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510(k) Data Aggregation

    K Number
    K020733
    Device Name
    PVS 1500 SDS
    Manufacturer
    PRECISION VASCULAR SYSTEMS, INC.
    Date Cleared
    2002-03-21

    (15 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K960806,K001966
    Predicate For
    K032494,K033726,K050630
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusion of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic Or interventional procedures.

    The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and neurovasculature for selective, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.

    Device Description

    The PVS 1500 SDS is a 2.4 F tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polyment material and has an inside diameter of 0.021". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned 31 mm apart at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the 1500 SDS. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

    AI/ML Overview

    The provided text describes a medical device, the PVS 1500 SDS (an infusion catheter), and its testing to demonstrate substantial equivalence to predicate devices, rather than a study evaluating an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

    Here's an analysis based on the provided text:

    Acceptance Criteria and Device Performance for PVS 1500 SDS

    The study primarily focused on demonstrating the PVS 1500 SDS's substantial equivalence to existing predicate devices by meeting established performance standards for infusion catheters.

    Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Tests PerformedReported Device Performance
    BiocompatibilityISO 10993-1, Biological Evaluation of Medical Devices - Part 1Confirmed biocompatibility as an external communicating, blood contact, short duration (<24 hours) device.
    Safety and PerformanceISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1Yielded acceptable results.
    - Dimensional inspectionAcceptable results.
    - Hub integrityAcceptable results.
    - Flow rate measurementsAcceptable results.
    - Burst strengthAcceptable results.
    - Tensile strengthAcceptable results.
    - Guide wire compatibility testingAcceptable results.
    - Performance under simulated conditionsAcceptable results.
    - Torsional strengthAcceptable results.
    - TorqueabilityAcceptable results.
    - Corrosion resistanceAcceptable results.

    Information Not Applicable or Not Provided in the Text (Primarily relevant for AI/ML studies):

    1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document doesn't specify sample sizes for each performance test, nor does it mention data provenance in the context of an AI/ML test set. The tests described are laboratory-based engineering and material performance tests.
    2. 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. "Ground truth" in this context refers to the physical and chemical properties of the device, established through standardized testing procedures, not expert interpretation of data.
    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance was measured against established engineering standards.
    4. 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 not an AI/ML device.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from standardized engineering and biocompatibility testing against recognized industry standards (ISO 10993-1, ISO 10555-1).
    7. The sample size for the training set: Not applicable. This is not an AI/ML device.
    8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

    Summary of Study Approach:

    The study for the PVS 1500 SDS was a series of benchtop and laboratory-based engineering and biocompatibility tests. The objective was to demonstrate that the device's physical, mechanical, and biological properties met established standards for infusion catheters and were substantially equivalent to legally marketed predicate devices. The "acceptance criteria" were the thresholds and specifications defined by relevant ISO standards (ISO 10993-1 and ISO 10555-1) for medical devices of this type. The device "met the acceptance criteria" by yielding "acceptable results" in all conducted tests.

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