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510(k) Data Aggregation

    K Number
    K960056
    Device Name
    USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1996-10-23

    (293 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K883051,K810412
    Why did this record match?
    Reference Devices :

    #K883051, #K810412, P790017/S8, P790017/S11

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

    The USCI® Pro-Flo, Pro-Flo with Soft Tip, Pro-Flo XT and Pro-Flo XT with Soft Tip are diagnostic intravascular catheters used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels.

    Device Description

    The USCI Pro-Flo and Pro-Flo XT catheters have the same technological characteristics as the USCI Positrol-II catheters. The designs are similar; all three catheters have polyurethane shaft and tip segments with the shaft comprising of an inner jacket of polyurethane, a stainless steel braid and an outer jacket of polyurethane. The soft tip segments are comprised of a softer polyurethane material and are bonded onto the shaft segment for PF ST and PF XT ST catheters.

    AI/ML Overview

    This document describes a 510(k) summary for the USCI Pro-Flo and Pro-Flo XT angiographic catheters, comparing them to predicate devices (USCI Positrol-II and Cordis Super Torque Plus). It focuses on demonstrating substantial equivalence rather than presenting an AI device study. Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert adjudication, or MRMC studies is not applicable.

    However, I can extract the acceptance criteria and reported device performance from the provided text, as it relates to the equivalence of the new catheters to existing ones.

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state numerical acceptance criteria in a dedicated table, but it implies that the performance data demonstrate equivalence to the predicate devices. The "performance characteristics" that are assessed are related to mechanical properties.

    Acceptance Criterion (Implied)Reported Device Performance
    Shaft stiffness equivalence to predicate devicesPerformance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
    Shaft torque equivalence to predicate devicesPerformance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
    Shaft burst equivalence to predicate devicesPerformance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
    Tensile strength (soft tip, tip joint, hub/shaft) equivalence to predicate devicesPerformance data demonstrate equivalence of the USCI PF, PF ST, PF XT and PF XT ST catheters to the predicate devices.
    Same indication statements"Yes." (USCI Pro-Flo, Pro-Flo XT, P-II, and Cordis ST Plus are intravascular diagnostic catheters used to record intracardiac pressures, sample blood, and introduce substances into the heart and vessels.)
    Same technological characteristics (design, materials, etc.)"Yes." (Similar designs, all three catheters have polyurethane shaft and tip segments with inner jacket of polyurethane, stainless steel braid, and outer jacket of polyurethane. Soft tip segments are softer polyurethane.)
    Descriptive characteristics precise enough to ensure equivalence"No." (Differences in durometers lead to minor differences in shaft diameter and stiffness, which is a performance characteristic not precisely describable without performance data.)

    Explanation of the Study and its Context:

    This document is a 510(k) summary for a medical device (angiographic catheters), not an AI device. The "study" described is a set of performance tests conducted to demonstrate substantial equivalence of the new catheters to existing, legally marketed predicate devices. The goal is to show that the new device is as safe and effective as the predicate devices, not that it meets specific performance metrics for AI algorithms.

    Regarding your specific questions for an AI device study, the following are "Not Applicable" (N/A) or "Not Provided" in this document as it is not an AI device study:

    1. Sample size used for the test set and the data provenance: N/A (This is a physical device performance test, not a data-driven AI test)
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth in this context would be physical measurements and established engineering standards, not expert clinical interpretation of data/images).
    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A
    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 (No human readers or AI in this context).
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests would be the established engineering specifications and performance of the predicate devices based on objective physical measurements (e.g., burst pressure, tensile strength limits, durometer readings).
    7. The sample size for the training set: N/A (No training set for a physical device).
    8. How the ground truth for the training set was established: N/A.
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