← Product Code FRO · K100429

# URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (K100429)

_Laboratoires Urgo · FRO · Jun 11, 2010 · SU · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K100429

## Device Facts

- **Applicant:** Laboratoires Urgo
- **Product Code:** FRO
- **Decision Date:** Jun 11, 2010
- **Decision:** SESE
- **Submission Type:** Special
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended 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.

## Device Story

Urgocell® Ag is a non-adhesive, non-occlusive, antimicrobial absorbent dressing. It consists of three layers: a polyester mesh impregnated with a matrix of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly, and silver sulphate (3.22 mg/sq.in) for wound contact; a super-absorbent polyurethane foam pad; and a semi-permeable polyurethane backing. The device is applied to wounds to provide a barrier and reduce infection. It is intended for use by healthcare professionals in clinical settings. The silver sulphate provides antimicrobial activity against various pathogens. The dressing absorbs exudate while maintaining a moist wound environment, aiding in the management of partial and full-thickness wounds.

## Clinical Evidence

Bench testing only. Biocompatibility studies included cytotoxicity, rabbit irritation, and guinea pig sensitization. Antimicrobial activity was evaluated in vitro against MRSA, Pseudomonas aeruginosa, Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, and Candida albicans.

## Technological Characteristics

Three-layer dressing: 1) Polyester mesh impregnated with hydrocolloid (carboxymethylcellulose), cohesion polymers, petroleum jelly, and silver sulphate (3.22 mg/sq.in); 2) Super-absorbent polyurethane foam pad; 3) Semi-permeable polyurethane backing. Non-adhesive, non-occlusive. Antimicrobial mechanism via silver sulphate release.

## Predicate Devices

- Urgotul Ag ([K061220](/device/K061220.md))
- Urgocell Aq ([K062559](/device/K062559.md))

## Submission Summary (Full Text)

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>
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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

- 5. 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

r

| FUNCTION                  | Urgocell Ag (K062559)                                                                                                                                                                                                                                                                                                                                                   | Urgocell Ag                                                                                                                                                                                                                                                                                                                                                |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use    | The barrier functions of Urgocell® Ag,<br>antimicrobial wound dressing with<br>silver, may help reduce infection in<br>moderately to high exuding partial<br>and full thickness wounds, including<br>decubitus ulcers, venous static<br>ulcers, diabetic ulcer, first and<br>second degree burns, donor and<br>graft sites.                                             | The barrier functions of Urgocell® Ag,<br>antimicrobial wound dressing with silver,<br>may help reduce infection in moderately<br>to high exuding partial and full thickness<br>wounds, including decubitus ulcers,<br>venous static ulcers, diabetic ulcer, first<br>and second degree burns, donor and<br>graft sites.                                   |
| Structure                 | Composed of three layers:<br>- in contact with the wound, a<br>polyester mesh impregnated with a<br>matrix comprising of hydrocolloid<br>particles (carboxymethylcellulose),<br>cohesion polymers , petroleum jelly<br>and silver sulphate,<br>- a non-sensitising, super-absorbent<br>polyurethane foam pad,<br>- a protective, semi-permeable<br>polyurethane backing | Composed of three layers:<br>-in contact with the wound, a polyester<br>mesh impregnated with a matrix of<br>hydrocolloid particles<br>(carboxymethylcellulose), cohesion<br>polymers, petroleum jelly and silver<br>sulphate,<br>- a non-sensitising, super-absorbent<br>polyurethane foam pad,<br>- a protective, semi-permeable<br>polyurethane backing |
| Antimicrobial<br>activity | Studies of antimicrobial activity<br>against MRSA, Pseudomonus<br>aeruginosa, and Streptococcus<br>pyogenes                                                                                                                                                                                                                                                             | Studies of antimicrobial activity against<br>MRSA, Pseudomonus aeruginosa,<br>Streptococcus pyogenes, Enterococcus<br>faecalis, Escherichia coli, and Candida<br>albicans                                                                                                                                                                                  |

#### 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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**Source:** [https://fda.innolitics.com/device/K100429](https://fda.innolitics.com/device/K100429)

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