Laboratory studies for Arglaes AB wound powder have shown the product to resist bacterial penetration through the dressing which may help minimize the risk of infection¹. This effect may be limited based upon evenness of application and contact with the wound surface.

Device Description

Arglaes-AB Powder is a dressing in powder form that is comprised of silver oxide stabilized within a polymer composed of phosphorus oxide, sodium oxide, calcium oxide and silver oxide. The balance of the powder is comprised of phosphorus oxide, sodium oxide and calcium oxide (no silver) and of sodium alginate powder.
Sodium alginate is substantially equivalent to the alginate component of the Arglaes-AB Antimicrobial Barrier Island Dressing. Its primary function is to absorb wound exudate and to help control minor bleeding.
The silver oxide is substantially equivalent to the silver oxide component of the Arglaes-AB Antimicrobial Barrier Film and Island dressings. This helps resist bacterial penetration through the dressing.³

AI/ML Overview

This document describes the FDA 510(k) clearance for the Arglaes-AB Antimicrobial Barrier Powder Dressing. It is important to note that this is a 510(k) clearance for a medical device (a wound dressing), not an AI/ML powered device. Therefore, many of the requested specific details related to AI/ML device studies (e.g., sample sizes for AI test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or available in this type of FDA submission.

However, I will extract and present the information that is relevant to the device's performance and testing as described in these documents.

The device in question is a wound dressing with antimicrobial barrier properties, not an AI/ML powered medical device. Therefore, the types of studies and acceptance criteria are focused on the physical and biological characteristics of the dressing, rather than algorithmic performance.

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

Acceptance Criteria Category	Specific Test/Performance Metric	Reported Device Performance	Comments
Antimicrobial Barrier	USP XXIII Preservative Test	"Arglaes™ Powder does resist bacterial penetration through the dressing by the listed organisms."	Organisms tested: Aspergillus niger, Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli. This indicates the product's ability to inhibit microbial growth/survival.
Antimicrobial Barrier	7-Day Antimicrobial Barrier (Strike Through) Test	"The product met all requirements for the above reference test, demonstrating that it effectively resists bacterial penetration through the dressing for a 7 day period in vitro."	Tested against a broad panel of bacteria and fungi (see list below). This test specifically assesses the physical barrier function against microbial invasion.
Biocompatibility	Cytotoxicity	"All test results were acceptable."	Tested in accordance with ISO 10993 requirements.
Biocompatibility	Primary Skin Irritation	"The product was not found to be either an irritant or a sensitizer and all test results were acceptable."	Tested in accordance with ISO 10993 requirements.
Biocompatibility	Dermal Sensitization	"The product was not found to be either an irritant or a sensitizer and all test results were acceptable."	Tested in accordance with ISO 10993 requirements.

Important Note: The document explicitly states: "Laboratory studies for Arglaes AB wound powder have shown the product to resist bacterial penetration through the dressing which may help minimize the risk of infection. This effect has not been demonstrated clinically at this time." This indicates that while in vitro performance criteria were met, clinical efficacy was not part of this 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample sizes used for the USP XXIII Preservative Test, 7-Day Antimicrobial Barrier Test, or biocompatibility tests. These are typically standard laboratory tests with defined numbers of samples per group (e.g., replicates for microbial assays, number of animals for biocompatibility).
Data Provenance: The studies are described as "Laboratory studies" and "in vitro." The sponsor, Maersk Medical, Ltd., is located in Redditch, Worcestershire, England. The studies were likely conducted either by Maersk Medical or contracted by them, but the specific country of origin for the data generation is not explicitly stated. These are in vitro and in vivo (animal for biocompatibility) studies, not human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this 510(k) submission for a wound dressing. "Ground truth" in the context of AI/ML usually refers to human-labeled data used to evaluate algorithm performance. For laboratory tests of a wound dressing, the "ground truth" is established by the well-defined procedures and objective measurements of the standardized tests themselves (e.g., microbial counts, visual inspection for irritation scores). No human experts are used in this capacity to "establish ground truth" for these types of tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are typical for resolving discrepancies among human readers/annotators in AI/ML studies. For standardized laboratory tests, results are typically determined by adherence to a protocol and objective measurement, not by expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specifically designed for evaluating diagnostic devices, often involving human interpretation of medical images, and are highly relevant for AI-assisted diagnostic tools. This submission is for a physical wound dressing, not a diagnostic or AI-powered device.

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

Not applicable. This is not an AI algorithm; it is a physical wound dressing with antimicrobial properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the antimicrobial tests, the "ground truth" is the demonstrable presence or absence of microbial growth or penetration based on objective laboratory assays (e.g., colony forming units, visual evidence of strikethrough). For biocompatibility, the "ground truth" is the observed biological response (e.g., cell viability in cytotoxicity, skin reaction scores in irritation/sensitization) as measured against control groups and defined thresholds within standardized test protocols.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no AI/ML component, there is no training set and no ground truth established for it.

Summary

FDA 510(k) Clearance Documentation - Arglaes-Ab Antimicrobial Barrier Powder Dressing

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.04

December 2, 2024

Maersk Medical, Ltd.
c/o Lara N. Simmons
Corporate Director, Regulatory Affairs
Medline Industries, Inc.
One Medline Place
Mundelein, Illinois 60060

Re: K004028
Trade/Device Name: Arglaes-Ab Antimicrobial Barrier Powder Dressing
Regulatory Class: Unclassified
Product Code: FRO

Dear Lara N. Simmons:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 27, 2001. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code FRO.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Yu-Chieh Chiu, OHT4: Office of Surgical and Infection Control Devices, 301-796-6196, YuChieh.Chiu@fda.hhs.gov.

Sincerely,

Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Page 2

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAR 2 7 2001

Maersk Medical, Ltd.
c/o Ms. Lara N. Simmons
Corporate Director, Regulatory Affairs
Medline Industries, Inc.
One Medline Place
Mundelein, Illinois 60060

Re: K004028
Trade Name: Arglaes AB Powder Dressing
Regulatory Class: II
Product Code: MGP
Dated: December 26, 2000
Received: December 27, 2000

Dear Ms. Simmons:

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 (Act). 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.

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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.

Page 3

Page 2 - Ms. Lara N. Simmons

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

Page 4

THE A.P. MOLLER GROUP

MAERSK MEDICAL

2.0 Indications for Use

Page 1 of 1

510(k) Number (if known): K004028

Device Name: Arglaes AB Wound Powder

Indications For Use:

A topical wound dressing for the treatment of difficult to dress wounds, surface wounds, exudating wounds, including:

pressure ulcers,
venous ulcers
diabetic ulcers
arterial ulcers
donor sites
dermal lesions
trauma injuries
incisions

¹This effect has not been demonstrated clinically at this time.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓ OR Over-The-Counter Use ______
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Division Sign-Off
Division of General, Restorative and Neurological Devices
03/20/01

510(k) Number K004028

Page 5

MAR 2 7 2001 K004028

THE A.P. MOLLER GROUP

MAERSK MEDICAL

510(K) SUMMARY

1.0 Sponsor

Maersk Medical, Ltd.
Thornhill Road, North Moons Moat
Redditch, Worcestershire, England
Registration Number: 8010113

2.0 Submission Correspondent

Medline Industries, Inc.
One Medline Place
Mundelein, IL 60060
Contact Name: Lara N. Simmons
Contact Title: Corporate Director, Regulatory Affairs
Phone: 847-949-2639
Fax: 847-837-2787
Email: Lsimmons@Medline.com

3.0 Regulatory Information

Device Name: Hydrophilic Wound Dressing
Proprietary Name: Arglaes-AB Powder Dressing
Common Name: Powder Wound Dressing
Device Code: 79 MGP
Device Classification: II

4.0 Substantial Equivalence

Arglaes-AB ™ Powder is substantially equivalent in form and content to the Arglaes-AB ™ Antimicrobial Film (K970566, K990810) and Island (K973657, K990810) dressings and the Sorbsan (K881854, K914575). It is similar in function to the Silverlon Wound Packing Strips (K984210).

5.0 Device Description

Confidential Page 8 03/20/01

Page 6

THE A.P. MOLLER GROUP

MAERSK MEDICAL

Sodium alginate is substantially equivalent to the alginate component of the Arglaes-AB Antimicrobial Barrier Island Dressing. Its primary function is to absorb wound exudate and to help control minor bleeding.

The silver oxide is substantially equivalent to the silver oxide component of the Arglaes-AB Antimicrobial Barrier Film and Island dressings. This helps resist bacterial penetration through the dressing.³

6.0 Intended Use

A topical wound for the treatment of difficult to dress wounds, surface wounds, exudating wounds, including:

pressure ulcers,
venous ulcers
diabetic ulcers
arterial ulcers
donor sites
dermal lesions
trauma injuries
incisions

Laboratory studies for Arglaes AB wound powder have shown the product to resist bacterial penetration through the dressing which may help minimize the risk of infection⁴. This effect may be limited based upon evenness of application and contact with the wound surface.

7.0 Technological Characteristics

There are no major differences in technical characteristics between this product and the predicate devices. The only difference is this is a powder form of the already marketed Arglaes-AB™ Film and Arglaes-AB™ Island dressings.

³ This effect has not been demonstrated clinically at this time
⁴ This effect has not been demonstrated clinically at this time

Confidential Page 9 03/20/01

Page 7

THE A.P. MOLLER GROUP

MAERSK MEDICAL

8.0 Substantial Equivalence

This product was tested using the USP XXIII Preservative Test and the 7 – day Antimicrobial Barrier (Strike Through) Test. Testing was conducted on the following organisms:

USP XXIII Preservative Test:

Similar to the Arglaes-AB™ Antimicrobial Film Dressing, a USP XXIII Preservative Test and a Microbial Barrier (Strike-Through) study were performed on the Arglaes™ Powder. These studies indicate that the Arglaes™ Powder does resist bacterial penetration through the dressing by the listed organisms.

Aspergillus niger
Candida albicans
Pseudomonas aeruginosa
Staphylococcus aureus
Escherichia coli

7-Day Antimicrobial Barrier (Strike Through) Test

Aspergillus niger (ATCC #16404)
Bacillus Subtilis (ATCC #9372)
Candida Albicans (ATCC #10231)
Enterobacter cloacae (ATCC #13047)
Enterococcus faecalis (vancomycin-resistant, ATCC #51575)
Enterococcus faecium (ATCC #19434)
Escherichia coli (ATCC #8739)
Klebsiella pneumoniae (ATCC#13883)
Proteus mirabilis (ATCC #12453)
Proteus vulgaris (ATCC #13315)
Serratia marcescens (ATCC #14756)
Staphylococcus aureus (methicillin- and gentamicin- resistant ATCC #33593)
Staphylococcus aureus (ATCC #6538)
Staphylococcus aureus (methicillin resistant ATCC #33591)
Staphylococcus epidermidis (ATCC #12228)
Streptococcus agalactiae (ATCC #13813)
Streptococcus pyogenes (ATCC #8669)

Confidential Page 10 03/20/01

Page 8

THE A.P. MOLLER GROUP

MAERSK MEDICAL

Arglaes-AB ™ Powder was tested for its ability to prevent bacterial strikethrough for a 7 day period. The product met all requirements for the above reference test, demonstrating that it effectively resists bacterial penetration through the dressing for a 7 day period in vitro.

9.0 Biocompatibility

This product was tested in accordance with ISO 10993 requirements for biocompatibility using the following tests:

Cytotoxicity
Primary Skin Irritation
Dermal Sensitization

The product was not found to be either an irritant or a sensitizer and all test results were acceptable.

Confidential Page 11 03/20/01

Regulation Number and Section

N/A