LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K090601
    Device Name
    FSC 2
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2009-05-11

    (67 days)

    Product Code
    NTN,LED,XXX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K053412
    Why did this record match?
    Device Name :

    FSC 2

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

    The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.

    Device Description

    The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device called "FSC 2," which is an endoscope camera and illumination system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

    Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission explicitly states "Performance: NA" for both the device and its predicate, indicating that a dedicated performance study for clinical efficacy, as typically understood for AI/algorithm devices, was not performed or deemed necessary for this type of device.

    Here's a breakdown of the information that can be extracted from the provided text, along with notes on what is not present:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Explicitly Stated or Implied)Reported Device Performance
    General Design: Camera with LED lamp typeCamera with LED lamp type
    Intended Use: Provide illumination and video visualization of optical images in conjunction with endoscopic devices."Use in conjunction with endoscopic devices to provide illumination and video visualization of optical images"
    Target Population: Any patient populationAny patient population
    Anatomical Sites: Any where endoscopic devices are usedAny where endoscopic devices are used
    Where Used: Hospitals, clinics, and physician officesHospitals, clinics, and physician offices
    Biocompatibility: NA - no patient contacting surfacesNA - no patient contacting surfaces
    Sterility: NA - non-sterileNA - non-sterile
    Electrical Safety: Conforms with IEC 60601-1Conforms with IEC 60601-1
    Mechanical Safety: NANA
    Performance: Substantially equivalent to predicate device K053412 (FSC 50 MH/50 MHC) in terms of general design and technology, indication for use, and function.Substantially Equivalent to FSC 50 MH/50 MHC (K053412)

    Study that proves the device meets the acceptance criteria:

    The "study" presented is a comparison to a predicate device (Schoelly FSC 50MH K053412) to demonstrate substantial equivalence, rather than a clinical performance study with specific device-centric acceptance criteria. The basis for meeting the criteria is the direct comparison of features and adherence to recognized standards for safety where applicable.

    Information Not Available in the Provided Text:

    1. Sample size used for the test set and the data provenance: Not applicable. No test set for algorithm performance was mentioned.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set for algorithm performance or ground truth establishment was mentioned.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/algorithm-based interpretive tool.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware component.
    6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
    7. The sample size for the training set: Not applicable. This device is not an AI/algorithm-based interpretive tool.
    8. How the ground truth for the training set was established: Not applicable. This device is not an AI/algorithm-based interpretive tool.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1