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510(k) Data Aggregation

    K Number
    K112293
    Device Name
    HTS EXTREMITY COIL, HTS SURFACE COIL
    Manufacturer
    TIME MEDICAL SYSTEMS INC
    Date Cleared
    2011-09-30

    (51 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K092230,K022863
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HTS Surface Coil is used to image peripheral anatomies, such as, wrist, ankle, Temporo-mandibular Joints (TMJ), Eye, finger and other parts of the body, close to the surface of skin. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

    HTS Extremity Coil is predominantly used for imaging anatomies, such as, knee, ankle, and wrist. It is compatible to be used with Time Medical's 0.35T PICA Whole Body MRI System.

    Device Description

    HTS Surface Coil (TM-HTS-SF001-0R35), HTS Extremity Coil (TM-HTS-KN001-0R35). Single-Channel, Receive-Only, LN2 (Liquid Nitrogen) Cooling liquid. HTS Surface Coil is Single Channel surface coil. HTS Extremity Coil is Single Channel Volume coil. Material: ABS.

    AI/ML Overview

    This document focuses on the substantial equivalence of the HTS Surface Coil and HTS Extremity Coil to a predicate device, rather than providing a study with specific performance metrics and acceptance criteria for the new devices. Therefore, much of the requested information, such as quantitative performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not present in the provided text.

    Here's what can be extracted based on the input:

    1. Table of Acceptance Criteria and Reported Device Performance

    Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied by the similarity to the predicate device. The performance is described qualitatively by stating they are "similar" and have "similar safety and effectiveness." No quantitative performance metrics are provided for the filing devices.

    Acceptance Criteria (Implied by Substantial Equivalence)Reported Device Performance
    Same principle of operationWorks on the same principle
    Similar designSimilar design
    Constructed of similar materialsConstructed of similar materials (ABS vs. PVC for predicate K022863, but ABS for K092230)
    Similar safety and effectivenessSimilar safety and effectiveness
    Does not induce new safety issues/warningsDoes not induce other safety issues and warning than already valid for the current cleared RF external coils.
    Intended Use aligns with predicate devices (for relevant anatomies and MRI system)HTS Surface Coil: images peripheral anatomies (wrist, ankle, TMJ, eye, finger, etc.) with Time Medical's 0.35T PICA Whole Body MRI System.
    HTS Extremity Coil: predominantly images knee, ankle, and wrist with Time Medical's 0.35T PICA Whole Body MRI System. (Matches predicates generally, with specific MRI system compatibility noted).
    Technical parameters (T/R, Coil Type, Cooling Liquid) align with predicate devicesT/R: Receive-Only (Matches both predicates)
    Coil Type: Single Channel Surface Coil (HTS Surface Coil, matches both predicates) / Single Channel Volume Coil (HTS Extremity Coil, differs from predicate K092230 which is surface, but K022863 is also surface)
    Cooling liquid: LN2 (Matches both predicates)

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

    Not applicable. This document does not describe a clinical study for testing the device. It's a submission for substantial equivalence based on technical and safety characteristics compared to existing devices.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    Not applicable. Ground truth establishment for a specific test set is not mentioned as no such study is detailed.

    4. Adjudication Method

    Not applicable. No study involving adjudication is described.

    5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

    Not applicable. This document does not describe an MRMC study or any comparison of human reader performance with or without AI assistance. The device in question is an MRI coil, not an AI-powered diagnostic tool.

    6. Standalone Performance Study

    Not applicable. The document describes an MRI coil, a hardware component, not a standalone algorithm. Its performance is intrinsically tied to the MRI system it's used with.

    7. Type of Ground Truth Used

    Not applicable. The concept of "ground truth" as typically used in performance studies for diagnostic algorithms does not apply to this regulatory submission for an MRI coil. The assessment revolves around engineering, safety, and functional equivalence to predicate devices.

    8. Sample Size for the Training Set

    Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

    Not applicable. No training set or associated ground truth establishment is mentioned.

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