Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202222
    Date Cleared
    2020-12-14

    (130 days)

    Product Code
    Regulation Number
    880.5475
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Irrisept Wound Debridement and Cleansing System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.

    Device Description

    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.

    AI/ML Overview

    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 ConductedReported Device Performance
    Antimicrobial EffectivenessUSP Antimicrobial Effectiveness TestingDemonstrated to be effective (implies comparable to predicate)
    Aseptic ProcessingISO 13408 Aseptic Processing of Health Care ProductsCompliant (implies comparable to predicate)
    SterilizationISO 11135 Sterilization of Health-Care Products Ethylene OxideCompliant (implies comparable to predicate)
    ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residualsCompliant (implies comparable to predicate)
    USP Sterility TestsCompliant (implies comparable to predicate)
    AAMI TIR 28 Product adoption and process equivalence for ethylene oxide sterilizationCompliant (implies comparable to predicate)
    Endotoxins and PyrogensUSP Bacterial Endotoxins TestCompliant (Endotoxin Limit ≤ 20 EU/device)
    USP Pyrogen Test (USP Rabbit Test)Compliant (implies comparable to predicate)
    USP Medical Devices Bacterial Endotoxin and Pyrogen TestsCompliant (implies comparable to predicate)
    Packaging and Shelf-LifeISO 11607 Packaging for Terminally Sterilized Medical DevicesCompliant, now 2-year shelf-life (vs. 6 months for predicate)
    ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesCompliant (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 PenetrationCompliant
    ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and SystemsCompliant
    BiocompatibilityISO 10993- Biological Evaluation of Medical DevicesConforms 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.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1