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510(k) Data Aggregation

    K Number
    K152275
    Device Name
    Pantheris System
    Manufacturer
    Avinger, Inc.
    Date Cleared
    2015-10-14

    (63 days)

    Product Code
    MCW,NQQ
    Regulation Number
    870.4875
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K061188,K140185
    Predicate For
    K153460,K162326
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

    Device Description

    The Pantheris System consists of the Pantheris Catheter (packaged with the Flush Fixture), Lightbox Sled (referred to as Sled), the Lightbox HS Imaging Console, the Lightbox Umbilical (referred to as Umbilical), Sterile Drape (accessory) and the Occlusion Sheath (optional accessory). The Pantheris System combines the use of Avinger's Optical Coherence Tomography (OCT) technology with peripheral vascular atherectomy capabilities.

    The Pantheris Catheter has a working length of 130 cm and is a sterile, singleuse device that is compatible with 8F sheaths and 0.014" guidewires. The Pantheris Catheter consists of an imaging assembly, a rotating cutter, an apposition mechanism (balloon) and a flexible, tiltable nosecone. It also incorporates an Optical Fiber that allows for real-time OCT guided directional atherectomy during the procedure. The Pantheris Catheter and optional Occlusion Sheath accessory are provided sterile and are intended for single-use only.

    The Pantheris Catheter is connected to the Lightbox HS Imaging Console via the Sled and the Umbilical. The Sled provides optical and rotational power to the Pantheris Catheter. The Umbilical is a 3-meter long optical and electrical extension cable that connects the Sled to the Lightbox HS Imaging Console.

    The Lightbox HS Imaging Console is an optical transceiver, transmitting light to the intraluminal environment through the optical fiber on the Pantheris Catheter and receiving and interpreting the signal from the tissue using a PC-based processing system. The Lightbox provides a visualization platform that allows for real-time OCT-assisted directional atherectomy. The Lightbox HS Imaging Console consists of a cart with two monitors; a PC based processing system, an isolation transformer and an OCT system.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: Pantheris System (Intraluminal Artery Stripper)

    1. Table of Acceptance Criteria and Reported Device Performance

    Criterion TypeAcceptance CriteriaReported Device Performance
    Primary EffectivenessTechnical success: Percent of target lesions with residual diameter stenosis < 50% post Pantheris device alone. Performance Goal: 92.13% with a lower 95% confidence bound of >= 87%.96% (158/164) of lesions treated achieved residual diameter stenosis < 50% post-Pantheris device alone. This met the performance goal of 92.13% with a lower 95% confidence bound of 87%.
    Primary SafetyFreedom from a composite of major adverse events (MAEs) through 6-Month follow-up. Performance Goal: 35.3% (meaning a maximum MAE rate of 35.3% was acceptable).Overall safety event rate of 21.5% (20/93) in the per protocol population (78.5% event free). This met the safety performance goal of 35.3% with a 95% 1-sided upper confidence bound of 43.2% (meaning the observed MAE rate was well below the acceptable threshold).
    Secondary EffectivenessProcedural success: Percent of target lesions with residual diameter stenosis ≤ 30% post-Pantheris and/or any other adjunctive therapy.Achieved in 79.3% of lesions.
    Secondary SafetyFreedom from MAEs through 30 days.Further confirmed clinical improvement in subjects' clinical status over time. (Specific numerical rate not explicitly provided, but stated as confirming improvement).
    Secondary SafetyFreedom from procedural related emboli (through 30 days).Further confirmed clinical improvement in subjects' clinical status over time. (Specific numerical rate not explicitly provided, but stated as confirming improvement).
    Secondary SafetyFreedom from target vessel revascularization (TVR) through 30 days and 6 months.Further confirmed clinical improvement in subjects' clinical status over time. (Specific numerical rate not explicitly provided, but stated as confirming improvement).

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

    • Total Subjects Enrolled: 162
    • Intention-To-Treat (ITT) Cohort: 134 subjects
    • Roll-In Cohort: 28 subjects
    • Per Protocol Cohort (primary focus for atherectomy performance): 130 subjects (This is the primary test set for effectiveness)
    • Safety Population (for primary safety endpoint): 93 subjects (This is the primary test set for safety, likely a subset of the per-protocol cohort or ITT cohort after accounting for censoring/follow-up).
    • Data Provenance: The study is described as a "prospective, multi-center" study. While the specific countries are not mentioned, the context of an FDA submission for a US company suggests it likely included US sites, and potentially international sites given "multi-center" can imply broader geographic inclusion.

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

    • Primary Effectiveness (Angiographic assessment): An "independent Angiographic Core Laboratory" assessed residual diameter stenosis. The number of individual experts or their specific qualifications (e.g., years of experience, specific certifications) are not specified in the provided text, only that it was an "independent" lab.
    • Primary Safety (Adjudication of MAEs): An "independent Clinical Events Committee (CEC)" adjudicated major adverse events. The number of experts or their specific qualifications are not specified in the provided text.

    4. Adjudication Method for the Test Set

    • Angiographic Assessment (Effectiveness): Performed by an "independent Angiographic Core Laboratory." The specific method of consensus (e.g., 2+1, 3+1) or if multiple readers were used and averaged/adjudicated is not specified.
    • Safety Events (MAEs): Adjudicated by an "independent Clinical Events Committee (CEC)." The specific adjudication method (e.g., consensus, majority rule, specific tie-breaking) is not specified.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

    • No, an MRMC comparative effectiveness study was not explicitly described. The study evaluates the Pantheris System's standalone safety and effectiveness against pre-defined performance goals, not in comparison to human readers with or without AI assistance.
    • The study design focuses on the device's technical success and safety outcomes in patients, not on observer performance or diagnostic accuracy improved by an AI component per se. The OCT-assisted orientation is a feature of the device itself, not a separate AI system augmenting human interpretation of other imaging modalities.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

    • Yes, a standalone performance evaluation of the device as a whole was performed. The study primarily assessed the performance of the Pantheris System (which includes OCT-assisted orientation as an inherent part of its mechanism) in removing plaque and its associated safety outcomes. The "algorithm" here is the device's overall function, including its OCT guidance technology, rather than a separate AI diagnostic algorithm. The primary effectiveness endpoint was based on a post-procedure angiogram read by an independent lab, directly assessing the device's effect.

    7. The Type of Ground Truth Used

    • Effectiveness Ground Truth: The primary effectiveness endpoint (residual diameter stenosis < 50%) was assessed by an "independent Angiographic Core Laboratory" based on angiographic imaging. While angiography is a clinical imaging modality, for this study, the core lab's interpretation of these images served as the ground truth for measuring the device's efficacy.
    • Safety Ground Truth: The primary safety endpoint (Major Adverse Events) was adjudicated by an "independent Clinical Events Committee (CEC)" based on clinical events and outcomes data. This would typically involve review of patient records, clinical notes, and potentially other diagnostic reports.

    8. The Sample Size for the Training Set

    • The provided document describes a clinical trial (VISION Study), which is typically designed to evaluate the safety and effectiveness of a device on a patient population. It is not a study describing the training of an AI algorithm. Therefore, there is no mention of a training set sample size in the context of machine learning model development. The 162 subjects are the studied patient cohort for evaluating the device's performance.

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

    • As this is a clinical trial evaluating a medical device rather than an AI or machine learning algorithm, the concept of a "training set ground truth" as typically understood in AI development does not apply here. The study gathered clinical data and patient outcomes to validate the device's performance against pre-defined clinical endpoints.
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