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    K Number
    K993695
    Device Name
    LIGA-LOOP SUTURE APPLICATOR
    Manufacturer
    HYSTERX, INC.
    Date Cleared
    2000-04-13

    (163 days)

    Product Code
    GAL,GAM,GAP,GEA
    Regulation Number
    878.4830
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K950126
    Why did this record match?
    Device Name :

    LIGA-LOOP SUTURE APPLICATOR

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

    The LIGA-LOOP Suture Applicator is intended for use in the suturing of soft tissue and ligation of blood vessels during open and guidance-assisted surgical procedures. The LIGA-LOOP Suture Applicator with polyglycolic acid (PGA) suture and the LIGA-LOOP Suture Applicator with gut suture (plain and chromic) are intended for the same use, excluding cardiovascular and neurological procedures.

    Device Description

    The LIGA-LOOP™ Suture Applicator is an instrument designed for ligation of soft tissue and blood vessels during surgical procedures. The device also incorporates a central lumen for use in irrigation and/or imaging to increase patient safety during suturing. The LIGA-LOOP™ Suture Applicator contains similar materials, is of similar design, and has the same operating principle as the predicate devices.

    AI/ML Overview

    The provided document describes the LIGA-LOOP™ Suture Applicator, a surgical instrument designed for ligation of soft tissue and blood vessels. The summary of safety and effectiveness mainly focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific acceptance criteria and performance data from a standalone study.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document does not explicitly state quantitative acceptance criteria for the LIGA-LOOP™ Suture Applicator or specific performance metrics against those criteria. Instead, it focuses on qualitative comparisons to predicate devices and general statements about "reliable performance."

    Acceptance Criteria (Explicitly Stated)Reported Device Performance
    Not explicitly stated in quantitative terms. The primary acceptance criterion was likely demonstrating substantial equivalence to predicate devices in terms of intended use, operating principle, and material characteristics, and ensuring no new safety or performance issues."Test results indicate reliable performance when the device is used in accordance with the Instructions for Use. Manipulation of the suture material does not affect suture diameter or knot pull-strength. The LIGA-LOOP™ Suture Applicator does not raise any new safety, effectiveness, or performance issues." (This is a general statement, not quantitative performance against a specific criterion).
    Knot pull strength of suture material"Manipulation of the suture material does not affect... knot pull-strength." (Implies meeting an unstated threshold relative to the predicate or industry standards).
    Suture diameter"Manipulation of the suture material does not affect suture diameter..." (Implies meeting an unstated threshold relative to the predicate or industry standards).

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

    The document does not specify the sample size used for the tests performed on the LIGA-LOOP™ Suture Applicator.
    The data provenance is not mentioned, but given the nature of the device (surgical instrument), the tests would have been conducted in a laboratory or simulated environment, likely in the US, as the applicant is a US company. The tests are non-clinical.

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

    Not applicable. The tests described are "Knot pull strength testing and diameter measurements of suture materials," which are objective physical measurements rather than assessments requiring expert judgment for ground truth establishment.

    4. Adjudication Method for the Test Set:

    Not applicable. As noted above, the tests involved objective physical measurements, not subjective evaluations requiring adjudication.

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

    No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve such a study.

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

    Not applicable. The device is a physical surgical instrument, not an algorithm.

    7. The Type of Ground Truth Used:

    The ground truth for the tests (knot pull strength and suture diameter) would be the objective measurements obtained from standardized testing methods.

    8. The Sample Size for the Training Set:

    Not applicable. The LIGA-LOOP™ Suture Applicator is a physical medical device, not an AI/machine learning model, so there is no training set in this context.

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

    Not applicable, for the same reason as point 8.

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