LogoFDA 510(k) Search
K Number
K973657
Device Name
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
Manufacturer
MAERSK MEDICAL, LTD.
Date Cleared
1997-12-01

(67 days)

Product Code
MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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.

N/A