DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING

K991608 · Dermaphylyx, Inc. · KMF · Jul 20, 1999 · General Hospital

Device Facts

• Record ID: K991608
• Device Name: DERMAPHYLYX CALCIUM ALGINATE WOUND 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 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 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 Diabctic ulcers Pressure ulcers Ancrial ulcers Superficial burns Abrasions and laccrations Donor sites Postoperative wounds The following Indications are for Over-the-Counter Usc: Abrasions Minor Burns Minor Cuts Minor Laccrations

Device Story

Dermaphylyx Calcium Alginate Wound Dressing consists of non-woven calcium alginate fibers in felt or rope configuration. Device absorbs wound exudate, forming a gel/fiber mat that maintains a moist wound healing environment and facilitates trauma-free removal. Used in professional clinical settings and OTC for minor wounds. Applied topically to wound site; absorbs exudate and provides pressure to control minor bleeding. Benefits include moist healing environment and non-traumatic dressing changes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-woven calcium alginate fibers; felt or rope configuration; absorptive; gel-forming upon contact with exudate.

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 professional/prescription use and OTC use for minor abrasions, burns, cuts, and 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

• 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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JUL 20 1999

# K991608

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

## 510(k) Summary

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

#### Description:

Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.

Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free 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 | Incisions |

Dermaphylyx Calcium Alginate 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.

Dermaphylyx Calcium Alginate Wound Dressings are substantially equivalent to Innovative Technologies Calcium AlginateWound Dressings (Innovative Technologies 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a bird-like figure with three lines representing the body and wings.

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: K991608 Trade Name: Calcium Alginate Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 7, 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) K991608, Dermaphylyx Calcium Alginate Wound Dressing 城市场 Dermaphylyx, Inc.

Page 1 of 1

### PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K991608 Dermaphylyx, Inc. |
|----------------|---------------------------------------------|
| Device Name: | Dermaphylyx Calcium Alginate Wound Dressing |

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 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 Diabctic ulcers Pressure ulcers Ancrial ulcers
Superficial burns Abrasions and laccrations Donor sites Postoperative wounds

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

Abrasions Minor Burns Minor Cuts Minor Laccrations

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K991608 |

| Prescription Use | <div style="text-align:center;">X</div> | OR | Over-the-Counter Use | <div style="text-align:center;">X</div> |
|----------------------|-----------------------------------------|----|----------------------|-----------------------------------------|
| (Per 21 CFR 801.109) | | | | |

(Optional Formal 1-2-96)