BIAFINE WOUND DRESSING EMULSION

• K Number: K964240
• Device Name: BIAFINE WOUND DRESSING EMULSION
• Manufacturer: MEDIX PHARMACEUTICALS AMERICAS, INC.
• Date Cleared: 1997-01-22 ( 90 days)
• Product Code: MGQ
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: K024367 , K041342 , K052643 , K060272 , K070309 , K090337 , K093544 , K110172 , K110762 , K113807 , K122595 , K173549

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 plysician

Device Description

BIAFINE® Wound Dressing Emulsion

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for BIAFINE® Wound Dressing Emulsion. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states:

• "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... to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria through a new study.

Therefore, I cannot provide the requested information from this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three people.

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 October 24, 1996 Received:

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:

• This device may not be labeled for use on third 1. . degree burns.
• 2. This device may not be labeled as havinq any accelerating effect on the rate of wound healing or epithelization.
• This device may not be labeled as a lonq-term, 3 . permanent, or no-change dressinq, or as an artificial (synthetic) skin.

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Page 2 - Mr. Wayne H. Matelski

• 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 reqistration, listing of devices, qood 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 Druq 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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Page 3 - Mr. Wayne H. Matelski

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,

[signature]

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

3

Enclosure

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510(k) Number (if known):

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 plysician

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A