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510(k) Data Aggregation
K Number
K210138Device Name
iTind System
Manufacturer
Date Cleared
2021-06-25
(157 days)
Regulation Number
876.5510Why did this record match?
Applicant Name (Manufacturer) :
Medi-Tate Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 is a prescription temporary implantable transprostatic tissue retractor system and consists of the iTind System and a Retrieval Kit. The iTind System consists of an implant and a delivery system. The iTind implant is pre-mounted on a dedicated guide wire. The iTind implant is made of nitinol super elastic shape memory alloy (SMA), and biocompatible material widely used in the manufacture of medical devices. When in its folded configuration, the device is inserted through a sheath and deployed within the bladder neck and prostatic urethra where it assumes its expanded configuration at a maximum diameter of 33 mm and a length of 50 mm. When in expanded configuration, the struts of the iTind implant exert radial force outwardly on the bladder neck and prostatic urethra to push 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. The iTind implant is left in position for 5–7 days. The device is subsequently removed using a sheath. The deployment and removal of the iTind implant should follow the Instructions For Use supplied by Medi-Tate and should only be attempted after the operator has been appropriately trained. The device is compatible with commercially available cystoscopes at least 19Fr in diameter.
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K Number
DEN190020Device Name
iTind System
Manufacturer
Date Cleared
2020-02-25
(329 days)
Product Code
Regulation Number
876.5510Why did this record match?
Applicant Name (Manufacturer) :
Medi-Tate Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
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