(328 days)
Not Found
GE LOGIQ P9, K181783
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware components and their functions.
Yes
The device is described as an ultrasonic propulsion device that delivers ultrasound pulses to reposition residual stone fragments to facilitate passage post-lithotripsy, indicating a direct therapeutic action. The clinical study also evaluates the "stone passage rate" as a primary effectiveness endpoint, which further supports its therapeutic intent.
No
The device description clearly states "The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy...". This indicates a therapeutic, not diagnostic, function. While it integrates a "diagnostic ultrasound imaging unit" for real-time guidance, the primary purpose of the Stone Clear device itself is therapeutic (repositioning stones), not diagnosing a medical condition.
No
The device description clearly states it consists of hardware components: a third-party diagnostic ultrasound imaging unit, a SonoMotion-manufactured signal generator, and a therapy probe. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stone Clear device uses ultrasound to physically reposition stone fragments within the upper urinary tract. It is a therapeutic device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is to "facilitate passage" of stone fragments, which is a therapeutic action, not a diagnostic one.
- Device Description: The description details a system that delivers ultrasound pulses to the body, not a system that analyzes biological samples.
While the device incorporates a diagnostic ultrasound imaging unit for guidance, the primary function and intended use of the Stone Clear system as a whole are therapeutic.
N/A
Intended Use / Indications for Use
The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.
Product codes
QNA
Device Description
The Stone Clear device consists of a commercially available third-party diagnostic ultrasound imaging unit (GE LOGIQ P9, K181783, Imaging Workstation) that is integrated with a SonoMotion-manufactured signal generator and therapy probe.
The Imaging Workstation and associated ultrasound imaging provide the user interface and real-time image guidance for the Stone Clear procedure, while the Generator controls and drives the Therapy Probe. The Therapy Probe delivers the ultrasound pulses to reposition stones. The Imaging Probe and Therapy Probe are coaxially aligned, with the Imaging Probe docking into the housing of the Therapy Probe through an adapter. A foot pedal is used to initiate the therapy from the Generator.
The 3Sc-RS phased array Imaging Probe is integrated with the Therapy Probe for real-time monitoring of stone motion and cavitation during treatment.
The Therapy Probe delivers the focused ultrasound pulses that result in stone motion.
The Generator is an external unit that provides the electrical excitation to the Therapy Probe that causes the stone to move. The Generator has no user controls and is enclosed within the printer bay of the LOGIO P9 imaging system. The Generator also contains the system firmware which interfaces with the Imaging Workstation. The Generator determines when therapy pulses are allowed and what therapy related messages and warnings will be displayed on the Imaging Workstation screen.
The system includes two primary software environments - Imaging Workstation (off the shelf ultrasound imaging system) and Generator (two microcontrollers and an FPGA residing on the Generator Main Board). The Imaging Workstation software is responsible for displaying the information to the user interface and passing parameter value changes from the user interface control elements to the Generator. The Imaging Workstation is also responsible for enabling/disabling the synchronization signal and serial communication with the Generator.
As stated above, the Generator software interfaces with the Imaging Workstation and drives the Therapy Probe.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Upper urinary tract
Indicated Patient Age Range
Adult patients. Subjects of the study included individuals from 23 to 92 years of age.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical testing included a prospective, multi-center, two-arm randomized controlled trial.
The study was conducted to assess the ability of the Stone Clear to reposition stones within the kidney and the subsequent clinical benefit of facilitating stone passage and reducing stone burden.
Subjects were selected from patients who had undergone a lithotripsy procedure to fragment urinary stones at least four weeks prior to randomization and still had residual stone fragments post-lithotripsy. The procedure targeted fragments 5mm or less in size, or clusters of fragments. Control arm subjects did not undergo the device procedure but maintained standard of care for the residual stone fragments.
Data was presented on two cohorts, the ITT population (24 treatment arm, 22 control arm) and the Supplemental population (12 treatment arm, 12 control arm). The ITT study was conducted at 2 sites, and the Supplemental study was conducted at 2 additional sites with six new users.
The primary effectiveness endpoint was measured by subjects reporting visual observation of stone passage in the 3 weeks following randomization.
Primary Effectiveness Endpoint: The proportion of subjects reporting visual observation of stone passage over 3-weeks following treatment (Treatment group) or randomization (Control group). The superiority of the Treatment group compared to the Control group was assessed.
Primary Safety Endpoint: The subject-level rate of low frequency adverse events (AEs) of interest defined as skin burn, clinically significant hematuria, renal injury requiring intervention, clinically significant hematoma, sepsis, or any other procedure or device related event meeting the definition of a serious adverse event (SAE) with onset after the initial procedure (Treatment group) or randomization (Control group) through the 3-week follow-up.
Secondary Endpoints:
The secondary effectiveness endpoint was demonstrating superiority with a 7.5% margin for the proportion of subjects reporting visual observation of stone passage during the 3-week follow-up period following treatment (Treatment group) or randomization (Control group).
The secondary safety endpoint was the subject-level rate of all adverse events with onset after the procedure through 3-weeks after treatment (Treatment group) or randomization (Control group).
Results:
Stone passage rate in the ITT cohort was 83.3% (20/24) in the Treatment group compared to 4.5% (1/22) in the Control group, corresponding to a 78.8% difference (95% CI - 53.1% to 92.7%: p-value
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR STONE CLEAR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Ultrasonic urinary stone propulsion device. An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage.
NEW REGULATION NUMBER: 21 CFR 876.4690
CLASSIFICATION: Class II
PRODUCT CODE: Q QNA
BACKGROUND
DEVICE NAME: Stone Clear
SUBMISSION NUMBER: DEN230082
DATE DE NOVO RECEIVED: December 7, 2023
SPONSOR INFORMATION:
SonoMotion, Inc. 1600 W. Hillsdale Blvd. Suite 105 San Mateo, CA 94402
INDICATIONS FOR USE
The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.
LIMITATIONS
The sale, distribution, and use of the Stone Clear are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS.
1
DEVICE DESCRIPTION
The Stone Clear device consists of a commercially available third-party diagnostic ultrasound imaging unit (GE LOGIQ P9, K181783, Imaging Workstation) that is integrated with a SonoMotion-manufactured signal generator and therapy probe.
The Imaging Workstation and associated ultrasound imaging provide the user interface and real-time image guidance for the Stone Clear procedure, while the Generator controls and drives the Therapy Probe. The Therapy Probe delivers the ultrasound pulses to reposition stones. The Imaging Probe and Therapy Probe are coaxially aligned, with the Imaging Probe docking into the housing of the Therapy Probe through an adapter. A foot pedal is used to initiate the therapy from the Generator.
Image /page/1/Picture/3 description: The image shows a GE ultrasound machine. The machine has a large monitor at the top and a smaller monitor on the control panel. The control panel has several buttons and knobs. The machine is on wheels and has a blue base.
Ultrasound Imaging System and Imaging Probe
The Ultrasound Imaging System has been modified for SonoMotion with a proprietary user interface, synchronization signal (for synchronizing imaging and therapy), and integration between the imaging system and Generator.
The 3Sc-RS phased array Imaging Probe is integrated with the Therapy Probe for real-time monitoring of stone motion and cavitation during treatment.
Therapy Probe
The Therapy Probe delivers the focused ultrasound pulses that result in stone motion.
2
Image /page/2/Picture/0 description: The image contains three different views of ultrasound probes. The first image, labeled (a) Top view, shows the top of the probe and its base. The second image, labeled (b) Side View, shows the side of the probe and its base. The third image, labeled (c) Probes shown individually, shows the probes detached from the base.
Generator
The Generator is an external unit that provides the electrical excitation to the Therapy Probe that causes the stone to move. The Generator has no user controls and is enclosed within the printer bay of the LOGIO P9 imaging system. The Generator also contains the system firmware which interfaces with the Imaging Workstation. The Generator determines when therapy pulses are allowed and what therapy related messages and warnings will be displayed on the Imaging Workstation screen.
Software
The system includes two primary software environments - Imaging Workstation (off the shelf ultrasound imaging system) and Generator (two microcontrollers and an FPGA residing on the Generator Main Board). The Imaging Workstation software is responsible for displaying the information to the user interface and passing parameter value changes from the user interface control elements to the Generator. The Imaging Workstation is also responsible for enabling/disabling the synchronization signal and serial communication with the Generator.
As stated above, the Generator software interfaces with the Imaging Workstation and drives the Therapy Probe.
SUMMARY OF NONCLINICAL/BENCH STUDIES
The following non-clinical test were leveraged to demonstrate safety and effectiveness for the subject device's indication for use.
REPROCESSING, STERILITY AND SHELF-LIFE
The Stone Clear is provided non-sterile and requires reprocessing prior to its first and subsequent uses for cleaning and disinfection. Reprocessing methods in the labeling were validated per the FDA Reprocessing guidance entitled, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and AAMI TIR30:2011(R) 2016.
BIOCOMPATIBILITY
The Stone Clear, per Table A.1 of the FDA Biocompatibility guidance entitled, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" is a surface device with direct contact with skin for a limited duration (