(87 days)
Vashe™ Wound Cleanser 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 Vashe™ Wound Cleanser is intended for use by qualified health care personnel trained in its use.
The subject device is a wound cleansing solution that is intended for cleansing, irrigating, 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. Vashe is offered in various volumes.
The provided text is a 510(k) summary for the Vashe™ Wound Cleanser and associated FDA correspondence. This device is a wound cleansing solution, and the documentation focuses on demonstrating its substantial equivalence to existing, legally marketed predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel diagnostic or therapeutic device.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or explicitly stated in this type of submission.
Here's an attempt to extract and interpret the information based on the provided text, noting where specific details are absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Device must not cause adverse biological reactions. | "Pre-clinical testing demonstrated biocompatibility of Vashe Wound Cleanser." |
| Functionality/Intended Use Equivalence: Device performs similar wound cleansing, irrigating, debriding, and moistening functions as predicates. | The submission asserts and FDA concurs that the device is "substantially equivalent in function and intended use" to the listed predicate devices based on its description and indicated uses. |
| Safety: Device is safe for its intended use. | Demonstrated through substantial equivalence to legally marketed predicate devices that are presumed safe. |
| Effectiveness: Device is effective for its intended use. | Demonstrated through substantial equivalence to legally marketed predicate devices that are presumed effective. |
2. Sample Size Used for the Test Set and Data Provenance
- The document describes pre-clinical testing for biocompatibility, but does not specify a "test set" in the context of clinical performance data or algorithm validation.
- Sample Size: Not specified. Pre-clinical testing often involves in-vitro or animal studies, but no numbers are provided here.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While "pre-clinical" implies lab or animal studies, the specific details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable to this type of submission. There is no mention of a "test set" requiring expert-established ground truth in the context of diagnostic performance. The evaluation is based on substantial equivalence to existing products.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" and corresponding adjudication methods are mentioned for evaluating device performance in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- Not applicable. This device is a wound cleanser, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical wound cleanser, not an algorithm.
7. The Type of Ground Truth Used
- For the biocompatibility testing, the "ground truth" would be established by standard biological assays and observation for adverse reactions, comparing results against established safety thresholds for medical devices.
- For the overall device, the "ground truth" for substantial equivalence is derived from a comparison of its characteristics (indications, technology, performance, safety) to those of the legally marketed predicate devices. The predicates themselves are considered "proven" safe and effective through prior FDA clearance.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not an AI model.
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