LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K970107
    Device Name
    INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
    Manufacturer
    UROHEALTH SYSTEMS, INC.
    Date Cleared
    1997-11-18

    (309 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.

    Device Description

    UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.

    AI/ML Overview

    The provided 510(k) summary for K970107, the UROHEALTH Intubation Endoscope and Introducer Sheath, describes performance testing but does not present specific acceptance criteria or detailed study results in a quantitative manner as typically expected for device performance. It outlines the types of tests to be conducted rather than reporting the outcomes against defined metrics.

    Here's a breakdown based on the provided text, addressing your points:

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

    Based on the provided text, specific quantitative acceptance criteria and reported device performance are not available. The summary states:

    Acceptance Criteria (Implied)Reported Device Performance
    Integrity of sterile barrier under normal usage conditions"will be tested to ensure integrity of the sterile barrier under normal usage conditions." (No specific results or metrics provided).
    Integrity of all bonded joints based on appropriate ASTM procedure"All bonded joints will tested according to the appropriate ASTM procedure." (No specific results or metrics provided).
    Biocompatibility (cytotoxicity, sensitization, irritation) in accordance with EN 30993 for medical devices with mucosal membrane contact (<24 hours)"Biocompatibility testing will be conducted on both component level and finished devices (sterile, if applicable). This testing will include but is not limited to cytotoxicity, sensitization, and irritation. The device is considered body contact surface of mucosal membranes for a limited (less than 24 hours) contact duration. This testing is in accordance with EN 30993 for medical Devices." (No specific results or metrics provided).

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

    • Sample Size: The document does not specify any sample sizes for the performance, integrity, or biocompatibility tests.
    • Data Provenance: The document does not specify the country of origin of the data, nor whether the studies are retrospective or prospective. It only mentions that the testing "will be conducted," implying prospective testing.

    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)

    This device is a medical instrument (bronchoscope/endoscope) for direct visualization, not an AI or diagnostic imaging device that requires interpretations of images by experts to establish ground truth. Therefore, these criteria are not applicable to this type of submission. Performance testing here refers to engineering and biological safety tests, not clinical or diagnostic accuracy studies involving expert readers.

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

    This criterion is not applicable as it relates to expert review for diagnostic/interpretive devices, which this is not. The performance tests described (sterile barrier, bonded joints, biocompatibility) would have specific pass/fail criteria for each test without an adjudication method.

    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 is not applicable. This device is a direct visualization tool, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI improvement statistics would be relevant or performed.

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

    This is not applicable. This device is a physical invasive medical instrument; there is no "algorithm only" component.

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

    For the tests mentioned:

    • Sterile Barrier & Bonded Joints: The "ground truth" would be the successful integrity of the materials and seals as per defined engineering specifications and ASTM standards.
    • Biocompatibility: The "ground truth" would be the absence of adverse biological responses (cytotoxicity, sensitization, irritation) as per the EN 30993 standard.
      This is not a diagnostic device requiring a "ground truth" for interpretation.

    8. The sample size for the training set

    This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

    This is not applicable for the same reason as point 8.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1