(52 days)
The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.
The Restore Wound Cleanser is a buffered isotonic water based surfactant solution that is a clear colorless slightly viscous liquid that is intended to remove foreign material such as dirt is a debris from dermal wounds. The device can be used on low, medium or high exudating and wounds. The product is available in an 80z. spray bottle. The Restore Wound Cleanser is applied to the dermal wound area using a trigger spray closure that helps facilitate the removal of foreign material such as dirt and debris.
The provided text is a 510(k) summary for the Restore Wound Cleanser. This type of regulatory submission historically did not typically include detailed performance studies with acceptance criteria in the same way modern AI/ML device submissions do. My analysis will explain why most of the requested information cannot be found in this document, and what limited information can be extracted.
Based on the provided document, the following information can be extracted or deduced:
The Restore Wound Cleanser is a legally marketed device that gained clearance based on substantial equivalence to predicate devices (Carrington Carra Klenz Wound Cleanser K022670, Allclenz Wound Cleanser K965120, Derma Sciences Dermagran Wound Cleanser with Zinc K945802). Substantial equivalence means that the device has the same intended use, and the same technological characteristics as the legally marketed predicate device, or if there are differences in technological characteristics, these differences do not raise different questions of safety and effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Explanation: This document does not describe specific numerical acceptance criteria or performance metrics for the Restore Wound Cleanser in terms of efficacy or performance compared to a standard. The 510(k) pathway relies on establishing substantial equivalence to a predicate device, not on meeting specific, pre-defined performance thresholds for device functionality in clinical use.
2. Sample size used for the test set and the data provenance
Sample Size for Test Set: Not applicable.
Data Provenance: Not applicable.
Explanation: This 510(k) clearance relied on a comparison of technological characteristics and safety data (biocompatibility) with predicate devices, rather than a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.
Explanation: As no clinical performance study on a test set (with ground truth) was conducted or presented, there were no experts involved in establishing ground truth for such a test set.
4. Adjudication method for the test set
Adjudication Method: Not applicable.
Explanation: No test set requiring expert adjudication was utilized for this 510(k) submission.
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
MRMC Study: No.
Effect Size: Not applicable.
Explanation: This device is a wound cleanser, not an AI/ML diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Standalone Performance Study: No.
Explanation: This device is not an algorithm, so a standalone algorithmic performance study is not applicable.
7. The type of ground truth used
Type of Ground Truth: Not applicable.
Explanation: As there was no clinical performance study requiring a "ground truth" for classification or measurement outcomes, this concept is not applicable. The primary "truth" established in a 510(k) is the safety and effectiveness on par with a predicate device, often supported by bench testing and biocompatibility data.
8. The sample size for the training set
Sample Size for Training Set: Not applicable.
Explanation: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Ground Truth Establishment for Training Set: Not applicable.
Explanation: No training set was used for this device.
Summary of what the document focuses on regarding "proof":
The "study" or evidence provided to prove the device meets acceptance criteria (specifically, being substantially equivalent to predicates) primarily consists of:
- Comparison of Intended Use: The Restore Wound Cleanser has the same intended use (removal of foreign material like dirt and debris from dermal wounds) as the identified predicate devices.
- Comparison of Technological Characteristics: It is a buffered isotonic water-based surfactant solution, similar to the predicates. All are intended for use on low, medium, or high exudating wounds.
- Biocompatibility Testing: The document states that "Issues of biomaterial safety or biocompatibility have been addressed based upon biomaterial history or in separate in-vitro or in-vivo laboratory evaluations using licensed commercial reference laboratories." This assessment followed principles and guidelines from ISO 10993, FDA G95-1, USP, FHSA, and FDA GLP regulations. This testing demonstrates that the device is "appropriate for its intended use" from a biological safety perspective.
In essence, for this 510(k), the "acceptance criteria" were that the device's intended use and technological characteristics were sufficiently similar to legally marketed predicate devices, and that any differences (including materials) did not raise new questions of safety or effectiveness, supported by biocompatibility testing. No specific performance study in a clinical setting with numerical acceptance criteria, as one might see for an AI/ML diagnostic, was required or performed.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.