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510(k) Data Aggregation

    K Number
    K210251
    Device Name
    ClearPath Disposable Introducer
    Manufacturer
    ClearMind Biomedical
    Date Cleared
    2021-04-02

    (63 days)

    Product Code
    GWG
    Regulation Number
    882.1480
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K061135,K142315
    Why did this record match?
    Reference Devices :

    K061135

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

    The ClearPath Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system and cerebrum of the brain.

    Device Description

    The ClearPath™ Disposable Introducer is a sterile, single-use, neurological endoscope Introducer, consisting of a Sheath and a Dilator.

    A locking mechanism design allows the Dilator to lock into the Sheath and prevent "push back" during insertion into the brain. The Dilator tip is designed to be atraumatic during insertion. The Sheath is graduated in centimeters to assist the surgeon in determining the Introducer insertion depth. The Sheath's transparency is useful for full endoscopic visualization during insertion.

    The proximal end of the Sheath is labeled 20F, indicating the inner diameter of the Sheath.

    AI/ML Overview

    The provided text is a 510(k) summary for the ClearPath™ Disposable Introducer. It focuses on demonstrating substantial equivalence to a predicate device (MINOP® Disposable Introducer 26F, K142315) rather than providing extensive details about acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/ML device.

    Therefore, many of the requested details, such as AI-specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established, are not available in this document as it pertains to a mechanical medical device, not an AI/ML device.

    However, I can extract the available information related to performance and testing from the document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied/Direct)Reported Device Performance
    BiocompatibilityCompliance with ISO 10993Demonstrates compliance with ISO 10993
    Device SpecificationsCompliance with its specifications and labeling claimsBench testing demonstrates compliance with its specifications and claims
    Transit PerformanceCompliance with ASTM D4169Demonstrates compliance with ASTM D4169
    Shelf LifeSterility for a specified durationShelf life studies demonstrate it can be stored sterile for 2 years
    Indications for UseTo obtain and maintain a temporary pathway into the ventricular system and cerebrum.Claims "clinically identical" indications for use as predicate.
    TechnologyFunction as an introducer with dilator and sheath."Technology is identical" to predicate device.
    Design FeaturesInterlocking hub, printed graduations.Features interlocking hub, printed graduations. Transparent sheath noted.

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

    • The document does not specify a "test set" in the context of data for an algorithmic device. The testing described (biocompatibility, bench testing, transit testing, shelf life) refers to physical device testing, not data-driven performance evaluation. Therefore, sample sizes for data-driven testing and data provenance are not applicable or provided.

    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 as the device is a physical medical instrument, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth from a test set of data.

    4. Adjudication method for the test set:

    • This information is not applicable for the same reasons as point 3.

    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 as the ClearPath™ Disposable Introducer is a physical medical device, not an AI-assisted device.

    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 a physical medical instrument, not an algorithm.

    7. The type of ground truth used:

    • For the performance aspects mentioned (biocompatibility, bench testing, transit testing, shelf life), the "ground truth" would be established by pre-defined engineering specifications, international standards (ISO 10993, ASTM D4169), and validated laboratory testing procedures. There is no "expert consensus" or "pathology" in the context of data for this type of device.

    8. The sample size for the training set:

    • This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

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

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

    In summary, the provided FDA 510(k) document is for a conventional medical device (an introducer) and thus does not contain the detailed AI/ML specific information requested in many of the questions. It uses standard engineering and biocompatibility testing to demonstrate safety and effectiveness and substantial equivalence to a predicate device.

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