(93 days)
Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
The provided text describes the Irrisept Antimicrobial Wound Lavage device and its 510(k) submission for clearance. The submission focuses on demonstrating substantial equivalence to a predicate device, particularly by specifying the removal of "microorganisms" through mechanical cleansing.
However, the documentation does not contain information related to an AI/ML medical device, nor does it conduct studies involving human reader performance, expert consensus on images, or training/test set data and ground truth establishment typically associated with such device evaluations.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and the study proving the device meets it, as they pertain to AI/ML device performance metrics which are not discussed in this medical device submission.
The document primarily focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices based on:
- Intended Use: Minor modification to explicitly include "microorganisms" in the removal of wound debris.
- Technological Characteristics: The proposed device remains largely unchanged from its primary predicate (Irrisept Wound Debridement and Cleansing System, K202222) in terms of solution composition, mechanism of action, how supplied, applicator, sterilization, and biocompatibility.
- Performance Testing: Extensive list of standard medical device performance tests (e.g., sterilization, biocompatibility, packaging integrity, shelf-life, endotoxin, pyrogen testing) confirming it performs as safely and effectively as the predicate. The only new specific performance claim for this 510(k) is "mechanical action equivalent to the predicate devices, demonstrating that the fluid dispensed during the use of the device is sufficient to mechanically remove debris, including microorganisms, from wounds." This implies a physical/mechanical study, not an AI/ML performance study.
Given the context, here's what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria and performance in the format of an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by meeting various medical device standards and demonstrating equivalence to a predicate device.
Acceptance Criteria (Implied by Substantial Equivalence Basis) & Reported Performance:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Device is intended for mechanical cleansing and removal of debris, dirt, foreign materials, AND microorganisms from wounds. | Confirmed; specified in Indications for Use. The change to include "microorganisms" is supported by substantial equivalence claim to secondary predicate. |
| Technological Characteristics | Must be substantially equivalent to predicate device (K202222) in terms of solution, applicator, mechanism, etc. | Confirmed; "unchanged from the legally marketed predicate Irrisept device (K202222) in its intended use, performance, and technological characteristics." |
| Biocompatibility | Device materials are biocompatible (per ISO 10993). | Confirmed; "Biocompatible per ISO 10993 testing." |
| Sterilization | Device components (bottle exterior, wraps, applicator) are sterilized (per ISO 11135, ISO 10993-7 for residuals) and solution is aseptically processed. | Confirmed; adherence to ISO standards and USP Sterility Tests. |
| Preservative Antimicrobial Effectiveness | Solution preservative (CHG) effective over shelf-life (per USP ). | Confirmed; "Demonstrated per USP testing." |
| Endotoxins & Pyrogens | Device/solution meets endotoxin and pyrogen limits (per USP , , ). | Confirmed; "Demonstrated per USP testing." |
| Packaging & Shelf-Life | Packaging maintains sterility and product integrity over shelf-life (per ISO 11607, ASTM F1980, F2096, F1929, D4169). | Confirmed; "Demonstrated per ASTM and ISO standards." |
| Mechanical Action | Fluid dispensed is sufficient to mechanically remove debris, including microorganisms. | Confirmed; "tested to show mechanical action equivalent to the predicate devices." |
| Safety & Effectiveness Concerns | No new safety and effectiveness concerns raised by the specified change to indications for use. | Confirmed; "does not raise new safety and effectiveness concerns." |
Regarding the other points, they are not applicable to this submission:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a medical device clearance based on substantial equivalence and standard performance testing, not an AI/ML performance study with a test set of data. The "mechanical action" testing would involve physical samples/models, not digital data sets.
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. No "ground truth" derived from expert consensus on images is mentioned or required for this type of device (wound lavage).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No AI/ML test set or expert adjudication process is described.
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 is not an AI/ML device assisting human readers. It's a wound lavage device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of AI/ML. The "ground truth" for this device would be its physical/chemical properties and its ability to mechanically remove debris, established through validated laboratory tests and engineering studies, not clinical outcomes or expert image interpretation.
8. The sample size for the training set
- Not applicable. There is no AI/ML model or training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model or training set.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.