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    K Number
    K101361
    Device Name
    REEFLEX PTA CATHETER
    Manufacturer
    CLEARSTREAM TECHNOLOGIES, LTD.
    Date Cleared
    2010-08-04

    (82 days)

    Product Code
    LIT
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K083596
    Why did this record match?
    Reference Devices :

    K083596

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

    Balloon dilatation of the femoral, popliteal and infra popliteal arteries. These catheters are not designed to be used in the coronary arteries.

    Device Description

    The ReeFlex™ is a balloon dilation catheter for angioplasty. It consists of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut. A heat shrinkable layer is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.

    The balloon material is a Nylon blend. Low profile radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.

    AI/ML Overview

    This document describes the testing and conclusions for the ClearStream Technologies Ltd. ReeFlex over the wire Peripheral Transluminal Angioplasty (PTA) Catheter, seeking substantial equivalence to its predicate device, the ReeKross.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the comprehensive in vitro testing performed according to FDA guidance documents and ISO standards, with the goal of demonstrating comparable performance to the predicate device. Specific numerical acceptance criteria are not explicitly stated in the provided text, but the conclusion states that the "technological characteristics and performance criteria of the ReeFlex PTA catheter are comparable to the predicate devices."

    Acceptance Criteria (Implied)Reported Device Performance
    Visual and functional integrityPerformance deemed comparable to predicate
    Catheter body diameter within specificationPerformance deemed comparable to predicate
    Inflation/deflation performancePerformance deemed comparable to predicate
    Introducer sheath withdrawal performancePerformance deemed comparable to predicate
    Balloon compliance within specificationPerformance deemed comparable to predicate
    Leak and rated burst pressure (cycle) performancePerformance deemed comparable to predicate
    Average burst pressure within specificationPerformance deemed comparable to predicate
    Compliance with ISO 10555-1Performance deemed comparable to predicate
    Compliance with ISO 10555-4Performance deemed comparable to predicate

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not explicitly stated. The document mentions "numerous device similarities" and that "VP 462 and VP 563 were carried out on the ReeFlex." However, the exact number of devices tested for each in vitro test is not provided.
    • Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting. No information on country of origin of data or whether it was retrospective/prospective is applicable for in vitro testing.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    Not applicable. The described testing is in vitro (bench testing) and does not involve human subjects or expert assessment for ground truth. The "ground truth" for these tests would be the established engineering and performance specifications for PTA catheters.

    4. Adjudication Method for the Test Set

    Not applicable. This was in vitro bench testing; there was no need for expert adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. This document describes in vitro bench testing for a medical device (PTA catheter), not an AI or imaging-related product that would typically undergo an MRMC study.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    Not applicable. This is not an algorithm or AI product.

    7. The Type of Ground Truth Used

    The ground truth implicitly used for the in vitro testing is the established performance specifications and safety standards for PTA catheters, as well as the performance characteristics of the legally marketed predicate device (ReeKross). The comparison is against these pre-defined engineering and regulatory benchmarks.

    8. The Sample Size for the Training Set

    Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. There is no training set for this device.

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