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K Number
DEN220073
Device Name
Revi System
Manufacturer
BlueWind Medical Ltd.
Date Cleared
2023-08-16

(315 days)

Product Code
QXM,OXM
Regulation Number
876.5305
Type
Direct
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

Device Description

The Revi System is a tibial neuromodulation system that consists of the following four different components:

  1. Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source.
  2. Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired.
  3. Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection.
  4. HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).
AI/ML Overview

Acceptance Criteria and Device Performance for the Revi System

This document outlines the acceptance criteria for the Revi System and details the studies that demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The Revi System's clinical performance was evaluated against primary and secondary effectiveness endpoints with pre-defined performance goals (PG). The device's safety was assessed by the incidence of adverse events.

Acceptance Criteria (Performance Goal)Reported Device Performance
Primary Effectiveness Endpoint:
Proportion of responders at 6 months post system activation with ≥50% improvement in average number of UUI episodes (PG: 50%)76.4% (95% CI: 68.7%-82.6%)
Secondary Effectiveness Endpoints:
Proportion of subjects with ≥10 points (MID) improvement in Health Related Quality of Life (HRQL) (based on OAB-q) at 6 months post system activation (PG: 50%)83.6% (95% CI: 76.7%-88.7%)
Proportion of responders at 12 months post system activation with ≥50% improvement in either average number of urgency related incontinence episodes or average number of severe/large urgency related incontinence episodes (PG: 50%)88% (95% CI: 81.6%-92.4%)
Proportion of responders at 6 months post system activation with ≥50% improvement in the average number of moderate-severe urgency episodes (PPIUS degree 3, 4) or

N/A