Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on sound generation and customization based on professional input, with no mention of AI/ML algorithms for analysis, adaptation, or prediction.

Therapeutic

Yes

The device is intended to provide temporary relief for people experiencing tinnitus symptoms, which qualifies it as a therapeutic function.

Diagnostic

No

The device is described as a "sound generating software" used in a "Tinnitus Management Program designed to provide temporary relief" by creating "customized sounds for sound therapy/masking." Its purpose is therapeutic (relief), not diagnostic.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that REVE134 consists of "software installed in PC (desktop or laptop computer)" and describes its function as generating sounds. There is no mention of accompanying hardware components that are part of the medical device itself, only the platform (PC) on which the software runs.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
REVE134's Function: REVE134 is a software that generates sounds for tinnitus management. It does not analyze any biological samples from the patient. Its function is to provide sound therapy/masking based on the patient's hearing characteristics and the professional's assessment.
Intended Use: The intended use is to provide temporary relief for tinnitus symptoms through sound generation, not to diagnose or analyze biological samples.

Therefore, REVE134 falls under the category of a therapeutic or management device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).
REVE134 is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus.
The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
REVE134 is targeted for healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend for a patient to listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level). A default starting level of REVE134 is 54 dBr. A hearing healthcare professional needs to adjust this default value of '54 dBr' into patient's barely audible level.

Product codes

KLW

Device Description

KW EAR LAB'S REVE134 consists of software installed in PC (desktop or laptop computer). REVE134 is fitted to the patient by the hearing healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking. REVE134 software can generate either modulated white noise (233~12912 Hz) or modulated narrow band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.
Software module embedded into a digital hearing instrument platform. Sound files generated by the REVE134 can be used only in a digital hearing instrument platform which provides MP3 codec (e.g.,

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

primarily for adults over 18 years of age, but may also be used for children 5 years of age or older.
primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.
Primarily adult population (>18yrs), can be used for patients >5yrs

Intended User / Care Setting

hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses.

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)

KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K133308, K110932

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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 stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

October 8, 2015

KW Ear Lab, Inc. Mr. Sungwoo Cho Vice President/General Counsel 18655 South Bishop Ave Carson, CA 90746

Re: K151719

Trade/Device Name: Reve134 Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: June 25, 2015 Received: July 1, 2015

Dear Mr. Cho:

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 (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

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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Exhibit 5 Indications for Use Statement

K151719 510(k) number (if known):

Device Name: REVE134

Indications for Use:

REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing timitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(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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Exhibit 6 510(k) Summary

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510(k) Summary (REVE134)

| Submitter: | KW EAR LAB, INC.
18655 South Bishop Ave, Carson, CA 90746
Phone: (310)-747-1390 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sungwoo Cho
KW EAR LAB, INC.
18655 South Bishop Ave, Carson, CA 90746
Phone: (310)-747-1390 |
| Date Prepared: | May 30, 2015 |
| Device Name: | REVE134 |
| Device Class: | Class II |
| Classification Name: | Tinnitus Masker |
| Classification Regulation: | 21 C.F.R. 874.3400 |
| Product Code | KLW |
| Predicate Devices: | K133308 Tinnitus SoundSupport, Oticon
K110932 Tinnitus Sound Generator, GN Resound |
| Intended Use / Indication for Use: | REVE134 is a sound generating software used in a Tinnitus
Management Program designed to provide temporary relief for
people experiencing tinnitus symptoms. It is intended
primarily for adults over 18 years of age, but may also be used
for children 5 years of age or older. REVE134 is for use by
hearing healthcare professionals who are familiar with the
evaluation and treatment of tinnitus and hearing losses. A
hearing healthcare professional should recommend that a
patient listen to the REVE134 signal for 30 minutes twice a
day at the barely audible level (minimally detectable level). |
| Technological Characteristics: | KW EAR LAB'S REVE134 consists of software installed in PC
(desktop or laptop computer). REVE134 is fitted to the patient by
the hearing healthcare professional. The software enables qualified
professional to create customized sounds with specific frequency
range for sound therapy/masking. REVE134 software can generate
either modulated white noise (233~12912 Hz) or modulated narrow |

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band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.

Performance Data:

KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected.

Fig. 1

Standard No.	Standard Title
IEC 62304	Medical device software – Software life-cycle
processes
ISO14971:2007	Medical devices- Application of risk
management to medical devices

Substantial Equivalence:

KW EAR LAB REVE134 is as safe and effective as Oticon's Tinnitus SoundSupport (K133308) and GN Resound's Tinntius Sound Generator (K110932). As shown in the table below, KW Ear lab's REVE134, Oticon's Tinnitus SoundSupport (K133308), and GN Resound's Tinntius Sound Generator (K110932) have the same intended use and similar indications, technological characteristics, and principles of operation. Minor technological differences do not present any new issues of safety or effectiveness. Thus, KW Ear lab's REVE134 is substantially equivalent to Oticon's Tinnitus SoundSupport (K133308), and GN Resound's Tinntius Sound Generator (K110932).

Comparison Table:

KW Ear lab Inc. REVE134

Substantial Equivalent Chart

Device	New	Predicate	Predicate
Manufacturer	KW Ear lab	Oticon	GN Resound
Name	REVE134	Tinnitus SoundSupport	Tinnitus Sound Generator
510(K) No.		K133308	K110932
Indication
for Use	REVE134 is a tool to
generate sounds to be used
in a Tinnitus Management
Program to relieve patients
suffering from tinnitus.	Tinnitus SoundSupport is a
tool intended to generate
sounds to provide temporary
relief to patients suffering
from tinnitus as part of a	The Tinnitus Sound
Generator is a tool to
generate sounds to be used
in a Tinnitus Management
Program to relieve patients
	The target population is
primarily the adult
population over 18 years of
age. This product may also
be used with children 5 years
of age or older.
REVE134 is targeted for
healthcare professionals who are
familiar with the evaluation
and treatment of tinnitus and
hearing losses. A hearing
healthcare professional
should recommend for a
patient to listen to the
REVE134 signal for 30
minutes twice a day at the
barely audible level
(minimally detectable level).
A default starting level of
REVE134 is 54 dBr. A
hearing healthcare
professional needs to adjust
this default value of '54 dBr'
into patient's barely audible
level.	tinnitus management
program.
The target population is the
adult population (>18yrs).
Tinnitus SoundSupport is
targeted for licensed hearingprofessionals
(audiologists, hearing aid
specialists, or
otolaryngologists) who are
familiar with the evaluation
and treatment of tinnitus and
hearing losses.
The fitting of Tinnitus
SoundSupport must be done
by a hearing care professional
participating in a tinnitus
management program.	suffering from tinnitus.
The target population is
primarily the adult
population over 18 years of
age. This product may also
be used with children 5
years of age or older.
The Tinnitus Sound
Generator Module is
targeted for healthcare
professionals, which are
treating patients suffering
from tinnitus, as well as
conventional disorders.
User
Population	Primarily adult population
(>18yrs), can be used for
patients >5yrs	Adult population (>18yrs)	Primarily adult population
(>18yrs), can be used for
patients >5yrs
Schedule of Use	All day	All day	All day in all environments
Mechanism	Volume is set by HCP and
can be adjusted by patients,
when in use. Default level
fixed.
Amplitude modulation noise
and frequency modulation
pure tone	Volume is set by HCP and can
be adjusted by patients, when
in use. Default level fixed.
Amplitude modulation and
steady noise.	Volume is set by HCP and
can be adjusted by patients,
when in use. Default level
fixed.
Amplitude modulation and
steady noise.
Technological
Characteristics	Software module embedded
into a digital hearing
instrument platform. Sound
files generated by the
REVE134 can be used only
in a digital hearing
instrument platform which
provides MP3 codec (e.g.,	Software module embedded
into a digital hearing
instrument platform	Software module embedded
into a digital hearing
instrument platform

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