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510(k) Data Aggregation

    K Number
    K173926
    Device Name
    DORADOnova MR3T
    Manufacturer
    LAP GmbH Laser Applikationen
    Date Cleared
    2018-09-14

    (262 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K152303,K052682
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K152303

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

    The DORADOnova MR3T system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system. The position coordinates are typically chosen by the operator or provided by an external system (e.g. treatment planning system). The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla.

    Device Description

    The LAP moving laser positioning system contains laser devices and a control system. The laser system is provided in a configuration that enables the movement of two projection planes by using an appropriate composition of motorized and fixed laser devices. The installation of the system is realized in a combined bridge solution.

    AI/ML Overview

    This FDA 510(k) summary (K173926) describes the DORADOnova MR3T system, a medical device used for reproducible patient positioning during radiation therapy planning. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for an AI/algorithm-driven device.

    Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and MRMC studies) are not applicable to this specific device and document, as it is a laser positioning system, not an AI-powered diagnostic or therapeutic device.

    However, based on the provided text, I can extract the relevant performance specifications and how they were tested.

    Device Name: DORADOnova MR3T (LAP moving laser positioning system)

    Device Type: Medical charged-particle radiation therapy system (21 CFR 892.5050, Class II) - Specifically, a laser positioning system.

    1. Table of Acceptance Criteria and Reported Device Performance

    Since this is a physical positioning device and not an AI/algorithm, "acceptance criteria" are tied to its physical specifications and safety standards, largely demonstrated through bench testing and compliance with recognized standards.

    Feature / CriterionAcceptance Criteria (Stated or Implied)Reported Device Performance / Characteristics
    Intended UseMust assist in reproducible patient positioning during radiation therapy planning and be utilized during treatment planning workflow, by projecting visual laser beams positionable at specified coordinates. Must be usable in MR environment (≤ 3 Tesla).The DORADOnova MR3T system "assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. The DORADOnova MR3T system projects visual laser beams which can be positioned at specified coordinates via a control system... The DORADOnova MR3T system is allowed to be used in MR environment with a magnetic field, less or equal to 3 Tesla." (Identical to intended use).
    Functional PrincipleMust use projection of visual light/laser lines on the patient's skin surface, with reflection aiding medical staff to determine patient's position."Projection of a visual laser lines on the patient's skin surface. Reflection of the laser lines aide's professional medical staff to determine the patient's position." (Similar to predicate/reference devices).
    Patient Reference Position InformationMust allow coordinates for 3 laser intersection points to be manually input or imported from a treatment planning system for reproducible patient positioning."The patient reference position information is the coordinates for 3 laser intersection points. They are either manually input into the device by the operator or imported from the treatment planning system." (Similar to predicate/reference devices).
    Positioning AccuracyMust be comparable to or better than predicate/reference devices. Reference device: +/- 0.1 mm. Predicate device: max mean: 0.27mm; max std dev: 0.65mm.+/- 0.1 mm (Matches reference device performance, superior to predicate device in terms of stated accuracy).
    Resolution / Line WidthMust be comparable to or better than predicate/reference devices. Reference device:
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