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510(k) Data Aggregation

    K Number
    K061679
    Device Name
    WALLACE ARTIFICIAL INSEMINATION CATHETER
    Manufacturer
    IRVINE SCIENTIFIC SALES CO., INC.
    Date Cleared
    2006-10-13

    (120 days)

    Product Code
    LKF,MQF
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K964848,K842231,K020951,K970492,K890869,K041094,K040238
    Predicate For
    K131491,K163318
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wallace SIS/AI Catheter is intended to be used in artificial insemination procedures intended for insertion of the catheter and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/Al Catheter is also intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection abnormalities within uterine cavities.

    Device Description

    The Wallace Artificial Insemination Catheter (K964848) is a single-use, sterile, disposable device that was originally submitted and cleared with the intended use for insertion of catheters and introduction of washed spermatozoa into the uterine cavity. The Wallace SIS/AI Catheter for the purpose of this submission is intended to be used in Saline Infusion Sonography (SIS), also known as Saline Infusion Sonohysterography (SIS) and Saline Ultrasound Infusion procedures in the detection of abnormalities within uterine cavities. The catheter is also intended to be used in artificial insemination (AI) procedures.

    The Catheter has two opposing smooth side eyes and a rounded smooth closed distal tip. It has an overall length of 18cm and consists of a flexible-end inner catheter and a detachable outer sheath attached to the inner catheter by a luer lock. The inner catheter is 16 gauge with a uniform lumen throughout its length. When the outer sheath luer is attached to the hub of the catheter, the inner catheter protrudes from the outer sheath by 5cm. The outer sheath has a series of 1cm graduations at the distal end, the graduations are used to assess the depth of the insertion.

    An inner tube with an outer sheath that covers 2/3 segments of the inner sheath with marks of the distance from the distal part of the catheter and a cover rigid protective tube.

    AI/ML Overview

    The provided documentation is a 510(k) summary for the Wallace SIS/AI Catheter. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than presenting a detailed study with specific acceptance criteria and detailed performance data on the device itself. Therefore, much of the requested information cannot be extracted directly from this document.

    However, I can extract the available information and highlight what is not present.

    Acceptance Criteria and Study Information for Wallace SIS/AI Catheter

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Material Equivalence: The new device should be materially similar to the predicate devices for its intended use.The device's material composition and design features (e.g., length, gauge, side eyes, rounded tip, graduations, flexible-end inner catheter, detachable outer sheath) are described and implicitly claimed to be equivalent to predicate devices.
    Technological Characteristics Equivalence: The technology of the device should be equivalent to predicate devices.The document states, "The proposed intended use of the Wallace Artificial Insemination and SIS Catheter is equivalent to the identified predicate devices." It highlights that similar catheters are "routinely used in Saline Infusion Sonography in diagnostic Obstetrics and Gynecological procedures."
    Intended Use Equivalence: The intended use should be equivalent to existing legally marketed predicate devices.The intended uses for both artificial insemination (introduction of washed spermatozoa) and Saline Infusion Sonography (detection of abnormalities within uterine cavities) are explicitly stated and compared to the intended uses of the listed predicate devices.
    Safety and Effectiveness: Implied to be safe and effective for its intended use based on substantial equivalence.The conclusion states: "The results from the field testing and evaluation of this product by the end-user demonstrate that the Wallace Artificial Insemination and SIS Catheter are suitable for their intended use." No specific safety or effectiveness metrics, such as complication rates or diagnostic accuracy rates, are provided in this summary.

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

    This information is not provided in the document. The document mentions "field testing and evaluation of this product by the end-user" but does not specify the sample size of patients or procedures, the design of the test, data provenance (e.g., country of origin), or whether it was retrospective or prospective.

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

    This information is not provided in the document. It mentions "evaluation by the end-user" but does not specify the number or qualifications of these end-users, nor how they established any ground truth.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. 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

    This information is not applicable/provided. The device is a physical catheter, not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be relevant.

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

    This information is not applicable/provided. The device is a physical catheter, not an AI algorithm.

    7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

    This information is not explicitly stated in the document. The "field testing and evaluation" implies clinical use and assessment by healthcare professionals (end-users), but the specific method of establishing ground truth (e.g., comparison to a gold standard like pathology or subsequent clinical outcomes) is not detailed.

    8. The Sample Size for the Training Set

    This information is not applicable/provided. As the device is a physical catheter and not an AI algorithm, there is no "training set" in the context of machine learning.

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

    This information is not applicable/provided. As the device is a physical catheter and not an AI algorithm, there is no "training set" or corresponding ground truth establishment in the context of machine learning.

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