(90 days)
For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.
The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years.
The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Anexa Wound Flush, Sterile Water & Sterile Normal Saline device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of "acceptance criteria" in the traditional sense of performance metrics for a medical device (e.g., sensitivity, specificity, accuracy). Instead, it describes a substantial equivalence (SE) determination based on a comparison to a predicate device and a series of non-clinical tests. The "performance" is demonstrated by passing these tests and showing similarity to the predicate.
| Acceptance Criteria (Demonstrated by) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Device (K083042) | The device is substantially equivalent to the legally marketed predicate device (Nurse Assist, Inc. Wound Flush, Sterile Water & Sterile Normal Saline). Similarities noted include: |
- Same Regulatory Product Code (FRO)
- Same Classification (Pre-amendment)
- Similar Indications for Use
- Similar Principle of Operation (mechanical action removing foreign objects)
- Same Chemical Composition (0.9% Sterile Saline or Sterile Water; no additives)
- Uses same materials and container designs
- Same method of sterilization (gamma) |
| Biocompatibility Testing | Anexa conducted and passed the following biocompatibility tests: - Cytotoxicity
- Dermal Sensitization
- Intracutaneous test (direct injection)
- Acute Systemic Toxicity
- Bacterial Endotoxin Test |
| Compliance with Recognized Standards (Non-Clinical Testing) | Anexa conducted and passed tests according to the following standards: - ASTM F1980-07 (Reapproved 2011)
- AAMI/ANSI/ISO 11607-1:2006/(R)2010
- AAMI/ANSI/ISO 11607-2:2006/(R)2010
- AAMI / ANSI / ISO 11137-1:2006/(R)2010
- AAMI / ANSI / ISO 11137-2:2013
- AAMI / ANSI / ISO 11737-1:2006 (R)2011
- AAMI / ANSI / ISO 11737-2:2009/(R)2014
- AAMI/ANSI/ISO 10993-1:2009/(R) 2013
- AAMI / ANSI/ISO 10993-5:2009/(R) 2014
- ISO 10993-10 Third Edition 2010-08-01
- AAMI/ANSI/ISO 10993-11:2006/(R)2010
- AAMI TIR 22:2007
- AAMI TIR 33:2005
- AAMI/ANSI/ISO TIR 13004:2013 |
| Device Stability / Shelf-life | Product has a shelf life of 2-years. This implies successful testing to demonstrate this. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical testing and a comparison to a predicate device, not a "test set" in the context of clinical performance evaluation (e.g., for an AI algorithm). The sample sizes for the specific non-clinical tests (biocompatibility, shelf-life, etc.) are not provided in this summary. The data provenance is also not explicitly stated beyond being part of Anexa Biomedical, Inc.'s internal testing records.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical testing for a wound flush solution, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical setting.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
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
This information is not applicable. The device is a wound flush solution, not an AI-powered diagnostic tool. An MRMC study is explicitly designed for evaluating the impact of AI on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a wound flush solution, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (biocompatibility, sterility, shelf-life), the "ground truth" would be established by:
- Reference Standards/Controls: For biocompatibility, comparisons are made to established safe materials and adverse reactions are assessed.
- Scientific Methods and Measurements: For sterility, microbiological testing to confirm absence of microorganisms. For shelf-life, stability studies measuring chemical and physical properties over time.
- Compliance with Recognized Standards: Meeting the pass/fail criteria outlined in the referenced ASTM, AAMI/ANSI/ISO standards.
For the substantial equivalence claim, the "ground truth" is the legally marketed predicate device and its established safety and effectiveness profile.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
N/A