SEARE BIOMEDICAL CHIN IMPLANTS by SEARE BIOMEDICAL CORP.

Seare Biomedical Chin Implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. The chin implant is used to augment or reconstruct the chin. It is placed over the anterior aspect of the mandible in the midline and placed under the periosteum. It is inserted via an intra-oral or submental incision according to the surgeon's preference. The Seare Biomedical Chins will be available in many sizes and styles, all of which are very similar differing only by a few millimeters in length and projection. The Seare Biomedical Chin Implants will be provided sterile and nonsterile.

AI/ML Overview

This document describes a 510(k) submission for the Seare Biomedical Chin Implants, which are silicone elastomer implants used for chin augmentation or reconstruction. The submission states that no clinical tests were performed to establish substantial equivalence or device performance.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from a study are provided.
Sample size used for the test set and the data provenance: No test set was used for clinical evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
Adjudication method: Not applicable as there was no clinical test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, the document explicitly states "Clinical Tests: None". Therefore, no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not a software algorithm.
The type of ground truth used: Not applicable as there was no clinical test.
The sample size for the training set: Not applicable as there was no training set for an algorithm.
How the ground truth for the training set was established: Not applicable.

The basis for the 510(k) clearance was substantial equivalence to a predicate device (Allied Biomedical Chin Implants) in material, function, performance, and design, with identical indications for use and similar sizes and options.

Summary

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SEARE BIOMEDICAL CORPORATION

K982752.

510(k) Summary

Contact Information:	Seare Biomedical Corporation3190 Chula Vista CircleSalt Lake City, Utah 84121Telephone: 1(801) 355-5533Facsimile: 1(801) 942-1999
Trade Name:	Seare Biomedical Chin Implants
Common Name:	Silicone Elastomer Chin Implants
Classification Name:	Prosthesis, Chin, Internal (per CFR section 878.3550)

Substantial Equivalence: The Seare Biomedical Chin Implant configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Chin Implants manufactured and marketed by Allied Biomedical (

Device Description: Seare Biomedical Chin Implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. The chin implant is used to augment or reconstruct the chin. It is placed over the anterior aspect of the mandible in the midline and placed under the periosteum. It is inserted via an intra-oral or submental incision according to the surgeon's preference. The Seare Biomedical Chins will be available in many sizes and styles, all of which are very similar differing only by a few millimeters in length and projection. The Seare Biomedical Chin Implants will be provided sterile and nonsterile.

Indications For Use: Seare Biomedical Chin Implants are utilized to augment or reconstruct the chin or anterior mandibular contour.

Predicate Devices: The Seare Biomedical Chin Implant configurations are substantially equivalent in material, function, performance, and design to the Allied Biomedical Chin Implants manufactured and marketed by Allied Biomedical. The products have identical indications for use and are offered in the same exact size and options.

Clinical Tests: None

Adverse S&E Information: None

William J. Sloan, Jr., M.D.

William J. Seare, Jr. N President & C.E.O.

8/4/98

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

William J. Seare, M.D. President & C.E.O. Seare Biomedical Corporation 3190 Chula Vista Circle Salt Lake City, Utah 84121

Re: K982752 Trade Name: Seare Biomedical Chin Implants Requlatory Class: II Product Code: EWP Dated: August 03, 1998 Received: August 06, 1998

Dear Dr. Seare:

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 (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 - Dr. William J. Seare

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/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): K982752

Device Name: Seare Biomedical Chin Implants

Indications For Use:

Seare Biomedical Chin Implants are utilized to augment or reconstruct the chin or anterior mandibular contour.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisio 510(k) Nt Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.