(115 days)
Not Found
No
The summary describes a wound dressing with antimicrobial properties and does not mention any computational or analytical functions that would involve AI/ML.
Yes
The device is described as an "antimicrobial wound dressing" used to "help reduce infection" and mentions treating various types of ulcers and burns, which are therapeutic actions.
No
The device is a wound dressing designed to help reduce infection and manage exudate in various types of wounds, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical wound dressing composed of various materials, including a polyester mesh, hydrocolloid particles, polymers, petroleum jelly, and silver. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a wound dressing applied externally to treat wounds. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a wound dressing with a physical barrier and antimicrobial properties. This is consistent with a topical medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The device is clearly a wound care product intended for direct application to the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies of antimicrobial activity 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Urgotul Ag (K061220), Urgocell Ag (K062559)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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:
- 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
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$\mathbb{Z}$
| 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 |
-
- 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
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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
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):
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