ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012

K974892 · Acutek Adhesive Specialties, Inc. · MGP · Oct 13, 1998 · SU

Device Facts

• Record ID: K974892
• Device Name: ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
• Applicant: Acutek Adhesive Specialties, Inc.
• Product Code: MGP · SU
• Decision Date: Oct 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. The dressing is also intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.

Device Story

Hydrocolloid wound dressing designed for management of lightly to moderately exudating wounds. Functions by absorbing wound exudate and maintaining moist environment to support autolytic debridement; backing material facilitates gas exchange. Applied topically to wound sites; intended for clinical or home use. Provides protective barrier; maintains moist environment to facilitate healing. Not for use on third-degree burns; not intended as artificial skin or long-term dressing.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Hydrocolloid-based wound dressing; includes adhesive component and gas-permeable backing. Non-active device.

Indications for Use

Indicated for management of lightly to moderately exudating wounds including venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns. Contraindicated for third-degree burns.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 13 1998

Mr. Greg Holland Director of Regulatory Affairs Acutek Adhesive Specialties, Inc. 540 North Oak St. Inglewood, California 90302

Re: K974892

> Trade Name: Acutek Hydrocolloid Wound Dressing, TIB 197012 Regulatory Class: Unclassifed Product Code: MGP Dated: July 30, 1998 Received: July 31, 1998

Dear Mr. Holland:

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:

- 1. This device may not be labeled for use on third degree burns.
- 2. This device may not be labeled as having any accelerating effect on the rate 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 wound. 4.

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

{1}------------------------------------------------

Page 2 - Mr. Greg Holland

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,

lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of_

510(k) Number (if known): K 974892

Device Name: Acutek Hydrocolloid Wound Dressing, TIB 197012

Indications For Use:

The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. The dressing is also intended for the management of lightly to moderately exudating wounds by absorbing exudate and by maintaining a moist wound environment. The moist wound environment supports autolytic debridement. The dressing backing allows for gas exchange. The dressing is indicated for use in the following types of wounds: venous stasis ulcers, pressure ulcers, surgical incision sites, and minor burns.

(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 | K944892 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use (Optional Format 1-2-96) |