(56 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: X 1. Slight X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness
Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
The provided document is a 510(k) premarket notification for the Phonak "MicroZoom P 2" hearing instrument. This type of submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and detailed performance metrics as might be seen for novel, higher-risk devices.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against such criteria, information on test sets, ground truth establishment, or multi-reader multi-case studies.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance:
The document states: "Technical specifications comply with ANSI S3.22 - 1987". This implies that the acceptance criteria for the device's technical characteristics are adherence to this engineering standard. The reported device performance is that it "comply[ies] with ANSI S3.22 - 1987".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ANSI S3.22 - 1987 for Technical Specifications | Technical specifications comply with ANSI S3.22 - 1987 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, and typically does not include detailed independent test set data in this manner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. There is no mention of a test set where experts establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided. This device is a hearing aid, not an AI-assisted diagnostic tool, so such a study would not be applicable or expected for this submission type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not provided. This device is a hearing aid; it is inherently a human-in-the-loop device for its function (wearing it).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The primary "ground truth" for this 510(k) submission is the technical specifications conforming to ANSI S3.22 - 1987 and the established safety and effectiveness of the legally marketed predicate devices to which it is substantially equivalent. No specific "ground truth" in the context of clinical study data is discussed.
8. The sample size for the training set:
This information is not provided. If any "training" occurred, it would be in the context of the device's design and manufacturing processes to meet the ANSI standard, not in the sense of an AI model's training data.
9. How the ground truth for the training set was established:
This information is not provided. As above, the concept of a "training set" and associated "ground truth" in the AI/clinical study sense is not applicable to this 510(k) submission for a hearing aid.
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K972097 14
Exhibit 8
Summary of Safety and Effectiveness Information JUL 30 0 1997
| Name of Device: | Phonak MicroZoom P 2 |
|---|---|
| Type of Device: | Programmable in-the-canal hearinginstrument. Substantially equivalent toother programmable in-the-canal hearinginstruments |
| Intended Use: | To amplify and transmit sound to the ear |
| Features: | Two programmable memories, 3 choicesof signal processing, optional remotecontrol |
| Assembly: | Assembled from components available tohearing instruments manufacturer.Delivered completely assembled to thehearing aid dispenser |
| Technical Characteristics: | Technical specifications comply withANSI S3.22 - 1987 |
| Audiometric Fit: | Frequency response, gain, and output arefitted to the individual audiogram |
| Controls: | Operated with remote control |
| Power Source: | Standard hearing instrument battery, size312 |
A user's manual and other information is supplied with each hearing instrument.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1997
Laura M. Voll, M.S. Regulatory Affairs Coordinator Phonak, Inc. 850 E. Diehl Rd. P.O. Box 3017 Naperville, IL 60566
Re: K972097 Phonak "MicroZoom P 2" Dated: May 30, 1997 Received: June 4, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Ms. Voll:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
While your device has been decmed substantially equivalent to other legally marketed hearing aids, please be advised that electromagnetic interference from digital cellular telephones, as well as from other sources is increasingly becoming a concern. Typically, this interference takes the form of a buzzing sound that can range from annoying to very loud and may render a hearing aid temporariiy ineffective for the wearer. Because electromagnetic interfarence may affect your device, you may be asked to test for electromagnetic compatibility in the future. In this interim period, we encourage you to modify your device labeling to inform practitioners and users of the potential for electromagnetic interference. Please be aware that a 510(k) submission is required for any claims that infer that your device is compatible with potential sources of clectromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Willian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: MicroZoom P 2
Indications For Use:
General Indications: ....... . .......
The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
| Severity: | Configuration: | Other |
|---|---|---|
| X 1. Slight | X 1. High Frequency- Precipitously Sloping | X 1. Low toleranceTo Loudness |
| X 2. Mild | X 2. Gradually Sloping | 2. |
| X 3. Moderate | X 3. Reverse Slope | 3. |
| X 4. Severe | X 4. Flat | |
| 5. Profound | 5. Other |
B. Specific Indications (only if appropriate.): (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William Yin
Restricted device (per 21 CFR 801.420 & 21 CFR 801.421)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number .
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.