PROXIDERM, MODELS TN 460, TN 90 460, BK 460

K982439 · Progressive Surgical Products, Inc. · MKY · Sep 8, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982439
• Device Name: PROXIDERM, MODELS TN 460, TN 90 460, BK 460
• Applicant: Progressive Surgical Products, Inc.
• Product Code: MKY · General, Plastic Surgery
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4320
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The Proxiderm is intended to be utilized prior to a surgical procedure to remove a defect or prior to implantation of a prosthesis to provide additional skin for coverage of the defect or prosthesis.

Device Story

Proxiderm (Models TN460, TN90 460, BK 460) is a surgical device used to expand or provide additional skin coverage. It is utilized by surgeons in a clinical or surgical setting prior to procedures involving defect removal or prosthetic implantation. The device functions to increase available skin surface area, facilitating closure or coverage of surgical sites. It is intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical device for skin expansion/coverage. Specific materials, dimensions, and sterilization methods are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring additional skin coverage prior to surgical defect removal or prosthetic implantation.

Regulatory Classification

Identification

A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 8 1098 SEP

Mr. Robert Oddsen Vice President, Research & Development/Regulatory Progressive Surgical Products, Inc. 89 Garden Street Westbury, New York 11590

Re: K982439

> Trade Name: Proxiderm, Models TN460,TN90 460, BK 460 Regulatory Class: Unclassified Product Code: MKY Dated: July 10, 1998 Received: July 14, 1998

Dear Mr. Oddsen:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirements . 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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. Robert Oddsen

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

scooll

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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Page __ of __

) 10(k) Number (if known): K982439

Device Name:____ PROXIDERAL________________

Indications For Use:

## Additional Indication -

The Proxiderm is intended to be utilized prior to a surgical procedure to remove a defect or prior to implantation of a prosthesis to provide additional skin for coverage of the defect or prosthesis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 14982439

Prescription Use
(Per 21 CFR 801.409)
OR
Over-The-Counter Use

(Optional Format 1-2-96)