(163 days)
Prescription Use:
Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
OTC Use:
Skin and Wound Cleanser for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, minor abrasions, minor lacerations and minor burns.
The proposed devices, Skin and Wound Cleanser, is a clear, colorless solution that is intended for wound management including cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze).The solution of Skin and Wound Cleanser contains purified water, PHMB, undecylenamidopropyl betaine, and trace ingredients (allantoin, citric acid). During the application of product, fluid moving across the wound aids in the removal of foreign objects such as dirt and debris. Skin and Wound Cleanser solution contains PHMB, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus niger, Methicillinresistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterocccus faecalis (VRE) to maintain quality of the product during storage of the wound cleansing solution.
The provided document is an FDA 510(k) summary for a medical device called "Skin and Wound Cleanser." It outlines the regulatory submission, identity of the device, identification of predicate devices, device description, intended use, and non-clinical test conclusions.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical tests performed to ensure the device meets design specifications and is substantially equivalent to predicate devices. The acceptance criteria are implicitly tied to compliance with the standards listed and the successful demonstration of the specified performance.
| Acceptance Criteria (Implicit from Standards/Tests) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5:2009 (Cytotoxicity) | Device complies with the standard |
| ISO 10993-6:2016 (Local Effects after Implantation) | Device complies with the standard |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | Device complies with the standard |
| ISO 10993-11:2017 (Systemic Toxicity) | Device complies with the standard |
| Antimicrobial Effectiveness: | |
| USP Antimicrobial Effectiveness Testing | Effectiveness to inhibit growth of microorganisms (E. coli, P. aeruginosa, S. aureus, C. albicans, A. niger, MRSA, VRE) within the wound cleansing solution. |
| Physical/Chemical Characteristics: | |
| Appearance: Clear, colorless solution | Clear, colorless solution |
| Application method: Spray/Squeeze bottle | Spray bottle; Squeeze bottle (matches predicate) |
| Characteristics: Aqueous | Aqueous |
| Density (at 20°C): 0.9 – 1.0 g/ml | 0.9 – 1.0 g/ml |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of replicates, number of animals, etc.) used for each non-clinical test. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: Not explicitly stated in terms of country of origin but refers to established international (ISO) and US (USP) standards. The tests are presented as being conducted by the applicant, Winner Medical Co., Ltd. The study appears to be a prospective non-clinical study specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable (N/A) as the tests conducted are non-clinical, laboratory-based analyses (biological evaluation and antimicrobial effectiveness), rather than studies requiring human expert interpretation or a "ground truth" derived from expert consensus. The "ground truth", in this context, is the quantitative or qualitative outcome specified by the respective ISO or USP standard, assessed by laboratory personnel.
4. Adjudication Method for the Test Set:
- This information is N/A for the same reasons as point 3. The non-clinical tests are evaluated against predefined criteria in the standards, not through adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is typically for image-based diagnostic or prognostic devices involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is N/A as the device is a "Skin and Wound Cleanser," which is a physical solution, not a software algorithm or an AI device.
7. The type of ground truth used:
- The "ground truth" for the non-clinical tests is derived from established scientific standards and methodologies. For example:
- Biocompatibility: The "ground truth" is determined by observing cellular responses (cytotoxicity), tissue reactions (local effects, irritation), and systemic effects in laboratory models, as per the guidelines and endpoints defined in the ISO 10993 series.
- Antimicrobial Effectiveness: The "ground truth" is measured by the reduction in microbial population over time, in comparison to specified log reductions or absence of growth criteria as defined by USP for various microorganisms.
8. The Sample Size for the Training Set:
- This question is N/A as the device is a physical wound cleanser and does not involve a "training set" in the context of machine learning or AI. The non-clinical tests are performed on the device itself.
9. How the Ground Truth for the Training Set was Established:
- This question is N/A for the same reasons as point 8.
In summary, the K231564 submission relies on non-clinical, laboratory-based testing to demonstrate conformance to recognized standards for biocompatibility and antimicrobial effectiveness, establishing substantial equivalence to predicate devices, rather than clinical studies or AI algorithm performance evaluations.
N/A