DERMAMEND HYDROGEL GAUZE DRESSING

K972336 · Dermarx Corp. · KMF · Jul 29, 1997 · General Hospital

Device Facts

• Record ID: K972336
• Device Name: DERMAMEND HYDROGEL GAUZE DRESSING
• Applicant: Dermarx Corp.
• Product Code: KMF · General Hospital
• Decision Date: Jul 29, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To absorb exudate and to create and maintain a moist environment for partial and full thickness wounds including pressure ulcers, stage I-IV; stasis ulcers; dermal wounds; 1st and 2nd degree burns; cuts, abrasions, and other irritations of the skin.

Device Story

DermaMend™ Hydrogel Gauze Dressing is a wound care product designed to manage exudate and maintain a moist wound environment. It is applied topically to the wound site by a clinician or patient. The dressing functions as a passive barrier and absorbent medium to facilitate healing in various skin wounds. It is not indicated for third-degree burns, nor is it intended to accelerate healing, act as artificial skin, or serve as a permanent dressing. The device provides a moist environment which may benefit patient comfort and wound management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrogel-impregnated gauze dressing. Designed for exudate absorption and moisture maintenance. Non-implantable. No electronic or software components.

Indications for Use

Indicated for patients with partial and full thickness wounds, including pressure ulcers (stage I-IV), stasis ulcers, dermal wounds, 1st and 2nd degree burns, cuts, abrasions, and skin irritations requiring exudate absorption and a moist wound environment.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

972336

Ms. Maryanne Carroll President DermaRx Corporation 400 S. Colorado Boulevard, Suite 420 Denver, Colorado 80222

JUL 2 9 1997

K972336 DermaMend™ Hydrogel Gauze Dressing Regulatory Class: Unclassified Product Code: KMF Dated: June 23, 1997 Received: June 23, 1997

Dear Ms. Carroll:

Re:

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 2. of 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.
- This device may not be labeled as a treatment or a cure for any type of 4. 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

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Page 2 - Ms. Maryanne Carroll

registration, listing of devices, good manufacturing practices, 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 (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,**

fo

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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Page --/ of /

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

DermaMend™ Hydrogel Gauze Dressing Device Name:

Indications For Use:

- To absorb exudate and to create and maintain a moist environment for partial and full -To absorb exudate and to create and manual a more estasis ulers; dermal wounds;
thickness wounds including pressure ulcers, stage I-V; stasis ulers; dermal wounds;
thickness thickness wounds including pressure alocre, busers, and other imitations of the skin.
1ª and 2ª degree burns; cuts, abrasions, and other imitations of the skin.
(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 | K972336 |

| Prescription Use<br>(Per 21 CFR 801.109) | ✓ |
|------------------------------------------|---|
| OR | |
| Over-The-Counter Use | |

(Optional Format 1-2-96)