ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING

K990810 · Maersk Medical, Ltd. · FRO · Sep 17, 1999 · SU

Device Facts

• Record ID: K990810
• Device Name: ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING
• Applicant: Maersk Medical, Ltd.
• Product Code: FRO · SU
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

ARGLAES-AB Antimicrobial Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters. ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressingscomposed of a calcium alginate pad presented on a visually clear, selfadherent, antimicrobial barrier film backing. ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected: Pressure Ulcers Venous Ulcers Diabetic Ulcers Arterial Ulcers Donor Sites and other bleeding surface wounds Dermal lesions, trauma injuries or incisions. ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns or for use on individuals with a known sensitivity to silver.

Device Story

ARGLAES-AB dressings are sterile, self-adherent wound dressings providing antimicrobial barrier protection. Film dressing is a transparent, moisture-vapor permeable film; Island dressing combines a calcium alginate pad with the antimicrobial film backing. Used in clinical settings for wound management and IV site protection. The device acts as a physical and antimicrobial barrier against microbial contamination. Effectiveness is supported by in vitro 7-day strike-through testing against various pathogens, including MRSA and VRE. The device is applied topically by healthcare providers to protect wounds and facilitate healing.

Clinical Evidence

Bench testing only. In vitro 7-day antimicrobial barrier (strike-through) studies were conducted to evaluate efficacy against 15 microbial strains, including Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE), Escherichia coli, and Candida albicans. Results demonstrated sustained antimicrobial barrier activity for all tested strains.

Technological Characteristics

Sterile, self-adherent wound dressings. Film dressing: transparent, oxygen/moisture vapor permeable film. Island dressing: calcium alginate pad on antimicrobial film backing. Antimicrobial barrier function. No software or electronic components.

Indications for Use

Indicated for local management of chronic wounds, incisions, donor sites, minor burns, abrasions, lacerations, pressure sores, superficial leg ulcers, and other dermal ulcers; also for venipuncture site management and securing/protecting IV catheters. Island dressing indicated for exuding wounds (infected/non-infected) including pressure, venous, diabetic, and arterial ulcers, donor sites, and trauma injuries. Contraindicated for third-degree burns and individuals with known silver sensitivity.

Predicate Devices

• ARGLAES-AB™ Antimicrobial Barrier Film Dressing (K970566)
• ARGLAES-AB™ Antimicrobial Barrier Island Dressing (K973657)

Submission Summary (Full Text)

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K990810

SEP 1 7 1999

# MAERSK MEDICAL

# 510(k) SUMMARY

### ARGLAES-AB™ Antimicrobial Barrier Film Dressing/ ARGLAES-AB™ Antimicrobial Barrier Island Dressing/ (79 MGP)

- SUBMITTER'S NAME 1.
- CONTACT PERSON AT MAERSK MEDICAL. LTD. 2.
- DATE THAT 510(k) SUMMARY WAS PREPARED 3.
- NAME OF THE MEDICAL DEVICE (Classification / Common / Proprietary) 4.
- LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED 5.
- DESCRIPTION OF THE DEVICE 6.
- 7. INTENDED USE OF THE DEVICE
- TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES 8.
- SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM 9. PRECLINICAL PERFORMANCE STUDIES

SUBMITTER'S NAME

MAERSK MEDICAL, LTD. 26/27 Thornhill Road Redditch, Worcestershire B98 9NL ENGLAND

Tel: [phone] 011-44-1-527 592111 Fax:

U.S. REGULATORY CONTACT PERSON FOR MAERSK MEDICAL, LTD.

Evan Dick, Ph.D. E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, MO 63105

Tel: [phone] Fax: [phone]

> Maersk Medical Ltd., Thornhill Road Redditch, Worcestershire B98 9NL, England

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Page 3 of 5

Image /page/1/Picture/3 description: The image shows a handwritten string of characters, which appears to be a code or identifier. The characters are 'KQ90810', written in a simple, slightly irregular style. The numbers are clearly distinguishable, and the letters are uppercase.

#### 510(k) SUMMARY ARGLAES-AB™ Antimicrobial Barrier Film and Island Dressings

page 2 of 4

### DATE THAT 510(k) SUMMARY WAS PREPARED

March 11, 1999

| 4. NAME OF THE MEDICAL DEVICE | |
|-------------------------------|-----------------------------------------------------------------|
| Classification name | Dressing, wound and burn, occlusive<br>(Surgery, 79 MGP) |
| Common / usual name | Topical wound Dressing |
| Proprietary names | ARGLAES-ABTM Antimicrobial Barrier<br>Film and Island Dressings |

LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

ARGLAES-AB™ Antimicrobial Barrier Film Dressing (K970566) ARGLAES-AB™ Antimicrobial Barrier Island Dressing (K973657)

### 6.

ARGLAES-AB™ Antimicrobial Barrier Film Dressings are sterile, visually clear, oxygen and moisture vapor permeable, and self-adherent dressings for use in wound care and venipuncture site management. ARGLAES-AB™ dressings are an effective protection against microbial contamination.

ARGLAES-AB™ Antimicrobial Barrier Island Dressings are sterile wound dressings composed of a calcium alginate pad presented on a visually clear, self-adherent, antimicrobial barrier film backing. The ARGLAES-AB™ island dressing combines the advantages of a calcium alginate wound dressing together with ARGLAES-AB™ antimicrobial barrier film protection against wound site contamination.

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Page 4 of 5

K9908810

510(k) SUMMARY ARGLAES-AB™ Antimicrobial Barrier Film and Island Dressings

page 3 of 4

### 1.

ARGLAES-AB™ Antimicrobial Barrier Film Dressing and ARGLAES-AB™ Antimicrobial Barrier Island Dressing are intended to be used as topical wound dressings for the local management of chronic wounds incisions, donor sites, minor burns, and abrasions and lacerations. The film dressing is also intended to be used for venipuncture site management.

TECHNOLOGICAL COMPARISON BETWEEN SUBJECT AND PREDICATE DEVICES

The subject devices were previously reviewed under K970566 (film dressing) and K973657 (island dressing).

The subject devices are physically identical with the wound dressings reviewed under K970566 and K973657.

The predicate devices have been shown to have "antimicrobial barrier activity".

The present 510(k) presents in vitro, 7-day antimicrobial barrier (strike-through) studies to: (1) support the claim of sustained antimicrobial barrier activity, and (2) extend the list of microorganisms used to challenge the antimicrobial barrier activity of ARGLAES-AB dressings.

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510(k) SUMMARY

ARGLAES-AB™ Antimicrobial Barrier Film and Island Dressings

page 4 of 4

### SUMMARY OF PRECLINICAL PERFORMANCE STUDIES AND CONCLUSIONS FROM PRECLINICAL PERFORMANCE STUDIES

ARGLAES-AB™ Antimicrobial Barrier Film Dressing and ARGLAES-AB ™ Antimicrobial Barrier Island Dressing were previously reviewed under K970566 and K973657, respectively. Studies reviewed under K970566 and K973657 showed these products to be safe for use as topical wound dressings.

In vitro, 7-day antimicrobial barrier (strike-through) tests were performed in which the ARGLAES film was challenged by the following microbial strains:

> Staphylococcus aureus (MRSA, ATCC #33591) Staphylococcus aureus (MRSA, ATCC #33593) Staphylococcus aureus Enterococcus faecalis (VRE) Staphylococcus epidermidis Enterococcus faecium Escherichia coli Streptococcus agalatiaea Streptococcus pyogenes Candida albicans Acinetobacter baumanii Enterobacter cloacae Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Serratia marcescens

For each microbial strain tested, above, ARGLAES-AB film was found to demonstrate sustained antimicrobial barrier activity.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird, with three curved lines representing its wings or feathers.

SEP 1 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maersk Medical, LTD. c/o E. G. Dick & Associates 7527 Westmoreland Avenue St. Louis. Missouri 63105

Re: K990810

Trade Name: Arglaes -- AB Antimicrobial Barrier Film Dressing Arglaes -- AB Antimicrobial Barrier Island Dressing Regulatory Class: Unclassified Product Code: MGP Dated: June 18, 1999 Received: June 21, 1999

Dear Dr. Dick:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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). You may, therefore, market the devices, 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 devices are 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 devices 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 devices 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 - Dr. E. G. Dick

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely vours.

fioceley

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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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ¥990810

Device Name: ARGLAES-AB Antimicrobial Film Dressing ARGLAES-AB Antimicrobial Island Dressing

Indications For Use:

#### FILM DRESSING

ARGLAES-AB Antimicrobial Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers.

ARGLAES-AB Antimicrobial Film Dressings are also intended to help secure and protect intravenous catheters.

- continued on second page for ISLAND DRESSINGS -

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

(Division Sign-Off)
Division of General Restorative Devices IC990810
510(k) Number

Prescription Use
(per 21 CFR 801.109) X

OR Over-The-Counter Use_

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## INDICATIONS FOR USE STATEMENT (continued)

#### ISLAND DRESSING

ARGLAES-AB Antimicrobial Barrier Island Dressings are sterile wound dressingscomposed of a calcium alginate pad presented on a visually clear, selfadherent, antimicrobial barrier film backing.

ARGLAES-AB Antimicrobial Barrier Island Dressings are intended for the local management of exuding wounds, including infected and non-infected:

- · Pressure Ulcers
- Venous Ulcers
- Diabetic Ulcers
- · Arterial Ulcers
- · Donor Sites and other bleeding surface wounds
- · Dermal lesions, trauma injuries or incisions.

ARGLAES-AB Antimicrobial Barrier Island Dressings are contraindicated for third degree burns or for use on individuals with a known sensitivity to silver.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center"></div> |
|-----------------------------------------|----------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990810 |

| Prescription Use | X |
|----------------------|---|
| (per 21 CFR 801.109) | |

OR Over-The-Counter Use_

.