| Regulation Number | 21 CFR 874.3400 | 21CFR 874.3400 | 21 CFR 874.3400 |
| Indications for Use | 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. | The Levo 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 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. |
| Components | TinniLogic Mobile Tinnitus
Management Device
with software pre-installed
Earphones
Accessories (adaptor, power cable,
USB cable) | Levo Manager software
supplied pre-installed on
iPad or iPad Air
Levo Patient software
supplied pre-installed on
iPod touch
Ear buds
Accessories (standard
Apple charger with
Apple device) | Serenade Treatment Software
(to be used with user's
commercially available
computer)
Serenade patient device with
software pre-installed
Earphones
Accessories (power supply,
power cord, USB cable) |
| Sounds | Sounds customized to the patient
by qualified healthcare
professional.
The subject device just only
displays the following sounds and | Sounds customized to the
patient by qualified
health care professional.
From 1 to ten (10)
combinations of the
following sounds: | Sounds customized to the
patient by qualified health care
professional. Individual
patient selectable from the
following sounds:
Sinusoidal amplitude |
| | | | |
| | the combination of them:
Sinusoidal amplitude modulated
(SAM) tinnitus pitch matched
sounds
Narrow-band noise centered at the
tinnitus frequency
Broad-band noises
Pure tone
White noises
Natural sounds
Relax sounds | Pure Tone
White Noises
Narrow Band Noises
(bandwidth selectable by
HCP)
Includes the ability to
create sinusoidal
amplitude modulated
(SAM) tones. | modulated (SAM) tones (S-
Tones) (choice of 2 predefined
by HCP)
White Noises
Band Noises |
| Data Logging | Data logging of patient use. | Data logging of patient
use. | Data logging of patient use. |
| Volume Control | Individual volume control per ear
of the application software;
Physical volume controls | Individual volume
control per ear of the
application software;
Physical volume controls | Individual volume control per
ear of the application software;
Physical volume controls |
| Maximum Sound
Loudness Output | 90 dB SPL | 85 dB SPL | 92 dB SPL |
| Sound
Output
Frequency | 50Hz~15KHz | 100Hz- 16KHz | 1 KHz to 14 KHz |
| Power | Rechargeable lithium-Ion (Li-Ion)
Battery, external power supply
with power cord for recharging | Rechargeable lithium-Ion
(Li-Ion) Battery, external
power supply with power
cord for recharging.
(Battery and charger
provided by Apple for
Apple devices) | Rechargeable lithium-Ion
(Li-Ion) Battery, external
power supply with power cord
for recharging. |
| Communication | USB cable and/or Wireless | Wireless | USB cable |
| Patient
contact
material | 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
7
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.
8
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.