DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

K991061 · Dermaphylyx, Inc. · NAE · Jun 28, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991061
• Device Name: DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
• Applicant: Dermaphylyx, Inc.
• Product Code: NAE · General, Plastic Surgery
• Decision Date: Jun 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4022
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Dermaphylyx Calcium Alginate Wound Dressings 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. 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 Postoperative wounds The following Indications are for Over-the-Counter Use: Abrasions Minor Burns Minor Cuts Minor Lacerations

Device Story

Dermaphylyx Calcium Alginate Wound Dressing consists of calcium alginate fibers in felt or rope configurations. Device absorbs wound exudate; transforms into gel/fiber mat upon contact with exudate. Gel formation facilitates removal from wound. Used in professional clinical settings and OTC environments for wound management and minor bleeding control. Healthcare providers or patients apply dressing directly to wound site. Output is physical wound coverage and exudate management; aids in healing process by maintaining moist wound environment and controlling minor hemorrhage.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Calcium alginate fibers; felt and rope configurations. Absorptive material; gel-forming upon exudate contact. Standalone dressing; non-electronic. No software or algorithm 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 postoperative wounds. Also indicated for control of minor bleeding. Suitable for prescription use by healthcare professionals and OTC use for abrasions, minor burns, minor cuts, and minor lacerations.

Regulatory Classification

Identification

A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

• Innovative Technologies Calcium Alginate Wound Dressings (Innovative Technologies Group, Ltd.)
• Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories)

Submission Summary (Full Text)

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#### Dermaphylyx Calcium Alginate Wound Dressing 510(k) = Dermaphylyx, Inc.

# 510(k) Summary

Dermaphylyx Calcium Alginate Wound Dressing Proprietary Name:

Common Name: Dressing

Classification: Unclassified

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

## Description:

Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations.

Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.

Dermaphylyx Calcium Alginate 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 | Postoperative wounds |

Dermaphylyx Calcium Alginate Wound Dressings may also be used to control minor bleeding.

Over the Counter applications include abrasions, minor laccrations, as well as minor burns and the control of minor bleeding.

Dermaphylyx Calcium Alginate Wound Dressings are substantially cquivalcat to Innovative Technologies Calcium AlginateWound Dressings (Innovative Technologics Group, Ltd.) and Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories). These devices are absorptive Calcium Alginate Wound Dressings, manufactured from calcium alginate 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 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" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a profile view of a person's head and shoulders.

Public Health Service

JUN 288 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Andrew M. Reed, Ph.D. Principal Dermaphylyx, Inc. 78-E Olympia Avenue Woburn, Massachusetts 01801

Re: K991061

Trade Name: Calcium Alginate Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: March 26, 1999 Received: March 30, 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.

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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K991061

### Dermaphylyx Calcium Alginate Wound Dressing 510(k) Dermaphylyx, Inc.

Page 1 of 1

## PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

K 991061 510(k) Number: Dermaphylyx, Inc.

Dermaphylyx Calcium Alginate Wound Dressing Device Name:

Indications for Use:

Dermaphylyx Calcium Alginate Wound Dressings 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.

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

- Venous ulcers Diabctic ulcers Pressure ulcers Arterial ulcers
Superficial burns Abrasions and lacerations Donor sites Postoperative wounds

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 Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

AND

Over-The-Counter Use

(Optional Format 1-2-95)

(Division
D
Restorative Devices K99106/
51 IDel