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510(k) Data Aggregation

    K Number
    K162842
    Device Name
    ASAHI PTCA Guide Wire ASAHI SUOH 03
    Manufacturer
    ASAHI INTECC CO., LTD.
    Date Cleared
    2017-01-27

    (108 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K141339,K141751,K122468,K083904
    Why did this record match?
    Device Name :

    ASAHI PTCA Guide Wire ASAHI SUOH 03

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

    ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

    Device Description

    The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire. and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wire: ASAHI SUOH® 03. The distal portion of the guidewire has a hydrophilic coating, and the proximal portion of the guidewire is coated with PTFE. The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available Asahi Intecc extension wire.

    AI/ML Overview

    The provided document is a 510(k) Summary for a medical device (Asahi PTCA Guide Wire Asahi SUOH 03) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information typically requested in an AI/ML context regarding acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.

    The document outlines the device's technical specifications and compares them to predicate devices, along with non-clinical performance testing to ensure safety and effectiveness.

    Here's a breakdown of the non-clinical performance data and acceptance criteria as presented in the document, which primarily revolve around engineering and material properties, rather than diagnostic accuracy or AI performance.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Tests Performed (as listed)Reported Device Performance
    Mechanical PerformanceTensile StrengthMet all acceptance criteria and performed similarly to predicates.
    Torque StrengthMet all acceptance criteria and performed similarly to predicates.
    TorqueabilityMet all acceptance criteria and performed similarly to predicates.
    Tip FlexibilityMet all acceptance criteria and performed similarly to predicates.
    Material IntegrityCoating Adhesion/Coating IntegrityMet all acceptance criteria and performed similarly to predicates.
    Functional CompatibilityCatheter CompatibilityMet all acceptance criteria and performed similarly to predicates.
    Cleanliness/SafetyParticulate Testing / Coating IntegrityMet all acceptance criteria and performed similarly to predicates.
    Biocompatibility(Not explicitly listed as a test, but addressed)Verified to be the same as predicates/reference devices based on material similarity.

    Note: The document states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" for the listed tests. Specific numerical values for the criteria or performance are not provided in this summary but would have been part of the full 510(k) submission.

    Regarding the AI/ML specific questions (2-9):

    This document is for a conventional medical device (a guide wire), not an AI/ML-driven device. Therefore, the following information is not applicable and cannot be extracted from the provided text:

    1. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical guide wire samples for bench testing, not a dataset for an AI model.
    2. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to guide wire physical testing.
    3. Adjudication method: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not applicable. This type of study is for evaluating human performance with/without AI assistance.
    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
    6. The type of ground truth used: Not applicable. The "ground truth" for a guide wire's performance is its physical properties meeting engineering standards.
    7. The sample size for the training set: Not applicable. There is no AI model to train.
    8. How the ground truth for the training set was established: Not applicable.
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