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510(k) Data Aggregation

    K Number
    K993967
    Device Name
    ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Date Cleared
    1999-12-17

    (24 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K974664
    Why did this record match?
    Device Name :

    ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002

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

    The ORATEC® SpineCATH™ Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

    Device Description

    The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

    AI/ML Overview

    This 510(k) summary provides limited information regarding the specific studies performed. Here's what can be extracted and reported, and where information is missing:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (What was measured)Reported Device Performance
    "Safety and Performance" of device modificationNot explicitly stated as acceptance criteria, but generally implied for device changes.
    Compliance to 21 CFR 820.30 Design Control requirementsCertified compliance.
    Performance testing (validation testing) for the modificationResults provided (details not specified in this summary).
    Substantial equivalence to predicate deviceDetermined to be substantially equivalent based on indications for use, fundamental scientific technology characteristics, and comparison.

    Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum temperature reached) or the detailed quantitative results of the "performance testing (validation testing)."

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

    This information is not provided in the document. The summary only mentions "results of validation testing (performance testing)" without detailing the test set size, type of data (e.g., in-vitro, ex-vivo, animal, human), or its provenance (e.g., country of origin, retrospective or prospective).

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

    This information is not provided in the document. This type of device (intradiscal catheter) does not typically involve image interpretation, so "ground truth" as it relates to expert review of images is not applicable here. The "ground truth" for this device would relate to engineering specifications and biological outcomes, which would be established through technical standards and clinical studies, respectively.

    4. Adjudication Method for the Test Set

    This information is not provided in the document. Given the nature of medical device testing (e.g., mechanical, electrical, biocompatibility), adjudication is typically not performed in the same way as in diagnostic AI studies. Test results are usually compared against predefined specifications.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

    This information is not applicable and not provided. The ORATEC SpineCATH™ Intradiscal Catheter is a medical device (catheter) used in a physical intervention, not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for this device would be established through a combination of:

    • Engineering Specifications: For mechanical properties, electrical safety, material compatibility, and function.
    • Biocompatibility Testing: To ensure the materials are safe for use in the human body.
    • Performance Data: Demonstrating the ability of the catheter to achieve its intended function (e.g., coagulation and decompression) in relevant models (e.g., ex-vivo tissue, animal models, and ultimately, human clinical data from the predicate device and potentially limited clinical data for the modified device if applicable, though not detailed here).
    • Clinical Outcomes Data: For the predicate device, showing its effectiveness in treating symptomatic patients. For the modified device, the "ground truth" for substantial equivalence relies on demonstrating that the modifications do not negatively impact the clinical outcomes or safety established for the predicate.

    The document states that "performance testing (validation testing)" was done, implying that the device was tested against these types of established standards and expected performance characteristics.

    8. The Sample Size for the Training Set

    This information is not applicable and not provided. This device is not an AI algorithm that requires a training set. The "training" for a physical device is its design and manufacturing process, validated through testing.

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

    This information is not applicable and not provided. As explained above, this device is not an AI algorithm.

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