STERILE SILICONE EXTERNAL WOUND COVER

K982065 · Specialty Surgical Products, Inc. · MIB · Aug 12, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K982065
• Device Name: STERILE SILICONE EXTERNAL WOUND COVER
• Applicant: Specialty Surgical Products, Inc.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Aug 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Specialty Surgical Products Sterile Silicone Wound Covers are intended for external use in short term applications related to wound treatment by temporarily covering traumatic areas where primary closure attempts must be abandoned in favor of a staged repair.

Device Story

Sterile Silicone External Wound Cover; intended for temporary coverage of traumatic wounds; used when primary closure is abandoned for staged repair; applied by clinicians in clinical settings; provides protective barrier for wound site; facilitates management of traumatic injuries.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics.

Technological Characteristics

Silicone-based external wound cover; sterile; designed for short-term application; class II device (Product Code: FTL).

Indications for Use

Indicated for patients with traumatic wounds requiring temporary coverage when primary closure is not feasible and staged repair is necessary.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 1998

Mr. T. Jan Varner President Specialty Surgical Products, Inc. 302 North First Street Hamilton, Montana 59840

Re: K982065 Trade Name: Sterile Silicone External Wound Cover Regulatory Class: II Product Code: FTL Dated: May 12, 1998 Received: June 12, 1998

Dear Mr. Varner:

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 - Mr. T. Jan Varner

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,

Russell P. Fazer

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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510(k) Number (if known): ___K982065

Device Name: Sterile Silicone External Wound Covers

Indications For Use:

Specialty Surgical Products Sterile Silicone Wound Covers are intended for external use in short term applications related to wound treatment by temporarily covering traumatic areas where primary closure attempts must be abandoned in favor of a staged repair.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Vincenzo Lagano fu I2P

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use