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    K Number
    K170784
    Device Name
    PNEUMOCLEAR
    Manufacturer
    W.O.M World Of Medicine GmbH
    Date Cleared
    2017-05-15

    (61 days)

    Product Code
    HIF,OSV,THE
    Regulation Number
    884.1730
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    K122180,K090456,K153513,K143404
    Why did this record match?
    Reference Devices :

    K122180, K090456

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

    The device PNEUMOCLEAR™ is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans anal minimal invasive surgery.

    Device Description

    The PNEUMOCLEAR™ is a microprocessor controlled CO2 insufflator that consists of the following major components and features: (1) a casing, (2) a world power supply, (3) pressure reducers, (4) pressure sensors, (4) venting systems, (5) various safety valves. (6) a suction pump. (7) a fluid sensor and (8) a software controlled graphical user interface (GUI) touch screen with various setting keys and display elements. The proposed device offers six operating modes (i.e. Standard, High Flow/Bariatric, Pediatric, Advanced Flow, Vessel Harvest, and TAMIS. The PNEUMOCLEAR™is not intended to enter the sterile field, and cannot be sterilized. It is to be used with specially designed single-use insufflation tube sets that are delivered sterile. Specifically, five different tube sets may be used with the proposed device: (1) insufflation tube set with integrated filter, (2) insufflation tube set with integrated filter and heating wire; (3) insufflation tube set with integrated filter, heating wire and humidification media; (4) insufflation and smoke evacuation tube set with integrated filter, heating wire, and humidification media; and insufflation and smoke evacuation tube set with integrated filter. When used with a smoke evacuation tube set the PNEUMOCLEAR™ allows for removal and filtration of CO2 and surgical smoke from the abdomen, rectum or colon during laparoscopic and transanal minimally invasive procedures and at the end of a procedure.

    AI/ML Overview

    The PNEUMOCLEAR™ device is a CO2 insufflator for endoscopic procedures. The information provided outlines several performance tests but does not present a formal table of acceptance criteria with reported device performance or extensive details on study design as typically found in clinical trials for AI/ML devices.

    However, based on the provided text, we can infer some "acceptance criteria" through the comparisons made against predicate devices and adherence to relevant standards. The "study" refers to a series of bench tests, electrical safety and electromagnetic compatibility testing, software verification and validation, biocompatibility testing, and sterilization and package testing.

    Here's an attempt to structure the information as requested, with caveats regarding the absence of explicit acceptance criteria and detailed study parameters for each test:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test CategoryAcceptance Criteria (Implicit)Reported Device Performance
    Electrical Safety & EMCConformance to IEC 60601-1 and IEC 60601-1-2 standards."Test results demonstrate that the proposed device conforms to the below standards: IEC 60601-1 2005/(R)2012 and A1:2012. C1:2009/(R)2012 andA2:2010/(R)2012 (consolidated text); and IEC 60601-1-2 Third Edition: 2007-03."
    SoftwareDevice performs as intended, developed, tested, and verified according to FDA guidance and IEC 62304."Software verification and validation testing of the PNEUMOCLEAR™ demonstrates that the device performs as intended. It was developed, tested and verified in accordance with the above FDA guidance document and in accordance with the following standard: IEC 62304 First Edition 2006-05."
    BiocompatibilityConformance to AAMI/ANSI/ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 standards for insufflation tube sets."Biocompatibility testing was performed on the insufflation tube sets of the proposed device PNEOMOCLEAR™ in accordance with: AAMI/ANSI/ISO 10993-1 Fourth Edition 2009-10-15; ISO 10993-5: 2009 (R) 2014; ISO 10993-10 Third Edition 2010-08-01; and ISO 10993-11 Second Edition 2006-08-15."
    Sterilization & PackagingETO sterilization validation per ISO 11135-1, ISO 14937, ISO 10993-7, AAMI TIR 28. Residual EO
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