KELOCATE SHEETING

K982051 · Allied Biomedical Corp. · MDA · Aug 5, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982051
• Device Name: KELOCATE SHEETING
• Applicant: Allied Biomedical Corp.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Aug 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device may be used for the management of Keloid and hypertrophic scars occurring as a result of traumatic injury or surgical procedures. This device is not intended to be used on open wounds. This device is intended for over-the-counter use.

Device Story

Kelocote Silicone Sheeting is a topical device for scar management. It is applied to closed, healed skin to treat keloid and hypertrophic scars resulting from trauma or surgery. The device functions as a physical barrier to manage scar tissue. It is intended for over-the-counter use by patients. The device does not treat open wounds.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone-based sheeting; topical application; non-sterile/general use; physical barrier mechanism.

Indications for Use

Indicated for management of keloid and hypertrophic scars resulting from traumatic injury or surgical procedures. Contraindicated for use on open wounds. Intended for over-the-counter use.

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

AUG 5 1998

Ms. Catherine Riple Compliance Manager Allied Biomedical Corporation 3850 Ramada Drive, Suite C-2 Paso Robles, California 93446

K982051 Re: Trade Name: Kelocote Sheeting Regulatory Class: Unclassified Product Code: MDA Dated: June 9, 1998 Received: June 11, 1998

Dear Ms. Riple:

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 (QS) 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 i 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 - Ms. Catherine Riple

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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## Indications for Use Form

510(k) Number (if known): __ K982051

Device Name:__Kelocote Silicone Sheeting

Indications for Use:

This device may be used for the management of Keloid and hypertrophic scars occurring as a result of traumatic injury or surgical procedures.

This device is not intended to be used on open wounds.

This device is intended for over-the-counter use.

## 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_