DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING

K990438 · Dermaphylyx, Inc. · MGP · Mar 25, 1999 · SU

Device Facts

• Record ID: K990438
• Device Name: DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
• Applicant: Dermaphylyx, Inc.
• Product Code: MGP · SU
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds. The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters

Device Story

Dermaflex Foam Wound Dressing is a sterile, self-adhesive, absorptive dressing. It consists of a porous adhesive wound contact layer and a microporous polyurethane foam layer. The device provides a moist wound environment, absorbs exudate, and acts as a barrier against dirt while maintaining breathability. It is intended for use by healthcare professionals in clinical settings or by patients for OTC applications. The dressing is applied directly to the wound site to manage various wound types, aiding in protection and maintenance of an optimal healing environment. It does not accelerate healing or serve as a permanent skin substitute.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile, self-adhesive, absorptive foam dressing. Composed of a porous adhesive wound contact layer and a microporous polyurethane foam layer. Provides barrier protection and breathability.

Indications for Use

Indicated for management of partial and full-thickness wounds including venous stasis ulcers, diabetic ulcers, pressure sores, incisions, donor sites, skin tears, and burns (electrical/chemical). OTC use indicated for abrasions, minor cuts/lacerations, blisters, poison ivy, and sunburn. Contraindicated for third-degree burns.

Predicate Devices

• Spyroflex® Wound Dressings (Innovative Technologies US. Inc.)
• Flexzan Topical Wound Dressings (Dow Hickarn Pharmaceuticals. Inc.)

Submission Summary (Full Text)

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FROM : Andrew M. Reed, PhD.

: : 1

3/25/99

K990438

510(k) Dermaflex™ Wound Dressing Dermaphylyx, Inc. K990438

## 510(k) Summary

| Proprietary Name: | Dermaflex™ Foam Wound Dressing |
|-------------------|--------------------------------|
|-------------------|--------------------------------|

- Dressing Common Name:
- Unclassified Classification:
- Submitter's Details: Dermaphylyx, Inc. 78-E, Olympia Avenue, Woburn, MA 01801-2057 Tel: [phone] Fax: [phone]

## Description:

Dormaflex™ Foam Wound Dressings are sterile, self-adhesive, and absorptive.

Dennaflex provides moist wound environment characteristics and absorptive qualities of traditional therapies in a structure, which is both adhesive and conformable.

The wound contact surface of Dermallex is composed of a porous adhesive. A second layer consists of a microporous polyurethane foam. The product provides a barrier and dirt while maintaining breathability

Dermailex Foam Wound Dressings are intended for use in the management of partial and full- thickness wounds in both a professional and OTC environment. They may be used on the following wounds:

| Venous stasis ulcers | Burns, (electrical and chemical) |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Diabetic ulcers | Abrasions and lacerations |
| Pressure sores | Incisions |
| Donor sites | Burns and abrasions associated with resurfacing procedures such as dermabrasion, chemical, and laser resurfacing |
| Skin Tears | |

Over the Counter applications include abrasions, minor cuts, minor laccrations, and blisters. It may also be used on Poison Ivy and Sunburn.

Dermaflex Wound Dressings are substantially equivalent to Spyroflex®Wound Dressings (Innovative Technologies US. Inc.). and Flexzan Topical Wound Dressings (Dow Hickarn Pharmaceuticals. Inc.). These devices are self-adhesive wound dressings, which provide a degros of absorption and breathability. They are intended for use in the management of a wide variety of wounds.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

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

Re: K990438

> Trade Name:DermaflexTM Foam Wound Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: February 8, 1999 Received: February 11, 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- 4. This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 -Andrew M. Reed, Ph.D.

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 (CFR), Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.

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 301-443-6597 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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## 510(k) Dermaflex™ Wound Dressing Dermaphylyx, Inc. K990438

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## PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K990438 |
|----------------|-------------------|
| | Dermaphylyx, Inc. |

| Device Name: | Dermaflex™ Foam Wound Dressing |
|--------------|--------------------------------|
|--------------|--------------------------------|

Indications for Use:

Dermallex Foam Wound Dressings provide a degree of absorption and breathability. They are intended for use in the management of a variety of partial and full-thickness wounds.

The following indications are for Prescription Use or under the direction of a health care professional: Burns, (electrical and chemical) Venous stasis ulcers Abrasions and lacerations Diabetic ulcers Pressure sores Incisions Burns and abrasions associated with resurfacing procedures Donor sites such as dermabrasion, chemical, and laser resurfacing Skin Tears

The following indications are for Over-the-Counter Use: Abrasions Poison Ivy Sunburn Minor burns Minor cuts Minor lacerations Blisters

(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
(Optional Format 1-7-96)
(Division Sign-Off)
Division of General Restorative Devices

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