GELZONE

K013732 · Implantech Associates, Inc. · MDA · Feb 7, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013732
• Device Name: GELZONE
• Applicant: Implantech Associates, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Feb 7, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

Device Story

Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel sheet backed by polyester hook and loop fabric. Designed for management and prevention of keloid and hypertrophic scars. Intended for over-the-counter (OTC) use; does not require physician instruction for safe application. Device provides physical barrier and occlusive environment to scar site. Benefits include scar management and prophylactic retardation of scar formation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on material identity to predicate devices with established safety profiles and FDA Master File documentation for the silicone gel formulation.

Technological Characteristics

Soft, semi-occlusive, slightly adhesive silicone gel; polyester hook and loop fabric backing. Provided in various lengths, widths, and colors. Non-powered, passive device.

Indications for Use

Indicated for management of keloid and hypertrophic scars, and prophylactic use to retard scar formation in general patient population.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Predicate Devices

• Implantech Gel Sheeting (K964846)
• Implantech Conform Sheeting (K012419)
• PMT Amend Silicone Gel Sheeting (K972597)

Submission Summary (Full Text)

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### FEB 0 7 2002

### 510(k) Summary

February 07, 2001 Date:

### Manufacturer

Implantech Associates Inc. 2064 Eastman Ave. #101 Ventura, CA 93003

Telephone: [phone] [phone] Fax: Stephen Meade Contact:

Device Name Gelzone Common or Usual Name: Gel Sheeting Device Classification: Currently unclassified

### Product Description

Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.

### Indication For Use

Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

### Substantial Equivalence

Gelzone is substantially equivalent to the Implantech's Gel Sheeting and Conform Sheeting cleared under 510(k) K964846 and K012419 respectively. Gelzone is also substantially equivalent to PMT's Amend™ Silicone Gel Sheeting cleared under 510(k) number K972597.

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### Packaging and Labeling

Gelzone will be provided in various lengths, widths and colors and packaged in a box with see through window to permit potential users to see the device prior to purchase. Use instructions along with warnings, precautions and complications are displayed on the packaging and can be easily understood and followed by OTC users. The use of this product does not require instruction by a physician to insure adequate or safe use.

### Efficacy

Gelzone's silicone layer is manufactured with silicone gel. This silicone layer is the same material used in the current Implantech Gel Sheeting and Conform Sheeting products. The manufacturer of the gel has an FDA Master File which includes information on their formulation, on manufacturing methods, testing, and toxicology information.

Date: Feb 07 2001

Stephen Meade RA/QA Manager, Implantech Associates, Inc.

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Public Health Service

FEB 0 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Meade Regulatory Affairs/Quality Assurance Manager Implantech Associates, Inc. 2064 Eastman Avenue, Unit 101 Ventura, California 93003

Re: K013732 Trade/Device Name: Gelzone Regulatory Class: Unclassified Product Code: MDA Dated: November 5, 2001 Received: November 9, 2001

Dear Mr. Meade:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreases) 7 the enactment date of the Medical Device Amendments, or to conniner or nas nas nas 2011 ) 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 nean r lease of acrised that thermination that your device complies with other requirements of the Act that I Dri has made a assoc 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 - Mr. Stephen Meade

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough mating of substantial equivalence of your device to a legally prematicated 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 11 you dostro specific arrest 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 Frances of 301) 594-4659. Additionally, for question and advertising of Compliance at [phone] 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 Oiner general 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 yours,

iriam C. Provost

for 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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Implantech Associates, Inc.

# 13732

Gelzone 510(k) Submission

### INDICATIONS FOR USE

Applicant: Implantech Associates, Inc.

510(k) Number (if known): N/A*

Device Name: Gelzone

Indications For Use:

Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

Musiam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K013732

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## Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801.109

Over-the-Counter_ メ OR