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510(k) Data Aggregation

    K Number
    K171734
    Device Name
    HP PRO Positioning Device
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2017-07-25

    (43 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K151207
    Why did this record match?
    Reference Devices :

    K151207

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

    The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.

    Device Description

    The HP PRO Positioning Device is used by first attaching the base plate to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. An example of an immobilization device is the overlay base plate of the Proton Immobilization Solution.

    The HP PRO Positioning Device is a device that assists in the proper positioning and repositioning of patients for radiation therapy and radiosurgery with protons. It is an accessory to the Proton Immobilization Solution. The HP PRO Positioning Device is typically attached to the treatment table and supports the patient during treatment. The proposed HP PRO Positioning Device is essentially an extension of the treatment table.

    The HP PRO Positioning Device is made up of 4 components: Base Plate (PMMA and Carbon Fiber), Interface (Aluminum), Indexing Pins (POM (Polyoxymethylene)), and Sheet Screws (Stainless Steel).

    AI/ML Overview

    The provided document describes the HP PRO Positioning Device and its substantial equivalence to a predicate device, K151207 Proton Immobilization Solution. The study focuses on demonstrating that the new device performs comparably to the predicate device across various physical and dosimetric properties.

    Here's an analysis of the acceptance criteria and study details based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryAcceptance Criteria/RequirementReported Device Performance (HP PRO Positioning Device)
    Physical Properties
    LengthRange 45-52"50.17 inches (within range)
    Width21"21.61 inches (comparable, deemed SE)
    Height1.9"1.62 inches (comparable, deemed SE)
    Sag at cranial end (135kg distributed load)2.51 mm (from predicate)9.21 mm (Predicate: 2.51mm; Device: 9.21mm; Deemed SE, with a note that a 6DOF Robotic patient couch top can compensate for bending effect. **Implicit acceptance: Sag + Creep
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