Search Results

Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, 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, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Vashe® Wound Solution is a saline based wound cleanser that contains hypochlorous acid as a preservative that inhibits microbial contamination within the solution. Vashe® Wound Solution creates a moist environment and loosens contaminated exudate, slough and other foreign materials within the wound bed. As a result of mechanical action of solution moving across the wound bed, dirt, debris, and microorganisms are more readily removed. Moistening and cleansing a wound, such as by using Vashe Wound Solution, better allows for the natural healing process to take place. This device is presented as a prescription product that requires the physician to diagnose the disease state and prescribe the product.

The device is offered in three sizes of bottles, 4.0oz, 8.5oz, and 16.0oz and in two packaging configurations:

Configuration #1: A PET bottle with a laminated induction seal and a polypropylene flip-top-cap configuration enables the user to manually pour the solution directly onto a wound or wound dressing.

Configuration #2: The device is also offered in a PET bottle and a polypropylene cap (with septum configuration that forms the primary seal). The septum cap enables easy access to the solution by a healthcare professional by means of a vented spike connector.

The provided 510(k) summary for Vashe® Wound Solution (K131848) does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or quantifiable outcomes. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, safety, and effectiveness, primarily through non-clinical testing.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the format requested, as the submission relies on demonstrating substantial equivalence, not on meeting specific, quantifiable performance targets for the device's intended use in treatment. The "performance" is primarily shown through a comparison to existing, legally marketed predicate devices and through non-clinical safety/stability testing.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the implicit acceptance criteria is a compilation of non-clinical equivalency testing aimed at demonstrating substantial equivalence to predicate devices. This includes:

• Comparison of Technical Characteristics: A qualitative comparison highlighting similarities in chemical composition, mechanical action, intended use, and packaging/closure systems to K123072, K113820, K083355, and K111313.
• Biocompatibility Studies: In-vivo and in-vitro biocompatibility testing per ISO-10993-1 standards. These were conducted to prove the product is safe, particularly under worst-case scenarios for active ingredient concentration and pH.
• Shelf Life and Chemical Stability Testing: Non-clinical tests to evaluate the product's stability over its intended shelf life.
• Preservative Effectiveness Testing: To USP standards, demonstrating the solution's ability to inhibit microbial contamination within the product.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a "test set" for a clinical performance evaluation. The non-clinical studies (biocompatibility, stability, preservative effectiveness) would have their own sample sizes for the materials tested, but these are not detailed in the summary. For example, for biocompatibility, it would involve a certain number of test replicates or animal subjects, but these specifics are missing.
• Data Provenance: Not specified for the non-clinical tests. It's implied these were conducted internally or by contract labs in support of the submission. The origin (e.g., country) is not mentioned. They would be considered prospective for the purpose of demonstrating equivalence for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a solution, and the testing outlined is primarily chemical, physical, and biological in nature (biocompatibility, stability). There is no "ground truth" derived from expert consensus on images or clinical outcomes in the summary provided.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described as there isn't a "test set" requiring such a method for this type of device.

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 or imaging tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical solution, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the clinical sense. For the non-clinical tests:

• Biocompatibility: Ground truth is established by recognized international standards (ISO-10993-1) for evaluating biological response to medical devices.
• Chemical Stability: Ground truth is against established chemical specifications and analytical methods.
• Preservative Effectiveness: Ground truth is against microbial reduction targets defined by compendial standards (USP ).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set mentioned for this device.

Ask a specific question about this device