BIODERM FOAM WOUND DRESSING by BIODERM, INC.

The provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document only states that the device, "Bioderm Foam Wound Dressing," is "substantially equivalent" to legally marketed predicate devices for the following indications for use:

Venous stasis ulcers.
Pressure sores Stages 1, 2, 3, & 4.
Ulcers triggered by trauma.
Drainage dressing for tracheostomy and gastrostomy tubes.
Post operative incisions.

It also lists limitations on labeling claims, such as not being labeled for use on third-degree burns, or as having an accelerating effect on wound healing.

To provide the requested information, a different type of document, such as a clinical study report or a detailed summary of the premarket submission, would be necessary.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1997

Mr. George Worthley *President Bioderm Medical, Inc. PO Box 4882 Wheaton, Illinois 60189

Re: K973429 Bioderm Foam Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 5, 1997 Received: September 10, 1997

Dear Mr. Worthley:

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.
This device may not be labeled as a long-term, permanent, or no-change 3. 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 - Mr. George Worthley

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 (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,

Aiocella

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 of 1

510(k) Number (if known): K973429

Device Name: Bioderm Foam wound Dressing

Indications for Use:

1. Venous stasis ulcers.
1. Pressure sores Stages 1, 2, 3, & 4.
1. Ulcers triggered by trauma.
1. Drainage dressing for tracheostomy and gastrostomy tubes.
1. Post operative incisions.

(DO NOT WRITE BELOW THIS LINE-USE ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ice Evaluation (ODE)

(Division Sign-Off) Division of General Res 42-9 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.