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510(k) Data Aggregation

    K Number
    K070360
    Device Name
    KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Date Cleared
    2007-08-07

    (181 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601

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

    These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate hand-piece, providing for both irrigation and aspiration of the surgical site.

    Device Description

    These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate handpiece, providing conduits for both irrigation and aspiration of the surgical site.

    AI/ML Overview

    This document is a 510(k) summary for the Kirwan Disposable Manifold Tubing Set, a Class I device. It describes the device's intended use and demonstrates its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other diagnostic or treatment effectiveness measures.

    Instead, the document focuses on regulatory compliance and safety. The "acceptance criteria" discussed are related to manufacturing standards and hazard analysis, not performance evaluation in a clinical or diagnostic sense.

    Therefore, many of the requested sections regarding device performance studies, sample sizes, expert ground truth, and AI effectiveness cannot be extracted from this document.

    Here's a breakdown of what can be extracted and what cannot:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Compliance with ISO 11137 (Sterilization)Kirwan manifold tubing sets "have been found to comply with the requirements of the applicable sections within" this standard.
    Compliance with ISO 10993-1 (Biological evaluation)Kirwan manifold tubing sets "have been found to comply with the requirements of the applicable sections within" this standard.
    Hazard conditions acceptance (low-to-moderate level)Safety and hazard analysis "has determined that the hazard conditions for the Kirwan disposable manifold tubing sets range in the low-to-moderate level and for this reason are acceptable."
    Substantial Equivalence to Predicate DevicesDetermined to be substantially equivalent in intended use, technological safety and effectiveness, and performance to Integra LifeSciences C3600 (23 kHz) and C3601 (36 kHz) Manifold Tubing.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not applicable / Not provided. The document describes compliance with standards and a hazard analysis, not a clinical or performance study with a test set of 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 / Not provided. No ground truth establishment related to clinical performance is mentioned. The "ground truth" for compliance appears to be the standards themselves and the output of a hazard analysis.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable / Not provided.

    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 / Not provided. This is not an AI/diagnostic device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable / Not provided. This is not an AI/diagnostic device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Not applicable / Not provided in the context of clinical performance. The "ground truth" for the claims in this document is adherence to established medical device standards (ISO 11137, ISO 10993-1) and a hazard analysis.

    8. The sample size for the training set

    • Not applicable / Not provided. No training set for an algorithm is mentioned.

    9. How the ground truth for the training set was established

    • Not applicable / Not provided.
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