← Product Code FRO · K004028 # ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING (K004028) _Maersk Medical, Ltd. · FRO · Mar 27, 2001 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K004028 ## Device Facts - **Applicant:** Maersk Medical, Ltd. - **Product Code:** FRO - **Decision Date:** Mar 27, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **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. ## Predicate Devices - Arglaes-AB Antimicrobial Film ([K970566](/device/K970566.md), [K990810](/device/K990810.md)) - Arglaes-AB Island ([K973657](/device/K973657.md), [K990810](/device/K990810.md)) - Sorbsan ([K881854](/device/K881854.md), [K914575](/device/K914575.md)) - Silverlon Wound Packing Strips ([K984210](/device/K984210.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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, Yu-Chieh.Chiu@fda.hhs.gov. 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 {1} 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. {2} 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, 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 {3} THE A.P. MOLLER GROUP # MAERSK MEDICAL ![img-0.jpeg](img-0.jpeg) ## 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. --- (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 {4} 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: 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 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 Page 8 03/20/01 {5} 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 {6} 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 {7} THE A.P. MOLLER GROUP # MAERSK MEDICAL ![img-1.jpeg](img-1.jpeg) 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 --- **Source:** [https://fda.innolitics.com/device/K004028](https://fda.innolitics.com/device/K004028) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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