The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.

Device Description

Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.

Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.

Urgocell® Ag is composed of three layers :

in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
a non-sensitising, super-absorbent polyurethane foam pad, -
a protective, semi-permeable polyurethane backing. -

AI/ML Overview

The provided text describes the 510(k) premarket notification for Urgocell® Ag, an antimicrobial wound dressing. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving device performance through a clinical or standalone study as one might expect for a novel AI/software device.

Therefore, many of the requested points regarding AI/algorithm performance and study design are not applicable to this 510(k) submission for a wound dressing.

Here's an analysis based on the provided text, addressing the applicable points and noting where information is not available or relevant:

Description of Acceptance Criteria and Study for Urgocell® Ag Antimicrobial Wound Dressing

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Study Goal	Reported Performance/Outcome
Safety	Cytotoxicity	Comparable to predicate devices and other silver-containing wound dressings.
Safety	Irritation	Comparable to predicate devices and other silver-containing wound dressings.
Safety	Sensitization	Comparable to predicate devices and other silver-containing wound dressings.
Antimicrobial Activity	Activity against MRSA	Comparable to predicate devices.
Antimicrobial Activity	Activity against Pseudomonas aeruginosa	Comparable to predicate devices.
Antimicrobial Activity	Activity against Streptococcus pyogenes	Comparable to predicate devices.
Substantial Equivalence	Comparison to Predicate Devices (Contreet-Foam, Urgotul® Ag)	All three contain silver as the active antimicrobial agent. All three provide comparable functions and indications for use. Urgocell® Ag is substantially equivalent.

2. Sample size used for the test set and the data provenance:

Not Applicable. The submission describes in vitro (biocompatibility and antimicrobial) and comparative design studies, not a clinical "test set" in the context of an AI/software device. The biological studies would have used laboratory samples (e.g., cell cultures, animal models for irritation/sensitization, bacterial cultures). Specific sample sizes for these in vitro and animal studies are not provided in this summary.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective for these general safety and antimicrobial tests. These are typically standard laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is not an AI/software device requiring expert ground truth for image or diagnostic interpretation. The "ground truth" for the safety and antimicrobial studies would be laboratory measurements and established biological responses.

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

Not Applicable. This type of adjudication is relevant for human expert review in diagnostic studies, not for the in vitro and animal safety/efficacy tests described for this wound dressing.

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 a wound dressing, not an AI or imaging device with human reader interaction.

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

Not Applicable. This is a medical device (wound dressing), not an algorithm.

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

For Safety Studies (Cytotoxicity, Irritation, Sensitization): Ground truth would be established by standard biological assays and the observed cellular or animal responses according to scientific protocols (e.g., cell viability, erythema scores, immune responses).
For Antimicrobial Activity Studies: Ground truth would be established by microbiological methods measuring bacterial growth inhibition or reduction, typically compared against control groups and predicate devices.
For Substantial Equivalence: The ground truth for substantial equivalence is the demonstration of comparable characteristics (material, function, indications for use, safety, and effectiveness) to already legally marketed predicate devices, assessed by FDA.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device. The studies described are for physical and biological properties of a wound dressing.

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

Not Applicable. See point 8.

Summary

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5. 510(k) Summary

Premarket Notification Summary

JAN 2 9 2007

Sponsor Information: 1. Laboratories URGO 42 Rue de Longvic 21300 Chenove France

Contact Person:	Sophie Fortin
	Regulatory Affairs Manager
	Phone: +33.(0)3.80.44.79.67
	Fax: +33.(0)3.80.44.71.40

1. Device Name: Common or Usual Name: Antimicrobial Wound Dressing with Silver Proprietary Name: Urgocell® Ag Classification Name: Unclassified
1. Predicate Devices:

Contreet-Foam Antibacterial wound Dressing (K022416), Coloplast Corp. Urgotul® Ag Antimicrobial wound dressing with silver (K061220), Laboratoires URGO

Description of Device 4.

Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.

Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.

Urgocell® Ag is composed of three layers :

in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
a non-sensitising, super-absorbent polyurethane foam pad, -
a protective, semi-permeable polyurethane backing. -
న్. Indications for Use

1. Description of Safety and Substantial Equivalence:

Safety Studies

A standard battery of safety and biocompatibility studies have been conducted including: Cytotoxicity -

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K062559

Irritation study in rabbit

Sensitization study in guinea pigs -
The results of the biocompatibility studies are considered to be comparable to predicate devices and other silver containing wound dressings.

Studies of the antimicrobial activity of Urgocell® Ag wound dressing have been conducted against MRSA, Pseudomonus aeruginosa, and Streptococcus pyogenes. Results demonstrated that the antibacterial activities are comparable to those of the predicate devices.

Substantial Equivalence

ー

Urgocell® Ag wound dressing compared to Contreet F and Urgotu19 Ag : all three contain silver as the active antimicrobial agent. All three provide comparable functions and indications for use. Urgocell® Ag wound dressing, Contreet® Foam and Urgotul® Ag are substantially equivalent.

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Public Health Service

Image /page/2/Picture/2 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with its wings spread. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laboratories URGO % Ms. Sophie Fortin Manager, Regulatory Affairs 42 Rue de Longvic 21300 Chenove France

JAN 2 9 2007

Re: K062559

Trade/Device Name: Urgocell AG Antimicrobial Wound Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: November 10, 2006 Received: November 16, 2006

Dear Ms. Fortin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Sophie Fortin

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mellema

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Koh25

Indications for Use

1062559 510(k) Number (if known):

Device Name: Urgocell® Ag

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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, and Neurological Devices

510(k) Number

Regulation Number and Section

N/A