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510(k) Data Aggregation

    K Number
    K141070
    Device Name
    SUPER SHEATH
    Manufacturer
    TOGO MEDIKIT CO., LTD.
    Date Cleared
    2015-01-15

    (265 days)

    Product Code
    DRE,DYB
    Regulation Number
    870.1310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    k052557,k121504
    Predicate For
    K200379
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

    Device Description

    Major components of the SUPER SHEATH (PROPOSED) are a sheath and a dilator. In addition, a guidewire is covered under this premarket notification. The guidewire is placed in the gudiewire case including inserter. The sheath for the SUPER SHEATH (PROPOSED) is named as the SUPER SHEATH (PROPOSED) Introducer Sheath and is available in 4F- 9F diameters and in lengths ranging from 7 to 25 cm. Some types of sheaths have radiopaque markers. The SUPER SHEATH (PROPOSED) are provided sterile and are intended for one procedure use only. The one-piece construction of the sheath shaft and hub allows smooth passage of concomitantly interventional medical devices. The sheath shaft and hub are made of Ethylene Tetrafluoro ethylene (ETFE) and polyamide. The hubs, color-coded by French size, contain a hemostatic valve to minimize 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. Some types of sheaths contain a marker band that is embedded in the shaft approximately 2.0 mm from the distal tip. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The dilator is inserted into the introducer sheath. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator facilitates and supports the entry of the sheath into the patient's vasculature. Once the sheath is in place the dilator is removed. There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. The 4F dilators are only available with a 0.035" guidewire lumen dilator. The 5-9F dilators are available with a 0.035" or 0.038" guidewire lumen. The 4bes are made from Polypropylene (PP). The 9F dilator tubes are made of Fluorinated Ethylene Propylene (FEP). The dilator tubes are attached to the inner hub with a metal bush. The sheath hub and the dilator hub lock using a rotating motion. The SUPER SHEATH (PROPOSED) has a polypropylene suture wing which is color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures. The uncoated guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The guidewire, with inserter, is available in 45 cm and 80 cm lengths. The inserter is used strictly for guiding the guidewire into a cannula or introducer.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "SUPER SHEATH (PROPOSED)," a catheter introducer. The submission aims to establish substantial equivalence to previously marketed predicate devices, "SUPER SHEATH (K052557)" and "3.3F SUPER SHEATH (K121504)."

    The acceptance criteria are not explicitly stated as numerical performance targets (e.g., "sensitivity of 90%"). Instead, the acceptance criteria are implicitly met by demonstrating that the "SUPER SHEATH (PROPOSED)" device is substantially equivalent to its predicate devices through various bench tests and biocompatibility testing. The study's goal was to ensure the proposed device's safety and effectiveness amidst material changes to the sheath shaft and packaging modifications.

    1. Table of acceptance criteria and the reported device performance:

    Since specific numerical acceptance criteria (e.g., target tensile strength, specific kink resistance values) are not provided in the document, the table below lists the types of tests performed and the general findings as the "reported device performance." The acceptance criteria, in this context, were that the proposed device would perform comparably to its predicate device or meet international/in-house requirements without raising new safety or effectiveness concerns.

    Test CategorySpecific Bench Test TypeImplicit Acceptance Criteria (based on predicate equivalence/safety)Reported Device Performance
    Mechanical Performance (Sheath)Sheath Shaft Tensile TestThe sheath shaft must maintain sufficient tensile strength to prevent breakage during use and be comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Sheath Kink TestThe sheath must resist kinking to ensure proper device insertion and functionality, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Sheath Hub to Shaft Tensile TestThe connection between the sheath hub and shaft must be strong enough to withstand forces during use, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Valve Integrity of SheathThe hemostatic valve must effectively minimize blood leakage during a procedure, performing comparably to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Sheath Lubricity TestThe sheath must exhibit adequate lubricity for smooth insertion and removal, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Sheath Radiopacity TestThe sheath should be sufficiently radiopaque for visualization under fluoroscopy, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Cover Tube Durability TestThe cover tube must be durable enough for its intended purpose.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Hemostatic Valve Integrity/Sheath Pressure TestThe hemostatic valve and sheath must withstand internal pressure and maintain integrity.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Sheath/Dilator Corrosion Resistance TestNo significant corrosion should occur that could compromise functionality or patient safety, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Mechanical Performance (Dilator)Dilator Shaft Tensile TestThe dilator shaft must possess adequate tensile strength, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Dilator Hub to Shaft Tensile TestThe connection between the dilator hub and shaft must be strong enough to withstand forces during use, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Mechanical Performance (Guidewire)Guidewire Tensile TestThe guidewire must exhibit sufficient tensile strength to prevent breakage during manipulation, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Guidewire Combined Load TestThe guidewire must perform reliably under combined loads experienced during procedures, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Guidewire Torqueability TestThe guidewire must have acceptable torqueability for precise positioning, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Guidewire Radiopacity TestThe guidewire should be sufficiently radiopaque for visualization under fluoroscopy, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    Guidewire Corrosion Resistance TestNo significant corrosion should occur that could compromise functionality or patient safety, comparable to the predicate device.Bench testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).
    BiocompatibilityCytotoxicityNo unacceptable cytotoxic effects should be observed.No biocompatibility concern was raised in the biocompatibility testing reports.
    Intracutaneous ReactivityNo unacceptable intracutaneous reactivity should be observed.No biocompatibility concern was raised in the biocompatibility testing reports.
    SensitizationNo unacceptable sensitization (allergic reaction) should be observed.No biocompatibility concern was raised in the biocompatibility testing reports.
    Acute Systemic ToxicityNo unacceptable acute systemic toxic effects should be observed.No biocompatibility concern was raised in the biocompatibility testing reports.
    HemocompatibilityThe device should not cause adverse blood-material interactions (e.g., hemolysis, thrombosis).No biocompatibility concern was raised in the biocompatibility testing reports.
    Pyrogen TestThe device should be non-pyrogenic to prevent fever reactions.No biocompatibility concern was raised in the biocompatibility testing reports.
    LAL Test (Endotoxin)Limits for endotoxins must be met.No biocompatibility concern was raised in the biocompatibility testing reports.
    Sterilization & PackagingPackaging Integrity TestThe packaging must maintain a sterile barrier throughout the shelf-life.Packaging integrity test and sterility test demonstrates the packaging works as a sterile barrier for the SUPER SHEATH (PROPOSED) and is substantial equivalent to the packaging of the 3.3F SUPER SHEATH (K121504).
    Sterility TestThe device must remain sterile until opened for use and meet requirements for ethylene oxide sterilization.Packaging integrity test and sterility test demonstrates the packaging works as a sterile barrier for the SUPER SHEATH (PROPOSED) and is substantial equivalent to the packaging of the 3.3F SUPER SHEATH (K121504).
    Shelf-Life TestingThe device components and sterile barrier must remain stable and functional for the stated shelf-life (2 years for the proposed device), comparable to the predicate devices (3 years for predicates, although proposed is 2 years, this difference in shelf-life is not highlighted as a concern).Bench testing including shelf-life testing demonstrated that the performance of the main body of the SUPER SHEATH (PROPOSED) was comparable to that of the SUPER SHEATH (K052557).

    Regarding the study proving the device meets the acceptance criteria:

    The study described is a series of bench tests and biocompatibility tests designed to demonstrate that the "SUPER SHEATH (PROPOSED)" is substantially equivalent to its predicate devices, despite a material change in the sheath shaft and changes in packaging.

    • 2. Sample size used for the test set and the data provenance:

      • Sample Size: The document does not specify the exact number of devices or samples used for each bench test or biocompatibility test. It simply states that "bench testing" and "biocompatibility testing" were performed.
      • Data Provenance: The tests were conducted by TOGO MEDIKIT CO., LTD., a Japanese company. The data would therefore originate from their internal testing processes. The document does not specify if the tests were retrospective or prospective, but typically such verification tests are performed prospectively on newly manufactured devices or components.

    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This question is not applicable to this type of submission. This premarket notification is for a physical medical device (catheter introducer) and its performance is evaluated through objective physical and chemical testing (bench tests, biocompatibility tests). There is no "ground truth" established by human experts in the way that an AI diagnostic device would require (e.g., radiologist consensus on images). The "ground truth" for these tests are objective measurements against established engineering standards or comparative performance against predicate devices.

    • 4. Adjudication method for the test set:

      • This question is not applicable for the reasons stated above. There is no human interpretation or adjudication of "cases" as would be seen in an AI study. The results of the physical and chemical tests are objectively measured.

    • 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:

      • This question is not applicable. This is not an AI/software device that involves human interpretation of diagnostic data. It is a physical medical device.

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

      • This question is not applicable. This is not an AI/software device. The performance is of the physical device components.

    • 7. The type of ground truth used:

      • The "ground truth" in this context refers to the objective performance criteria derived from engineering specifications, international standards, and the established performance of the predicate devices. For biocompatibility, the ground truth is the absence of adverse biological reactions/toxicity as defined by ISO standards for biocompatibility.

    • 8. The sample size for the training set:

      • This question is not applicable. This submission does not involve an AI algorithm; therefore, there is no "training set." The device is a physical product.

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

      • This question is not applicable. As there is no AI algorithm, there is no training set or associated ground truth.
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