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510(k) Data Aggregation

    K Number
    K983279
    Device Name
    ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    1998-12-02

    (75 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K950502,K942817
    Why did this record match?
    Reference Devices :

    K950502, K942817

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

    The ICCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.

    Indication and Field of Application:
    For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.

    Device Description

    The electronic CCD Endoscope is a combination of an endoscope with integrated objective lense: and CCD camera. The CCD endoscope is connected to the camera controller 5502 via a quick connector with camera cable.

    AI/ML Overview

    The provided 510(k) summary (K983279) describes a medical device, the 1 CCD Endocam (Models 5502, 4934), which is an endoscopic video camera system. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the way a modern AI/ML device submission would.

    Here's an analysis of the provided information concerning acceptance criteria and study details:

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

    Based on the document, there are no specific quantitative acceptance criteria or detailed device performance metrics reported for this device in the context of diagnostic accuracy or clinical outcomes. The performance data section refers to compliance with safety standards rather than clinical performance.

    Acceptance Criteria CategorySpecific Criteria (from document)Reported Device Performance (from document)
    Safety Standards ComplianceIEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18, UL2601-1, AAMI safe current limitsEndocam 5502 and 5507 conforms to these standards.
    Medical Device Directive ComplianceRelevant provisions of Medical Device Directive 93/42/EECCamera system 5502 conforms to these provisions.
    Functional EquivalencePose the same type of questions about safety and effectiveness as existing devices; new technological characteristics have not diminished safety or effectiveness.Determined to be substantially equivalent to existing 510(k) devices (K950502, K942817).
    Clinical EfficacyN/A (No specific clinical efficacy criteria documented)No clinical tests were performed.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Test Set Sample Size: Not applicable. The submission explicitly states "No clinical tests performed."
    • Data Provenance: Not applicable, as no clinical tests were performed to generate a test set.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable, as no clinical tests were performed and therefore no ground truth establishment for a test set was required in this submission.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable, as no clinical tests were performed.

    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

    • No MRMC study was done. This device is a video camera system, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical tests performed." Therefore, no assessment of human reader improvement with or without AI assistance was conducted or reported.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    • No standalone algorithm performance study was done. This device is an imaging acquisition device, not an algorithm, and no clinical performance studies were conducted.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Not applicable, as no clinical tests were performed. The "ground truth" for this submission was primarily related to compliance with electrical and medical device safety standards and demonstration of substantial equivalence to predicate devices based on technological characteristics and intended use.

    8. The sample size for the training set

    • Not applicable, as this device is a hardware imaging system and does not involve AI/ML requiring a training set.

    9. How the ground truth for the training set was established

    • Not applicable, as no training set was used for this device.
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