BIAFINE WOUND DRESSING EMULSION

K964240 · Medix Pharmaceuticals Americas, Inc. · MGQ · Jan 22, 1997 · SU

Device Facts

• Record ID: K964240
• Device Name: BIAFINE WOUND DRESSING EMULSION
• Applicant: Medix Pharmaceuticals Americas, Inc.
• Product Code: MGQ · SU
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

BIAFINE™ is intended to be used as a wound dressing for the following indications: - superficial wounds - minor abrasions - leg ulcers - donor sites - 1st and 2nd degree burns, including sunburns - radiation dermatitis - for dermal ulcers, including full thickness wounds and pressure sores, consult a physician

Device Story

BIAFINE™ is a topical wound dressing emulsion. It is applied to the skin surface to manage superficial wounds, abrasions, ulcers, donor sites, burns, and radiation dermatitis. The device functions as a physical dressing; it is not labeled for accelerating healing, epithelization, or as a permanent synthetic skin. It is intended for prescription use. The healthcare provider applies the emulsion to the wound site to provide a protective environment. It does not treat or cure wounds.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

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

Indications for Use

Indicated for patients with superficial wounds, minor abrasions, leg ulcers, donor sites, 1st and 2nd degree burns (including sunburns), and radiation dermatitis. For dermal ulcers, including full thickness wounds and pressure sores, physician consultation is required.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JAN 22 1997

Medix Pharmaceuticals Americas, Inc.
c/o Mr. Wayne H. Matelski
Counsel
Arent Fox
1050 Connecticut Avenue, NW
Washington, D.C. 20036-5339

Re: K964240
BIAFINE® Wound Dressing Emulsion
Regulatory Class: Unclassified
Product Code: MGQ
Dated: October 24, 1996
Received: October 24, 1996

Dear Mr. Matelski:

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.

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4. This device may not be labeled as a treatment or a cure for any type of 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact

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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 at [phone].

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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510(k) Number (if known): K964240

Device Name: BIAFINE™ Wound Dressing Emulsion

Indications For Use:

BIAFINE™ is intended to be used as a wound dressing for the following indications:

- superficial wounds
- minor abrasions
- leg ulcers
- donor sites
- 1st and 2nd degree burns, including sunburns
- radiation dermatitis
- for dermal ulcers, including full thickness wounds and pressure sores, consult a physician

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The Counter Use ☐

(Optional Format 1-2-96)