Search Results

Vashe® Wound Therapy Solution is intended for cleansing, irrigating, moistening, and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin in addition to moistening and lubricating absorbent wound dressings.

Vashe® Wound Therapy Solution is a wound cleanser solution that contains hypochlorous acid generated from sodium chloride solution through the proprietary electrochemical process. Hypochlorous acid acts as a preservative that inhibits microbial contamination within the solution. The device is presented as a prescription product that requires the practitioner to diagnose the disease state and prescribe the product.

Here's a breakdown of the acceptance criteria and study information for the Vashe® Wound Therapy Solution, based on the provided 510(k) summary:

The document does not detail a clinical study with human subjects, but rather focuses on non-clinical equivalency testing related to product specifications and stability. This is a common approach for 510(k) submissions where a device is substantially equivalent to a predicate device and the changes made do not significantly alter its fundamental scientific technology or intended use.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the modified device (Vashe® Wound Therapy Solution manufactured centrally) are primarily based on the chemical specifications of the solution, which were slightly expanded compared to the predicate device.

Note: The document states "Lower specification expanded pH at 3.5 to 6.75ppm", which appears to be a typo and should likely read "pH at 3.5 to 6.75". The predicate device had a pH specification of "5.3 to 6.75ppm".

Study Details

The provided 510(k) summary indicates non-clinical equivalency testing was conducted.

1. Sample size used for the test set and the data provenance: Not specified in terms of number of samples, but the testing was for Shelf Life and Chemical Stability of the modified product. The data provenance is internal to PuriCore Inc. as the manufacturing process was moved from on-site generation to central manufacturing at PuriCore in Malvern, PA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For chemical stability testing, the "ground truth" is established by standard analytical chemistry methods and adherence to the defined chemical specifications.

3. Adjudication method for the test set: Not applicable. This was chemical and stability testing against predefined specifications.

4. 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 is a wound therapy solution, not an AI-powered diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a chemical solution, not an algorithm.

6. The type of ground truth used: For the non-clinical testing, the ground truth was chemical specifications and stability over time, assessed through analytical methods.

7. The sample size for the training set: Not applicable. This is a non-clinical submission for a chemical product, not a machine learning model.

8. How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Justification

The core of the submission for Vashe® Wound Therapy Solution relies on demonstrating substantial equivalence to its predicate device (Vashe® Wound Therapy System, K100918) through non-clinical testing. The key changes are:

• Place of Production: Moving from on-site generation at the customer's location to central manufacturing at PuriCore Inc.
• Expanded Specifications: The acceptable range for Available Free Chlorine (AFC) and pH was slightly expanded.
• Shelf Life and Stability: Non-clinical testing was performed to ensure that the modified device, with its expanded specifications and centralized production, maintains chemical stability and preservative effectiveness (due to hypochlorous acid) throughout its shelf life, including under worst-case scenarios for initial and final concentrations and pH.

The conclusion drawn by PuriCore Inc. (and accepted by the FDA for 510(k) clearance) is that these modifications have not changed the Intended Use or altered the Fundamental Scientific Technology of the device, thereby demonstrating substantial equivalence.

Ask a specific question about this device