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510(k) Data Aggregation

    K Number
    DEN190020
    Device Name
    iTind System
    Manufacturer
    Medi-Tate Ltd.
    Date Cleared
    2020-02-25

    (329 days)

    Product Code
    QKA
    Regulation Number
    876.5510
    Type
    Direct
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    DEN130023
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    DEN130023

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

    The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

    Device Description

    The iTind System consists of the iTind implant, delivery system, and retrieval kit. The iTind implant is made of nitinol and pre-mounted on a dedicated guide wire. In its folded configuration, the implant is inserted through a cystoscope sheath and deployed within the bladder neck and prostatic urethra where it assumes its expanded configuration. When expanded, the struts of the implant exert radial force on the bladder neck and prostatic urethra, pushing obstructive tissue away from the urinary path. The implant is designed to cover the entire length of the prostatic urethra, from the bladder neck to a point proximal to the external urinary sphincter. It is left in position for 5-7 days and subsequently removed using a Foley catheter. The delivery system is used to advance the iTind implant into the bladder through a standard cystoscope. The retrieval kit (snare) is used to remove the iTind implant by inserting it through a Foley catheter and tying the retrieval suture to the snare loop.

    AI/ML Overview

    Here's a breakdown of the iTind System's acceptance criteria and the supporting studies, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceStudy Proving Acceptance
    Effectiveness (Clinical)Primary Co-Endpoint 1: IPSS score difference between iTind and Sham groups at 3 months: Statistically significant improvement for iTind.Failed to meet: -10.6 IPSS change for iTind vs. -8.3 for Sham. Difference of 2.5 (95% CI: -0.5 to 5.6), p=0.104. 79% of iTind patients were responders (>3-point reduction) vs. 60% in Sham. Not statistically significant.MT-03 Study
    Effectiveness (Clinical)Primary Co-Endpoint 2: Change in IPSS Score at 12 months compared to baseline for the iTind group: Statistically significant improvement.Met: -8.7 IPSS change from baseline at 12 months (95% CI: -10.6 to -6.9), p 1.0 N in crimping diameter of 5mm to 11mm after crimping/expanding cycles.Met: All 30 systems met the acceptance criterion.
    Functional Performance (Bench)Tensile Force at Break: Withstand 2.5 times forces encountered during insertion/retrieval without failure.Met: All 30 systems met the acceptance criterion.Nonclinical/Bench Studies (Tensile Force at Break section)
    Functional Performance (Bench)Deployment: Correct deployment, removal, and positioning through anatomical model.Met: All 30 systems met the visual inspection criterion.Nonclinical/Bench Studies (Deployment section)
    Functional Performance (Bench)iTind Implant Dimensions: Complies with predefined criterion (difference in dimensions before and after crimping
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