AART CHIN IMPLANT

K021417 · Aesthetic and Reconstructive Technologies, Inc. · FWP · Jul 2, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021417
• Device Name: AART CHIN IMPLANT
• Applicant: Aesthetic and Reconstructive Technologies, Inc.
• Product Code: FWP · General, Plastic Surgery
• Decision Date: Jul 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.

Device Story

AART Chin Implant consists of molded medical-grade silicone elastomer; crescent-shaped convex design; available in seven styles with varying dimensions. Device intended for surgical augmentation and reconstruction of chin or anterior mandibular contour. Implant inserted by surgeon via intra-oral or submental incision. Provides structural support to chin area; improves aesthetic contour. Offered in sterile and non-sterile configurations.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance characteristics compared to legally marketed predicate devices.

Technological Characteristics

Medical-grade silicone elastomer; crescent-shaped convex form factor; seven styles with varying length, width, and height; smooth surface; sterilized via Gamma radiation per ANSI/AAMI/ISO 11137-1994.

Indications for Use

Indicated for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour in patients requiring surgical chin enhancement.

Regulatory Classification

Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

Predicate Devices

• Duralastic Anatomical Chin Implant (Allied Biomedical Corporation)
• Seare Biomedical Chin Implant (Seare Biomedical Corp.)

Submission Summary (Full Text)

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K021417

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510(k) Summary

April 29,2002

| Contact Information: | Aesthetic and Reconstructive Technologies, Inc. (AART)<br>3545 Airway Drive, Suite 108<br>Reno, NV 89511<br>[phone] / FAX [phone]<br>Winston A. Andrews |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | AART Chin Implant |
| Common Name: | Silicone Elastomer Chin Implant |
| Classification Name: | Prosthesis, Chin, Internal |

Substantial Equivalence: The AART Chin Implant is substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Chin Implant marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Chin Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah.

Device Description: The AART Chin Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped convex implants. They are provided in seven styles with dimensions varying in length, width, and height. The AART Chin Implants are intended to be used for augmentation and reconstruction of the chin or anterior mandibular contour. The surface characteristic of the implant is smooth. The AART Chin Implants will be offered sterile and non-sterile.

Intended Use: The intended use for the AART Chin Implant is augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.

Predicate Device: The AART Chin Implant is substantially equivalent in material, design, function, and performance to the Duralastic Anatomical Chin Implant marketed by Allied Biomedical Corp. and the Seare Biomedical Chin Implant marketed by Seare Biomedical Corp. All products have identical intended uses and are offered in similar shapes and sizes.

Sterilization Cycle: The AART Chin Implant will be sterilized by Gamma radiation. The sterilization cycle will be determined and validated following the ANSI/AAMI/ISO 11137-1994 standard "Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization".

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The profiles are arranged in a way that they form the body and wing of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food .and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Aesthetic and Reconstructive Technologies, Inc. c/o Ms. Catherine Riple 3545 Airway Drive, Suite 108 Reno, Nevada 89511

Re: K021417 Trade Name: AART Chin Implant Regulation Number: 878.3550 Regulation Name: Prosthesis, Chin Implant Regulatory Class: II Product Code: FWP Dated: April 29, 2002 Received: May 3, 2002

Dear Ms. Riple:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Catherine Riple

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, (Misbranding by reference to premarket notification( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stypt Rhode

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AMENUMEN 1

Page / of

| 510(k) NUMBER (IF KNOWN) : | K021417 |
|----------------------------|-------------------|
| DEVICE NAME: | AART Chin Implant |

INDICATIONS FOR USE:

The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter-Use er The Councer 650-96)

Styph Rurdee

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KOZ 1417 510(k) Number_