(166 days)
Not Found
Not Found
No
The summary describes a film dressing and does not mention any AI or ML capabilities.
No.
The ARGLAES Film Dressings are intended for the local management of various types of wounds and to secure/protect catheters, which are supportive functions for healing and care, but do not directly exert a therapeutic effect on the body in the manner of a drug or an active medical treatment.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a dressing for the local management of various wounds and for securing catheters. This indicates a therapeutic or protective function, not a diagnostic one. Diagnostic devices are used to identify or characterize medical conditions.
No
The device description clearly identifies it as a "Film Dressing," which is a physical, tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dressing for the local management of various wounds and for securing catheters. This is a topical application and does not involve testing samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
- Device Description: The description "ARGLAES-AB Antimicrobial Barrier Film Dressing" further reinforces its function as a physical barrier and dressing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, the ARGLAES Film Dressing falls under the category of a medical device used for wound care and securing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.
Product codes
MGP
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 29 1997
Maersk Medical Ltd. c/o Evan Dick, Ph.D. E.G. Dick & Associates ······················································································································································· 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re: K970566
ARGLAES-AB Antimicrobial Barrier Film Dressing Regulatory Class: Unclassified Product Code: MGP Dated: May 29, 1997 Received: May 30, 1997
Dear Dr. Dick:
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.
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- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
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- 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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- 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
1
Page 2 - Evan Dick, Ph.D.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact 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 301-443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celía M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K970566
Device Name:
ARGLAES FILM DRESSING
Indications For Use:
ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers.
ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.
(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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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970566
OR
Prescription Use
(per 21 CFR 01.109)
Over-The-Counter Use_
(Optional Format 1-2-96)