BIODERM CALCIUM ALGINATE DRESSING

• K Number: K980451
• Device Name: BIODERM CALCIUM ALGINATE DRESSING
• Manufacturer: BIODERM, INC.
• Date Cleared: 1998-04-09 ( 63 days)
• Product Code: KMF
• Regulation Number: 880.5090
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

• 1. Venous Stasis Ulcers
• 2. Pressure Ulcers
• 3. Diabetic Ulcers
• 4. Surgical Wounds

Device Description

Bioderm Calcium Alginate Wound Dressing

AI/ML Overview

This document is a marketing clearance letter for a medical device (Bioderm Calcium Alginate Dressing) and does not contain the specific information required to complete your request. The letter confirms that the device is substantially equivalent to existing devices based on its stated indications for use but does not provide details of acceptance criteria, study methodologies, or performance data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 1998

Mr. George Worthley President BioDerm, Incorporated P.O. Box 4882 Wheaton, Illinois 60189

Re: K980451

Trade Name: Bioderm Calcium Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: January 27, 1998 Received: February 5, 1998

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.
• 2. 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 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 misbranding and adulteration.

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Page 2 - Mr. Worthley

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,

pooley

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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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K980451

Bioderm, Inc.

Page 3. of 3.

510(k) Number (if known): K980451

Device Name: Bioderm Calcium AlginateWound Dressing

Indications for Use: REVISED

• 1. Venous Stasis Ulcers
• 2. Pressure Ulcers

...

• 3. Diabetic Ulcers
• 4. Surgical Wounds

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K980481

Prescription Use (Per 21 CFR 801.109)	OR	Over-the-Counter Use
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(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.