Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

Device Description

The Low Adherent AFM Ag Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are designed to contact the wound as a primary dressing and permit the passage of fluids. The dressings provide a protective environment for the wound and an effective protection against microbial contamination in the dressing. The devices are effective antimicrobial barrier dressings against both Gram-positive and Gram-negative bacteria, including the following organisms: methicillin-resistant Staphylococcus aureus (MRSA). methicillin- resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus faecalis (VRE), Pseudomonas aeruginosa, and Acinetobacter baumannii.

AI/ML Overview

The provided text does not describe a study that proves the device meets specific acceptance criteria in the context of typical medical device performance studies for diagnostic or therapeutic efficacy.

Instead, this document is a 510(k) Summary for a wound dressing, which focuses on substantial equivalence to a previously cleared predicate device. The "performance testing" mentioned is for validation activities rather than a comparative effectiveness or standalone performance study in the way one might expect for a diagnostic AI device.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth, and expert involvement are not applicable or cannot be extracted from this specific document.

Here's an attempt to answer the questions based on the available information, highlighting where the information is missing or not relevant to the requested structure:

Acceptance Criteria and Device Performance Study for Low Adherent AFM Ag Dressings

The provided 510(k) Summary for the Low Adherent AFM Ag Dressings describes validation activities to support the modified device, rather than a study with explicit acceptance criteria and device performance metrics as would typically be presented for a diagnostic or AI-driven device.

The core of this submission is to demonstrate substantial equivalence to a predicate device (Milliken Silver Wound Dressing, K051445) and to confirm that the modification (addition of a low adherent wound contact layer) does not affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance / Validation Achieved
Biocompatibility	Not explicitly stated	Biocompatibility Testing was conducted.
Antimicrobial Effectiveness	Not explicitly stated, but inferred from predicate device's claims	Validation of Antimicrobial Effectiveness was conducted. The device is effective antimicrobial barrier against Gram-positive and Gram-negative bacteria, including MRSA, MRSE, VRE, Pseudomonas aeruginosa, and Acinetobacter baumannii.
Sterility	Not explicitly stated	Sterility Validation was conducted.
Overall Performance	Fulfill prospectively defined performance criteria; modified system meets user needs (post-modification).	"Testing... has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modified system meets user needs."
Substantial Equivalence	Device is identical to predicate except for low adherent layer; modification does not affect safety and effectiveness.	FDA found the device to be substantially equivalent to the predicate device K051445.

Missing Information: Precise quantitative acceptance criteria (e.g., specific cytotoxicity thresholds, minimum microbial reduction percentages, or sterility assurance levels as defined in standards) are not detailed in this summary. The "reported device performance" is described qualitatively as "validation conducted" and meeting "prospectively defined performance criteria."

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of a performance study for a diagnostic or therapeutic effect. The validation activities (biocompatibility, antimicrobial effectiveness, sterility) typically involve standardized laboratory tests, for which sample sizes are determined by the specific test methods and regulatory standards (e.g., ISO, ASTM). The document does not provide these sample sizes or data provenance (country, retrospective/prospective) for these lab tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The validation activities for a wound dressing (biocompatibility, antimicrobial effectiveness, sterility) do not involve expert-established "ground truth" in the way a diagnostic imaging study would. Standardized laboratory methods and controls are used.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication is described or relevant for these types of validation tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study is not relevant for a wound dressing and was not conducted or mentioned in this 510(k) summary. This type of study is typically for diagnostic devices, especially those involving human interpretation of data (e.g., radiology AI).

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical wound dressing, not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable here. For the described validation activities:

Biocompatibility: Ground truth is established by standardized material safety tests and comparison to established safe materials or acceptable toxicity limits (e.g., ISO 10993 standards).
Antimicrobial Effectiveness: Ground truth is established by laboratory cultures and validated methods for measuring microbial reduction or inhibition (e.g., ATCC strains, established protocols).
Sterility: Ground truth is established by validated sterilization processes and sterility testing (e.g., USP guidelines, ISO 11137).

8. The Sample Size for the Training Set

Not applicable. This device is a physical wound dressing and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, this question is not relevant.

Summary of Device Rationale from the Document:

The 510(k) describes a modification to an already cleared predicate device (Milliken Silver Wound Dressing K051445). The modification is the "addition of a low adherent wound contact layer." The key argument for substantial equivalence is that this modification is "minor and does not affect safety and effectiveness of the device." The "performance testing" (biocompatibility, antimicrobial effectiveness, sterility validation) was conducted to confirm that the modified device continues to meet expected performance criteria, implying these tests re-verified the properties of the device post-modification without necessarily presenting a new comparative efficacy study.

Summary

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K103441

510(k) Summary (per 21 CFR 807.92) Low Adherent AFM Ag Dressings

1. SPONSOR

も

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JAN 21 2011

Milliken Healthcare Products, LLC 920 Milliken Road Spartanburg, SC 29303 Contact Person: Brian J. Lindsay Telephone: (864) 503-1323

Date Prepared: October 22, 2010

2. CONSULTANT/CONTACT

Medical Device Consultants, Inc. 11440 West Bernardo Drive, Suite 300 San Diego, CA 92127 Telephone: 858-753-1961 Facsimile: 858-753-1962

Primary Contact: Ron Warren

3. DEVICE NAME

Proprietary Name:	Low Adherent AFM Ag Dressings
Common/Usual Name:	Wound Dressing
Classification Name:	Dressing, Wound, Drug (Product Code, FRO)

4. DEVICE CLASSIFICATION

FDA has not finally classified silver-containing wound dressings. The Office of Device Evaluation has published the document, Draft Guidance for the Prèparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing, revision March 31, 1995, which includes Hydrophilic (procode KMF), Occlusive (procode MGP), Hydrogel (procode MGQ), and Porcine dressings (procode KGN). Other types of wound dressings are also non-interactive, and the guidance document is applicable to them as well, including Dressing (procode FRO) and Dressing, Wound, Hydrophilic (procode NAC). Most silver-containing wound dressing devices have been given the product code FRO but not classified, including the applicable predicate devices.

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5. PREDICATE DEVICES

· Milliken Silver Wound Dressing (Milliken Healthcare Products, LLC) Cleared August 22, 2005 under K051445.

6. DEVICE DESCRIPTION

7. INTENDED USE

Low Adherent AFM Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). The Low Adherent AFM Ag Dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing.

8. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The subject of this Special 510(k) is a modification of the Milliken Silver Wound Dressing that was previously cleared on August 22, 2005 under Premarket Notification Number K051445. The subject of this Special 510(k) is the addition of a low adherent wound contact layer.

No modification is being made to any other components. The Low Adherent AFM Ag Dressings is identical to the original Milliken Silver Wound Dressings (K051445) except that it has been modified by the addition of a low adherent wound contact layer. The modification is minor and does not affect safety and effectiveness of the device.

9. PERFORMANCE TESTING

Validation activities to support the use of the Low Adherent AFM Ag Dressings consisted of three main elements:

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Biocompatibility Testing
Validation of Antimicrobial Effectiveness
Sterility Validation

Testing of the Low Adherent AFM Ag Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modified system meets user needs.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Milliken Healthcare Products, LLC % Medical Device Consultants, Inc. Mr. Ronald S. Warren 11440 West Bernardo Court, Suite 300 San Diego, California 92127

JAN 21 2011

Re: K103141 '

Trade/Device Name: Low Adherent AFM Ag Dressings Regulatory Class: Unclassified Product Code: FRO Dated: December 10, 2010 Received: December 13, 2010

Dear Ms. Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Ronald S. Warren

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A.G. B. M. h.

Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

KIO3141 510(k) Number (if known):

Device Name: Low Adherent AFM Ag Dressings

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Daid Kume

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Levices

510(k) Number K103141

Regulation Number and Section

N/A