(154 days)
Urgoclean Absorbent Wound Dressing is indicated to manage all 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, donor sites, dermatological); partial thickness burns; management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided.
Urgoclean Absorbent Wound Dressing is a sterile non-woven highly absorbent pad coated with a 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, allowing a one piece and painless removal. It is supplied sterile in an individual pouch.
This 510(k) summary (K123219) describes a wound dressing and focuses on establishing substantial equivalence to existing predicate devices, rather than a clinical study with detailed acceptance criteria and performance metrics for a novel medical device. Therefore, many of the requested categories related to a clinical performance study with AI assistance, expert ground truth, and specific statistical analyses are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility in permanent contact with altered surface (>30 days): | All tests conducted in accordance with ISO 10993: |
| - Cytotoxicity test | Test passed |
| - Primary Skin Irritation test | Test passed |
| - Sensitization test | Test passed |
| - Genotoxicity tests (Bacterial reverse mutation, chromosomal aberration, Mouse bone marrow micronucleus) | All tests passed |
| - 28-day systemic toxicity study | Test passed |
| Similar Properties to Predicate Devices: | Demonstrated similarity to Aquacel® Hydrofiber® Wound Dressing: |
| - Fibers-based and visually similar aspects | Yes |
| - Absorption of exudates/body fluids leading to gel formation | Comparable |
| - Creation of a moist environment | Comparable |
| - Non-sticking/pain-free removal | Comparable |
| - Conformability to the wound | Comparable |
| - Sterility | Yes |
| Similar Indications for Use: | Indications are similar to predicate, covering various exuding wounds. |
| Additional Claim (Urgoclean only): | Higher resistance/tensile strength allowing "one-piece removal". |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are implicitly met if the new device demonstrates similar safety and effectiveness to a legally marketed predicate device. This is primarily shown through:
- Compliance with recognized standards (e.g., ISO 10993 for biocompatibility).
- Demonstration of comparable technological characteristics and performance (e.g., absorption, gelling, non-sticking).
- Alignment of intended use and indications.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document describes biocompatibility testing and a comparison of physical properties, not a clinical trial with a "test set" of patients or data in the typical sense.
- Data Provenance: The biocompatibility tests would have been performed in a laboratory setting, likely in France (where the sponsor is located) or a contracted lab. The comparative properties are based on laboratory analysis and comparison to the predicate device specifications, not on clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "ground truth" derived from expert consensus on a test set of patient cases described in this document. The "truth" for biocompatibility is whether the tests meet ISO standards. The "truth" for substantial equivalence is the demonstration of comparable properties.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method for a test set of data is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This device is a physical wound dressing, not an algorithm or AI product.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" is established by adherence to the criteria set forth in ISO 10993 standards. These standards define acceptable levels for cytotoxicity, irritation, sensitization, genotoxicity, and systemic toxicity based on established scientific principles.
- For Substantial Equivalence: The "ground truth" is the established safety and effectiveness profile of the predicate device (Aquacel® Hydrofiber® Wound Dressing), against which Urgoclean Absorbent Wound Dressing is compared based on its materials, design, and performance characteristics.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no training set in that context. The "training" here would be the development and testing performed during the device's design phase to ensure it functions as intended, which isn't quantified by a "training set" size in this type of document.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
N/A