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.
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.
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.
The provided document is a 510(k) Summary for a medical device submitted to the FDA in 1999. It focuses on establishing substantial equivalence to previously cleared devices for wound care dressings with antimicrobial barrier properties.
Based on the content, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sustained Antimicrobial Barrier Activity | For each microbial strain tested, ARGLAES-AB film was found to demonstrate sustained antimicrobial barrier activity. |
| Antimicrobial Barrier Activity against Extended Microorganism List | ARGLAES-AB film demonstrated sustained antimicrobial barrier activity against an extended list of microbial strains including Staphylococcus aureus (MRSA, various ATCC strains), Enterococcus faecalis (VRE), Staphylococcus epidermidis, Escherichia coli, Streptococcus agalatiaea, Streptococcus pyogenes, Candida albicans, Acinetobacter baumanii, Enterobacter cloacae, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, and Serratia marcescens. |
| Safety for Topical Wound Dressing Use | Previous studies reviewed under K970566 and K973657 (for the predicate devices) showed these products to be safe for use as topical wound dressings. |
| Physical Identity to Predicate Devices | The subject devices are physically identical with the wound dressings reviewed under K970566 and K973657. |
Explanation of "Acceptance Criteria": In a 510(k) submission, formal "acceptance criteria" for performance are often outlined by the FDA and/or derived from recognized standards. This summary focuses on demonstrating equivalence, so the "acceptance criteria" here are implicitly linked to the performance characteristics of the predicate devices and the specific claims being made (sustained antimicrobial barrier). The success criterion for the in vitro tests was that the film "demonstrate sustained antimicrobial barrier activity."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of dressings tested) for the in vitro 7-day antimicrobial barrier (strike-through) tests. It lists the microbial strains challenged but not the number of replicates or individual dressings used for each challenge.
- Data Provenance: The studies were "in vitro," meaning they were conducted in a laboratory setting, not on human or animal subjects. The country of origin of the data is not explicitly stated, but the submitter is "MAERSK MEDICAL, LTD." from England. The studies are described as "preclinical performance studies," and there is no indication of retrospective or prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: This was an in vitro laboratory study. There was no "ground truth" to be established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" was the objective measurement of microbial growth through the barrier film in a controlled laboratory environment.
4. Adjudication Method for the Test Set
- Not Applicable: As an in vitro study with objective measurements of microbial growth, there would be no need for an adjudication method by human observers.
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: This is not a study involving AI, human readers, or diagnostic image interpretation. It's an in vitro performance study of a wound dressing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable: See point 5. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Objective Laboratory Measurement / Experimental Result: The ground truth for the antimicrobial barrier studies was the measurable outcome of the in vitro experiments – specifically, whether the microbial strains successfully "struck through" the ARGLAES-AB™ film within the 7-day test period. A "sustained antimicrobial barrier activity" was the desired objective result.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in this context. This is a traditional medical device (wound dressing) being evaluated for physical and biological properties, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: See point 8.
{0}------------------------------------------------
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.
-
- 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: 011-44-1-527 587 700 011-44-1-527 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: (314) 721-0112 Fax: (314) 721-7591
Maersk Medical Ltd., Thornhill Road Redditch, Worcestershire B98 9NL, England
{1}------------------------------------------------
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(Surgery, 79 MGP) |
| Common / usual name | Topical wound Dressing |
| Proprietary names | ARGLAES-ABTM Antimicrobial BarrierFilm 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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
{6}------------------------------------------------
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_
{7}------------------------------------------------
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)
| (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_
.
N/A