The barrier functions of Urgotul Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.

Device Description

Urgotul® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing, composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver (2.25 mq/sq.inch).

AI/ML Overview

The provided text describes Urgotul Ag, an antimicrobial wound dressing with silver, and its substantial equivalence to a predicate device (Urgotul Ag K061220). The document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. As such, it primarily details comparative characteristics and safety studies rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically found in efficacy trials for novel devices or AI algorithms.

However, based on the provided text, we can extract the information related to antimicrobial activity studies, which serve as the "performance" data for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Urgotul Ag K100430)
Antimicrobial Activity	Efficacy against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes (as demonstrated by predicate Urgotul Ag K061220).	Demonstrated antimicrobial activity against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes. Additionally, data was submitted concerning antimicrobial activity against three new strains: Enterococcus faecalis, Escherichia coli, and Candida albicans.
Indications for Use	"The barrier functions of Urgotul® Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites." (from predicate K062559)	"The barrier functions of Urgotul® Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderately exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites." (identical to predicate)
Structure/Composition	Non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing; polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly, and silver (2.25 mg/sq.inch). (from predicate K062559)	Non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing; polyester mesh impregnated with hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly, and silver (2.25 mg/sq.inch). (identical to predicate)
Biocompatibility/Safety	Demonstrated non-cytotoxic, non-irritating (rabbit), and non-sensitizing (guinea pigs) (as per predicate Urgocell Ag).	Standard battery of safety and biocompatibility studies (Cytotoxicity, Irritation study in rabbit, and Sensitization study in guinea pigs) previously conducted showed the Urgocell Ag (a similar device from the same manufacturer) to be comparable to predicate devices and other silver-containing wound dressings. This implies the current device also meets these safety profiles.

Study Details:

The document describes an antimicrobial activity study that was conducted to support the substantial equivalence claim.

2. Sample Size Used for the Test Set and Data Providence:

Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. For the antimicrobial activity study, the "test set" consists of three new bacterial/fungal strains: Enterococcus faecalis, Escherichia coli, and Candida albicans.
Data Provenance: The document does not specify the country of origin for the antimicrobial activity study. Given the sponsor is Laboratories URGO in France, it is plausible the studies were conducted in France or a European lab. The study appears to be retrospective in the sense that it builds upon previously conducted studies for K061220 and K062559, explicitly stating "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains" with this submission, implying these were studies already performed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. For antimicrobial studies, "ground truth" would typically be established by laboratory culturing and identification methods, not by expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials where human experts evaluate patient data (e.g., medical images). For laboratory-based antimicrobial activity testing, the results are typically determined by standard microbiological assays.

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:

This is not applicable. The device is an antimicrobial wound dressing, not an AI algorithm for medical image interpretation or diagnosis. Therefore, no MRMC study or AI assistance comparison was performed.

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

This is not applicable. The device is a physical wound dressing, not an algorithm.

7. The type of ground truth used:

For the antimicrobial activity study, the "ground truth" would be the laboratory results from standardized microbiological assays. These assays directly measure the device's ability to inhibit or kill specific microorganisms.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not an AI algorithm that requires a training set. The safety and antimicrobial activity studies are product evaluations, not machine learning model training.

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

This is not applicable as there is no training set for this device.

Summary

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K100430 //2

5. 510(k) Summary

Additional Information to Premarket Notification Summary

JUN 1 1 2010

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

Sophie Fortin Regulatory Affairs Director Phone: +33.(0)3.80.44.28.78 Fax: +33.(0)3.80.44.71.40 Email: s.fortin@fr.urgo.com

Device Name: 2. Common or Usual Name: Antimicrobial Wound Dressing with Silver Proprietary Name: Urgotul Ag Unclassified Classification Name:
1. Predicate Devices: Urgotul Ag (K061220), Laboratoires URGO Urgocell Ag (K062559), Laboratoires URGO
Description of Device ধ

Indications for Use ပ်
The barrier functions of Urgotul® Ag, antimicrobial wound dressing with silver, may help reduce infection in light to moderate exudative partial and full thickness wounds, including diabetic ulcers, first and second degree burns, decubitus ulcers, venous stasis ulcers, and graft and donor sites.

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6.		Technological Characteristics
----	--	-------------------------------

FUNCTION	Urgotul Ag (K062559)	Urgotul Ag
Indications forUse	The barrier functions of Urgotul® Ag,antimicrobial wound dressing withsilver, may help reduce infection inlight to moderate exudative partial andfull thickness wounds, includingdiabetic ulcers, first and seconddegree burns, decubitus ulcers,venous stasis ulcers, and graft anddonor sites.	The barrier functions of Urgotul® Ag,antimicrobial wound dressing withsilver, may help reduce infection inlight to moderate exudative partialand full thickness wounds, includingdiabetic ulcers, first and seconddegree burns, decubitus ulcers,venous stasis ulcers, and graft anddonor sites.
Structure	Composed of a non-adhesive,non-occlusive, antimicrobialhydrocolloid wound contact dressing,composed of a polyester meshimpregnated with a matrix comprisingof hydrocolloid particles(carboxymethylcellulose), cohesionpolymers, petroleum jelly and silver(2.25 mg/sq.inch).	Composed of a non-adhesive,non-occlusive, antimicrobialhydrocolloid wound contact dressing,composed of a polyester meshimpregnated with a matrix comprisingof hydrocolloid particles(carboxymethylcellulose), cohesionpolymers, petroleum jelly and silver(2.25 mg/sq.inch).
Antimicrobialactivity	Studies of antimicrobial activity againstMRSA, Pseudomonas aeruginosa,and Streptococcus pyogenes	Studies of antimicrobial activityagainst MRSA, Pseudomonasaeruginosa, Streptococcuspyogenes, Enterococcus faecalis,Escherichia coli, and Candidaalbicans

1. Description of Safety and Substantial Equivalence:

Safety Studies

The standard battery of safety and biocompatibility studies that were previously conducted showed the Urgocell Ag to be comparable to predicate devices and other silver containing wound dressings. These studies included: Cytotoxicity, Irritation study in rabbit, and Sensitization study in guinea pigs.

Studies of the antimicrobial activity of Urgotul Ag wound dressing (K061220) were previously conducted against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes. S VVith this submission, data was submitted
concerning the antimicrobial activity of Urgocell® Ag on three new strains: Enterococcus faecalis, Escherichia coli and Candida albicans.

Substantial Equivalence

Urgotul Ag compared to Urgotul Ag (K061220) shows substantial equivalence in comparable functions and indications for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The bird is oriented to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 1 2010

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

Re: K100430

Trade/Device Name: Urgotul Ag Antimicrobial Wound Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: May 25, 2010 Received: June 03, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Sophie Fortin

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Statement of Indications for Use

510(k) Number (if known):

K100430

URGOTUL AG, Antimicrobial Wound Dressing with Silver Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(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 Sien Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100430

Regulation Number and Section

N/A