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510(k) Data Aggregation

    K Number
    K170027
    Device Name
    Inflation Device
    Manufacturer
    SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
    Date Cleared
    2017-10-06

    (276 days)

    Product Code
    MAV
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K102648
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

    Device Description

    The inflation device consists of barrel, threaded plunger assemble with a handle, a trigger, pressure gauge, an outer shell assembly that retains the internal components, and a pressure connecting tubing with rotating adapter. Also enclosed is a stopcock to aid in preparation and use of device. The inflation device is 20 mL disposable device capable of producing a maximum pressure of 30 atm.

    The inflation device is sterilized by EO.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for an "Inflation Device". This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, many of the requested elements are not applicable to this type of submission.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a specific clinical outcome. Instead, it refers to compliance with established international standards for medical devices and device specifications.

    Acceptance Criteria CategorySpecific Standard/RequirementReported Device Performance
    Functional PerformanceISO 594-1:1986 (Conical Fittings, General Requirements)Device complies with the standard.
    ISO 594-2:1998 (Conical Fittings, Lock Fittings)Device complies with the standard.
    Device specifications (e.g., volume, pressure range, mechanism of operation)Verified through bench tests; performance is equivalent to predicate device (20 mL, 0-30 ATM).
    BiocompatibilityISO 10993 series StandardsConforms to requirements (No hemolysis, No Acute Systemic Toxicity, No cytotoxicity, No intracutaneous reactivity, No Sensitization).
    SterilizationSterility Assurance Level (SAL)10-6
    Sterilization MethodEO Sterilization
    Sterilization ValidationConforms to ISO 11135
    PackagingPackage IntegrityConforms to ISO 11607
    Material ResidualsEO ResidualConforms to ISO 10993-7
    Other SafetyPyrogenicityNon-pyrogenic
    LabelingFDA RequirementsConforms to FDA Requirements

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: The document does not specify a "test set" in the context of clinical data. The tests performed are bench tests on the device itself (e.g., for mechanical properties, material testing). The number of units tested per bench test is not detailed.
    • Data Provenance: Not applicable as no human data is used. The tests are performed on the manufactured device.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    • Not applicable. There is no ground truth established by experts in this context as it's a device performance study, not a diagnostic accuracy study relying on human interpretation.

    4. Adjudication Method

    • Not applicable. No expert review or adjudication process is described as it's not a clinical study involving human assessment.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No. This is a 510(k) submission for a physical medical device, not an AI software or diagnostic imaging tool. Therefore, a MRMC comparative effectiveness study is not performed or relevant.

    6. Standalone Performance

    • Yes, in a way. The "standalone" performance here refers to the device's ability to meet its technical specifications and regulatory standards independently. The non-clinical bench tests assess the device's functional and safety characteristics in a standalone manner.

    7. Type of Ground Truth Used

    • The "ground truth" for this device's performance is compliance with established international standards (ISO) and the manufacturer's own validated specifications. For example, for conical fittings, the ground truth is adherence to ISO 594-1 and ISO 594-2 standards. For biocompatibility, it's the outcome of tests against ISO 10993 standards.

    8. Sample Size for the Training Set

    • Not applicable. There is no "training set" as this is not an AI/machine learning model.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable.
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