(35 days)
For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.
The provided document describes a 510(k) premarket notification for the "Anexa Wound Flush, Sterile Water and Sterile Normal Saline" device. This is a medical device clearance, not an AI/ML device approval, therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.
Based on the information provided in the document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria/Tests (as per document) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 standard tests for: | Found to be non-cytotoxic |
| - Cytotoxicity | Found to be non-irritating | |
| - Irritation | Found to be non-sensitizing | |
| Material/Composition | 0.9% Sterile Saline or Sterile Water | Meets USP requirements |
| No antimicrobial or other substance added | Confirmed | |
| Sterility | (Implied by "Sterile Water" and "Sterile Normal Saline", and adherence to ISO standards like AAMI / ANSI / ISO 11137-1:2006/(R)2010 for Sterilization) | Not explicitly detailed in performance column, but clearance implies compliance |
| Shelf Life/Stability | ASTM F1980-07 (Reapproved 2011) - Accelerated Aging | Not explicitly detailed in performance column, but implied by testing |
| Packaging Integrity | AATNU / ANSI/ ISO 11607-1:2006/(R)2010 | Not explicitly detailed in performance column, but implied by testing |
| Packaging Processes | AAMI / ANSI / ISO 11607-2:2006/(R)2010 | Not explicitly detailed in performance column, but implied by testing |
| Biocontamination Control | AAMI / ANSI / ISO 11737-1:2006 (R)2011 (Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products) | Not explicitly detailed in performance column, but implied by testing |
| Bacterial Endotoxins Testing | AAMI / ANSI / ISO 11737-2:2009/(R)2014 (Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process) | Not explicitly detailed in performance column, but implied by testing |
The document concludes that "Sterile Water and Sterile Normal Saline perform at least as well as the predicates' devices" and are "substantially equivalent" based on these comparisons and tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not specify a "test set" in the context of an AI/ML algorithm. The tests conducted (biocompatibility, sterility, etc.) are standard material and device performance tests, not AI model evaluations. Therefore, information about sample size, country of origin, or retrospective/prospective nature of data for an AI/ML test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This device is not an AI/ML algorithm that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This device is not an AI/ML algorithm that requires an adjudication method for a test set.
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 flush solution, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a wound flush solution, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device would be its chemical composition, sterility, and biocompatibility, which are verified through laboratory testing against established physical, chemical, and biological standards (e.g., USP , ISO 10993 standards). This is not equivalent to ground truth in the context of AI/ML.
8. The sample size for the training set:
Not applicable. This device is a wound flush solution, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needs to be established for it.
N/A