(90 days)
The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.
The InMode System is a computerized device intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. . The System consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The single use vTone Applicator is connected to the console via pulse generator adaptor.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
The System emits an electrical signal of rectangular bi-phasic wave, and allows selecting intensity level of stimulation pulses from 1 to 50 intensity levels (equivalent to 5-54V). The system pulse width ranges from 50 to 450usec.
The system pulse frequency ranges from 3 to 100Hz. In addition, the device emits the pulses in bursts of 1-60 sec, with a succeeding relaxation time of 1-60 sec, depending on the intensity level chosen by the user.
The System supports the following components:
- LCD display touch screen ●
- Audio loudspeaker ●
- 48V AC/DC power supply ●
- . Controller
- Fans
The System operates while connected to the following applicator:
- · vTone Applicator
The InMode System with vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for clinical performance in terms of specific thresholds for efficacy. Instead, the device establishes substantial equivalence to a predicate device (Kegel8, K081480) by demonstrating similar indications for use, mechanism of action, and comparable performance specifications, alongside compliance with relevant safety standards and satisfactory non-clinical testing.
Therefore, the "acceptance criteria" are implied to be demonstration of substantial equivalence to the predicate device as outlined in the comparative table, and compliance with recognized safety and performance standards through bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1. Substantial Equivalence to Predicate Device (K081480) | Demonstrated through a detailed comparison highlighting similar Indications for Use, Target Population, Anatomical Sites, Environment Used, Mechanism of Action, Electrical Type, Number of Output Modes, Number of Output Channels (similar concept for a single channel device), Waveform, Pulse Shape, Net Charge @ 500 ohms, Maximum Phase Charge, Standards Met, and Compatibility with Environment and Other Devices. Minimal differences in some specs (e.g., power source, maximum voltage/current, other specific metrics like timer range, on/off time) were deemed not to alter safety or effectiveness. The predicate device uses a 9V PP3 battery while the subject device uses an AC line power. |
| 2. Compliance with Recognized Safety and Performance Standards | A. IEC 60601-1 (Basic Safety and Essential Performance): Tested and complies. |
| B. IEC 60601-1-2 (Electromagnetic Compatibility - EMC): Tested and complies. | |
| C. IEC 60601-2-10 (Nerve and Muscle Stimulators - Performance): Tested and complies. | |
| D. IEC 60601-1-6 (Usability): Tested and complies. | |
| 3. Non-Clinical (Bench) Performance Data for Device Functionality | Bench testing conducted to validate output waveform, basic unit characteristics, and output specifications. Results demonstrated the device performs as expected under anticipated conditions of use. |
| 4. Biocompatibility of Patient-Contacting Materials (vTone Applicator) | Biocompatibility tests performed according to ISO 10993-1:2018 and FDA Guidance. |
| * Cytotoxicity Study: Non-toxic (no evidence of cell lysis or toxicity). | |
| * ISO Acute Systemic Toxicity Study: Non-toxic (no evidence of systemic toxicity in mice). | |
| * ISO Guinea Pig Maximization Sensitization Test: No irritation/sensitization (no evidence of delayed dermal contact sensitization). | |
| * ISO Vaginal Irritation Sensitization in Rabbit: No irritation (non-irritant to vaginal tissue). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There was no clinical study involving human subjects or patient data to generate a "test set" for efficacy. The assessment was based on non-clinical (bench) testing and a comparison to a predicate device.
- Data Provenance: Not applicable. The data is from laboratory (bench) testing conducted by the manufacturer, InMode Ltd., and its consultants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As there was no clinical test set involving human subjects to evaluate efficacy, no experts were used to establish ground truth for this purpose. The assessment relied on engineering and scientific principles for device design, safety, and functionality, and comparison to a legally marketed predicate device. Biocompatibility testing was outsourced to independent labs.
4. Adjudication Method for the Test Set
Not applicable. No test set involving expert adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrical stimulation device for pelvic floor muscle rehabilitation, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. Performance was assessed through engineering bench tests of its electrical and mechanical properties, and compliance with safety standards.
7. The type of ground truth used
The concept of "ground truth" in the clinical efficacy sense (e.g., pathology, outcomes data) is not directly applicable here. The "truth" for this submission is established through:
- Compliance with recognized consensus standards: Demonstrating that the device meets established safety and performance benchmarks for medical electrical equipment and nerve/muscle stimulators.
- Bench Test Results: Verification that the device's electrical output, physical characteristics, and biocompatibility meet its design specifications and regulatory requirements.
- Substantial Equivalence: The foundation of the 510(k) submission is showing that the new device is as safe and effective as a legally marketed predicate device (Kegel8, K081480), which previously gained clearance. The "ground truth" for the predicate device's safety and effectiveness was established during its original clearance process.
8. The sample size for the training set
Not applicable. As there was no machine learning or AI component, there was no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).