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    K Number
    K121504
    Device Name
    SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
    Manufacturer
    TOGO MEDIKIT CO., LTD.
    Date Cleared
    2012-09-27

    (129 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K060190,K052557
    Why did this record match?
    Reference Devices :

    K060190

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

    The Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets are indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature of adult and pediatric patients of all ages.

    Device Description

    The Super Sheath Introducer Sheaths and Super Sheath Sets are similar to the 4F-9F with the addition of the 3.3 French sheath, compatible dilator and guidewire to the sheath line. The Super Sheath Introducer Sheath is available in 3.3F and lengths of 5 cm and 7 cm. The device is provided sterile and intended for one procedure use only.

    The Super Sheath Introducer Sheath is packaged with one dilator. The Super Sheath Introducer Sheath Set consists of one sheath, one dilator, and one guidewire with inserter. The sheath shaft and hub are manufactured of polyamide and ethylene tetrafluoro ethylene; one-piece construction of the sheath shaft and hub allows smooth passage of medical devices. The hub, color-coded by French size, contains a hemostatic valve to prevent blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling.

    The dilator is an open, tapered plastic tube with an integral luer hub for guidewire insertion. The guidewire is inserted into the introducer sheath to facilitate and support entry of the sheath into the patient's vasculature. The dilator is longer than the sheath with a rounded tapered distal tip. The 3.3F Super Sheath Introducer Sheaths and provided dilator are compatible with a maximum recommended 0.025" guidewire. The dilator tubes are manufactured of polypropylene. Dilator tubes are press-fit into the dilator hub with a bushing. The sheath hub and dilator hub lock using a rotating motion.

    AI/ML Overview

    The provided text describes a medical device (Super Sheath Introducer Sheaths and Sets) and its equivalence to a predicate device, rather than the acceptance criteria and study results for a new AI or diagnostic device. As such, most of the requested information (sample sizes, expert qualifications, MRMC studies, ground truth types, training data, etc.) is not applicable or present in this document.

    However, I can extract the information related to the functional testing conducted to establish the performance of this medical device.

    Acceptance Criteria and Device Performance (Functional Testing)

    The document states that "Functional testing was conducted to verify the 3.3F Super Sheath Introducer Sheaths and Super Sheath Introducer Sheath Sets met product specification." While specific numerical acceptance criteria are not provided, the types of tests performed indicate the performance characteristics that were evaluated and met.

    Acceptance Criteria (Implied)Reported Device Performance
    Sheath Shaft Tensile Strength: Must withstand tensile forces.Met product specification through testing.
    Sheath Kink Resistance: Must resist kinking during use.Met product specification through testing.
    Connection Strength: Connections must be secure.Met product specification through testing.
    Hemostatic Valve Pressure Integrity: Valve must prevent blood leakage under pressure.Met product specification through testing.
    Sheath Valve Integrity / Sheath Pressure: Valve and sheath must maintain integrity under pressure.Met product specification through testing.
    Sheath Lubricity: Sheath must allow smooth passage.Met product specification through testing.
    Sheath Radiopacity: Sheath must be visible under fluoroscopy.
    (Note: Predicate had a marker, new device states "Not applicable" for marker. This implies the sheath material itself might be radiopaque or it's not a P.criterion for the 3.3F based on its intended use/size.)Met product specification through testing.
    Sheath / Dilator Corrosion Resistance: Must resist corrosion.Met product specification through testing.
    Dilator Tensile Strength: Dilator must withstand tensile forces.Met product specification through testing.
    Dilator Connection Strength: Dilator connections must be secure.Met product specification through testing.
    Guidewire Tensile Strength: Guidewire must withstand tensile forces.Met product specification through testing.
    Guidewire Radiopacity: Guidewire must be visible under fluoroscopy.Met product specification through testing.
    Guidewire Corrosion Resistance: Guidewire must resist corrosion.Met product specification through testing.
    Guidewire Torque Load: Guidewire must withstand torque.Met product specification through testing.
    Guidewire Torqueability: Guidewire must be steerable/torqueable.Met product specification through testing.
    Sterilization Efficacy: Device must be sterile.Validated in accordance with ISO 11135-1:2007.
    Biocompatibility: Device materials must be biocompatible.Demonstrated by similarity to predicate in K052557.
    Packaging Integrity: Packaging must maintain sterility and product integrity.Demonstrated by similarity to predicate in K052557.
    Product Shelf Life: Device must maintain performance over time.Demonstrated by similarity to predicate in K052557 (3 years).

    Study Details (for a medical device, not AI)

    1. Sample size used for the test set and the data provenance: Not explicitly stated. The testing was functional/engineering testing of the device itself, not patient data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, functional tests performed according to protocols. "Ground truth" in this context would refer to engineering specifications and international standards, not expert medical opinion.
    3. Adjudication method for the test set: Not applicable. Results would be compared against established product specifications and standards.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.
    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, not applicable.
    6. The type of ground truth used: Product Specifications, International Standards (e.g., ISO 11135-1:2007 for sterilization), and in-house requirements.
    7. The sample size for the training set: Not applicable. This document describes the testing of a physical medical device, not a machine learning model.
    8. How the ground truth for the training set was established: Not applicable.
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