(291 days)
Not Found
No
The document describes a wound dressing with silver, focusing on its physical properties and intended use for managing exuding wounds. There is no mention of AI or ML technology in the device description, intended use, or any other section.
No
The device is a wound dressing designed to help manage exuding wounds and provide an antibiotic barrier, not directly treat a disease or condition in a therapeutic manner.
No
Explanation: The device is a wound dressing designed to manage exuding wounds and provide an antibiotic barrier; it does not diagnose medical conditions.
No
The device description clearly states it is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer, indicating it is a physical wound dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wound dressing for managing exuding wounds and providing an antibacterial barrier. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a sterile nonwoven pad with a silver-containing layer that interacts with wound exudate to form a gel. This is consistent with a wound dressing, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Predicate Devices: The listed predicate devices (Aquacel® Ag) are also wound dressings, further supporting that this device falls under the category of wound care products, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer on the dressing/wound interface.
In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, which allows for an easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain.
It is supplied sterile in an individual pouch.
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): 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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Laboratoires URGO Ms. Sophie Fortin Regulatory Affairs Manager 42 Rue de Longvic 21300 Chenove France
Re: K143017
Trade/Device Name: Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver Regulatory Class: Unclassified Product Code: FRO Dated: July 7, 2015 Received: July 9, 2015
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number: K143017
Device Name: Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
Indications For Use:
Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.
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)
3
Part 5 - 510(k) Summary
Premarket Notification Summary -July 28, 2015
- Sponsor Information: 1.
Laboratoires URGO 42 Rue de Longvic 21300 Chenove France
Contact Person: Sophie Fortin Regulatory Affairs Manager Phone: +33.3.80.44.28.78 Fax: +33.3.80.44.71.40
-
- Device Name:
Common or Usual Name: Antibacterial Absorbent Wound Dressing with Silver Proprietary Name: Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver Classification Name: Unclassified
- Device Name:
-
Description of Device 4.
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is a sterile nonwoven highly absorbent pad coated with a silver containing soft-adherent lipido-colloid layer on the dressing/wound interface.
In contact with body fluids (exudates, slough) it forms a gel creating a moist environment, which allows for an easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain.
It is supplied sterile in an individual pouch.
- న్. Indications for Use
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver is indicated to manage exuding wounds, especially during the debridement of slough. This includes chronic exuding wounds such as venous stasis ulcers, arterial ulcers, pressure ulcers (stage II-IV), diabetic ulcers; surgical wounds (post-operative, dermatological); partial thickness burns; traumatic wounds; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided. The dressing also provides an antibiotic barrier for bacterial penetration of the dressing, which may help reduce infection.
4
-
- Description of Substantial Equivalence:
Substantial Equivalence with Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing is based on technology, indications and safety.
- Description of Substantial Equivalence:
Both products have similar properties & claims, leading to similar indications.
Both products are fiber-based, and contain silver.
Key properties of both dressings are
- Absorption of exudates/body fluids by fibres => gel formation -
- Creation of a moist environment to enhance healing -
- Antibacterial properties (barrier effect), the dressing provides a barrier against bacterial penetration
- Non-sticking => easy removal of the dressing with little or no damage to healing tissues, leading to no or minor pain
- Conformability to the wound -
- -Sterility
When compared to Aquacel® Ag Hydrofiber® Wound Dressing, it was demonstrated that Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver have similar properties such as, both are made of sterile fibers, contain silver and have comparable absorption and gelling properties leading to comparable indications for use.
Thus we conclude that Urgoclean Ag Antibacterial Absorbent Wound Dressing with Silver and Aquacel® Ag Hydrofiber® Wound Dressing are substantially equivalent.
In terms of Safety, biocompatibility tests were conducted in accordance with standards ISO 10993 for a product considered as being in prolonged contact with an altered surface (24 hours to 30 days), as long as an overall evaluation of silver dressings tolerance.
From these elements we conclude that Urgoclean Ag. Antibacterial Absorbent Wound Dressing with Silver is as safe as its proposed predicate Aquacel® Ag Hydrofiber® Silver Impregnated Antimicrobial Dressing.