(60 days)
The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories : Severity : Slight , Mild , Moderate . . . . . . . Configuration : High Frequency Precipitously Sloping , Gradual Sloping Reverse Slope , Flat
Air Conduction Hearing Aid. To amplify and transmit sound to the ear. Features: Volume Control. On/Off switch built into Volume Control. Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical Characteristics: Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed. Fit: The frequency response of this product is dictated by the individual audiogram from each client. Power: Standard hearing aid battery #312.
This document describes a 510(k) premarket notification for the Scientific Plastics Model SP ITC Hearing Aid, which is an air conduction hearing aid. The information provided heavily focuses on regulatory approval based on substantial equivalence, rather than detailed performance studies with acceptance criteria as might be expected for a novel AI/software-based medical device.
Therefore, many of the requested sections (e.g., sample sizes, ground truth establishment, MRMC studies) are not applicable or cannot be extracted from the provided text, as this is a traditional medical device approval based on established standards and substantial equivalence to predicate devices, not a study evaluating an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Indication | To amplify sound for individuals with impaired hearing, specifically for losses in categories: Slight, Mild, Moderate, and configurations: High Frequency Precipitously Sloping, Gradual Sloping, Reverse Slope, Flat. This is based on the substantial equivalence to predicate devices for these indications. | The device is intended for and described as meeting these indications. The FDA's substantial equivalence determination implies it meets the performance characteristics of predicate devices for these uses. |
| Technical Characteristics | Compliance with S3.22-1987 ANSI Specifications. | Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed (not provided in this excerpt). |
| Safety and Effectiveness | Substantial equivalence to devices marketed prior to May 28, 1976, or reclassified devices, under the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). This implies it meets the safety and effectiveness profile of legally marketed predicate devices. Compliance with Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820). | The FDA determined the device is substantially equivalent for the stated indications, subject to general controls and GMP compliance. |
| Electromagnetic Compatibility (EMC) | No explicit acceptance criteria provided in this document as it was not a requirement at the time of initial approval. However, the FDA notes it may be a future consideration. | The FDA advises that electromagnetic interference from digital cellular telephones and other sources is a concern and encourages labeling modification to inform users. A 510(k) submission would be required for any claims of compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document pertains to a traditional medical device (hearing aid) and its regulatory clearance based on substantial equivalence to predicate devices, not a performance study of an AI algorithm with a test set. There is no mention of a "test set" in the context of an algorithmic evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. See point 2. The "ground truth" for this device's performance is established by its adherence to ANSI standards and its equivalence to established predicate devices, rather than an expert panel adjudicating results from a test set.
4. Adjudication Method for the Test Set
Not applicable. See point 2 and 3.
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
Not applicable. This device is a hearing aid, not an AI-assisted diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical hearing aid. It is inherently a "human-in-the-loop" device as it amplifies sound for a human wearer. There is no standalone algorithm in this context.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety profiles of legally marketed predicate hearing aids, coupled with compliance to technical specifications (e.g., ANSI S3.22-1987) for the physical device characteristics (e.g., frequency response, amplification). The FDA's determination of "substantial equivalence" is the primary mechanism of "ground truthing" here.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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FEB 19 '97 04:25PM
JUN - 6 1997
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Name of Device: Scientific Plastics Model SP ITC Hearing Aid
| Type of Device:Intended Use: | Air Conduction Hearing AidTo amplify and transmit sound to the ear. |
|---|---|
| Features: | Volume Control. On/Off switch built into Volume Control. |
| Assembly: | Assembled from standard components which are widely utilized by otherhearing aid manufacturers. |
| TechnicalCharacteristics: | Technical specifications were obtained in accordance with S3.22-1987ANSI Specifications.Preliminary data sheets for the SP models are enclosed. |
| Fit: | The frequency response of this product is dictated by the individualaudiogram from each client. |
| Power: | Standard hearing aid battery #312 |
.A user's manual and other information is supplied with each hearing aid.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 1997
Jeffrey Stegman …… Vice President Scientific Plastics, Inc. 243 W. 30th Street New York, NY 10001
Re: K971299 - - - - -Scientific Plastics ITC Model SP Dated: March 26, 1997 Received: April 7, 1997 Regulatory class: I 21 CFR 874.3300/Procode: 77 ESD
Dear Mr. Stegman:
华
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 in a classification for your device and thus, permits your device to proceed to the market.
While your device has been deemed substantially equivalent to other legaily 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 temporarily ineffective for the wearer. Because electromagnetic interference 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 your device is compatible with potential sources of electromagnetic interference, such as "compatible with digital cellular telephones", and that data supporting such claims is necessary.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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Page 1 of 1
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510(k) Number (if known): _ K971299
Device Name: Scientific Plastics Model SP ITC Hearing Aid
Indications For Use:
The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories :
m - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Severity : Slight , Mild , Moderate . . . . . . .
. ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Configuration : High Frequency Precipitously Sloping , Gradual Sloping Reverse Slope , Flat
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restricted device
Prescription Use (Psr 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
David G. Segerson
(Division Sign-Off)
1 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.