ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING

K004028 · Maersk Medical, Ltd. · FRO · Mar 27, 2001 · SU

Device Facts

• Record ID: K004028
• Device Name: ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
• Applicant: Maersk Medical, Ltd.
• Product Code: FRO · SU
• Decision Date: Mar 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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 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 may be limited based upon evenness of application and contact with the wound surface.

Device Story

Arglaes-AB Powder is a topical wound dressing; composed of silver oxide stabilized within a polymer matrix (phosphorus oxide, sodium oxide, calcium oxide) and sodium alginate. Applied to wound surface; sodium alginate absorbs exudate and controls minor bleeding; silver oxide provides antimicrobial barrier properties by resisting bacterial penetration through the dressing. Used in clinical settings for difficult-to-dress or exudating wounds. Benefits include exudate management and potential reduction in infection risk via bacterial barrier. Effectiveness depends on application evenness and wound contact.

Clinical Evidence

Bench testing only. No clinical data provided. In vitro studies included USP XXIII Preservative Test and 7-day Antimicrobial Barrier (Strike-Through) Test against 17 organisms (including S. aureus, E. coli, P. aeruginosa, and various resistant strains). Results demonstrated the powder effectively resists bacterial penetration for 7 days. Biocompatibility testing performed per ISO 10993 (cytotoxicity, primary skin irritation, dermal sensitization) showed acceptable results.

Technological Characteristics

Powder dressing composed of silver oxide, phosphorus oxide, sodium oxide, calcium oxide, and sodium alginate. Functions as a physical barrier and exudate absorbent. Biocompatibility tested per ISO 10993. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients with difficult to dress, surface, or exudating wounds, including pressure, venous, diabetic, and arterial ulcers, donor sites, dermal lesions, trauma injuries, and incisions.

Predicate Devices

• Arglaes-AB Antimicrobial Film (K970566, K990810)
• Arglaes-AB Island (K973657, K990810)
• Sorbsan (K881854, K914575)
• Silverlon Wound Packing Strips (K984210)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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, [e-mail].

Sincerely,

Yu-chieh Chiu -S

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAR 27 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Muram C. Phorst

for

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

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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

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.

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

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(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)

Muan C. Puroot

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

03/20/01

510(k) Number K004028

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MAR 27 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: [phone]
Fax: [phone]
Email: [e-mail]

### 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

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.

Confidential
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03/20/01

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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.

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

Confidential
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03/20/01

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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)

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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
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03/20/01