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510(k) Data Aggregation

    K Number
    K060721
    Device Name
    LARIAT LOOP APPLICATOR
    Manufacturer
    SENTREHEART
    Date Cleared
    2006-06-02

    (77 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K021019,K963329,K022410,K993695
    Why did this record match?
    Device Name :

    LARIAT LOOP APPLICATOR

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

    The LARIAT Loop Applicator facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.

    Device Description

    The LARIAT Loop Applicator is a one piece, single-use suture delivery and deployment device with a pre-tied polyester suture loop that is pre-loaded on the device. A central lumen within the LARIAT Loop Applicator is designed for aspiration and stabilization of tissue during the delivery of the LARIAT Suture Loop.

    AI/ML Overview

    The provided 510(k) notification describes a medical device, the LARIAT Loop Applicator, and its intended use. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets particular acceptance criteria in the manner typically associated with studies for AI/ML devices or diagnostic tools.

    Instead, this 510(k) focuses on demonstrating substantial equivalence to predicate devices, primarily through in-vitro testing and assessment of biocompatibility. The information provided is characteristic of a medical device submission that relies on established safety and effectiveness profiles of already cleared devices and materials.

    Given this, I cannot fully complete all sections of your request as they are not explicitly addressed in the provided text. I will fill in what is available and indicate where information is missing.

    Here's the breakdown based on the provided text:

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

    Acceptance Criteria (Implied)Reported Device Performance
    Safe and Effective for Intended Use"Results of in-vitro testing demonstrate that the LARIAT Loop Applicator is safe and effective for its intended use." (Based on comparison to predicate devices and material biocompatibility.)
    Biocompatible"Biocompatibility testing determined the LARIAT Loop Applicator components and materials to be biocompatible. The materials are used in the identified predicates and are also commonly used in other medical devices."
    Substantial Equivalence to Predicate Devices (Ethicon Endosuture System K963329, Genzyme Saph-Loop Ligating Lopic K022410, HysteRx Liga-Loop Suture Applicator K993695)"Based on the intended use, product, performance and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices."

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

    • Sample Size: Not specified for in-vitro testing.
    • Data Provenance: Not specified, but generally, in-vitro testing for 510(k) submissions would be conducted in a controlled lab setting, likely within the US where the applicant is located.
    • Retrospective/Prospective: Neither. The testing mentioned is in-vitro performance and biocompatibility testing, not clinical data collection.

    3. 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)

    Not applicable. This device is a surgical applicator, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for its performance would be its mechanical functionality (e.g., suture delivery, knot tying) and material safety, evaluated through engineering and biocompatibility testing.

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

    Not applicable. This type of adjudication method is relevant for studies involving human interpretation or clinical endpoints, not for the in-vitro performance and biocompatibility testing described.

    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

    Not applicable. This device is a surgical tool, not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies and AI improvement effect sizes are not relevant to this submission.

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

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

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

    The "ground truth" implicitly used for this device involves:

    • Engineering specifications and functional requirements for safe suture delivery and deployment.
    • Biocompatibility standards and established safety profiles for the materials used and similar predicate devices.
    • The effectiveness of the predicate devices in their intended uses.

    8. The sample size for the training set

    Not applicable. This device is not an AI/ML algorithm that requires a training set.

    9. How the ground truth for the training set was established

    Not applicable.

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