(87 days)
No
The summary describes a traditional wound dressing with antimicrobial properties and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a wound dressing designed to help reduce infection and manage exudate in wounds, which falls under wound care products rather than therapeutic devices aimed at treating or curing diseases.
No
The device is a wound dressing designed to help reduce infection and facilitate healing, not to diagnose a medical condition. Its function is descriptive of a treatment or management device, not a diagnostic one.
No
The device description clearly states it is a physical wound dressing composed of materials like polyester mesh, hydrocolloid particles, polymers, and Vaseline containing 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 the body to manage wounds and potentially reduce infection. This is a therapeutic or protective function, not a diagnostic one.
- Device Description: The description details the physical composition of a wound dressing. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing 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
FRO
Device Description
Urgotul® Ag wound dressing is a sterile, antimicrobial hydrocolloid wound contact dressing with silver.
Urgotul® Ag wound dressing is non-occlusive and non-adhesive for painless removal.
Urgotul® Ag is composed of a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
///
5. 510(k) Summary
Premarket Notification Summary
-
- Sponsor Information: Laboratories URGO 42 Rue de Longvic 21300 Chenove France
JUL 2 7 2006
- Sponsor Information: Laboratories URGO 42 Rue de Longvic 21300 Chenove France
| Contact Person: | Sophie Fortin |
|---|---|
| Regulatory Affairs Manager | |
| Phone: +33.(0)3.80.44.79.67 | |
| Fax: +33.(0)3.80.44.71.40 |
-
- Device Name: Common or Usual Name: Proprietary Name: Classification Name:
Antimicrobial Wound Dressing with Silver Urgotul® Ag Unclassified
- Device Name: Common or Usual Name: Proprietary Name: Classification Name:
-
- Description of Device Urgotul® Ag wound dressing is a sterile, antimicrobial hydrocolloid wound contact dressing with silver.
Urgotul® Ag wound dressing is non-occlusive and non-adhesive for painless removal.
Urgotul® Ag is composed of a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver.
-
- Indications for Use The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing 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.
1
Image /page/1/Picture/1 description: The image shows a black and white logo. The logo consists of a circle with text around the perimeter. Inside the circle are three stylized, curved lines that resemble a bird in flight. The text around the circle is small and difficult to read, but it appears to be the name of an organization or agency.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2006
Laboratories URGO % Ms. Sophie Fortin Reglatory Affairs Manager 42 Rue de Longvic 21300 Chenove France
Re: K061220
Trade/Device Name: Urgotul® Ag Regulatory Class: Unclassified Product Code: FRO Dated: April 5, 2006 Received: May 1. 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. I'arts 800 to 898. In addition. FDA mav 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): good manufacturing practice requirements as set 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.
2
Page 2 – Ms. Sophie Fortin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C. Mark N. Melkerson
ark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
//
Indications for Use
510(k) Number (if known): __ K 061220
Device Name: Urgotul® Ag
Indications For Use:
The barrier functions of Urgotul® Ag Antimicrobial Wound Dressing 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 X (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 COE
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Revision submitted 26/07/06 following FDA request
510(k) Number K061220