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510(k) Data Aggregation

    K Number
    K111284
    Manufacturer
    Date Cleared
    2011-08-17

    (103 days)

    Product Code
    Regulation Number
    870.5100
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion.

    Device Description

    The Flash-C PTCA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon that enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

    AI/ML Overview

    The Flash-C PTCA Balloon Dilatation Catheter did not undergo a study that would typically involve acceptance criteria and device performance reported in the context of AI/ML or diagnostic devices. Instead, this a medical device (a catheter) with a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device.

    The "acceptance criteria" and "device performance" in this context refer to the results of engineering bench testing and pre-clinical in-vivo studies that confirm the device meets established specifications and operates as intended.

    Here's an attempt to structure the information based on your request, understanding that it's a different type of device assessment:

    1. Table of Acceptance Criteria and Reported Device Performance

    Given that this is a physical medical device (catheter) and not a diagnostic/AI device, the "acceptance criteria" are the established specifications for various physical and performance characteristics of the catheter. The "reported device performance" refers to the results from the specific tests against these specifications.

    Acceptance Criterion (Test)Reported Device Performance
    Biocompatibility (ISO 10993)Met requirements. Test results indicated materials are non-toxic and non-sensitizing to biological tissues.
    - ISO MEM Elution AssayPassed
    - ASTM Hemolysis AssayPassed
    - Complement Activation C3a and SC5b-9 AssayPassed
    - Thromboresistance EvaluationPassed
    - Pyrogen (LAL) ChromogenicPassed
    - Materials Mediated PyrogenPassed
    - ISO Guinea Pig Maximization SensitizationPassed
    - ISO Acute Systemic ToxicityPassed
    - ISO Intracutaneous ReactivityPassed
    In-Vitro Performance Bench TestingMet established specifications. Confirmed performance characteristics, no specific quantitative values provided in the summary.
    - Balloon Crossing ProfileVerified
    - Catheter Shaft DiameterVerified
    - Balloon Rated Burst Pressure (Angioplasty)Verified
    - Balloon Burst Volume (Anchoring)Verified
    - Angioplasty Balloon ComplianceVerified
    - Balloon Inflation TimeVerified
    - Balloon Deflation TimeVerified
    - Angioplasty Balloon FatigueVerified
    - Anchoring Balloon FatigueVerified
    - Catheter Bond StrengthVerified
    - Catheter Tip Pull StrengthVerified
    - Catheter Torque StrengthVerified
    - Simulated Use/Flexibility/KinkVerified
    Simulated Use Testing (Flash-C vs. Predicate)Substantially equivalent. Performance was comparable to the Maverick XL Monorail PTCA Dilatation Catheter (predicate).
    In-Vivo Testing (Swine Model)Met requirements and demonstrated safety. No adverse downstream or cognitive effects observed during the predetermined observation period in post-procedure animals.

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

    • Test Set (In-Vivo): "test and control groups" in a swine model. The exact number of animals in each group is not specified in the summary.
    • Data Provenance: Pre-clinical, in-vivo animal study (swine model). Country of origin is not specified, but typically conducted in a controlled laboratory setting. Retrospective or prospective is not explicitly stated, but animal studies are generally prospective.

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

    • Not Applicable. This is a physical device where "ground truth" refers to objective measurements against engineering specifications and observation of physiological effects in an animal model, not expert interpretation of data or images. The evaluation would be performed by qualified laboratory personnel and veterinarians overseeing the animal study, not "experts" in the context of establishing diagnostic ground truth from images or clinical data.

    4. Adjudication Method for the Test Set

    • Not Applicable. As above, this is not a study involving human interpretation or subjective assessments that would require an adjudication method like 2+1 or 3+1. Performance is based on objective measurements and observations in controlled environments.

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

    • No, an MRMC study was NOT done. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data, especially when comparing AI assistance to unassisted reading. This device is a therapeutic catheter, not an interpretive diagnostic tool.

    6. If a Standalone Performance Study Was Done

    • Yes, in essence. The in-vitro performance bench testing and biocompatibility testing represent "standalone performance" in that they assess the device's intrinsic characteristics against predetermined specifications. The in-vivo swine model also assesses the device's standalone performance and safety in a biological system, comparing it to a control device (Sterling PTA Balloon Dilatation Catheter). The simulated use testing specifically compared the Flash-C to the predicate device, Maverick XL.

    7. The Type of Ground Truth Used

    • Engineering Specifications and Physiological Observations. For the in-vitro tests, "ground truth" is defined by established engineering and material specifications (e.g., burst pressure limits, diameter tolerances, fatigue cycles). For biocompatibility, it's the lack of toxic or sensitizing reactions per ISO 10993 standards. For the in-vivo study, it's direct physiological observations in the animal model and the absence of pre-defined adverse events.

    8. The Sample Size for the Training Set

    • Not Applicable. This device uses conventional engineering design and manufacturing processes, not AI/ML algorithms that require training data.

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

    • Not Applicable. As there is no AI/ML component, there is no training set and therefore no ground truth established for it.
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