LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K181608
    Device Name
    Disposable Standard Clamp
    Manufacturer
    Standard Bariatrics
    Date Cleared
    2018-09-27

    (100 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K170379
    Predicate For
    K190788
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.

    Device Description

    The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the "Standard Clamp, Disposable". This application asserts substantial equivalence to a predicate device, K170379, also named "Standard Clamp, Disposable". The core argument for substantial equivalence relies on the subject device having identical technological characteristics to the predicate and the performance data for the predicate device still being applicable.

    Here's an analysis of the provided information regarding acceptance criteria and the study:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state specific acceptance criteria in measurable terms (e.g., a specific percentage of reduction in staple cartridges, a maximum adverse event rate). Instead, it discusses the study's findings qualitatively.

    Acceptance Criteria (Explicitly stated in doc)Reported Device Performance (from study)
    Not explicitly stated as pass/fail criteria. The study aimed to evaluate the number of staple cartridges used and safety.Safety: "no significant difference in post-operative adverse event rate (9.5% vs. 5.6%, p = NS)" between Standard Clamp and no clamp group.
    Adverse Events (Standard Clamp group): No readmission or additional intervention required. One patient seen for syncope unrelated to procedure.
    Adverse Events (No Clamp group): One patient admitted for IV hydration due to persistent nausea/emesis.
    Serious Adverse Events (Both groups): "no occurrences of postoperative leak, bleeding, or stricture formation noted in either group."
    Effect on Staple Cartridges: The document states the study "evaluated the number of staple cartridges used" but does not report specific performance data or a comparison result regarding staple cartridge usage. It implicitly suggests the clamp's use is safe and guides staplers, but the direct outcome on cartridge quantity isn't quantified here.

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

    • Test Set Sample Size: 30 subjects
    • Data Provenance: Prospective, single-center, randomized controlled study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S. or internationally applicable clinical trial standards. The study was performed independently of Standard Bariatrics.

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

    • This information is not provided in the document. The study involves surgical procedures and post-operative follow-up, implying medical professionals were involved in assessing outcomes, but the specific number and qualifications of experts establishing ground truth (e.g., for adverse events) are not detailed.

    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

    • No, an MRMC comparative effectiveness study was not done. The study described is a clinical study comparing the use of the device (Standard Clamp) against a control (no clamp) in a surgical setting. It does not involve human readers interpreting data.

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

    • Not applicable. This device is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of standalone algorithm performance does not apply.

    7. The Type of Ground Truth Used

    • The ground truth used was clinical outcomes data (e.g., post-operative adverse event rates, readmissions, interventions, specific complications like leak, bleeding, stricture formation). This would have been established through direct clinical observation, patient records, and follow-up examinations by medical professionals.

    8. The Sample Size for the Training Set

    • Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. The performance testing relies on engineering bench tests and a clinical study.

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

    • Not applicable. As stated above, there is no training set for this type of device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1