LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K241025
    Device Name
    JADE PLUS PTA Balloon Dilatation Catheter
    Manufacturer
    OrbusNeich Medical (Shenzhen) Co., Ltd.
    Date Cleared
    2024-06-11

    (57 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K202231,K201794
    Why did this record match?
    Device Name :

    JADE PLUS PTA Balloon Dilatation Catheter

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

    The JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilation of balloon expandable and self-expanding stents in the peripheral vasculature.

    Device Description

    The JADE PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications with Over-The-Wire (OTW) structure. The overthe-wire design permits the use of standard 0.014 inch, 0.018 inch and 0.035 inch guidewires respectively.

    AI/ML Overview

    This document is a 510(k) summary for the JADE PLUS PTA Balloon Dilatation Catheter. It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and studies are not applicable in the context of an AI/ML device.

    The document discusses the substantial equivalence of the JADE PLUS PTA Balloon Dilatation Catheter to a predicate device, based on in vitro performance tests. The acceptance criteria and reported device performance mentioned relate to physical properties and functionality of the catheter, not to an AI algorithm's performance or accuracy.

    The relevant information from the document is related to the device's physical performance testing:

    Acceptance Criteria and Reported Device Performance:

    The document states that "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the JADE PLUS PTA Balloon Dilatation Catheter design and construction are suitable for their intended use."

    The specific performance tests conducted and the general nature of their acceptance criteria are listed:

    Acceptance Criteria Category/TestReported Device Performance
    Mechanical Performance:Met all acceptance criteria
    Balloon Rated Burst PressureMet acceptance criteria (same or similar to predicate)
    Balloon FatigueMet acceptance criteria (same or similar to predicate)
    Balloon ComplianceMet acceptance criteria (same or similar to predicate)
    Balloon Rated Burst Pressure (in-stent)Met acceptance criteria (same or similar to predicate)
    Balloon Fatigue (in-stent)Met acceptance criteria (same or similar to predicate)
    Flexibility and KinkMet acceptance criteria (same or similar to predicate)
    Shaft burstMet acceptance criteria (same or similar to predicate)
    Torque StrengthMet acceptance criteria (same or similar to predicate)
    Catheter Bond StrengthMet acceptance criteria (same or similar to predicate)
    Tip Pull StrengthMet acceptance criteria (same or similar to predicate)
    Balloon Preparation, Deployment, and Retraction (Simulated Use)Met acceptance criteria (same or similar to predicate)
    Balloon Inflation and Deflation TimeMet acceptance criteria (same or similar to predicate)
    Visual and Material Properties:Met all acceptance criteria
    Visual InspectionMet acceptance criteria (same or similar to predicate)
    Marker Band RadiopacityMet acceptance criteria (same or similar to predicate)
    Dimensional VerificationMet acceptance criteria (same or similar to predicate)
    Particulate EvaluationMet acceptance criteria (same or similar to predicate)
    Coating IntegrityMet acceptance criteria (same or similar to predicate)
    Other:Met all acceptance criteria
    Packaging and sterilization validationMet acceptance criteria (same or similar to predicate)
    Shelf LifeMet acceptance criteria (same or similar to predicate)
    BiocompatibilityLeveraged from predicate device (Jade OTW series) and determined acceptable

    The study that proves the device meets acceptance criteria is an in vitro performance test study conducted on the subject device in accordance with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters" issued on April 14, 2023.

    Given that this is a 510(k) summary for a physical medical device (balloon dilatation catheter) and not an AI/ML powered device, the following points are not applicable and therefore cannot be extracted from the provided text:

    1. Sample size used for the test set and the data provenance.
    2. Number of experts used to establish the ground truth for the test set and their qualifications.
    3. Adjudication method.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
    6. The type of ground truth used.
    7. The sample size for the training set.
    8. How the ground truth for the training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1