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    K Number
    K182408
    Device Name
    Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2019-05-15

    (253 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K092309,K171158
    Why did this record match?
    Device Name :

    Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645

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

    KD-625
    These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
    These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

    KD-645
    This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using highfrequency current within the digestive tract.
    This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.

    Device Description

    These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
    This system consists of the electrosurgical knives (subject devices), flushing pump, and water tubes (accessories). The subject devices are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. They will be marketed as sterilized (ETO) devices for single use.

    AI/ML Overview

    This document describes the premarket notification for the Olympus Single Use Electrosurgical Knives KD-625 and KD-645. It does not contain information about an AI/ML device. Therefore, I cannot provide details on acceptance criteria and study designs related to an AI/ML device from this document.

    However, I can extract the general performance data and acceptance criteria mentioned for these electrosurgical knives:

    1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML Device):

    Performance Test CategoryAcceptance Criteria / StandardReported Device Performance
    Sterilization/Shelf-lifeFDA's Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile" & ASTM F1980-16 for accelerated aging.Sterilization/shelf-life testing was conducted in accordance with the specified FDA guidance and ASTM F1980-16. Accelerated aging tests were completed. Real-time aging tests for three years will be performed to further support stability.
    BiocompatibilityFDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'."Biocompatibility testing included: Cytotoxicity Study (Colony Assay), Intracutaneous Study (Rabbits), Guinea Pig Maximization Sensitization Test, Systemic Toxicity Study (Mice), and USP Rabbit Pyrogen Study (Material Mediated). These tests were conducted in accordance with ISO 10993-1.
    Electrical Safety & EMCAAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Safety) & IEC 60601-2-18:2009 (Safety) & IEC 60601-1-2 Edition 3: 2007 (EMC).The device system complies with the specified AAMI/ANSI and IEC standards for electrical safety and electromagnetic compatibility.
    Performance Testing (Bench)Established in-house acceptance criteria based on design requirements and risk analysis (ISO 14971:2007).Bench testing was conducted to ensure the device performs as intended and meets design specifications. This included: Evaluation Test for Performance to Cut Digestive Tract Mucosa, Evaluation Test for Lifting of Digestive Tract Mucosa, Histopathological Evaluation Test of Thermal Damage on Digestive Tract, and Evaluation Test for safety against perforation by saline feeding function. All tests assessed according to design requirements.
    Risk AnalysisEstablished in-house acceptance criteria based on ISO 14971:2007.Risk analysis was conducted, and the design verification tests and acceptance criteria were identified and performed as a result of this assessment.

    Since this document is for a traditional electrosurgical knife and not an AI/ML device, the following points are not applicable or cannot be extracted from the provided text:

    1. Sample size used for the test set and the data provenance: Not applicable for this type of device.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models typically involves expert annotation of data.
    3. Adjudication method: Not applicable.
    4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for an electrosurgical tool, not an interpretive diagnostic aid.
    5. Standalone (algorithm only without human-in-the loop performance) performance: Not applicable.
    6. Type of ground truth used: Not applicable for an AI/ML device; for this device, ground truth established by physical and functional testing.
    7. Sample size for the training set: Not applicable (no AI/ML model for training).
    8. How the ground truth for the training set was established: Not applicable.
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