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510(k) Data Aggregation

    K Number
    K250732
    Device Name
    Disposable Endoscopy Valve Set
    Manufacturer
    Yangzhou Fartley Medical Instrument Technology Co,. Ltd
    Date Cleared
    2025-06-20

    (101 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K220210
    Why did this record match?
    Device Name :

    Disposable Endoscopy Valve Set

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

    The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.

    • Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

    • Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.

    • Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.

    • Disposable Water Jet Adapter: This unit is designed to prevent backflow and intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

    Device Description

    The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

    AI/ML Overview

    This FDA 510(k) clearance letter pertains to a Disposable Endoscopy Valve Set, which is a Class II device. The document explicitly states that no clinical study was conducted for this submission (K250732) and that no clinical test data is included. Instead, the clearance is based on the device being "substantially equivalent" to a predicate device (Disposable Endoscopy Adapter Set, K220210) through non-clinical performance data, primarily bench testing.

    Therefore, many of the requested criteria related to clinical studies, human readers, ground truth, and training sets are not applicable to this specific clearance. I will extract the information that is present in the document regarding the acceptance criteria and the study (bench testing) that supports it.

    Here's a breakdown of the requested information based on the provided document:

    Acceptance Criteria and Device Performance for Disposable Endoscopy Valve Set (K250732)

    1. Table of acceptance criteria and the reported device performance:

    The document details extensive performance characteristics for each component of the Disposable Endoscopy Valve Set. Since the submission relies on substantial equivalence through bench testing, the reported device performance is indicated as "Substantially equivalent supported by bench testing" for each characteristic compared to the predicate device.

    Disposable Air/Water Valve:

    Acceptance Criteria (Proposed Device)Reported Device Performance
    Appearance: Smooth, clean, uniform color, no defects (flashes, scratches, microcosm, plastic flow, oil stains, defects, breakages, rubber threads, rubber chippings, foreign matters, dirt, deformations, fractures, defects, blooming, singe, etc.). Correct assembly.Substantially equivalent supported by bench testing. Tested against predicate criteria: Same general appearance criteria.
    Connection Firmness: Withstand axial static tension of 15N for 15s without falling off.Substantially equivalent supported by bench testing. Tested against predicate criteria: Withstand axial static tension of 15N for 15s without falling off.
    Fitting Performance: Switch smoothly without obstruction. Return to original position within 1s after pressing.Substantially equivalent supported by bench testing. Tested against predicate criteria: Switch smoothly without obstruction, cooperate well with endoscope.
    Corrosion Resistance (Spring): Good corrosion resistance, removable trace if present after wiping.Substantially equivalent supported by bench testing. (Predicate did not specify spring corrosion resistance, but this implies the proposed device met its own criteria.)
    Depression Force: Initial pressure between 6.5-9.0N, complete pressure ≤ 13.0N.Substantially equivalent supported by bench testing. Tested against predicate criteria: Depression force ≤ 12N at 3mm.
    Air Feeding Performance: Air volume ≥ 950ml/min. No water feeding during air feeding, no water leakage at connection.Substantially equivalent supported by bench testing. Tested against predicate criteria: Time to reach 8KPa pressure ≤ 12s.
    Water Feeding Performance: Water volume ≥ 45ml/min. No air feeding during water feeding, no air leakage at connection.Substantially equivalent supported by bench testing. Tested against predicate criteria: Time to feed 10ml water ≤ 12s.
    Sealing Performance: a. No air/liquid leakage at endoscope front end (30mm depth) without plugging/pressing. b. Counterflow rate
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