(130 days)
The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
Irrisept® Wound Debridement and Cleansing System 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 a 510(k) submission for the Irrisept Wound Debridement and Cleansing System (K202222), claiming substantial equivalence to its predicate device (K080779). This is a "catch-up 510(k)" primarily addressing updates responsive to user feedback, longer-term shelf-life data, and supplier/contractor changes.
The document does not provide acceptance criteria or a study that specifically proves the device meets distinct acceptance criteria in the context of comparative effectiveness or standalone performance of an AI/algorithm-based device as requested in the prompt. The testing described is focused on demonstrating that the changes made to the device do not raise new questions of safety and effectiveness compared to the predicate device, rather than establishing performance against new, explicit acceptance criteria for a novel AI or diagnostic system.
Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a different type of device evaluation (e.g., AI/algorithm performance).
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense for a new AI/algorithm device (e.g., minimum sensitivity, specificity, or AUC). Instead, the performance testing focuses on demonstrating that the modified device is as safe and effective as the predicate.
The table below outlines the performance testing conducted, which implicitly serves to "meet acceptance criteria" by confirming the safety and effectiveness of the updated device is maintained compared to the cleared predicate. The reported "performance" is that the tests were successfully passed, indicating equivalence to the predicate.
| Acceptance Criteria Category (Implicit) | Specific Test Conducted | Reported Device Performance |
|---|---|---|
| Antimicrobial Effectiveness | USP Antimicrobial Effectiveness Testing | Demonstrated to be effective (implies comparable to predicate) |
| Aseptic Processing | ISO 13408 Aseptic Processing of Health Care Products | Compliant (implies comparable to predicate) |
| Sterilization | ISO 11135 Sterilization of Health-Care Products Ethylene Oxide | Compliant (implies comparable to predicate) |
| ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residuals | Compliant (implies comparable to predicate) | |
| USP Sterility Tests | Compliant (implies comparable to predicate) | |
| AAMI TIR 28 Product adoption and process equivalence for ethylene oxide sterilization | Compliant (implies comparable to predicate) | |
| Endotoxins and Pyrogens | USP Bacterial Endotoxins Test | Compliant (Endotoxin Limit ≤ 20 EU/device) |
| USP Pyrogen Test (USP Rabbit Test) | Compliant (implies comparable to predicate) | |
| USP Medical Devices Bacterial Endotoxin and Pyrogen Tests | Compliant (implies comparable to predicate) | |
| Packaging and Shelf-Life | ISO 11607 Packaging for Terminally Sterilized Medical Devices | Compliant, now 2-year shelf-life (vs. 6 months for predicate) |
| ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Compliant (supports 2-year shelf-life) | |
| ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | Compliant | |
| ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Compliant | |
| ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems | Compliant | |
| Biocompatibility | ISO 10993- Biological Evaluation of Medical Devices | Conforms for a surface device with breached/compromised contact (≤ 24 hours) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the performance tests, nor does it mention data provenance (country of origin, retrospective/prospective). The tests listed are primarily bench/laboratory tests on the device itself or its components (e.g., solution, packaging). This is not a clinical study involving patient data.
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 is not an AI/algorithm or diagnostic device that requires expert-established ground truth from clinical cases. The tests are laboratory and engineering-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication is mentioned.
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 a medical device for wound cleansing (Jet Lavage), not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical "ground truth." The "truth" for the performance tests is based on adherence to established international and USP standards (e.g., sterility, endotoxin limits, packaging integrity, biocompatibility).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/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 this type of device.
§ 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.