(137 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and there is no other language suggesting the use of these technologies. The device description focuses on playing customized sounds and facilitating professional counseling, not on adaptive or learning algorithms.
Yes
The device is indicated for use in the "temporary relief of tinnitus symptoms" and is described as a "tinnitus device," which points to its therapeutic intent.
No
The device is indicated for temporary relief of tinnitus symptoms by playing customized sounds, not for diagnosing tinnitus or other conditions.
Yes
The device description explicitly states that the Peace N Quiet tinnitus device is "software as a medical device implemented as a mobile application". While it runs on an Apple iPhone, the device itself is the software application.
Based on the provided information, the Peace N Quiet device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The core function of an IVD is to examine biological samples (like blood, urine, tissue, etc.) to provide information about a person's health status, diagnose conditions, or monitor treatments.
- The Peace N Quiet device provides sound therapy. Its intended use is to relieve tinnitus symptoms by playing customized sounds. It does not involve the analysis of any biological samples.
- The device description focuses on software and sound delivery. The description details a mobile application that facilitates sound therapy and professional guidance, not laboratory analysis.
Therefore, the Peace N Quiet device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other healthcare professional.
Product codes
KLW
Device Description
The Peace N Quiet tinnitus device is software as a medical device implemented as a mobile application for patients suffering from tinnitus. The Peace N Quiet tinnitus mobile app can be downloaded from the Apple Store onto a personal Apple iPhone device facilitates a qualified healthcare professional (HCP). i.e., physician or audiologist, to provide professional counseling or education to the patient. The HCPs can direct and assist patients to self-administer customized treatments using the Peace N Quiet tinnitus device.
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
18 years or older
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D) and can be used in a tinnitus management program.
Intended use with the advice of a physician, audiologist or other healthcare professional.
At-home and healthcare facilities
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)
Software verification and validation testing was performed per IEC 62304:2015 Medical device software – Software life cycle processes to demonstrate safety and performance based on current industry standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
February 27, 2024
PNQ Health % Alexia Haralambous Senior Principal Ram+ 2251 San Diego Avenue Suite B-257 San Diego, California 92110
Re: K233435
Trade/Device Name: Peace N Quiet (0.7.0) Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: January 29, 2024 Received: January 29, 2024
Dear Alexia Haralambous:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Peace N Quiet (0.7.0)
Indications for Use (Describe)
The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other healthcare professional.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
DATE PREPARED
February 23, 2024
MANUFACTURER AND 510(k) OWNER
PNQ Health, Inc. 110 Cheshire Lane, Ste 385 Minnetonka, MN 55305 Telephone: +1 (651) 280-7624 Official Contact: Kurtis Goos, Chief Executive Officer
REPRESENTATIVE/CONSULTANT
Alexia Haralambous, MS, RAC Hrishikesh Gadagkar, Ph.D. ROM+ 2251 San Diego Ave, Suite B-257 San Diego, CA 92110, USA Telephone: +1 (267) 778-5114 Email: aharalambous@rqmplus.com hgadagkar@rqmplus.com
DEVICE INFORMATION
Proprietary Name/Trade Name: Peace N Quiet Common Name: Tinnitus masker Regulation Number: 21 CFR 874.3400 Class: II Product Code: KLW Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1), Division of Dental and ENT Devices (DHT1B) Review Panel: Ear, Nose, and Throat
PREDICATE DEVICE IDENTIFICATION
The Peace N Quiet device is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate | Reference
Device |
|---------------|------------------------------------------------------------------------------------|----------------------|---------------------|
| K161562 | Sound Options Tinnitus Treatment / Sound Options
Tinnitus Treatments, Inc. | ✓ | |
| K163094 | TinniLogic Mobile Tinnitus Management Device /
Jiangsu BetterLife Medical, Ltd. | | ✓ |
4
DEVICE DESCRIPTION
The Peace N Quiet tinnitus device is software as a medical device implemented as a mobile application for patients suffering from tinnitus. The Peace N Quiet tinnitus mobile app can be downloaded from the Apple Store onto a personal Apple iPhone device facilitates a qualified healthcare professional (HCP). i.e., physician or audiologist, to provide professional counseling or education to the patient. The HCPs can direct and assist patients to self-administer customized treatments using the Peace N Quiet tinnitus device.
INDICATIONS FOR USE
The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
PNO Health. Inc. believes that the Peace N Ouiet device is substantially equivalent to the predicate device based on the information summarized here:
The subject device has the same intended use as the primary predicate, the Sound Options Tinnitus Treatment (K161562), i.e., software intended for the temporary relief of tinnitus symptoms, with a target population of patients who are 18 years or older and suffering from tinnitus. The subject device shares several technological characteristics with the primary predicate (K161562). Both are software-only medical devices that provide audio sound outputs customized to the patient to mask tinnitus as part of a tinnitus management program, and both systems are compatible with pre-specified earbuds (non-medical device). The subject device differs in that its sounds are customized to the patient by a qualified HCP, whereas the primary predicate (K161562) has sounds that are primarily customized by the device manufacturer (Sound Options Tinnitus Treatments, Inc.) in addition to the HCP. Both allow for physical volume control and maintain the same output maximum. 85 dBA, with similar output frequency ranges that fall within normal human hearing frequency ranges. In addition, both utilize primarily amplitude-modulated stimuli. The primary predicate (K161562) relies on broadband frequency sound prescribed and customized to the patient by the HCP, whereas the subject Peace N Quiet device includes frequency modulation (in addition to amplitude modulation) that is customized to the patient within the device by a qualified HCP. The periodic signal types offered by the subject device provide additional options for HCP and patient customization of timitusmatched sounds. To allow the HCP and patient to further tailor the customized sounds to match the patient's perceived tinnitus, the primary predicate (K161562) uses broadband noise adjustments, while the subject device offers the user the option of additive pseudorandom noise adjustments such as white or pink noise. Both sets of options offer the user ways to tailor the customized sounds to come as close as possible to the patient's perceived tinnitus, with the subject device offering a higher number of adjustable parameters as compared to the primary predicate.
The TinniLogic Mobile Tinnitus Management Device (K163094) device was used as a reference device to support the technology of temporary relief of tinnitus symptoms through customized
5
masking sounds. The reference device (K163094) utilizes sinusoidal amplitude-modulated sounds with a combination of narrow-band noise, broad-band noise, and other types of noise such as white noise and natural sounds, to allow the user ways to tailor the customized sounds. These options differ slightly from the additive noise options of the subject device, but both the reference device (K163094) and primary predicate noise options offer the user a variety of options intended to allow them to match the patient's perceived tinnitus as closely as possible. These differences do not present new or modified risks, and therefore they do not raise different questions of safety and effectiveness. This information is summarized in the following table.
| | Subject Device:
Peace N Quiet | Primary Predicate:
Sound Options Tinnitus
Treatment (K161562) | Reference Device:
TinniLogic Mobile
Tinnitus Management
Device (K163094) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Peace N Quiet device
is indicated for use in the
temporary relief of
tinnitus symptoms. The
device plays customized
sounds to relieve patients
suffering from tinnitus
and can be used in a
tinnitus management
program. The target
population is for patients
who are 18 years or
older. This device should
only be used with the
advice of a physician,
audiologist or other
hearing healthcare
professional. | The device, Sound
Options Tinnitus
Treatment, version SO
2.0, is for the temporary
relief of tinnitus
symptoms. The device is a
software application that
embeds sounds and
spectral content into
music to relieve patients
suffering from tinnitus
and can be used as part
of a tinnitus management
program for adults 18
years and older. The
device is for prescription
use by a physician,
audiologist or other
healthcare professional. | 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. |
| Target Population | Adult (18 years and
older) tinnitus patients | Adult (18 years and
older) tinnitus patients | Adult (18 years and
older) tinnitus patients |
| Use Environment | At-home and healthcare
facilities | At-home and healthcare
facilities | At-home and healthcare
facilities |
| Patient Medium | Software only | Software only | Hand-held audio device
for use with earphones |
| Professional
Counseling/
Education | Guidance is provided via
the HCP and prompts on
the software app | Guidance is provided via
the HCP | Guidance is provided via
the HCP as well as
prompts on the provided
tablet |
| Device
Components | Peace N Quiet Software | ● Sound Options
software only device,
SO 2.0 | ● TinniLogic Mobile
Tinnitus Management
Device with software
pre-installed |
| | Subject Device:
Peace N Quiet | Primary Predicate:
Sound Options Tinnitus
Treatment (K161562) | Reference Device:
TinniLogic Mobile
Tinnitus Management
Device (K163094) |
| | | | Earphones Accessories (adaptor, power cable, USB cable) |
| Sounds | Sounds customized to the
patient by a qualified
health care professional. | Sounds customized by
Sound Options Tinnitus
Treatments, Inc.
(manufacturer)
Customized music tracks
are available to patients
by download or on CD. | Sounds customized to the
patient by a qualified
healthcare professional. |
| Stimuli Type | Periodic Signal Type (Sine, Triangle, Sawtooth, Square) Amplitude Frequency Phase Duty Cycle (for square type only) Pseudorandom Type (Random, Pseudorandom) Random Noise Type (White, Pink) Amplitude Frequency Limits (Low & High) Modulation Amplitude (A signal played at various amplitudes) Frequency (A signal played at various frequencies) Pulse (A signal that is pulled on and off) | Amplitude-modulated tinnitus matching Broadband frequency sound Broadband noise | Sinusoidal amplitude modulated (SAM) tinnitus pitch matched sounds Narrow-band noise centered at the tinnitus frequency Broad-band noises Pure tone White noise Natural sounds Relax sounds |
| Volume Control | Individual volume control
per ear of the application
software | Patients are to listen to
the sound therapy at a
comfortable volume level | Individual volume control
per ear of the application
software |
| | Subject Device:
Peace N Quiet | Primary Predicate:
Sound Options Tinnitus
Treatment (K161562) | Reference Device:
TinniLogic Mobile
Tinnitus Management
Device (K163094) |
| | | by adjusting the volume
control on their personal
music-playing device. | Physical volume controls |
| | | Safe levels were
determined through bench
testing for each of the
recommended
commercial device
options described in the
user manuals. | |
| Maximum Output | 85 dB | 85 dB | 90 dB |
| Output Frequency | 500 Hz16,000Hz | Dependent on patient15,000Hz |
headphones (commercial) | 50Hz
| Performance
Testing | ● IEC 62304:2015 | ● IEC 62304:2006 | ● IEC 60601-1
● IEC 60601-1-2 |
6
7
SUMMARY OF NON-CLINICAL TESTING
Software verification and validation testing was performed per IEC 62304:2015 Medical device software – Software life cycle processes to demonstrate safety and performance based on current industry standards.
SUMMARY OF CLINICAL TESTING
Clinical testing was not performed as part of this submission.
CONCLUSION
Based on the verification and validation testing performed in accordance with IEC 62304:2015, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The Peace N Quiet device is demonstrated to be substantially equivalent to the predicate device.