(329 days)
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.
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.
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 Category | Specific Criteria | Reported Device Performance | Study 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 |
§ 876.5510 Temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia.
(a)
Identification. A temporarily-placed urethral opening system for symptoms of benign prostatic hyperplasia (BPH) is a prescription use device that is inserted transurethrally and deployed at the prostate. The implant is designed to increase prostatic urethral patency by increasing prostatic opening. It is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing with the device under anticipated conditions of use must evaluate improvement in urinary outflow symptoms and document the adverse event profile.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Deployment and removal; and
(ii) Mechanical strength.
(6) Labeling must include:
(i) Instructions for use, including the recommended training for safe use of the device;
(ii) A summary of the clinical performance testing conducted with the device, including device- and procedure-related adverse events; and
(iii) A shelf life.