(152 days)
Not Found
No
The description details a physical wound dressing with antimicrobial properties and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No.
The device acts as a barrier and dressing to help reduce infection and absorb exudate from wounds, which is a supportive rather than directly therapeutic role in the healing process.
No
The device is described as an "antimicrobial wound dressing" used for "reducing infection in moderately to high exuding partial and full thickness wounds." Its function is therapeutic (wound care), not diagnostic.
No
The device description clearly outlines a physical wound dressing composed of multiple material layers, indicating it is a hardware medical device, not software-only.
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 wounds to help reduce infection and manage exudate. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a wound dressing (mesh, foam pad, backing) and its function in wound care. It does not describe any components or processes related to analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
The device is clearly intended for direct application to a wound for therapeutic purposes, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.
Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.
Urgocell® Ag is composed of three layers :
- in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
- a non-sensitising, super-absorbent polyurethane foam pad, -
- a protective, semi-permeable polyurethane backing. -
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)
Safety Studies
A standard battery of safety and biocompatibility studies have been conducted including: Cytotoxicity -
Irritation study in rabbit
- Sensitization study in guinea pigs -
The results of the biocompatibility studies are considered to be comparable to predicate devices and other silver containing wound dressings.
Studies of the antimicrobial activity of Urgocell® Ag wound dressing have been conducted against MRSA, Pseudomonus aeruginosa, and Streptococcus pyogenes. Results demonstrated that the antibacterial activities are comparable to those of the predicate devices.
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.
Contreet-Foam Antibacterial wound Dressing (K022416), Urgotul® Ag Antimicrobial wound dressing with silver (K061220)
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
5. 510(k) Summary
Premarket Notification Summary
JAN 2 9 2007
- Sponsor Information: 1. 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: Antimicrobial Wound Dressing with Silver Proprietary Name: Urgocell® Ag Classification Name: Unclassified
-
- Predicate Devices:
Contreet-Foam Antibacterial wound Dressing (K022416), Coloplast Corp. Urgotul® Ag Antimicrobial wound dressing with silver (K061220), Laboratoires URGO
Description of Device 4.
Urgocell® Ag wound dressing is a sterile, antimicrobial absorbent wound contact dressing with silver.
Urgocell® Ag wound dressing is non-occlusive and non-adhesive for painless removal.
Urgocell® Ag is composed of three layers :
- in contact with the wound, a polyester mesh impregnated with a matrix of carboxymethylcellulose hydrocolloid particles, cohesion polymers and Vaseline containing silver,
- a non-sensitising, super-absorbent polyurethane foam pad, -
- a protective, semi-permeable polyurethane backing. -
- న్. Indications for Use
The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft sites.
-
- Description of Safety and Substantial Equivalence:
Safety Studies
A standard battery of safety and biocompatibility studies have been conducted including: Cytotoxicity -
1
Irritation study in rabbit
- Sensitization study in guinea pigs -
The results of the biocompatibility studies are considered to be comparable to predicate devices and other silver containing wound dressings.
Studies of the antimicrobial activity of Urgocell® Ag wound dressing have been conducted against MRSA, Pseudomonus aeruginosa, and Streptococcus pyogenes. Results demonstrated that the antibacterial activities are comparable to those of the predicate devices.
Substantial Equivalence
ー
Urgocell® Ag wound dressing compared to Contreet F and Urgotu19 Ag : all three contain silver as the active antimicrobial agent. All three provide comparable functions and indications for use. Urgocell® Ag wound dressing, Contreet® Foam and Urgotul® Ag are substantially equivalent.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with its wings spread. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laboratories URGO % Ms. Sophie Fortin Manager, Regulatory Affairs 42 Rue de Longvic 21300 Chenove France
JAN 2 9 2007
Re: K062559
Trade/Device Name: Urgocell AG Antimicrobial Wound Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: November 10, 2006 Received: November 16, 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, 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); 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.
3
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,
Mark N. Mellema
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Koh25
Indications for Use
1062559 510(k) Number (if known):
Device Name: Urgocell® Ag
Indications For Use:
The barrier functions of Urgocell® Ag, antimicrobial wound dressing, may help reduce infection in moderately to high exuding partial and full thickness wounds including decubitus ulcers, venous stasis ulcers , diabetic ulcers , first and second degree burns, donor and graft 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 (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number