ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 by ACUTEK ADHESIVE SPECIALTIES, INC.

The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily 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 Description

Acutek Hydrocolloid Wound Dressing, TIB 197013

AI/ML Overview

This document is a 510(k) clearance letter for the Acutek Hydrocolloid Wound Dressing, TIB 197013. It determines that the device is substantially equivalent to devices marketed prior to May 28, 1976. This type of document, particularly one from 1998, focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study is not applicable to this document.

The document states the "Indications For Use" (which can be considered the intended use and scope), and these are:

Indications For Use:
The Hydrocolloid Dressing is intended for applications where gentle adhesion to the skin is desirable. Also, the dressing is intended for the management of lightly to heavily 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.

Limitations (equivalent to acceptance criteria exclusions from labeling):

This device may not be labeled for use on third-degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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.

The "study that proves the device meets the acceptance criteria" in the context of a 510(k) for a traditional medical device prior to the widespread use of sophisticated AI would have involved demonstrating equivalence to a predicate device, often through bench testing, materials testing, and sometimes limited clinical data, but not typically in the format of an AI performance study as outlined in the request. The letter confirms that based on the submission, the device is substantially equivalent, allowing it to proceed to market under general controls.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1 1998

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

Re: K974891

Trade Name: Acutek Hydrocolloid Wound Dressing, TIB 197013 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:

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 of 2. wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. 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

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or 301-443-6597 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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Page 1

510(k) Number (if known):_K 974891

Device Name: Acutek Hydrocolloid Wound Dressing, TIB 197013

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General Restorative Devices 510(k) Number _ OR Prescription Use_ Over-The-Counter Use (Optional Format 1-2-96) (Per 21 CFR 801.109)

Regulation Number and Section

N/A