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    K Number
    K240164
    Device Name
    NovaLine SP-C35 Transducer Protector (956007)
    Manufacturer
    Bain Medical Equipment (Guangzhou) Co., Ltd.
    Date Cleared
    2024-06-28

    (158 days)

    Product Code
    FIB
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K072988
    Why did this record match?
    Device Name :

    NovaLine SP-C35 Transducer Protector (956007)

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

    The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

    Device Description

    The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.

    The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

    The devices are packaged sterile and labeled for single use only.

    The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the NovaLine SP-C35 Transducer Protector based on the provided FDA 510(k) summary.

    Note: This document describes a medical device, not an AI or software-based medical device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.

    1. Table of Acceptance Criteria and Reported Device Performance

    Device: NovaLine SP-C35 Transducer Protector

    Acceptance Criteria CategorySpecific Test / CharacteristicAcceptance Criteria (Target)Reported Device Performance (Result)Relevant Standard (if applicable)
    Physical PerformanceAppearanceComplies with specificationsComplies with specifications---
    Structural IntegrityMaintainedMaintained---
    DimensionComplies with standardComplies with standardISO 80369-7:2021
    SterilitySAL of 10^-6Achieved SAL of 10^-6---
    Positive Pressure Limitation500 mmHg500 mmHg (matches predicate)---
    Negative Pressure Limitation-500 mmHg-500 mmHg (matches predicate)---
    Connections ConformanceConforms to standardConforms to standardISO 80369-7:2016
    BiocompatibilityCytotoxicityNon-toxicComplies with ISO 10993-5ISO 10993-5
    SensitizationNon-sensitizingComplies with ISO 10993-10ISO 10993-10
    Irritation/Intradermal ReactivityNon-irritatingComplies with ISO 10993-23ISO 10993-23
    Systemic Toxicity/Acute Systemic ToxicityNon-toxicComplies with ISO 10993-11ISO 10993-11
    Pyrogens/Material-mediated PyrogensNon-pyrogenicComplies with ISO 10993-11ISO 10993-11
    In Vitro HemolysisNon-hemolyticComplies with ISO 10993-4ISO 10993-4
    Complement ActivityNo adverse complement activityComplies with ISO 10993-4ISO 10993-4
    Partial Thromboplastin TimeNo adverse effectComplies with ISO 10993-4ISO 10993-4
    Platelet CountNo adverse effectComplies with ISO 10993-4ISO 10993-4
    HematologyNo adverse effectComplies with ISO 10993-4ISO 10993-4
    SterilizationSterility Assurance LevelSAL of 10^-6Achieved SAL of 10^-6---
    PackagingSeal StrengthComplies with standardComplies with standardASTM F88/F88-15
    Dye PenetrationComplies with standardComplies with standardASTM F1929-15
    Shelf LifePackaging Performance (aged samples)Complies with acceptance criteriaComplies with acceptance criteriaISO 80369-7 (for connections)
    Performance Tests (aged samples)Complies with acceptance criteriaComplies with acceptance criteria---
    MicrobiologicalBacterial Endotoxin
    Microbial ChallengeSterile Barrier IntegrityMaintains sterile barrierComplies with standardsASTM F1671/F1671M-2022, YYT1497-2016, ASTM F838-2020
    Distribution SimulationWithstands distribution stressesComplies with standardComplies with standardASTM D4169-22
    Comparative PerformanceOverall performance vs. predicateEquivalentEquivalent to predicate device---

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

    The document does not specify exact sample sizes for each test within the finished product performance, packaging, or shelf-life evaluations. It mentions "proposed devices" were tested, implying a statistical sample was used according to the relevant standards, but the specific number is not provided.

    Data Provenance: The tests were conducted by Bain Medical Equipment (Guangzhou) Co., Ltd. in China. The data is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    Not Applicable. This is a medical device (transducer protector) and not an AI/software device. The "ground truth" here refers to the physical and biological properties of the device, established through standardized laboratory testing, not human expert interpretation of data.

    4. Adjudication Method for the Test Set

    Not Applicable. As this is not an AI/software device involving human interpretation, there is no adjudication method in the traditional sense. Device performance is determined by objective, measurable laboratory tests against pre-defined specifications and standards.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. An MRMC study is relevant for imaging or diagnostic AI, comparing human readers with and without AI assistance. This device is a component of a hemodialysis system, and its performance is assessed through physical, chemical, and biological testing.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Not Applicable. This device is hardware, not an algorithm or software.

    7. The Type of Ground Truth Used

    The "ground truth" for this device's performance is established by:

    • Standardized Test Results: Objective measurements from various laboratory tests (e.g., dimensional measurements, sterile barrier integrity, biocompatibility assays).
    • Compliance with Recognized Standards: Adherence to international and national standards such as ISO 80369-7, ISO 10993 series, ASTM F88, ASTM F1929, ASTM D4169, USP , ASTM F1671, etc.
    • Predicate Device Equivalence: Direct comparison to the performance characteristics of a legally marketed predicate device (Nipro Transducer Protector TP-SURE, K072988) where applicable.

    8. The Sample Size for the Training Set

    Not Applicable. This is a physical medical device, not an AI/machine learning model, so there is no training set.

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

    Not Applicable. See response to #8.

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