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510(k) Data Aggregation

    K Number
    K221077
    Device Name
    Auryon Atherectomy System
    Manufacturer
    Eximo Medical Ltd.
    Date Cleared
    2022-06-09

    (58 days)

    Product Code
    MCW,CLA
    Regulation Number
    870.4875
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K100462,K202835
    Why did this record match?
    Reference Devices :

    K100462

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

    The Auryon™ Atherectomy System and Auryon Atherectomy Catheters with aspiration are indicated for use as atherectomy devices for arterial stenoses, including in-stent restenosis (ISR), and to aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries.

    The Auryon™ Atherectomy System and Auryon Atherectomy Catheters without aspiration are indicated for use in the treatment, including atherectomy, of infra-inguinal stenoses and occlusions.

    Device Description

    The Auryon™ Atherectomy Catheters are single use catheters made of an array of optic fibers and surrounded by a circumferential blunt blade at its distal tip. The Auryon™ catheter is connected to the laser of the Auryon™ Atherectomy System via its connector and transmits energy at pre-set fluence levels of 50 and 60 ml/mm² to the occluded or narrowed artery. The Auryon™ Atherectomy Catheter must work over a commercially available 300cm 0.014" guide wire that crosses the lesion intra-luminally.

    The Auryon™ Atherectomy catheters are available in four sizes (0.9mm, 1.5mm, 2.0mm and 2.35mm):

    • For the small size catheters (i.e., 0.9mm and 1.5mm), there is a designated lumen tube for a guidewire at the center of the inner blunt blade. The 0.9mm and 1.5mm catheters do not have an aspiration feature and have not been tested in ISR lesions.
    • . The larger Auryon™ catheters (i.e., 2.0mm and 2.35mm) have an eccentric guidewire lumen, and include additional features consisting of an aspiration feature (both catheters) and an "offcenter" feature (2.35mm only). The aspiration feature is intended for debris and thrombus collection and removal from the vessel during the atherectomy procedure.
    • . The "off-center" feature is included in the 2.35 mm catheter only and is designed to facilitate debulking of lesions in blood vessels beyond the catheter's diameter.
    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would find for a software or AI-powered medical device. Instead, it is a 510(k) premarket notification for the Auryon™ Atherectomy System, a physical medical device.

    The document describes Indication for Use for a medical device (Auryon™ Atherectomy System) and asserts its Substantial Equivalence to a predicate device, rather than providing details of an AI-based system's performance metrics against acceptance criteria.

    The key points from the document regarding the device and its testing are:

    • Device: Auryon™ Atherectomy System (physical device, not AI/software)
    • Purpose of 510(k): To revise the Indications for Use for the existing device. No physical or software changes were made to the device itself.
    • Revised Indication: Specifically includes the ability for Auryon™ Atherectomy Catheters with aspiration to "aspirate thrombus adjacent to stenoses in native and stented infra-inguinal arteries."
    • Performance Testing for revised indication:
      • Methodology: Fresh thrombus was created in simulated blood vessels and then removed using the Auryon™ Atherectomy System with aspiration.
      • Efficacy Measurement: Thrombus removal efficacy was based on the weight of thrombus removed.
      • Safety Measurement: Confirmation that emboli were not generated during thrombus removal was based on the absence of emboli in an in-line embolic protection device.
      • Conclusion: This testing "confirmed that there are no new questions of safety or effectiveness" with the inclusion of thrombus removal in the Indications for Use.

    Therefore, since the request is for details related to acceptance criteria and a study for an AI/software device, and the provided document is for a physical medical device and its updated indications for use, I cannot fulfill the request as specified. The document does not discuss:

    1. A table of acceptance criteria and reported device performance (for AI/software).
    2. Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, or how ground truth was established for the training set.

    These are all metrics and details relevant to AI/software validation, which are not present in this physical device 510(k) submission.

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