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510(k) Data Aggregation

    K Number
    K160593
    Device Name
    Indy OTW Vascular Retriever
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2016-09-02

    (185 days)

    Product Code
    MMX
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K142829,K102484,K110009,K110163,K150970,K112185
    Why did this record match?
    Reference Devices :

    K142829, K102484, K110009, K110163, K150970

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

    The Indy OTW™ Vascular Retriever is intended to snare a foreign body and withdraw it to a peripheral vascular location.

    Device Description

    The Indy OTW™ Vascular Retriever consists of a 4-loop nitinol wire snare attached to an inner catheter (which is attached proximally to a metal cannula) and includes an outer Flexor sheath. The device is compatible with a 0.035 inch wire guide for over-the-wire introduction. The Flexor sheath has a radiopaque band incorporated within the sheath material to identify the location of the sheath's distal tip.

    AI/ML Overview

    The provided text describes the Cook Incorporated Indy OTW™ Vascular Retriever, a medical device for snaring and retrieving foreign bodies in the vascular system. However, it does not contain the specific information requested about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

    The document is a 510(k) summary for a medical device cleared by the FDA. It focuses on demonstrating substantial equivalence to a predicate device through manufacturing and performance testing, not on the performance of a software algorithm or AI.

    Therefore, I cannot fulfill your request for the specific points listed (AI performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) based on the provided text.

    The closest information related to "acceptance criteria" and "device performance" in this document is in Section VII, "PERFORMANCE DATA". It lists various types of engineering and materials testing performed, but these are for the physical device itself, not an AI component.

    Here's what can be extracted from the provided text regarding "acceptance criteria" and "device performance" for the physical device, recognizing it does not apply to an AI system:

    1. Table of Acceptance Criteria and Reported Device Performance (as much as can be inferred from the text):

    Test TypeAcceptance Criteria (Inferred from text)Reported Device Performance (Summary from text)
    Biocompatibility TestingAcceptable and demonstrate the device is biocompatible.All test results were acceptable.
    Tensile Strength TestingPeak load values of joints between device components in accordance with predetermined acceptance criteria.Peak load values of joints between device components were in accordance with the predetermined acceptance criteria.
    Simulated Use TestingCapable of snaring and removing wire guides and catheter fragments or snaring and repositioning wire guides and catheters within an anatomical model in accordance with the instructions for use.The predetermined acceptance criteria were met.
    Liquid Leak Pressure TestingSheath hub, Touhy-Borst, and catheter hub did not leak water while pressurized.The predetermined acceptance criterion was met.
    Structural Integrity TestingMaintained structural integrity under the conditions of the study.The predetermined acceptance criteria were met.
    Radiopacity TestingCatheter tip, sheath tip, and wire loops are visible under standard fluoroscopy.The predetermined acceptance criterion was met.
    Immersion Corrosion TestingNo evidence of corrosion was observed.No evidence of corrosion was observed. The predetermined acceptance criterion was met.

    Regarding the other requested information (which is specific to AI/software performance):

    • 2. Sample sized used for the test set and the data provenance: Not applicable to the provided document, as it describes a physical medical device, not an AI system.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    • 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.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
    • 8. The sample size for the training set: Not applicable.
    • 9. How the ground truth for the training set was established: Not applicable.

    The document details the evaluation of a physical vascular retriever based on mechanical, material, and simulated use tests designed to establish its safety and effectiveness and substantial equivalence to a predicate device. It does not involve any artificial intelligence or machine learning components.

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