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    K Number
    K090661
    Device Name
    NES REPROCESSED VARICOSE VEIN RF CATHETER
    Manufacturer
    Northeast Scientific, Inc.
    Date Cleared
    2010-07-21

    (496 days)

    Product Code
    NUJ
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K061373
    Why did this record match?
    Device Name :

    NES REPROCESSED VARICOSE VEIN RF CATHETER

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

    The NES Reprocessed Varicose Vein RF Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

    Device Description

    NES Reprocessed Varicose Vein RF Catheters are specially designed electrosurgical catheters. RF (radiofrequency) energy is delivered to an intravascular catheter in order to heat a blood vessel to a predetermined heat and coagulate that blood vessel. NES Reprocessed Varicose Vein RF Catheters incorporate a hand piece, a flexible shaft and a distal tip section containing the RF (radiofrequency) electrode.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Northeast Scientific, Inc. NES Reprocessed Varicose Vein RF Catheter (K090661), based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Inferred)Reported Device Performance
    Safety: Device must not pose undue risks to patients or users after reprocessing.Demonstrated via Biocompatibility Validation of Reprocessing and Sterilization Validation. The overall conclusion states the reprocessed catheters are "safe."
    Effectiveness: Device must perform its intended function of endovascular coagulation of blood vessels for superficial vein reflux.Demonstrated via Function Test(s), and performance testing on animals which "demonstrates that NES Reprocessed Varicose Vein RF Catheters perform as originally intended." The overall conclusion states the reprocessed catheters are "effective."
    Substantial Equivalence: Device must perform comparably to the predicate device (VNUS® ClosureFast™ Catheter, Model CF7-7-60 (K061373)).Performance data (bench, laboratory, animal testing) was conducted to demonstrate substantial equivalence. The conclusion explicitly states the reprocessed catheters are "substantially equivalent to the predicate device."
    Integrity/Reliability: Device must maintain its physical integrity and packaging over time.Demonstrated via Packaging Validation.
    Compliance to Standards: Device must meet relevant industry standards.Compliance with IEC60601-1, IEC60601-2-2, IEC60601-1-2 is stated.

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

    • Sample Size: The document does not specify exact sample sizes for each test (Biocompatibility, Sterilization, Function, Packaging, Animal Testing). It only broadly states that "Bench, laboratory and animal testing was conducted."
    • Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the nature of bench, lab, and animal testing for a reprocessed device, it's highly likely this was prospective testing conducted at Northeast Scientific, Inc. facilities or contracted labs.

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

    This information is not provided in the given summary. The "ground truth" for this type of device (reprocessed electrosurgical catheter) is established through objective performance metrics from bench, lab, and animal testing rather than human expert interpretation of data like images.

    4. Adjudication Method for the Test Set

    This information is not applicable and therefore not provided. Adjudication methods are typically used when there's subjective human interpretation involved (e.g., in diagnostic image analysis), which is not the primary method for evaluating the performance of this device.

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

    This information is not provided and is not applicable to this device. This device is an electrosurgical catheter, not an AI-powered diagnostic tool requiring human reader studies.

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

    This information is not provided and is not applicable to this device. This is a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    The ground truth for this device's performance was established through:

    • Objective measurements and scientific validations:
      • Biocompatibility tests (e.g., cytotoxicity, sensitization, irritation)
      • Sterilization efficacy tests (e.g., sterility assurance level)
      • Function tests (e.g., RF energy delivery, temperature control, mechanical integrity)
      • Packaging integrity tests
      • Animal studies: Demonstrating the intended physiological effect (coagulation of blood vessels) in a living system.

    8. The Sample Size for the Training Set

    This information is not provided and is not applicable to this device. As a physical medical device, it does not involve machine learning or "training sets" in the conventional sense. The "training" of the device's design implicitly comes from engineering principles and prior knowledge of electrosurgical catheters.

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

    This information is not provided and is not applicable to this device for the reasons stated in point 8.

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