SCARAID SILICONE GEL SHEETING

K992146 · Biodermis Corp. · MDA · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992146
• Device Name: SCARAID SILICONE GEL SHEETING
• Applicant: Biodermis Corp.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.

Device Story

ScarAid Silicone Gel Sheeting is a topical dressing for scar management. Device functions as a physical barrier to manage hypertrophic and keloid scars; applied directly to closed skin sites. Intended for use by patients or clinicians to improve scar appearance. No complex inputs, algorithms, or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone gel sheeting; topical dressing form factor; non-sterile or sterile (implied by product type); no electronic components or software.

Indications for Use

Indicated for the management of hypertrophic and keloid scars. Contraindicated for use on open wounds.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Jeff S. Schleuning, Ph.D. General Manager BIODERMIS Corp. 3078 East Sunset Road, Suite #1 Las Vegas, Nevada 89120

Re: K992146 Trade Name: ScarAid Silicone Gel Sheeting Regulatory Class: Unclassified Product Code: MDA Dated: June 15, 1999 Received: June 24, 1999

Dear Dr. Schleuning:

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 (OS) 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 - Jeff S. Schleuning, Ph.D.

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 [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 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 [phone] or [phone] 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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K992146
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510 (k) NUMBER (IF KNOWN) : __ K992146

SCARAID DEVICE NAME:

INDICATIONS FOR USE:

Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.

(PLEASE DO NOT MRITE BELOG THIS LINE-CONTINUE ON ANOTHER PAS IF NEEDED.)

Concurrence of CORH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-U: (Optional Format

pc.all 8

(Division Sign-Off) Division of General Resto 510(k) Number