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510(k) Data Aggregation

    K Number
    K983764
    Device Name
    VIEWPOINT TOOLS- STERRAD
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Date Cleared
    1999-07-08

    (255 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K963221,K970604
    Why did this record match?
    Reference Devices :

    K963221, K970604

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

    The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

    The ViewPoint is indicated for use in:

    · Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)

    · Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.

    Device Description

    Prior to use the ViewPoint tools must be sterilized. Testing has been completed to validate the use of the Sterrad 100 system for this process. The Guide Block (Non-Trackable and Trackable) and the Trackable Awl are three additional tools now available for the ViewPoint. The Guide Blocks guide and track the trajectory of a biopsy needle during a procedure. The Trackable Awl is a standard awl that has been adapted to include infrared emitting diodes so that the tip of the awl can be tracked similar to the standard ViewPoint Y-probe.

    AI/ML Overview

    The provided text describes the ViewPoint Tools - Sterrad, an Image Assisted Surgery Device. The submission is a 510(k) for new tools (Guide Blocks and Trackable Awl) and a new sterilization technique (Sterrad 100 system) for the previously cleared ViewPoint system. The document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on the device's diagnostic performance for its intended use.

    Here's the breakdown of the acceptance criteria and the study as described in the document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission primarily aims to demonstrate that the new ViewPoint tools (Guide Blocks and Trackable Awl) and the new sterilization technique (Sterrad 100 system) are substantially equivalent to previously cleared predicate devices and sterilization methods. The acceptance criteria are implicit in proving this equivalence, particularly regarding the existing accuracy specifications of the ViewPoint system.

    ParameterAcceptance Criteria (from Predicate Device)Reported Device Performance (ViewPoint - Sterrad)
    ToolsY-Probe, Cable, Head Tracker, Spine Tracker, Drill Guide (Non-Trackable and Trackable)Y-Probe, Cable, Head Tracker, Spine Tracker, Drill Guide (Non-Trackable and Trackable), Guide Block (Non-Trackable and Trackable), Trackable Awl (New tools claimed equivalent)
    Material ConsiderationsCombination of metal and non-metal, IREDs sensitive to heat.Same.
    LumensDead-end lumen in LEMO Connector for trackable tools; single-channel stainless steel lumen for drill guides.Same.
    Use limitsNone specified for predicate.Same (None).
    Accuracy (Y-probe)Repeatability/Resolution: 1mm; Distance measurement: ± 0.75 mm; 3D Localization: $\leq$ 1.57 mm; Fourth Fiducial Checkpoint: $
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