(67 days)
ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected:
- Pressure Ulcers
- · Venous Ulcers
- · Diabetic Ulcers
- Arterial Ulcers
- Donor Sites and other bleeding surface wounds
- Dermal lesions, trauma injuries or incisions.
ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns, for use on individuals with a known sensitivity to silver, and are not intended to be surgically implanted.
ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "Arglaes-AB Antimicrobial Barrier Island Dressing."
This letter confirms that the FDA has reviewed the manufacturer's submission (K973657) and determined the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. It outlines the regulatory class, product code, and specific limitations on labeling claims for the device. The "Indications For Use Statement" provides details on what the dressing is intended for and its contraindications.
However, the document does not contain:
- A table of acceptance criteria or reported device performance.
- Details on sample sizes, data provenance, or types of studies conducted (e.g., test sets, training sets) for performance evaluation.
- Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
- Any discussion of standalone algorithm performance or specific ground truth types used for device validation.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical trials or performance studies that would typically include the kind of detailed information you're asking for.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined strands. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maersk Medical Ltd. c/o Evan G. Dick, Ph.D. E.G. Dick & Associates 7527 Westmoreland Ave. St. Louis, Missouri 63105
DEC - 1 1997
K973657 Re:
Arglaes-AB Antimicrobial Barrier Island Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 25, 1997 Received: September 25, 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. 1.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change 3. dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of 4. 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 G. 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,
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
{2}------------------------------------------------
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K973657
ARGLAES-AB Antimicrobial Barrier Island Dressing Device Name:
Indications For Use:
)
)
ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing.
ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected:
- Pressure Ulcers
- · Venous Ulcers
- · Diabetic Ulcers
- Arterial Ulcers
- Donor Sites and other bleeding surface wounds
- Dermal lesions, trauma injuries or incisions.
ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns, for use on individuals with a known sensitivity to silver, and are not intended to be surgically implanted.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K973657 |
| Prescription Use (per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
N/A