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510(k) Data Aggregation

    K Number
    K221472
    Device Name
    Filter and HME/Filter
    Manufacturer
    Ningbo Huakun Medical Equipment Co., Ltd.
    Date Cleared
    2023-02-08

    (264 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Filter and HME/Filter

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K192713
    Device Name
    Altera Filter and HME/Filter
    Manufacturer
    Meditera Tibbi Malzeme San. ve Tic. A.S.
    Date Cleared
    2020-03-16

    (171 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K151498
    Why did this record match?
    Device Name :

    Altera Filter and HME/Filter

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

    Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours.

    HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours.

    Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home

    For patient with Tidal Volumes > 300 ml.

    Device Description

    The subject device is provided in two (2) configurations.

    • Filter only ●
    • . HME / Filter combination
    • The common features are:
      • Standard conical 15 mm / 22 mm fittings for connections
      • Female luer lock port for gas sampling for end-tidal CO2 ●
    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "Altera Filter and HME/Filter". It details the device's characteristics, indications for use, and a comparison with a predicate device, including performance data from nonclinical testing.

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

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

    Test Method (Attribute)Acceptance CriteriaReported Device Performance
    ISO 9360-1 (Resistance to Flow)Equivalent to a predicate76 kPa
    ISO 80369-7 Luer / ISO 5356-1 Conical (Connectors)Passes RequirementsMeets the Standards
    ASTM F2101 (Bacterial Filtration Efficiency - BFE)Equivalent to predicate>99.998%
    ASTM F2101 (Viral Filtration Efficiency - VFE)Equivalent to predicate>99.96%
    ISO 9360-1 (HME Performance - Moisture Output)Moisture Output equivalent to predicate39 mg/L (Vt = 1000 ml @ 24 hours)
    ISO 10993 and ISO 18562 (Cytotoxicity)Non-cytotoxicNon-cytotoxic
    ISO 10993 and ISO 18562 (Sensitization)Non-sensitizerNon-sensitizer
    ISO 10993 and ISO 18562 (Irritation)Non-irritantNon-irritant
    ISO 10993 and ISO 18562 (Chemical Characterization TRA)Margin of Safety > 1Margin of Safety > 1
    ISO 10993 and ISO 18562 (Acute Systemic Toxicity)Non-systemicNon-systemic
    ISO 10993 and ISO 18562 (Volatile Organic Compound)Identified VOCIdentified VOC
    ISO 10993 and ISO 18562 (Particulate Matter)
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