(29 days)
Not Found
Not Found
No
The summary describes a physical implant and contains no mention of AI, ML, image processing, or software-driven analysis.
No.
The device is an implant used for augmentation or reconstruction, which are structural modifications rather than therapeutic treatments aimed at curing or preventing disease.
No
The device is described as an implant used to augment or reconstruct the mandible. Its purpose is to physically modify a body part, not to identify a disease, condition, or state of health.
No
The 510(k) summary describes "Standard Chin implants," which are physical devices intended for surgical implantation. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "augment or reconstruct the anterior of the mandible for cosmetic or reconstructive surgery." This describes a surgical implant used directly on a patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The description clearly indicates a device used in vivo (within the body) for surgical purposes, not a test performed in vitro (outside the body) on a sample.
N/A
Intended Use / 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.
Product codes
FWP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior of the mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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