Revi System
by BlueWind Medical Ltd Israel 510(k)
510(k) K240037 Product code QXM
Overview
The Revi System is an implanted tibial electrical urinary continence device, classified as a Class II medical device under FDA regulations. It employs tibial nerve neuromodulation to modulate bladder activity, providing a non-pharmacological treatment for urge urinary incontinence (UUI). Designed for long-term use, it targets the sacral nerve pathways to improve bladder control without medication. This device is intended for patients with refractory UUI who have not responded adequately to conservative therapies.
The Revi System is implanted surgically under local or general anesthesia, with electrodes positioned near the tibial nerve to deliver electrical stimulation. It is supplied as a sterile, implantable device with associated programming tools for patient-specific adjustments. The system is not MRI-safe and requires post-procedural follow-up for optimization. Authorized under FDA 510(k) clearance (K240037), it adheres to regulatory standards for implanted neuromodulation devices, with no third-party manufacturing involvement. Storage and handling follow sterile surgical protocols as per manufacturer guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240037 | Date2 May 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QXM
- FDA applicant
- Bluewind Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5305
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bluewind Medical Ltd.
Questions
What is the Revi System used for?
The Revi System is designed to treat urge urinary incontinence (UUI) in patients who have not responded adequately to conservative therapies. It employs tibial nerve neuromodulation to modulate bladder activity, providing a non-pharmacological alternative to medication. This approach targets sacral nerve pathways to improve bladder control over the long term.
How is the Revi System supplied and prepared for use?
The Revi System is supplied as a sterile, implantable device. It requires surgical implantation under local or general anesthesia, with electrodes positioned near the tibial nerve to deliver electrical stimulation. The system includes programming tools for patient-specific adjustments to optimize effectiveness post-implantation.
Is the Revi System single-use or reusable?
The Revi System is intended for long-term implantation and is not designed for single-use. Once implanted, it remains in place for continuous neuromodulation therapy. The associated programming tools may require periodic adjustments, but the device itself is not removed or reused.
What safety considerations should be noted with the Revi System?
The Revi System is not MRI-safe, meaning patients should avoid MRI scans after implantation. Additionally, post-procedural follow-up is required to optimize device settings. Storage and handling must adhere to sterile surgical protocols to maintain device integrity and patient safety.
How is the Revi System regulated and authorized?
The Revi System is authorized under FDA 510(k) clearance (K240037) and is classified as a Class II medical device. It adheres to regulatory standards for implanted neuromodulation devices, with no third-party manufacturing involvement. The clearance confirms it is substantially equivalent to a legally marketed predicate device.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K240037