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510(k) Data Aggregation

    K Number
    K193095
    Device Name
    Ambu aScope 4 Cysto
    Manufacturer
    Ambu A/S
    Date Cleared
    2020-04-02

    (147 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K160766
    Why did this record match?
    Device Name :

    Ambu aScope 4 Cysto

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

    Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Ambu® aScope™ 4 Cysto is intended to provide visualization via Ambu® displaying unit and can be used with endoscopic accessories.

    Ambu® aScope™ 4 Cysto is intended for use in a hospital environment or medical office environment. Ambu® aScope™ 4 Cysto is designed for use in adults.

    Device Description

    Ambu® aScope™ 4 Cysto is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by Ambu® displaying unit. The Ambu® aScope™ 4 Cysto is intended to be used with a reusable Ambu® displaying unit to visualize the urethra and the bladder. The Ambu® aScope™ 4 Cysto can be operated by either the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

    Ambu® aScope™ 4 Cysto has the following physical and performance characteristics:
    Maneuverable tip controlled by the user
    Flexible insertion cord
    Working channel that can be used for graspers or other instrumentation
    Camera and LED light source at the distal tip
    Luer lock connector for irrigation and aspiration
    Sterilized by Ethylene Oxide sterilization
    For single use

    AI/ML Overview

    The provided text describes the 510(k) summary for the Ambu® aScope™ 4 Cysto, a medical device. It focuses on demonstrating substantial equivalence to predicate devices through various performance tests and compliance with recognized standards.

    However, the document specifically states "Performance Data - Clinical: Not applicable." This indicates that a clinical study with human subjects, which would typically involve assessing how human readers (like radiologists) improve with or without AI assistance, or the performance of an AI algorithm in a clinical setting, was not performed or required for this 510(k) submission.

    Therefore, many of the requested elements for describing the acceptance criteria and study that proves the device meets the acceptance criteria (specifically in the context of AI performance or human reader improvement) cannot be directly extracted from this document, as the device is a physical endoscope, not an AI/software device.

    I will provide the information that can be extracted or reasonably inferred from the provided text regarding the device's performance, focusing on the physical and functional aspects tested.

    Acceptance Criteria and Device Performance for Ambu® aScope™ 4 Cysto

    The acceptance criteria for the Ambu® aScope™ 4 Cysto are based on compliance with recognized consensus standards and meeting specified physical and performance characteristics, demonstrating substantial equivalence to predicate devices. The study proving these criteria were met involved a series of bench tests and a declaration of conformity to relevant standards.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria / Standard AppliedReported Device Performance (Result)
    Declaration of ConformityISO 8600-1 (Optics & Optical Inst. - Medical Endoscopes)All tests were passed.
    ISO 8600-3 (Optics & Optical Inst. - Medical Endoscopes)All tests were passed.
    ISO 8600-4 (Optics & Optical Inst. - Medical Endoscopes)All tests were passed.
    IEC 60601-2-18 ED 3.0:2009 (Medical Electrical Equipment - Endoscopic Equipment)All tests were passed.
    Physical/Performance CharacteristicsInsertion cord working lengthTested and passed. (Noted as 390 mm, predicate 380 mm)
    Insertion cord outer diameterTested and passed. (Noted as 5.4 mm, predicate 4.8 mm)
    Maximum diameter of the insertion portionTested and passed.
    Distal end outer diameterTested and passed. (Noted as 5.4 mm, predicate 4.8 mm)
    Minimum diameter of the working channelTested and passed.
    Irrigation possibleTested and passed.
    Luer Lock Connector to working channelTested and passed.
    Angulations range (Distal bending section)Tested and passed. (Noted as larger than predicate due to no integrated grasper)
    Field of viewTested and passed.
    Depth of fieldTested and passed. (Noted as 3-100 mm, predicate 3-50 mm)
    Direction of ViewTested and passed.
    SterilizationISO 11135:2014 (Ethylene Oxide Sterilization)Sterility Assurance Level (SAL) of 10-6 achieved using half-cycle overkill approach.
    Shelf LifePerformance and Sterile Packaging Integrity after agingTested and passed.
    BiocompatibilityISO 10993-1 (Biological evaluation of medical devices)All tests were passed.
    ISO 10993-5 (Cytotoxicity)All tests were passed.
    ISO 10993-10 (Sensitization)All tests were passed.
    ISO 10993-10 (Intracutaneous reactivity test)All tests were passed.
    Electromagnetic Compatibility (EMC)IEC 60601-1-2All tests were passed.
    Electrical SafetyIEC 60601-1 and IEC 60601-2-18All tests were passed.

    Regarding the AI-specific questions (2-7), the supplied document explicitly states "Performance Data - Clinical: Not applicable." This means no clinical study involving human readers, AI assistance, or standalone AI performance was conducted or submitted for this specific 510(k) clearance, as the device is a physical endoscope and not an AI/software product.

    Therefore, I cannot provide information for the following points based on the provided text, as they are not relevant to this device's 510(k) submission:

    1. Sample sized used for the test set and the data provenance.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
    3. Adjudication method for the test set.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
    7. The sample size for the training set.
    8. How the ground truth for the training set was established.

    Conclusion stated in the document:
    Based on the indication for use, technological characteristics, performance data, and comparison to predicate devices, it was concluded that the functionality and intended use of Ambu® aScope™ 4 Cysto is equivalent to the predicate and reference devices. The device is concluded to be as safe and effective and performs as well as the chosen legally marketed predicate device.

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