BIODERM FOAM WOUND DRESSING

K982778 · Bioderm, Inc. · KMF · Oct 21, 1998 · General Hospital

Device Facts

• Record ID: K982778
• Device Name: BIODERM FOAM WOUND DRESSING
• Applicant: Bioderm, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist wound healing environment and manage exudate. The dressing is indicated for the local management of the following types of wounds: 1. Partial and full thickness wounds, moderate to heavily exudating wounds such as; a. venous stasis ulcers. b. pressure sores. c. post operative incisions. d. diabetic ulcers. 2. Partial thickness wounds such as; a. abrasions. b. lacerations. c. donor sites. d. superficial burns. 3. Other indications include; a. drainage dressing for tracheostomy and gastrostomy tubs.

Device Story

Bioderm Foam Wound Dressing is an external wound dressing; functions to maintain moist wound healing environment and manage exudate. Used in clinical settings for local management of various wound types including ulcers, incisions, and burns. Applied by healthcare professionals. Device does not accelerate healing, is not a permanent dressing, and is not synthetic skin.

Technological Characteristics

Foam wound dressing. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for local management of partial and full thickness wounds, including venous stasis ulcers, pressure sores, post-operative incisions, diabetic ulcers, abrasions, lacerations, donor sites, superficial burns, and as a drainage dressing for tracheostomy and gastrostomy tubes. Contraindicated for third-degree burns.

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

OCT 21 1998

Mr. George Worthley President Bioderm, Inc. P.O. Box 4882 Wheaton, Illinois 60189

Re: K982778

> Trade Name: Bioderm Foam Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: August 05, 1998 Received: August 07, 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.
- 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. George Worthley

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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

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Bioderm, Inc.

Attachment # 3.

Revised Indications for Use Statement (Originally Exhibit # 3.)

August 14, 1998

510(k) Number (if known): K982778

Device Name: Bioderm Foam Wound Dressing

## Indications for Use:

The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist wound healing environment and manage exudate.

The dressing is indicated for the local management of the following types of wounds:

- 1. Partial and full thickness wounds, moderate to heavily exudating wounds such as;
- a. venous stasis ulcers.
- b. pressure sores.
- c. post operative incisions.
- d. diabetic ulcers.
- 2. Partial thickness wounds such as;
- a. abrasions.
- b. lacerations.
- c. donor sites.
- d. superficial burns.
- 3. Other indications include;
- a. drainage dressing for tracheostomy and gastrostomy tubs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K982778

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

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