(235 days)
Nexodyn AOS Wound Care Solution is intended for use under the supervision of healthcare professionals for cleansing, irrigating, moistening and debriding, to remove organic debris from partial or full thickness acute and chronic dermal lesions, such as leg ulcers, diabetic ulcers, stage I-IV pressure ulcers, post-surgical wounds, grafted and donor sites and 1st and 2nd degree burns, together with cleansing and moistening minor burns, superficial abrasions and minor skin irritations.
Nexodyn AOS Wound Care Solution is a clear, liquid solution wound cleanser that helps maintain a moist wound environment by removing dirt, debris and foreign material by the action of the wound cleanser moving across the wound bed. The device contains hypochlorous acid (HClO) acting as a preservative by inhibiting the growth of microorganisms within the solution.
The principle of operation of Nexodyn AOS Wound Care Solution to be irrigated across the wound being treated, by using bottles with a spray cap or by sluicing with larger quantity of solution from an open bottle.
The mechanism of action of Nexodyn AOS Wound Care Solution is based on the mechanical action of the solution flowing through the lesion and removing biological and inert materials such as microorganisms, biological debris and environmental dirt.
Nexodyn AOS Wound Care Solution is obtained by electrolysis, carried out on a saline solution, the starting raw materials being water and sodium chloride.
The provided text describes a 510(k) premarket notification for a medical device called "Nexodyn AOS Wound Care Solution." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a full-fledged clinical study with performance metrics in the way a new, high-risk device might.
Therefore, the information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance is not directly applicable in the format requested, as this document is a regulatory submission for substantial equivalence.
However, I can extract the relevant performance data and nonclinical testing that supports the claim of safety and effectiveness, which is the basis for substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
As this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for a specific performance metric like sensitivity/specificity are not explicitly stated or demonstrated in the provided text. Instead, the performance is demonstrated by nonclinical testing showing that the device is safe and effective compared to a predicate device.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Microbiological Efficacy | Meet requirements of USP 'Antimicrobial Effectiveness Testing', including FDA specified additional requirements, at lowest available chlorine and end of shelf life. | Microbiological efficacy studies conducted at the lowest specification level of available chlorine and on three date-expired batches demonstrated that device specifications and labeling claims are met at the end of the device's shelf life. Tests were in accordance with USP 'Antimicrobial Effectiveness Testing', including additional requirements specified by FDA, performed by an independent laboratory, with a starting inoculum of at least 1 x 10^6^ CFU/ml. The effectiveness has been demonstrated by successful completion of these tests. |
| Biocompatibility | Meet relevant ISO 10993 standards. | Biocompatibility testing in accordance with ISO 10993 standards was performed, including Cytotoxicity (ISO 10993-5), Implantation (ISO 10993-6), Sensitization (ISO 10993-10), Skin Irritation (ISO 10993-10), and Acute Systemic Toxicity (ISO 10993-11). The safety of the device with its free chlorine content and pH has been adequately demonstrated by these results. |
| Stability | Validate shelf life and in-use life. | Stability testing validated a 2-year shelf life and a 30-day in-use life. |
| Batch Analysis | Conformity to specified physical and chemical properties. | Bulk batch analysis and test included appearance, color, pH, ORP, chlorine assay, chloride assay, and microbiological tests. Device batch analysis and test included appearance, pH, ORP, conductivity, total chlorine assay, free chlorine assay, chloride assay, and microbiological tests. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For the microbiological efficacy studies, the starting inoculum was "at least 1 x 10^6^ CFU/ml." The number of batches used was "three date expired batches." The number of organisms or specific samples for biocompatibility and other nonclinical tests are not specified in this summary.
- Data Provenance: The microbiological efficacy studies were conducted by an "independent laboratory." The location of this lab and the country of origin are not specified. All tests are non-clinical, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are nonclinical (in vitro/laboratory and animal testing for biocompatibility) and do not involve human subjects or expert assessment for establishing ground truth in the context of clinical performance.
4. Adjudication method for the test set:
Not applicable, as this is nonclinical testing and does not involve adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a wound care solution, not an AI-powered diagnostic device, and therefore, no MRMC studies or AI assistance for human readers are relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a wound care solution, not an algorithm.
7. The type of ground truth used:
- Microbiological Efficacy: The "ground truth" was established by comparing the results against the requirements of USP 'Antimicrobial Effectiveness Testing' and FDA specified additional requirements. This typically involves measuring microbial reduction compared to controls.
- Biocompatibility: The "ground truth" was conformity to the relevant ISO 10993 standards. This involves observing biological responses (e.g., cytotoxicity, irritation) against established criteria in those standards.
- Stability and Batch Analysis: The "ground truth" was the predefined specifications and analytical methods for the physical, chemical, and microbiological properties of the solution.
8. The sample size for the training set:
Not applicable. This is a physical wound care solution, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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