(129 days)
Vashe® Wound Therapy System (including 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.
The subject device includes a wound cleanser solution that is intended for cleansing, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings. The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.
Vashe® Wound Therapy System consists of a Vashe® Wound Therapy Generator and Vashe® Wound Therapy+ Solution. The Vashe® Wound Therapy+ Solution is produced from a Vashe® Wound Therapy Generator. The generator is an electromechanical device containing an electromechanical cell, power supply, storage tank, pump, valve, tubing, various mechanical hardware, etc. The Vashe® Wound Therapy Solution is a clear solution with a controlled pH and containing free available chlorine at a designated concentration (ppm). Cleaning and debriding is caused by the physical action of the of the Vashe® Wound Therapy Solution moving across the wound while the hypochlorous acid acts as a preservative to ensure no growth of micro-organisms in the solution. In addition. The Vashe® Wound Therapy Solution also moistens and lubricates absorbent wound dressings.
The provided document describes the Vashe® Wound Therapy System and its 510(k) submission (K100918) for market clearance. The information focuses on demonstrating substantial equivalence to predicate devices and provides details on performance testing related to safety and biocompatibility, as well as the solution's ability to inhibit contamination.
However, the document does not contain the following information typically found in studies related to AI/algorithm-based medical devices:
- Acceptance Criteria for Device Performance (beyond safety and biological compatibility): The document establishes basic safety and inhibitory properties of the solution but does not specify performance metrics for "cleansing, irrigating, moistening, and debriding" with quantitative acceptance criteria.
- Study proving device meets acceptance criteria (in terms of clinical efficacy compared to a standard or a specific performance benchmark).
- Sample size for test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training set.
- How ground truth for the training set was established.
Summary of available information from the document related to performance/testing:
The document describes performance testing primarily focused on safety, biocompatibility, and the preservative effectiveness of the Vashe® Wound Therapy Solution. It does not present a clinical study with specific performance metrics for the "cleansing, irrigating, moistening, and debriding" functions against pre-defined acceptance criteria.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Generator Safety | Compliance with UL 61010 and EN 61010-1:2001 (electrical safety, etc.). | "None of the testing demonstrated any design characteristics that violated the requirements or resulted in any safety hazards. It was concluded that the Vashe® Wound Therapy Generator tested met all relevant requirements of the aforementioned test." |
| Solution Biocompatibility | No irritation, skin sensitization, or mutagenic effects. Acute oral toxicity showing no toxic effects. Meeting ISO 10993-5 requirements (grade less than 2 for reactivity). | "The solution showed no irritation or skin sensitization and was not mutagenic in the bacterial mutation genotoxicity assay. In addition, the acute oral toxicity studies showed no toxic effects. In all cases, the Vashe® Wound Therapy Solution test articles met the requirements of the ISO 10993-5 since the grade was less than a grade 2 (mild reactivity)." |
| Solution Antimicrobial / Preservative Effectiveness | Inhibiting contamination within the solution. Meeting USP 51 requirements when aged beyond shelf-life. Achieving significant reduction against various microorganisms. | "The Vashe® Wound Therapy Solution, at its minimum recommended concentration and aged beyond its shelf-life, meets USP 51 requirements. No growth was observed from any of the 21 tests micro-organisms when challenged with aged Vashe solution. Results showed a >99.999% reduction against 20 organisms and 99.995% reduction was observed against the Staphyloccoccus aureus strain (ATCC 6538). Endospore Time Kill Assay results showed that the aged Vashe® Wound Therapy Solution after 15 seconds contact time produced >99.999% reduction against Clostridium difficile endospores." |
| GMP Compliance | Manufacturing according to product specifications and Good Manufacturing Practices (GMP). Risk analysis performed to identify potential failure modes. Manufacturing controls developed and implemented. | "The Vashe® Wound Therapy Generator containing the automatic dispense feature will be manufactured according to product specifications and under the guidelines of Good Manufacturing Practices (GMP). Risk analysis has been performed to identify possible failure modes during manufacturing. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. All established GMPs will assure that the device manufactured at PuriCore meets all the established specifications prior to release and is safe and effective for its intended use." |
| Substantial Equivalence | Similar function and intended use to predicate devices, including managing wounds by maintaining a moist environment, debridement, and inhibiting microorganism growth via free available chlorine. | The device is deemed substantially equivalent to Anasept™ Antimicrobial Skin and Wound Cleanser and Gel (K073547), Oculus Puracyn™ Skin and Wound Cleanser with Preservatives (K090206), and Microcyn™ Wound Gel (K090725) due to similar intended uses, mechanism of action (mechanical cleansing, moistening, and preservative action of FAC), and device characteristics. The predicate devices' labeled uses include maintaining a moist wound environment, debridement, and antimicrobial properties. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated for any clinical performance or efficacy studies. For the antimicrobial efficacy, 21 test microorganisms were used.
- Data Provenance: Not explicitly stated as being from a specific country or whether it was retrospective or prospective for a clinical efficacy study. The testing for generator safety (UL, Demko A/S) and toxicology/biocompatibility does not represent patient 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 provided because no clinical efficacy study with expert interpretation of the results is described. The evaluations were laboratory-based (UL, Demko A/S, toxicology labs, microbiology labs).
4. Adjudication method for the test set:
- Not applicable/Not provided, as no clinical study amenable to such a method is described.
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 is not an AI or imaging device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for the tests performed was based on established laboratory testing standards:
- Generator Safety: Compliance with UL and EN standards.
- Biocompatibility: ISO 10993-5 (reactivity grade), bacterial mutation genotoxicity assay, acute oral toxicity studies, irritation/sensitization tests.
- Antimicrobial Efficacy: USP 51 requirements, quantitative reduction against specific microorganisms (e.g., Staphyloccoccus aureus, Clostridium difficile endospores).
8. The sample size for the training set:
- Not applicable, as this is not a machine learning/AI device, and no training set was used.
9. How the ground truth for the training set was established:
- Not applicable, as this is not a machine learning/AI device.
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