(115 days)
Not Found
No
The document describes a wound dressing with antimicrobial properties and does not mention any computational or analytical functions that would involve AI or ML.
Yes
The device is described as an "antimicrobial wound dressing with silver" intended to "help reduce infection" in various types of wounds, indicating a therapeutic function. Additionally, it lists predicate devices that are also wound care dressings, which are generally considered therapeutic.
No
The device is described as an "antimicrobial wound dressing with silver" for reducing infection, which indicates a therapeutic or protective function, not a diagnostic one.
No
The device description clearly describes a physical wound dressing with multiple material layers and silver sulphate, 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that Urgocell Ag is a wound dressing applied directly to the wound to help reduce infection and absorb exudate. It does not involve testing samples taken from the body.
- Lack of Diagnostic Function: The device's function is therapeutic and protective (providing a barrier and absorbing exudate), not diagnostic (identifying a disease or condition through testing).
- Performance Studies: The performance studies mentioned focus on the antimicrobial activity of the dressing against specific bacteria and fungi, which is relevant to its function as a wound dressing, not as a diagnostic test.
Therefore, Urgocell Ag is a medical device, but it falls under the category of a wound dressing, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
FRO
Device Description
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.
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
Safety Studies: The standard battery of safety and biocompatibility studies 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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
1/2
5. 510(k) Summary
Additional Information to Premarket Notification Summary
JUN 1 1 2010
-
- Sponsor Information: Laboratories URGO 42 Rue de Longvic 21300 Chenove France
Contact Person:
- Sponsor Information: Laboratories URGO 42 Rue de Longvic 21300 Chenove France
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 -
- 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.
- Indications for Use
1
2/2
6. Technological Characteristics
r
| FUNCTION | Urgocell Ag (K062559) | Urgocell Ag |
|---|---|---|
| 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. | 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. | ||
| Structure | Composed of three 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, - a non-sensitising, super-absorbent
polyurethane foam pad, - a protective, semi-permeable
polyurethane backing | Composed of three layers:
-in contact with the wound, a polyester
mesh impregnated with a matrix of
hydrocolloid particles
(carboxymethylcellulose), cohesion
polymers, petroleum jelly and silver
sulphate, - a non-sensitising, super-absorbent
polyurethane foam pad, - a protective, semi-permeable
polyurethane backing |
| Antimicrobial
activity | Studies of antimicrobial activity
against MRSA, Pseudomonus
aeruginosa, and Streptococcus
pyogenes | Studies of antimicrobial activity against
MRSA, Pseudomonus aeruginosa,
Streptococcus pyogenes, Enterococcus
faecalis, Escherichia coli, and Candida
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.
2
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
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/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
4
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
Page 1 of 1