(6 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 bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and accessories for irrigation. 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 document is a 510(k) summary for the Irrisept® Antimicrobial Wound Lavage (150 mL), which is a modified version of a previously cleared device (450 mL Irrisept® Antimicrobial Wound Lavage, K210536). This submission asserts substantial equivalence to the predicate device, meaning the new device generally adheres to the same performance standards established for the predicate.
The document does not detail specific acceptance criteria values or a standalone study demonstrating the device's meeting of these criteria in the context of a new clinical or performance trial for effectiveness in all aspects. Instead, it relies on demonstrating that the modified device performs equivalently to the predicate device through various tests and that the modifications do not raise new safety or effectiveness concerns.
Here's an analysis based on the provided text, addressing your specific questions to the extent the document allows:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria with corresponding reported performance values for each functional aspect. Instead, it lists various tests performed and asserts that the device (150 mL version) demonstrated the "same level of performance as the predicate device" or was "equivalent to the predicate device" in functional testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meets ISO 10993-1 | Biocompatible per ISO 10993 Testing (Identical to predicate) |
| Aseptic Processing: Meets ISO 13408 | Confirmed for aseptic processing |
| Preservative Antimicrobial Effectiveness: Meets USP | Demonstrated per USP testing (Identical to predicate) |
| Endotoxins and Pyrogens: Meets USP , , | Confirmed to meet USP Bacterial Endotoxins Test, USP Pyrogen Test, and USP Medical Devices- Bacterial Endotoxin and Pyrogen Tests (Implied to be compliant with predicate's performance, although "identical" is not explicitly stated for all these specific tests in the comparison table, it is for Biocompatibility). |
| Shelf-Life: Meets USP (Antimicrobial Effectiveness) and USP (Sterility) and chemistry | Demonstrated per USP Antimicrobial Effectiveness, Sterility USP and chemistry |
| Functional Testing (Mechanical removal of wound debris): Equivalent to predicate device | Assessed for performance through custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device. |
| Distribution Testing: Meets ASTM D4169-22 | Confirmed to meet ASTM D4169-22 - Standard Practice for Performance Testing of Shipping Containers and Systems |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the tests mentioned (e.g., number of units tested for functional performance, biocompatibility, etc.).
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given that this is a 510(k) summary for a modified device, the testing would be conducted prospectively for the new iteration to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this document. The document describes a medical device (wound lavage) and its physical and chemical properties and functional equivalence to a predicate device, not a diagnostic or AI-driven decision support system that requires expert ground truth establishment for a test set.
4. Adjudication method for the test set
This is not applicable for the same reasons as point 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 is not applicable. The device is a wound lavage, not an AI or imaging diagnostic tool that would be part of a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing, the "ground truth" would be established by the validated methods described (e.g., ISO standards for biocompatibility, USP methods for antimicrobial effectiveness and sterility, custom tests for functional equivalence to the predicate). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would. For the functional testing, "custom tests designed to show the mechanical removal of wound debris, including microorganisms, is equivalent to the predicate device" implies a controlled experimental setup to measure the efficacy of removing debris, with the predicate device's performance serving as the benchmark.
8. The sample size for the training set
This is not applicable. The device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.