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K Number
K163062
Device Name
PHMB Antimicrobial Foam Wound Dressing
Manufacturer
Advanced Medical Solutions Ltd.
Date Cleared
2017-07-25

(265 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K082296
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PHMB Foam Wound Dressings are indicated for use in the temporary management (

Device Description

The subject device, PHMB Foam Wound Dressing, is a polyurethane foam impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment. Based on in vitro performance data, the PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria within the dressing while in use (

AI/ML Overview

The provided documentation is a 510(k) Summary Statement for a medical device called "PHMB Foam Wound Dressing." It describes the device, its intended use, claims substantial equivalence to a predicate device, and summarizes performance testing. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

This document describes a conventional wound dressing, not an AI/ML powered device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance with AI, etc.) are not applicable to this document.

Here's a breakdown of what the document does provide and why it doesn't fit the AI/ML framework:

1. A table of acceptance criteria and the reported device performance:

  • Acceptance Criteria (Implied/General): The document implies acceptance criteria are met by demonstrating substantial equivalence to a predicate device and by providing in-vitro and animal testing results that show the dressing's functional and biological safety properties. These are not explicitly numerical or threshold-based acceptance criteria for an AI model's performance metrics.
  • Reported Device Performance:
    • **Barrier to bacterial penetration and prevention of colonization and proliferation within the dressing (

N/A