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510(k) Data Aggregation

    K Number
    K170010
    Device Name
    Salle Intraoperative Pyeloplasty Stent Set
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2017-08-28

    (237 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K141344,K060673
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to establish and maintain nephrostomy and internal drainage following pyeloplasty for pediatic patients. This device is intended for patients 6 months and older.

    Device Description

    The Salle Intraoperative Pyeloplasty Stent is a single-lumen ureteral stent inserted following pyeloplasty in order to provide internal and external drainage. It is a prolonged indwelling device not to exceed 4 weeks in the body.

    The Salle Intraoperative Pyeloplasty Stent Set is comprised of a stent, wire guide, connecting tube, adaptor, and retention disc with pull tie. The Salle Intraoperative Pyeloplasty Stent is a double pigtail stent that advances from the renal pelvis to the bladder with a flexible extended portion that is brought out percutaneously through the kidney. The Salle stent is available in outer diameters of 4.0 or 4.7 French with working lengths of 12 to 18 cm. The stent's proximal pigtail forms in the renal pelvis, while the distal pigtail forms in the bladder. Drainage can occur internally (from the kidney to the bladder) or externally (from renal pelvis to the outside of the patient). The distal (bladder) pigtail coil is available in a multi-length stent configuration with drainage holes. The proximal (kidney) pigtail coil also contains sideports and ink marks to facilitate the visualization of accurate placement. The proximal end of the stent has an internal stylet which acts as a positioning stylet.

    The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

    Device: Salle Intraoperative Pyeloplasty Stent Set

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Biocompatibility Testing (Performed per ISO 10993-1)Not explicitly detailed as numerical criteria in the table, but the successful completion of the listed tests is the criterion.All listed tests successfully completed.
    - CytotoxicityPass
    - SensitizationPass
    - IntracutaneousPass
    - Acute Systemic ToxicityPass
    - Material-Mediated PyrogenicityPass
    - Implantation - 2 WeekPass
    - Implantation - 4 WeekPass
    - Subacute/Subchronic ToxicityPass
    - GenotoxicityPass
    - Toxicological Risk Assessment of Extractable ChemicalsPass
    Retention Strength and Break Strength Testing (Simulated use – Time Zero and post aging)Retention Strength: The minimum retention strength shall be greater than or equal to 0.03 N, but less than or equal to 3.9 N (90% coverage, 90% confidence).
    Break Strength: The minimum break strength shall be greater than 3.9 N (90% coverage, 90% confidence).All acceptance criteria were met. Pass
    Retention Strength and Break Strength Testing (Following a 30 Day Artificial urine Soak – Time Zero and post aging)Retention Strength: The minimum retention strength shall be greater than or equal to 0.03 N, but less than or equal to 3.9 N (90% coverage, 90% confidence).
    Break Strength: The minimum break strength shall be greater than 3.9 N (90% coverage, 90% confidence).All acceptance criteria were met. Pass
    Wire Guide Compatibility, Kink Radius, Flow Rate and Leakage Post Kinking TestingWire Guide Compatibility: The appropriate size wire guide shall pass through the inner lumen of each test article.
    Kink Radius: The kink radius of each test article shall be less than 30 mm based on worst-case analysis.
    Flow Rate and Leakage Post Kinking: Flow rate performed for characterization purposes only. If leakage detected, test article deemed a failure.All acceptance criteria were met. Pass
    Radiopacity Testing (Per ASTM F640-12)The Salle Stent is visible under fluoroscopy.
    Visibility of the Salle Stent is equal to or greater than the visibility of the user-defined standard.All acceptance criteria were met. Pass
    MR TestingMagnetically Induced Displacement Force: Deflection Angle
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