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510(k) Data Aggregation

    K Number
    K020790
    Device Name
    INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
    Manufacturer
    SURGI-VISION, INC.
    Date Cleared
    2002-05-21

    (71 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K994436,K011781,K003436
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intercept™ Internal MR Coils are recommended for high-resolution Magnetic Resonance Imaging of internal anatomical structures. The single use, disposable coils were designed to be inserted into body orifices of the patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the coil. The unique coil shapes facilitate orientation of the coils to the anatomy. These products are to be used with a 1.5T Philips MRI system.

    The Intercept™ Urethral Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the male and female urethra and surrounding tissue. The single use, disposable coil was designed to be inserted in the urethra of a patient during MRI scans in order to obtain improved image quality in the anatomical regions surrounding the urethra and including the prostate in males. The flexible coil facilitates placement of the coil in the anatomy, This product is to be used with a 1.5T Philips MRI system. The signals picked up by the coil are conducted through a small coaxial cable to a connection with the standard surface coil connector for MRI systems. The coil and cable are completely sealed inside the insulating layer.

    The Intercept™ Vascular Internal MR Coil is recommended for high-resolution Magnetic Resonance Imaging of the peripheral vasculature. The single use, disposable coil is designed for insertion into an artery or vein of a patient during MRI scans in order to obtain improved image quality in the peripheral vasculature. The flexible coil facilitates placement of the coil in the peripheral vascular anatomy. The coil would most commonly be used through femoral artery access similar to .035" guidewires currently in use. The handling characteristics of this device are familiar to vascular interventionalists thereby facilitating integration into their practices. This product is to be used with a 1.5T Philips MRI system.

    Device Description

    The Intercept™ Internal MR Coils are intracavitary specialty coils for use in MR imaging of the anatomical regions surrounding a body cavity. The signals picked up by the coil are conducted through a small coaxial cable and interfacing network to a connection with the standard surface coil connector for MRI systems. The coil is insulated with polymeric housing that protects is from contact from body fluids.

    AI/ML Overview

    This 510(k) summary describes a device that is essentially an accessory to an MRI system (internal MR coils). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating that the new device (Philips compatible version of existing coils) is substantially equivalent to legally marketed predicate devices, particularly regarding safety and compatibility with the new MRI system.

    Here's an analysis based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceStudy Type
    Possibility of excess RF heating: No excess heating, temperature change within acceptable range (< 2 degrees C in the trunk).Change in temperature within the same range with the coil in place as without it in a phantom. Not significantly different than without the coil.Phantom Study
    Possibility of increased susceptibility of patients to peripheral nerve stimulation: No possibility of increased susceptibility to peripheral nerve stimulation.Experiments done previously to determine current leakage by the MRI pulsed gradient field demonstrate no possibility of increased susceptibility. Remains true despite change from GE to Philips system.Previous Experiment (referenced)
    Imaging Performance: Enhanced resolution (specifically for aortic regions visualized from the esophagus). Functions like any other specialty MRI coil for general diagnostic imaging.Imaging performance demonstrates enhanced resolution of aortic regions visualized from the esophagus. Images taken using the coil in a volunteer illustrating its use in the esophagus on the Philips 1.5T MRI system.Volunteer Imaging Study
    Mechanical Testing: Bonds between connector/coaxial connector and connector/introducer sleeve display strengths in excess of 1 lb/f.Results on the Esophageal Coil showed strengths in excess of required 1lb/f. (Stated as identical to predicate, so previous results apply).Mechanical Testing

    Study Details

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

      • RF Heating Study: A "phantom" was used. The specific type or number of phantoms is not detailed.
      • Peripheral Nerve Stimulation: No specific test set described for this submission; it references "experiments done previously" and asserts that the findings remain true for the Philips system.
      • Imaging Performance: "a volunteer" was used. No further details on the volunteer or data provenance (e.g., country of origin, retrospective/prospective).
      • Mechanical Testing: Not explicitly stated for this particular submission, but references "the Esophageal Coil" and states it's identical to the "original Surgi-Vision Esophageal Stylet Coil," implying prior mechanical testing. No specific sample size or provenance for this re-affirmation.

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

      • This submission focuses on engineering and compatibility testing, not diagnostic accuracy requiring expert interpretation for ground truth.
      • For imaging performance, the enhanced resolution is an objective observation, not dependent on establishing a "ground truth" through expert consensus in the same way a diagnostic AI algorithm would be. No experts are mentioned for ground truth establishment.

    3. Adjudication method for the test set: Not applicable for this type of technical and compatibility assessment.

    4. 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: Not applicable. This is not an AI diagnostic device, nor is it a study comparing human readers with and without AI assistance.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (MRI coil), not an algorithm.

    6. The type of ground truth used:

      • RF Heating: Direct temperature measurements in a phantom, compared to baseline (without the coil). This is an objective physical measurement.
      • Peripheral Nerve Stimulation: Current leakage measurements from previous experiments are the basis. This is an objective physical measurement.
      • Imaging Performance: Visual assessment of image resolution (e.g., "enhanced resolution of aortic regions"). While qualitative, it's based on visual clarity and detail. This is an objective physical measurement (image quality metrics), not clinical "ground truth" derived from patient outcomes or pathology.
      • Mechanical Testing: Force/load tests. This is an objective physical measurement.

    7. The sample size for the training set: Not applicable. This device does not use machine learning or AI models with training sets.

    8. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

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