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    K Number
    K021571
    Device Name
    TRANSONIC FLOW-QC SET MODEL ADT1010
    Manufacturer
    TRANSONIC SYSTEMS, INC.
    Date Cleared
    2002-08-12

    (90 days)

    Product Code
    MQS
    Regulation Number
    876.5820
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K002816
    Why did this record match?
    Device Name :

    TRANSONIC FLOW-QC SET MODEL ADT1010

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

    The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HD01 System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.

    Device Description

    In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Flow-QC® Sets which are Hemodialysis extension sets for connection into standard Hemodialysis circuits. These sets provide tubing segments of consistent material and wall thickness to which our HD01 Hemodialysis system can be calibrated. They also provide an injection port for making cardiac output measurements with the HD01 system.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Transonic Flow-QC® Sets, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a medical device with an algorithm.

    Therefore, the information requested regarding acceptance criteria, device performance, study characteristics (sample sizes, ground truth, experts, adjudication), and multi-reader multi-case (MRMC) or standalone studies is not explicitly available in the provided document. This document emphasizes material testing, compliance with standards, and comparison to a predicate device, which is a common approach for certain classes of medical devices.

    Here's a breakdown based on the provided text, indicating where information is missing:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Physical Testing (as defined by Quality Control Test Procedure documents ensuring conformance to product design specifications)All finished products are tested and must meet all required release specifications before distribution. These tests are established to ensure the product's performance parameters conform to the product design specifications.
    Visual Examination (in-process and finished product)All finished products are tested and must meet all required release specifications before distribution.
    Material Compliance (ISO Standard 10993)The Transonic Flow-QC® Sets are made of materials which have been tested in accordance with the ISO Standard 10993 and therefore suitable for the intended use of this product.
    Design and Production Standard Compliance (ANSI/AAMI RD17-1994)The ANSI/AAMI standard "American National Standard for Hemodialyzer Blood Tubing" RD17-1994 was followed for the design and will continue to be followed for the production and quality assurance testing of this device.

    Study Details

    Below is a response to each specific point, indicating that the information is not present in the provided 510(k) summary for the Transonic Flow-QC® Sets. This type of 510(k) submission, particularly for accessories, often relies on material compliance and comparison to a predicate rather than extensive clinical performance studies as would be seen for a diagnostic algorithm.

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

      • Information Not Provided. The document describes manufacturing quality control and material testing, not a clinical performance study with a "test set" in the context of an algorithm.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

      • Information Not Provided. No "ground truth" establishment by experts is mentioned, as this is not a diagnostic device or an algorithm requiring such validation.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Information Not Provided. No adjudication method is mentioned, as there is no "test set" in the context of a diagnostic performance study.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Information Not Provided. No MRMC study was performed or is relevant, as this device is a hemodialysis accessory, not an AI-assisted diagnostic tool.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Information Not Provided. This device does not involve an algorithm, hence no standalone performance study was conducted or is applicable.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • Information Not Provided. "Ground truth" in the context of diagnostic accuracy is not addressed. The "truth" for this device relates to manufacturing specifications and material compliance.

    7. The sample size for the training set:

      • Information Not Provided. There is no "training set" as this device does not involve machine learning or an algorithm.

    8. How the ground truth for the training set was established:

      • Information Not Provided. Not applicable, as there is no training set.
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