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510(k) Data Aggregation

    K Number
    K111380
    Manufacturer
    Date Cleared
    2011-07-19

    (64 days)

    Product Code
    Regulation Number
    870.1250
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    NEURON MAX SYSTEM

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

    The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

    Device Description

    The Neuron MAX System is an additional configuration to the currently available Neuron Intracranial Access System. The Neuron Max System provides a larger lumen to assist in utilizing contrast injections to further optimize anatomical visualization while maintaining a flexible distal tip. This larger lumen also accommodates larger therapeutic devices like the Penumbra System® and Penumbra Coil 400™ devices. The devices are provided sterile, non-pyrogenic, and intended for single use only.

    AI/ML Overview

    The provided text describes the non-clinical testing performed for the Penumbra Neuron™ MAX System to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. It does not contain information about studies conducted on diagnostic devices with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. Therefore, I cannot provide a table of acceptance criteria and reported device performance in that sense.

    However, I can summarize the acceptance criteria and the studies performed to meet those criteria based on the provided text for the Neuron™ MAX System, which is a medical device (catheter) for introducing interventional devices.

    Here's a breakdown of the information that can be extracted:

    1. Table of Acceptance Criteria and the Reported Device Performance

    For this type of device, "acceptance criteria" are generally that the device "Met established criteria" and "Reported device performance" is the outcome of the tests.

    Test CategorySpecific Test / AttributeAcceptance CriteriaReported Device Performance
    BiocompatibilityIn Vitro CytotoxicityNo evidence of cell lysis or toxicityNo evidence of cell lysis or toxicity
    SensitizationNon-SensitizingNon-Sensitizing
    Acute Intracutaneous Reactivity (Irritation)No evidence of irritationNo evidence of irritation
    Acute Systemic ToxicityNo evidence of systemic toxicityNo evidence of systemic toxicity
    Rabbit Pyrogen StudyNo evidence of material-mediated pyrogenicityNo evidence of material-mediated pyrogenicity
    Hemo-compatibility (In Vitro Hemolysis)Non-HemolyticNon-Hemolytic
    Hemo-compatibility (In Vitro Coagulation - PT, PTT)Coagulation times not significantly different than corresponding controlCoagulation times are not significant different than corresponding control
    Hemo-compatibility (Partial Thromboplastin Time (PTT) Assay)Non-ThrombogenicNon-Thrombogenic
    Complement ActivationNo greater biological response than corresponding controlNo greater biological response than corresponding control
    Dog ThrombogenicityNon-ThrombogenicNon-Thrombogenic
    Genotoxicity (Mouse Lymphoma)Non-MutagenicNon-Mutagenic
    Genotoxicity (Ames Mutagenicity)Non-MutagenicNon-Mutagenic
    Genotoxicity (In Vivo Mouse Micronucleus)Non-ClastogenicNon-Clastogenic
    Bench-top TestingPouch Seal StrengthMet established criteriaMet established criteria
    Dimensional / Visual InspectionUnits meet all inspection criteria for release of finished goods (clinically acceptable)Met established criteria
    Simulated Use (Intracranial Access & Vessel Access Entry Performance)Units meet all inspection criteria for release of finished goods (clinically acceptable)Met established criteria
    Hub / Shaft & Mid-shaft or Shaft Tensile Strength (MAX 088 Delivery Catheter / Dilator, 6F Select Catheter)Met established criteriaMet established criteria
    Hub Air Aspiration (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator)Met established criteriaMet established criteria
    Burst Test (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator)Met established criteriaMet established criteria
    Particulate Testing (Hydrophilic Coating) (MAX 088 Delivery Catheter)Met established criteriaMet established criteria
    Friction Force (MAX 088 Delivery Catheter / 8F Sheath compatibility, etc.)Met established criteriaMet established criteria
    Flow Rate (MAX 088 Delivery Catheter / 6F Select Catheter)Met established criteriaMet established criteria
    Elongation to Failure (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator)Met established criteriaMet established criteria
    Corrosion (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator / RHV / HVA)Met established criteriaMet established criteria
    Torsion (MAX 088 Delivery Catheter / 6F Select Catheter)Met established criteriaMet established criteria
    Animal StudyVessel injury on final angiogramsNo vessel injury notedNo vessel injury was noted
    Gross or histology findings in test vessel segmentsNo abnormal gross or histology findings notedNo abnormal gross or histology findings were noted
    Significant vascular responseNo significant vascular response in experimental conditionsThe use of the Neuron MAX System resulted in no significant vascular response

    2. Sample size used for the test set and the data provenance

    • Biocompatibility: The sample size for each specific test (e.g., number of cell cultures, animals for sensitization/toxicity tests) is not explicitly stated in the provided document. The data provenance is described as "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," indicating a regulatory framework for the testing, likely conducted in the USA or adhering to international standards.
    • Bench-top Testing: The sample size for each test is not explicitly stated. The testing was conducted internally based on "standard test methods." Data provenance is not specified beyond being "Design Verification (Bench-Top Testing)."
    • Animal Study: The sample size is referred to as "a swine model," meaning the study involved pigs. The number of animals is not specified. Data provenance is not specified beyond being "an animal study."

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This information is not applicable to the provided document, as it describes the testing of a medical device (catheter) for physical, mechanical, and biological compatibility, not a diagnostic device requiring expert interpretation for ground truth establishment.

    4. Adjudication method for the test set

    This information is not applicable for the same reason as point 3. Performance criteria are based on objective measurements and observations in laboratory and animal settings, not on expert consensus or adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    This information is not applicable. The device is an interventional catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness study was performed.

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

    This information is not applicable, as the device is not an algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    For the Neuron™ MAX System, the "ground truth" or reference for evaluating performance was:

    • Biocompatibility: Established ISO 10993-1 guidelines, ASTM methods, and USP methods, focusing on biological responses (e.g., cell lysis, irritation, systemic toxicity, hemolysis, thrombogenicity, mutagenicity). The "ground truth" is adherence to these established biological safety profiles.
    • Bench-top Testing: "Standard test methods" for physical and mechanical properties. The "ground truth" is meeting pre-determined engineering and functional specifications.
    • Animal Study: Direct observation during and after the procedure (e.g., angiograms for vessel injury) and histopathological examination of tissues for gross or histology findings. The "ground truth" is the pathological and angiographic findings in the swine model.

    8. The sample size for the training set

    This information is not applicable, as the device is not an AI algorithm requiring a training set. The descriptions pertain to R&D and verification testing, not machine learning model development.

    9. How the ground truth for the training set was established

    This information is not applicable for the same reason as point 8.

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