AART SILICONE SHEETING

K022223 · Aesthetic and Reconstructive Technologies, Inc. · MIB · Aug 8, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K022223
• Device Name: AART SILICONE SHEETING
• Applicant: Aesthetic and Reconstructive Technologies, Inc.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Aug 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications.

Device Story

AART Silicone Sheeting is a medical-grade silicone elastomer block provided in reinforced or non-reinforced forms of varying thicknesses. Intended for surgical and non-surgical applications, the device is trimmed by a surgeon using a scalpel or scissors to achieve desired shape. It is used in clinical settings for various reconstructive and protective procedures. The device is supplied sterile via Gamma Radiation. Surgeons utilize the sheeting as a structural or protective implant to facilitate healing or reconstruction in various anatomical sites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical grade silicone elastomer; reinforced or non-reinforced; various sizes and thicknesses; Gamma radiation sterilization (min 25kGy); SAL 10^-6.

Indications for Use

Indicated for short-term use including nasal splinting, wound dressing, keloid/hypertrophic scar management, temporary TMJ disease management, temporary joint shims, and laboratory uses. Indicated for long-term use including nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, durameter repair, staged omphalocoel repair, extraocular muscle lengthening, and as protective sheathing for neural regeneration, tendon anastomosis, and osteogenesis. Contraindicated for permanent treatment of TMJ disease per American Academy of Oral Maxillofacial Surgeons.

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

• Seare Biomedical Silicone Sheeting

Submission Summary (Full Text)

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022223

AUG 0 8 2002

## ATTACHMENT 7

## 510(k) Summary

July 2, 2002

| Applicant: | Aesthetic and Reconstructive Technologies, Inc. (AART) |
|----------------------|--------------------------------------------------------|
| | 3545 Airway Drive, Suite 108 |
| | Reno, NV 89511 |
| | [phone] / FAX [phone] |
| Contact Person: | Catherine Riple |
| | Consultant for AART, Inc. |
| | [phone] |
| Proprietary Name: | AART Silicone Sheeting |
| Common Name: | Silicone Carving Block |
| Classification Name: | Elastomer, Silicone Block |

Substantial Equivalence: The AART Silicone Sheeting is substantially equivalent in function, design, performance and materials to the Seare Biomedical Silicone Sheeting marketed by Seare Biomedical Corporation of Salt Lake City, Utah.

Device Description: The AART Silicone Sheeting is manufactured from a medical grade silicone elastomer intended for long term implantation. The sheeting will be provided reinforced or non-reinforced in three sizes of varying thicknesses. The AART Silicone Sheeting is intended to be used for various surgical and non-surgical applications and may be trimmed by scalpel or scissors where additional shaping by the surgeon may be necessary.

The intended use for the AART Silicone Sheeting is for various surgical and non-Intended Use: surgical applications. The silicone sheeting is intended for short term and long term applications.

Predicate Device: The AART Silicone Sheeting is substantially equivalent in material, design, function, and performance to the Seare Biomedical Silicone Sheeting marketed by Seare Biomedical Corporation of Salt Lake City, Utah. All products have virtually identical intended uses and are offered in similar sizes, thicknesses, and options of reinforcement or nonreinforcement.

Packaging: The AART Silicone Sheeting will be offered sterile. The sheeting will be packaged individually in a double Tyvek® pouch configuration. One size of sheeting will be offered both individually or in boxes of ten. Once steallized the individual sheeting will then be packaged in a protective plastic bag along with a package insert for inventory and shipping. Sheeting sold in boxes of ten will be boxed after sterilization along with a package insert.

Sterilization: The AART Silicone Sheeting is offered sterile. Sheeting will be sterilized by Gamma Radiation. The radiation dose level will be a minimum of 25kGy or as determined by the validation studies. The sterility assurance level (SAL) for the AART Silicone Sheeting will be 10 - .

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, creating a sense of depth and connection.

AUG 0 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesthetic and Reconstructive Technologies, Inc. c/o Catherine Riple 5871 Lone Pine Place Paso Robles, California 93446

Re: K022223

Trade/Device Name: AART Silicone Sheeting Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: July 2, 2002 Received: July 9, 2002

Dear Ms. Riple:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it mav 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 Ripple

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" (21 CFR 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 http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Stypt Elwrdn
LNSulie M. Witte, Ph.D., M.D.

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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## ATTACHMENT 1

Page 1 of 1

510 (k) NUMBER (IF KNOWN): K022223.

DEVICE NAME:

AART Silicone Sheeting

## INDICATIONS FOR USE:

The AART Silicone Sheeting has a variety of intended uses. The silicone sheeting is intended for short term and long term applications.

Short term indications for use:

- Nasal splinting ●
- Wound dressing ●
- Management of keloid or hypertrophic scarring �
- Temporary use in TMJ disease .
- Temporary joint shims .
- Laboratory-uses ●

Long term indications for use:

- Nasal septal repair ●
- Orbital floor reconstruction ●
- Tympanic membrane repair ●
- Dialysis shunt anchoring ●
- Durameter repair ●
- Staged repair of omphalocoel .
- Lengthening of extraocular muscles
- As a protective sheathing to help facilitate neural regeneration and tendon anastomosis .
- As a protective sheathing to help facilitate osteogenesis .
- Other uses deemed appropriate by the using surgeon ●

Caution: The American Academy of Oral Maxillofacial Surgeons recommends against the use of silicone products for permanent treatment of Temporo Mandibular Joint Disease.

(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 1-2-96)

Hyt Purdu

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

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