Who is the manufacturer of URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER?

Laboratoires Urgo filed the 510(k) submission for URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (K100430).

What is the FDA product code for URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER?

510(k) clearance (submission type: Special).

What are the predicate devices for URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER?

Urgotul Ag (K061220); Urgocell Ag (K062559).

Who can help prepare an FDA 510(k) submission like URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

K100430 · Laboratoires Urgo · FRO · Jun 11, 2010 · SU

Device Facts

Record ID	K100430
Device Name	URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
Applicant	Laboratoires Urgo
Product Code	FRO · SU
Decision Date	Jun 11, 2010
Decision	SESE
Submission Type	Special
Device Class	Class U
Attributes	Therapeutic

Intended Use

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.

Device Story

Urgotul Ag is a non-adhesive, non-occlusive, antimicrobial hydrocolloid wound contact dressing. It consists of a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers, petroleum jelly, and silver (2.25 mg/sq.inch). The device is applied topically to wounds by healthcare providers to provide a barrier and reduce infection. The silver component provides antimicrobial activity. It is intended for use in clinical settings for managing various wound types.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (cytotoxicity, rabbit irritation, guinea pig sensitization) and antimicrobial efficacy studies against MRSA, Pseudomonas aeruginosa, Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, and Candida albicans.

Technological Characteristics

Non-adhesive, non-occlusive hydrocolloid wound dressing. Materials: polyester mesh, carboxymethylcellulose, cohesion polymers, petroleum jelly, silver (2.25 mg/sq.inch). Antimicrobial mechanism: silver-based. Form factor: mesh dressing.

Indications for Use

Indicated for patients with 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.

Predicate Devices

Urgotul Ag (K061220)
Urgocell Ag (K062559)

Related Devices

K061220 — URGOTUL AG · Laboratoires Urgo · Jul 27, 2006
K100429 — URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER · Laboratoires Urgo · Jun 11, 2010
K062559 — URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER · Laboratoires Urgo · Jan 29, 2007
K143017 — Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver · Laboratoires Urgo · Aug 7, 2015
K242758 — Atrauman® Ag · Hartmann USA, Inc. · Dec 9, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ 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: - 3. Predicate Devices: Urgotul Ag (K061220), Laboratoires URGO Urgocell Ag (K062559), Laboratoires URGO - Description of Device ধ 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). - 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. Page 1 of 2 {1}------------------------------------------------ \$\mathbb{Z}\$ | 6. | | Technological Characteristics | |----|--|-------------------------------| |----|--|-------------------------------| | FUNCTION | Urgotul Ag (K062559) | Urgotul Ag | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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. | 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. | | Structure | Composed of 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 mg/sq.inch). | Composed of 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 mg/sq.inch). | | Antimicrobial activity | Studies of antimicrobial activity against MRSA, Pseudomonas aeruginosa, and Streptococcus pyogenes | Studies of antimicrobial activity against MRSA, Pseudomonas aeruginosa, Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, and Candida albicans | - 7. 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. Page 2 of 2 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ ### 4. Statement of Indications for Use 510(k) Number (if known): K100430 URGOTUL AG, Antimicrobial Wound Dressing with Silver Device Name: 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. 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 Page 1 of 1 510(k) Number K100430