LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250414
    Device Name
    CaloPix
    Manufacturer
    Tribun Health
    Date Cleared
    2025-05-14

    (90 days)

    Product Code
    QKQ
    Regulation Number
    864.3700
    Type
    Traditional
    Panel
    Pathology (PA)
    Reference & Predicate Devices
    K213883,K232202
    Why did this record match?
    Reference Devices :

    K213883, K232202

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

    For In Vitro Diagnostic Use Only

    CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue.

    CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis.

    CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

    It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix.

    CaloPix is intended to be used with the interoperable components specified in the below Table:

    Scanner HardwareScanner Output File FormatInteroperable Displays
    Leica Aperio GT 450 DX scannerSVSDell U3223QE
    Hamamatsu NanoZoomer S360MD Slide scannerNDPIJVC Kenwood JD-C240BN01A
    Device Description

    CaloPix, version 6.1.0 IVDUS, is a web-based software-only device that is intended to aid pathology professionals in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed on the Dell U3223QE display.

    CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.

    CaloPix is for viewing digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.

    As a whole, CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing. CaloPix consists of:

    • Integration with Laboratory Information Systems (LIS): Allows to obtain automatically from the LIS patient data associated with the cases, scanned whole slide images and other related medical images to be analyzed. The data stored in the database is automatically updated according to the interface protocol with the LIS.

    • DataBase: After ingestion, scanned WSI can be organized in the CaloPix database consisting of folders (cases) containing patient identification data and examination results from a LIS.

    Ingestion of the slides is performed through an integrated module that allows their automatic indexation based on patient data retrieved from the LIS. After their ingestion, image files are stored in a CaloPix-specific file storage environment, that can be on premises or in the cloud.

    • The CaloPix viewer component to process scanned whole slide images, that includes functions for panning, zooming, screen capture, annotations, distance and surface measurement, and image registration. This viewer relies on image servers (IMGSRV) which extract image tiles from the whole slide image file and send these tiles to the CaloPix viewer for smooth and fast viewing.
    AI/ML Overview

    The FDA 510(k) clearance letter for CaloPix indicates that the device's performance was evaluated through a series of tests to demonstrate its safety and effectiveness. The primary study described in the provided document focuses on technical performance testing rather than a clinical multi-reader multi-case (MRMC) study.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Pixel-wise comparison (Image Reproduction Accuracy)The 95th percentile of the pixel-wise color differences (CIEDE2000, ΔE00) in any image pair between CaloPix and the predicate device's IRMS must be less than 3 (ΔE00
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1