(29 days)
Surgical Technology Laboratories, Inc. Standard Chin implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.
Not Found
This is an FDA 510(k) clearance letter for the "Standard Chin" device from 1998. It is a premarket notification for a medical device that determines substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the way a PMA (Premarket Approval) would.
Therefore, the document does not contain the kind of detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or AI performance metrics that you are requesting. This type of information is typically found in clinical study reports, scientific publications, or more recent 510(k) submissions for AI/ML-driven devices.
Here's why your requested information isn't in this document:
- Device Type: The "Standard Chin" is an implant intended for cosmetic or reconstructive surgery of the mandible. This is a physical, passive medical device, not an AI/ML diagnostic or prognostic tool.
- Regulatory Pathway (510(k) in 1998): At the time, a 510(k) for devices like this primarily focused on demonstrating that the new device is "substantially equivalent" to a device already on the market (a predicate device). This generally involves comparing materials, design features, and intended use, often supported by bench testing and sometimes limited clinical data to assess safety. It does not typically involve the rigorous performance evaluation studies (like standalone performance or MRMC studies) associated with AI-driven diagnostic tools today.
- AI/ML was not a factor: Artificial intelligence and machine learning in medical devices were not a significant part of the regulatory landscape in 1998, especially for physical implants.
Therefore, I cannot provide the requested information based on the provided text. The document simply states the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent, allowing it to be marketed.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1998
Mr. Richard T. Nock Vice President Surgical Technology Laboratories, Inc. 1588 East 40th St. Cleveland, Ohio 44103
Re: K983754 Trade Name: Standard Chin Regulatory Class: II Product Code: FWP Dated: October 16, 1998 Received: October 22, 1998
Dear Mr. Nock:
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) 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.
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Page 2 - Mr. Richard T. Knock
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.
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) 594-4595. 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/dsma/dsmamain.html".
Sincerely yours,
tcollafa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Surgical Technology Laboratories, Inc. The text "Surgical Technology Laboratories, Inc." is written in a bold, sans-serif font. Above the logo, the text '98-11-19 11:35 SURGIFORM' is printed in a smaller font. There is a black bar on the left side of the image.
Image /page/2/Picture/1 description: The image shows a series of bold, black numbers and letters. The characters are 'K143754'. The font is thick and stylized, making the characters appear somewhat abstract.
H. C
1588 East 40th St. Cleveland, Ohio 44103
(216) 431-5055
510(k) Number (if known): K 983754
Device Name: Standard Chin
Indications for Use:
Surgical Technology Laboratories, Inc. Standard Chin implants are intended to be used to augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery.
Prescription Use
(Per 21 CFR 801.109)
Acoelof
983754
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.