DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS

K992302 · Dermaphylyx, Inc. · MGP · Sep 14, 1999 · SU

Device Facts

• Record ID: K992302
• Device Name: DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
• Applicant: Dermaphylyx, Inc.
• Product Code: MGP · SU
• Decision Date: Sep 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns. The following indications for use are for Prescription and Over-the-Counter Use: Dermaphylyx Skin Protectors are intended for the prevention of: - Blisters . - Friction Burns .

Device Story

Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, absorptive dressings. Device acts as an extra layer of skin to prevent blisters and friction burns. Construction consists of a porous pressure-sensitive adhesive on the skin-contact surface and a polyurethane foam outer layer. Provides a barrier against exogenous water and dirt while maintaining breathability. Used by patients or clinicians in various settings to protect skin from friction-related injury.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-sterile, self-adhesive, flexible, absorptive dressing. Materials: porous pressure-sensitive adhesive (skin contact side) and polyurethane foam (outer layer). Provides barrier to water/dirt while maintaining breathability.

Indications for Use

Indicated for the prevention of blisters and friction burns in patients requiring skin protection. Suitable for both prescription and over-the-counter use.

Predicate Devices

• Spyroflex® Skin Protectors (Innovative Technologies US, Inc.)

Submission Summary (Full Text)

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# SEP | 4 |999

### 510(k) Dermaphylyx Skin Protectors Dermaphylyx, Inc.

K992302

## 510(k) Summary

| Proprietary Name: | Dermaphylyx Skin Protector |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Skin Protector |
| Classification: | Unclassified |
| Submitter's Details: | Dermaphylyx, Inc.<br>78-E, Olympia Avenue,<br>Woburn, MA 01801-2057 |

Tel: [phone] Fax: [phone]

#### Description:

Dermaphylyx Skin Protectors are non-sterile, self-adhesive, flexible, and absorptive.

Dermaphylyx Skin Protectors act as an extra layer of skin protection. They are intended to be used in the prevention of blisters and friction burns.

The skin contact surface of Dermaphylyx Skin Protectors is composed of a porous pressure sensitive adhesive. A second layer consists of a polyurethane foam. The product provides a barrier to exogenous water and dirt while maintaining breathability

Dermaphylyx Skin Protectors are intended for the prevention of:

- Blisters .
- Friction Burns .

Dermaphylyx Skin Protectors are substantially equivalent to Spyroflex® Skin Protectors (Innovative Technologies US, Inc.). They are intended for both prescription and over-the-counter use.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 1999

Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106, West 75th Lane Arvada, Colorado 80005

Re: K992302

> Trade Name: Dermaphylyx Skin Protector Regulatory Class: Unclassified Product Code: MGP Dated: July 2, 1999 Received: July 8, 1999

Dear Dr. Reed:

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 -- Andrew M. Reed, 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 ي ڪري واري "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

-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) Dermaphylyx Skin Protectors Dermaphylyx, Inc.

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ي سمي موجود و

#### PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

510(k) Number:

K992802 Dermaphylyx, Inc.

Dermaphylyx Skin Protectors Device Name:

Indications for Use:

Dermaphylyx Skin Protectors act like an extra layer of skin. They are intended to be used in the prevention of blisters and friction burns.

The following indications for use are for Prescription and Over-the-Counter Use:

Dermaphylyx Skin Protectors are intended for the prevention of:

- Blisters .
- Friction Burns .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K992302 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use<br>(Optional Format 1-2-96) |
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