DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING

K991609 · Dermaphylyx, Inc. · KMF · Jul 20, 1999 · General Hospital

Device Facts

• Record ID: K991609
• Device Name: DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
• Applicant: Dermaphylyx, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Jul 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound. The following Indications are for Prescription Use or under the direction of a health care professional: Venous ulcers, Diabetic ulcers, Pressure ulcers, Arterial ulcers, Superficial burns, Abrasions and lacerations, Donor sites, Incisions. The following Indications are for Over-the-Counter Use: Abrasions, Minor Burns, Minor Cuts, Minor Lacerations.

Device Story

Dermaphylyx Absorbent Fiber Wound Dressing is a soft, non-woven, absorptive dressing available in felt or rope configurations. Designed for management of partial and full-thickness wounds; absorbs wound exudate to form a fiber mat, creating a moist healing environment and facilitating trauma-free removal. Used in professional clinical settings and by patients for OTC applications (abrasions, minor burns, minor cuts, minor lacerations). Applied topically to wounds; provides pressure to control minor bleeding. Benefits include exudate management and support of moist wound healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Soft, non-woven, absorptive fiber dressing; felt or rope configuration. Principle of operation involves absorption of wound exudate to form a fiber mat. No energy source or software components.

Indications for Use

Indicated for management of partial and full-thickness wounds including venous, diabetic, pressure, and arterial ulcers, superficial burns, abrasions, lacerations, donor sites, and incisions. Also indicated for control of minor bleeding. Suitable for professional/prescription use and OTC use for abrasions, minor burns, minor cuts, and minor lacerations.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Aquacel Hydrofiber Wound Dressings (Convatec)
• Kaltostat Wound Dressings (Calgon Vestal Laboratories)

Submission Summary (Full Text)

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JUL 20 1999

991609

## 510(k) Dermaphylyx Absorbent Fiber Wound Dressing K991609. Dermaphylyx, Inc.

### 510(k) Summary

| Proprietary Name: | Dermaphylyx Absorbent Fiber Wound Dressing |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dressing |
| Classification: | Unclassified |
| Submitter's Details: | Dermaphylyx, Inc.<br>78-E, Olympia Avenue,<br>Woburn, MA 01801-2057<br>Tel: [phone]<br>Fax: [phone] |

#### Description:

Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of Absorbent fibers fabricated into a felt or rope configuration.

Dermaphylyx Absorbent Fiber Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a fiber mat which provides an environment conducive to moist wound healing. The fiber mat facilitates traums free removal from the wound.

Dermaphylyx Absorbent Fiber 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 ulcers | Superficial burns |
|-----------------|---------------------------|
| Diabetic ulcers | Abrasions and lacerations |
| Pressure ulcers | Donor sites |
| Arterial ulcers | Incisions |

Dermaphylyx Absorbent Fiber Wound Dressings may also be used to control minor bleeding.

Over the Counter applications include abrasions, minor lacerations, as well as minor burns and the control of minor bleeding by application of pressure to the wound.

Dermaphylyx Absorbent Fiber Wound Dressings are substantially equivalent to Aquace!™ Hydrofiber™ Wound Dressings (Convated), and Kaltostat@ Wound Dressings (Calgon Vestal Laboratories). These devices are absorptive Wound Dressings, manufactured from Absorbent fibers. 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles embedded within the eagle's body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1999

Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 12106 West 75th Lane Arvada, Colorado 80005-5306

Re: K991609 Trade Name: Absorbent Fiber Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 6, 1999 Received: May 10, 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 (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 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 "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) Dermaphylyx Absorbent Fiber Wound Dressing K991609, Dermaphylyx, Inc.

# 991609

Page 1 of 1

## PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K991609 |
|----------------|---------|
| | Dermanh |

aphylyx, Inc.

Device Name:

Dermaphylyx Absorbent Fiber Wound Dressing

Indications for Use:

Dermaphylyx Absorbent Fiber Wound Dressings are soft, non-woven, and absorptive. They are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound,

The following Indications are for Prescription Use or under the direction of a health care professional:

Venous ulcers Diabetic ulcers Pressure ulcers Arterial ulcers

Superficial burns Abrasions and lacerations Donor sites Incisions

The following Indications are for Over-the-Counter Use:

Abrasions Minor Burns Minor Cuts Minor Lacerations

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

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Tóledo

(Division Sign-Off) Division of General Re 510(k) Number