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510(k) Data Aggregation
(146 days)
VASHE WOUND CLEANSING SYSTEM
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, 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. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Vashe® Wound Therapy System:
Based on the provided text, the Vashe® Wound Therapy System is a wound cleanser solution. The document is a 510(k) summary, which indicates a claim of substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to establish new acceptance criteria.
The device is not an AI-powered one, and therefore the details you requested regarding AI performance (test set, training set, experts, MRMC studies, standalone performance) are not applicable.
Here's a breakdown of the information that is available:
Acceptance Criteria and Device Performance for Vashe® Wound Therapy System
The acceptance criteria for the Vashe® Wound Therapy System are not explicitly stated in terms of specific performance metrics within this 510(k) summary. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices. This means the device is considered acceptable if its performance is comparable to or safe and effective as the predicate devices for its intended indications for use.
The study that "proves the device meets the acceptance criteria" is a pre-clinical testing study that demonstrated biocompatibility. The 510(k) process relies heavily on demonstrating similarity to already approved devices rather than establishing new efficacy or performance benchmarks via clinical trials, especially for devices like wound cleansers.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: The device should be safe for use in contact with human tissue and not cause adverse biological reactions. (Implied for medical devices) | "Pre-clinical testing demonstrated biocompatibility of the Vashe® Wound Therapy Solution." |
| Functional Equivalence: Performs the intended actions of cleansing, irrigating, moistening, and debriding dermal wounds, and other stated indications. (Implied by comparison to predicate devices) | The description states: "The subject device includes a wound cleanser 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. In addition, the subject device contains Free Available Chlorine (FAC) that inhibits contamination within the solution." The conclusion of the 510(k) is "substantially equivalent" to the predicate devices, implying functional equivalence. |
| Similar Mechanism of Action: Operates through a comparable mechanism to predicate devices. (Implied by comparison to predicate devices) | The device's description mentions "mechanical action of fluid moving across the wound" and "Free Available Chlorine (FAC) that inhibits contamination." This is implicitly compared to predicates like Anasept™ (which "delivering antimicrobial sodium hypochlorite") and Oculus Puracyn™ (which "includes a preservative which contains a broad spectrum of antimicrobial agents"), showing similar approaches to wound care and infection control. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate devices. (Fundamental requirement for 510(k) clearance) | The FDA's clearance letter ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") confirms that no new questions of safety or effectiveness were raised, based on the submitted information. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a non-AI device. The "test set" here would refer to the subjects in the biocompatibility testing, but specific numbers are not provided.
- Data Provenance: The biocompatibility testing likely involved in-vitro and/or in-vivo animal studies, which are standard for such evaluations. The specific country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as this is a non-AI device. Ground truth, in this context, would be the results of the biocompatibility tests themselves, assessed against established standards, not expert consensus on findings.
4. Adjudication Method for the Test Set
- Not applicable for a non-AI device. Adjudication methods are typically used in clinical studies or expert reviews of complex data (like medical images) where multiple interpretations are possible. Biocompatibility testing results are usually evaluated against pre-defined scientific standards.
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 not an AI product and does not involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is not an AI algorithm. Its performance is inherent to the chemical composition and mechanical action of the solution itself.
7. The Type of Ground Truth Used
- The "ground truth" for the biocompatibility testing would be scientific standards and established biological responses to the test materials. This could involve cell viability assays, irritation tests, sensitization tests, and systemic toxicity tests, where the absence of adverse reactions against predefined thresholds constitutes "truth."
8. The Sample Size for the Training Set
- Not applicable as this is a non-AI device. There is no training set mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is a non-AI device.
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(87 days)
VASHE WOUND CLEANSING SYSTEM
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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