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

Device Description

Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers:

in contact with the wound, a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in)
a non-sensitising, super-absorbent polyurethane foam pad,
a protective, semi-permeable polyurethane backing.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called Urgocell® Ag Antimicrobial Wound Dressing with Silver. The focus of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Urgocell Ag K062559).

The document does not describe a study that uses acceptance criteria in the traditional sense of a clinical trial proving specific performance metrics with statistical significance. Instead, it relies on demonstrating equivalence through various comparisons, primarily related to antimicrobial activity and safety.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" for a new, modified device in a 510(k) submission is typically focused on demonstrating that the modified device is as safe and effective as the predicate device. For this submission, the key acceptance criteria revolve around antimicrobial activity and safety.

Acceptance Criteria Category	Specific Criteria/Comparison	Reported Device Performance
Indications for Use	Identical to predicate device	Urgocell® Ag has identical indications for use as predicate Urgocell Ag (K062559): "The barrier functions of Urgocell® Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites."
Structure	Identical to predicate device	Urgocell® Ag has identical three-layer structure as predicate Urgocell Ag (K062559): polyester mesh with hydrocolloid particles, cohesion polymers, petroleum jelly and silver sulphate; super-absorbent polyurethane foam pad; protective, semi-permeable polyurethane backing.
Antimicrobial Activity	Antimicrobial activity against specified strains, including additional strains compared to predicate.	Demonstrated antimicrobial activity against MRSA, Pseudomonas aeruginosa, Streptococcus pyogenes (as per predicate) AND against Enterococcus faecalis, Escherichia coli, and Candida albicans (new strains for this submission). The exact level or quantitative measure of activity is not provided, only that "Studies of antimicrobial activity" were done.
Safety and Biocompatibility	Comparable to predicate devices and other silver-containing wound dressings.	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Antimicrobial Activity Studies: The text only states "Studies of antimicrobial activity were previously conducted" and "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains." It does not specify the sample size (e.g., number of replicates or experiments) for these in-vitro tests, nor does it explicitly state the data provenance (country or retrospective/prospective). These are typically laboratory-based, prospective studies.
Safety Studies (Cytotoxicity, Irritation, Sensitization): These are standard biocompatibility tests, likely conducted in a preclinical (animal or in-vitro) setting. The sample sizes (e.g., number of rabbits, guinea pigs, or cell cultures) are not specified in this summary. The text implies these were "previously conducted," suggesting prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. The "ground truth" (e.g., presence or absence of infection) for efficacy is not established by expert review of patient data, but rather through in vitro microbiological testing (for antimicrobial activity) and preclinical safety studies. There's no human diagnostic component that would require expert consensus for ground truth.

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

This is not applicable as there is no human interpretation or diagnostic task involved that would require adjudication.

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. This submission is for a wound dressing, not an AI-powered diagnostic device or a system that involves human readers interpreting images.

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

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

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

Antimicrobial Activity: The "ground truth" for antimicrobial activity is established through direct laboratory microbiological assays (e.g., measuring zones of inhibition, reduction in bacterial count).
Safety Studies: The "ground truth" for safety (cytotoxicity, irritation, sensitization) is established through standardized preclinical testing protocols (e.g., observing cellular viability, skin reactions, immune responses) as defined by ISO standards and regulatory guidelines.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing; it does not involve machine learning or a "training set."

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

This is not applicable for the same reason as point 8.

Summary

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K100429

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5. 510(k) Summary

Additional Information to Premarket Notification Summary

JUN 1 1 2010

1. Sponsor Information: 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. Antimicrobial Wound Dressing with Silver Common or Usual Name: Uraocell® Ag Proprietary Name: Unclassified Classification Name:
Predicate Devices: က် Urgotul Ag (K061220), Laboratoires URGO Urgocell Aq (K062559), Laboratoires URGO

Description of Device র্ব

Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers:

in contact with the wound, a polyester mesh impregnated with a matrix . comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in)

a non-sensitising, super-absorbent polyurethane foam pad,
a protective, semi-permeable polyurethane backing. i
1. Indications for Use
  The barrier functions of Urgocell® Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.

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6. Technological Characteristics

FUNCTION	Urgocell Ag (K062559)	Urgocell Ag
Indications forUse	The barrier functions of Urgocell® Ag,antimicrobial wound dressing withsilver, may help reduce infection inmoderately to high exuding partialand full thickness wounds, includingdecubitus ulcers, venous staticulcers, diabetic ulcer, first andsecond degree burns, donor andgraft sites.	The barrier functions of Urgocell® Ag,antimicrobial wound dressing with silver,may help reduce infection in moderatelyto high exuding partial and full thicknesswounds, including decubitus ulcers,venous static ulcers, diabetic ulcer, firstand second degree burns, donor andgraft sites.
Structure	Composed of three layers:- in contact with the wound, apolyester mesh impregnated with amatrix comprising of hydrocolloidparticles (carboxymethylcellulose),cohesion polymers , petroleum jellyand silver sulphate,- a non-sensitising, super-absorbentpolyurethane foam pad,- a protective, semi-permeablepolyurethane backing	Composed of three layers:-in contact with the wound, a polyestermesh impregnated with a matrix ofhydrocolloid particles(carboxymethylcellulose), cohesionpolymers, petroleum jelly and silversulphate,- a non-sensitising, super-absorbentpolyurethane foam pad,- a protective, semi-permeablepolyurethane backing
Antimicrobialactivity	Studies of antimicrobial activityagainst MRSA, Pseudomonusaeruginosa, and Streptococcuspyogenes	Studies of antimicrobial activity againstMRSA, Pseudomonus aeruginosa,Streptococcus pyogenes, Enterococcusfaecalis, Escherichia coli, and Candidaalbicans

Description of Safety and Substantial Equivalence: 7.

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 quinea pigs.

Studies of the antimicrobial activity of Urgocell Ag wound dressing (K062559) were previously conducted against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes. With 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

Urgocell Ag compared to Urgocell Ag (K062559) shows substantial equivalence in comparable functions and indications for use.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.

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: K100429

Trade/Device Name: Urgocell® 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/Resourcesfor You/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):

K100429

URGOCELL AG, Antimicrobial Wound Dressing with Silver Device Name:

Indications For Use:

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

Prescription Use × (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)

Daniel Kiano for MXU

(Division Sign-Off Division of Surgical. Orthopedic. and Restorative Devices

510(k) Number K100429

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Regulation Number and Section

N/A