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510(k) Data Aggregation

    K Number
    K131780
    Device Name
    EVIS EXERA III VIDEO SYSTEM
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Date Cleared
    2013-08-29

    (73 days)

    Product Code
    FDF,FDS,NWB
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K112680
    Predicate For
    K192793,K222584,K222861,K232244
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Endoscopes (GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190, COLONOVIDEOSCOPE CF-HQ190L/I, CF-H190L/I, PCF-H190L/I, PCF-PH190L/I)
    This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit (for CF-HQ190L/), light source, document, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

    The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-H190, GIF-HQ190 are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

    The EVIS EXERA III COLONOVIDEOSCOPE CF-H190L/I, CF-HQ190L/I, PCF-PH190U/I, PCF-H190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

    CV-190 VIDEO SYSTEM CENTER
    This video system center is intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.

    CLV-190 XENON LIGHT SOURCE
    This light source is intended to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

    Device Description

    The EVIS EXERA III VIDEO SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation within the upper and lower digestive tract.

    The primary components of the subject system are:

    • VIDEO SYSTEM CENTER OLYMPUS CV-190
    • XENON LIGHT SOURCE OLYMPUS CLV-190
    • ENDOSCOPES
    • GASTROINTESTINAL VIDEOSCOPE (GIF-H190,GIF-HQ190, GIF-XP190N)
    • COLONOVIDEOSCOPE (CF-HQ190L/I, CF-H190L/I, PCF- PH190L/I, PCF- H190L/I)
    AI/ML Overview

    The provided document is a 510(k) Summary for the Olympus EVIS EXERA III VIDEO SYSTEM. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining indications for use, rather than presenting a performance study with acceptance criteria for a new and distinct functional claim.

    Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning the following points:

    1. A table of acceptance criteria and the reported device performance: This information is not present. The document states that "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007," but it does not specify what those criteria were or how the device's performance against them was measured or reported.
    2. Sample size used for the test set and the data provenance: Not applicable as no specific device performance study is described.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
    5. 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: This document is for a video system, not an AI-assisted diagnostic device, so this type of study is not relevant here and is not mentioned.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not a standalone AI algorithm.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
    8. The sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.

    The document states that the purpose of the notification is to "add an additional colonoscopy-related marketing claim" to the existing device and that "There are no new technological features incorporated... No design changes have been made... other than this marketing claim modification." It relies on the substantial equivalence to the predicate device (K112680) and conformity to applicable safety standards (like ISO 14971:2007) and software guidance.

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