iTind System
by Medi-Tate, Ltd. Israel EUDAMED510(k)
510(k) K210138
Product code QKA
Overview
The iTind System is a Temporarily-Placed Urethral Opening System designed for symptoms of benign prostatic hyperplasia (BPH). Classified as a Class II device under FDA regulations, it is intended to provide temporary urethral dilation to alleviate urinary obstruction caused by an enlarged prostate.
This system is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K210138) and the European Medical Device Directive (MDD), with advisory committee oversight from Gastroenterology and Urology panels. Storage and handling must comply with sterile medical device protocols, and its use is restricted to clinical settings where urinary symptoms related to BPH are managed.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK210138 | Date25 Jun 2021 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring (legacy directive)
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QKA
- FDA applicant
- Medi-Tate , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5510
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medi-Tate, Ltd.
Questions
What specific urinary symptoms related to benign prostatic hyperplasia (BPH) is the iTind System designed to address?
The iTind System is specifically designed to provide temporary urethral dilation to alleviate urinary obstruction caused by an enlarged prostate, which is a primary symptom of BPH. It is intended for patients experiencing difficulty urinating due to the obstruction, aiming to restore adequate urine flow during its temporary placement.
Is the iTind System reusable, or is it meant for single-use only? How does this affect its storage and handling?
The iTind System is supplied sterile and intended for single-use only. This means each device is meant to be used once and then discarded. Due to its sterile packaging, storage and handling must follow strict sterile medical device protocols to ensure safety and efficacy, typically requiring storage in a clean, dry environment away from direct sunlight or extreme temperatures.
What regulatory pathways has the iTind System undergone, and which advisory committees were involved in its evaluation?
The iTind System has undergone FDA review through a 510(k) clearance process (K210138), classified as a Class II device and determined to be substantially equivalent to a predicate. Its evaluation was overseen by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its intended use in managing urinary symptoms related to BPH. Additionally, it complies with the European Medical Device Directive (MDD).
How should the iTind System be stored to maintain its sterility and usability?
Since the iTind System is sterile and single-use, it must be stored in accordance with standard sterile medical device protocols. This includes keeping it in its original, unopened packaging until immediately before use, in a clean, dry environment protected from contamination, extreme temperatures, and direct sunlight. Always follow manufacturer instructions for storage to ensure sterility and functionality.
What types of clinical settings is the iTind System intended for, and why?
The iTind System is restricted to clinical settings where urinary symptoms related to BPH are managed, such as urology clinics, hospitals, or specialized outpatient centers. Its temporary placement requires professional medical supervision to ensure proper insertion, monitoring, and removal, minimizing risks like infection or urethral trauma.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K210138
- EUDAMED