(90 days)
Not Found
Not Found
No
The 510(k) summary describes a wound dressing emulsion and does not mention any AI or ML capabilities.
Yes
The device is intended to be used as a wound dressing for various medical conditions, including superficial wounds, burns, and ulcers, which are therapeutic applications.
No
The "Intended Use / Indications for Use" states that BIAFINE™ is a wound dressing for various types of wounds, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states "BIAFINE® Wound Dressing Emulsion," indicating a physical product (an emulsion) used as a wound dressing, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes BIAFINE™ as a "wound dressing" for various types of wounds and burns. This is a topical application for treating the body directly.
- Device Description: It's described as a "Wound Dressing Emulsion," which is a physical product applied to the skin.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The provided information does not mention any such testing or analysis of specimens.
Therefore, BIAFINE™ is a medical device, but it falls under the category of a wound dressing, not an In Vitro Diagnostic.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
MGQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
-
- 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 (301) 594-4595. 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 (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 at (301) 443-6597.
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
3
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)
coooo
(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)