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K Number
K231088
Device Name
Copper Foam Dressing (Prescription and OTC)
Manufacturer
Roosin Medical Co., Ltd.
Date Cleared
2024-01-11

(269 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K180643
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Prescription use indications (Rx-only):

  • · Partial and full thickness wounds,
  • · Pressure ulcers (stage I-IV),
  • · Diabetic ulcers,
  • · Venous stasis ulcers,
  • · Arterial ulcers.
  • · 1st and partial thickness burns,
  • · Surgical wounds,
  • · Vascular access or peripheral IV sites,
  • · Orthopedic external pin sites, and
  • · Acute wounds such as lacerations, abrasions, and skin tears.

Over-The-Counter (OTC) use indications:
Local management of superficial wounds, minor burns, abrasions and lacerations (tears).

Device Description

"Copper Foam Dressing (Prescription and OTC)" is a sterile, single-use dressing composed of polyurethane and copper oxide particles, which absorbs wound exudate and releases copper ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

Based on in vitro laboratory testing, the copper has been shown to inhibit bacterial growth within the dressing for up to 7 days.

The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.

All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.

Stability study shows the product has a shelf life of three years.

AI/ML Overview

This is a medical device submission, specifically a 510(k) summary for a Copper Foam Dressing. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel AI/software device. As such, the information typically found in an AI/software device submission regarding acceptance criteria, study design, and performance metrics for an algorithm is not present in this document.

The provided text describes a traditional medical device (Copper Foam Dressing) and its physical and chemical properties, indications for use, and a comparison to a predicate device. It evaluates attributes such as material, design, antibacterial agents, and sterilization.

Therefore, I cannot provide the requested information, which is specific to AI/software device studies. The document does not contain:

  1. A table of acceptance criteria and reported device performance for an AI/software.
  2. Sample size used for a test set or data provenance for an algorithm.
  3. Number and qualifications of experts for establishing ground truth for an AI/software.
  4. Adjudication method for a test set for an AI/software.
  5. A multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Standalone (algorithm-only) performance data.
  7. Type of ground truth used for an AI/software (expert consensus, pathology, outcomes data).
  8. Sample size for a training set for an AI/software.
  9. How ground truth for a training set was established for an AI/software.

The closest information related to "acceptance criteria" for this device exists in the "Antibacterial Effectiveness" and "Absorbency" rows in Table 5.1 (Comparison of Intended Use, Design, and Material) and the "Antibacterial activity was measured following AATCC 100-2004" statement, but these are for the physical dressing, not an AI/software component.

N/A