(89 days)
Indications for Use: Urinary Incontinence; Stress, Urge and Mixed Incontinence Neuromuscular Reeducation Fecal Incontinence; EMG USE ONLY
Indications For Use
- Urinary Incontinence: Stress, Urge and Mixed Incontinence
- Neuromuscular Reeducation .
- Fecal Incontinence: EMG USE ONLY
The Pathway CTS2000 Pelvic Floor Training System provides electromyographic or pressure biofeedback from pelvic musculature as well as provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
The Pathway CTS 2000 uses Pathway Perineometer Sensors which are single-user sensors, and inserts the sensor into the vagina or rectum while using the Pathway CTS 2000 Pelvic Floor Training System to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can also use the Pathway CTS 2000 Pelvic Floor Training System to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.
The purpose of this premarket notification submission is to include additional electrical stimulation treatment frequencies of 100 and 200 Hz to the existing Pathway CTS2000 Pelvic Floor Therapy System, K001515.
The provided text is a 510(k) Premarket Notification for the "Pathway CTS2000 Pelvic Floor Training System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for device performance. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or extractable from this type of regulatory submission.
The submission primarily compares the technical characteristics of the new device with existing predicate devices to show it is as safe and effective.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
There are no explicit "acceptance criteria" for device performance in the traditional sense (e.g., clinical trial endpoints with predefined thresholds). Instead, the device is deemed acceptable if its technical characteristics are substantially equivalent to the predicate devices. The "reported device performance" is a comparison of these technical characteristics.
| Characteristic | Acceptance Criteria (Predicate Device K001515) | Proposed Device Performance (Pathway CTS2000) |
|---|---|---|
| Intended Use | Treatment of Urinary Incontinence | Treatment of Urinary Incontinence |
| Stimulator Output | 0-100 mA | 0-100 mA |
| Waveform | Asymmetrical Balanced Pulsed Current | Asymmetrical Balanced Pulsed Current |
| Charge/pulse at 500 ohms | 28uC | 28uC |
| Frequency | 12.5, 50 Hz | 12.5, 50, 100, 200 Hz (This is the primary change seeking approval) |
| Peak pulse intensity | 100 mA | 100 mA |
| Pulse width | .3 ms fixed | .3 ms fixed |
| Ramps | 2 sec on ramp, one sec off ramp | 2 sec on ramp, one sec off ramp |
| Duty Cycle | On (sec): 1-80, Off (sec): 0-80 | On (sec): 1-80, Off (sec): 0-80 |
| Session Duration (min) | 0-30 | 0-30 |
| Programmable features | None by Patient; Frequency, Duty cycle, Session Length by physician | None by Patient; Frequency, Duty cycle, Session Length by physician |
| Vaginal EMG/Stim Probe Used | Pathway Vaginal EMG/Stimulation Sensor K993976 | Pathway Vaginal EMG/Stimulation Sensor K993976 |
| Anal EMG/Stim Probe Used | Pathway Anal EMG/Stimulation Sensor K993976 | Pathway Anal EMG/Stimulation Sensor K993976 |
| Vaginal EMG/Stim probe electrode surface area | 2.31 cm² | 2.31 cm² |
| Anal EMG/Stim probe Electrode surface area | 2.12 cm² | 2.12 cm² |
| Current Density (full output) | Pathway Vaginal EMG/Stim Sensor: .043 A/cm² | |
| Pathway Anal EMG/Stim Sensor: .047 A/cm² (Max. Instantaneous) | Pathway Vaginal EMG/Stim Sensor: .043 A/cm² | |
| Pathway Anal EMG/Stim Sensor: .047 A/cm² (Max. Instantaneous) | ||
| Power Density (full output @ 500 ohms) | Pathway Vaginal EMG/Stim Sensor: .487 mW/cm² | |
| Pathway Anal EMG/Stim Sensor: .531 mW/cm² (.3mS pulse, 50Hz) | Pathway Vaginal EMG/Stim Sensor: 7.79 mW/cm² | |
| Pathway Anal EMG/Stim Sensor: 8.49 mW/cm² (.3mS pulse, 200Hz) | ||
| EMG Ranges | 0-5, 0-30, 0-100, 0-1000 uV Ranges | 0-5, 0-30, 0-100, 0-1000 uV Ranges |
| EMG Bandwidth | 20-500Hz | 20-500Hz |
| EMG Signal Processing | Root Mean Square (RMS) | Root Mean Square (RMS) |
| EMG Detection | Bipolar | Bipolar |
| Vaginal Pressure Probe Used | Pathway Vaginal Pressure Sensor manufactured by DesChutes Medical K934552 | Pathway Vaginal Pressure Sensor manufactured by DesChutes Medical K934552 |
| Anal Pressure Probe Used | Pathway Anal Pressure Sensor manufactured by DesChutes Medical K934552 | Pathway Anal Pressure Sensor manufactured by DesChutes Medical K934552 |
| Work Period (sec) | 1-80 seconds | 1-80 seconds |
| Rest Period (sec) | 0-80 seconds | 0-80 seconds |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on technical comparisons and bench testing rather than a clinical human test set.
- Data Provenance: The data is from laboratory (bench) tests conducted by The Prometheus Group, likely within the United States. It is retrospective in the sense that it evaluates the modified device against existing and approved predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No human experts were used to establish ground truth for a test set in this 510(k) submission. Equivalency is based on objective technical specifications and bench testing.
4. Adjudication method for the test set
Not applicable. There was no test set requiring human adjudication.
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 is not an AI-enabled device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. The assessment is of the physical and electrical characteristics of the device. Bench tests were performed on the device itself.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence is based on:
- Technical Specifications: Direct comparison of electrical and physical parameters (e.g., output current, frequency, pulse width, electrode surface area) against predicate devices.
- Bench Test Results: Laboratory testing for electrical safety and performance (e.g., current density, power density) and biocompatibility of sensor materials, all aligned with recognized standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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).