AART PECTORALIS IMPLANT

K021337 · Aesthetic and Reconstructive Technologies, Inc. · MIC · Jul 3, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K021337
• Device Name: AART PECTORALIS IMPLANT
• Applicant: Aesthetic and Reconstructive Technologies, Inc.
• Product Code: MIC · Ear, Nose, Throat
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

Device Story

AART Pectoralis Implant is a medical-grade silicone elastomer device; molded into convex oval shapes; available in three styles with left/right mirror images. Used for chest augmentation or reconstruction of pectoralis depression in Poland's Syndrome. Implanted submuscularly by a surgeon. Provides physical volume to the chest area to improve definition or correct congenital defects. Device is provided non-sterile.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional comparison to legally marketed predicate devices.

Technological Characteristics

Medical grade silicone elastomer; molded convex oval shapes; smooth surface; dimensions range 14.4-17.6 cm length, 10.0-13.5 cm width, 1.6-3.2 cm projection; non-sterile.

Indications for Use

Indicated for chest augmentation to define pectoralis muscle and reconstruction of pectoralis depression in patients with Poland's Syndrome (congenital absence of pectoralis muscle).

Regulatory Classification

Identification

Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

Predicate Devices

• Allied Biomedical Corporation Pectoralis Implant
• Seare Biomedical Pectoralis Implant

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Aesthetic and Reconstructive Technologies, Inc. % Ms. Catherine Riple 5871 Lone Pine Place Paso Robles, California 93446

Re: K021337

Trade/Device Name: AART Pectoralis Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose and Throat synthetic polymer material Regulatory Class: Class II Product Code: MIC Dated: April 15, 2002 Received: April 26, 2002

Dear Ms. Riple:

This letter corrects our substantially equivalent letter of July 3 2002.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

JAN 1 0 2017

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Page 2 - Ms. Catherine Riple

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 Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Olexander

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AMENDMENT 1

Page / of

K021337 510 (k) NUMBER (IF KNOWN) : AART Pectoralis Implant DEVICE NAME:

INDICATIONS FOR USE:

The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-9

MO. for Conni (Division Sign-Off) Division of General, Restorative

and Neurological Devices

KOZI337 510(k) Number_

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## KO21337

## JUL 3 2002

## ATTACHMENT 5

510(k) Summary

April 15,2002

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

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

Device Description: The AART Pectoralis Implants are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in three styles, each with a right and left mirror image. Dimensions of the implants will range from 14.4 cm to 17.6 cm in length with widths from 10.0 cm to 13.5 cm and projection (height) from 1.6 cm to 3.2 cm. The AART Pectoralis Implants are intended to be used for augmentation of the chest by placing the implant submuscular of the pectoralis muscle. They can also be used to reconstruct the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle). The surface characteristic of the implants is smooth. The AART Rectoralis. Implants will be offered non-sterile.

The intended use for the AART Pectoralis Implant is augmentation of the chest Intended Use: to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

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

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