(60 days)
The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The premarket notification is being submitted to the Agency to include the electrical stimulation parameter of 200 Hz to the existing InCare Pelvic Floor Therapy System with Desktop Computer, K961872.
The provided text is a 510(k) premarket notification for the InCare Pelvic Floor Therapy System with Desktop Computer. It focuses on demonstrating substantial equivalence to a predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K961872), primarily due to the addition of a 200 Hz electrical stimulation parameter.
This type of submission does not typically include detailed acceptance criteria in the sense of performance metrics (like sensitivity, specificity, accuracy) derived from a clinical study, nor does it present the results of such a study with sample sizes, ground truth establishment, or expert adjudication. Instead, the acceptance criteria are met by demonstrating that the new device's technological characteristics are substantially equivalent to a legally marketed predicate device, and that this new parameter does not raise new questions of safety or effectiveness.
Therefore, many of the requested fields cannot be directly extracted from this document as the safety and effectiveness summary relies on substantial equivalence to a predicate device rather than a new clinical performance study with specific acceptance criteria that would be typical for a novel device or a device with new indications.
However, I can extract information related to the device characteristics that are presented to support the claim of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the proposed device's characteristics must be comparable to the predicate device, or any differences must not raise new questions of safety or effectiveness. The "reported device performance" is essentially the detailed specifications of the proposed device, shown in comparison to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K961872) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Stimulation Characteristics | ||
| Intended Use | Treatment of Urinary Incontinence | Treatment of Urinary Incontinence |
| Computer Type | Desktop Computer | Desktop Computer |
| Output (nominal) | 0-30 VDC | 0-30 VDC |
| Waveform | Square, Symmetrical, Balanced, Biphasic | Square, Symmetrical, Balanced, Biphasic |
| Charge/pulse at 500Ω | 60 µC/phase; net charge/pulse = 0 | 60 µC/phase; net charge/pulse = 0 |
| Frequency | 12.5, 20, 50, 100 Hz | 12.5, 20, 50, 100, 200 Hz (This is the difference) |
| Peak Pulse Intensity | 30 VDC | 30 VDC |
| Pulse width | 0.3, 1 ms | 0.3, 1 ms |
| Ramps | 20%, 40%, 60%, 80%, 100% of “ON” time (no down ramping) | 20%, 40%, 60%, 80%, 100% of “ON” time (no down ramping) |
| Duty Cycle | On (sec): 1-80 in 1 sec increments; Off (sec): 0 - 80 in 1 sec increments | On (sec): 1-80 in 1 sec increments; Off (sec): 0 - 80 in 1 sec increments |
| Session Duration (min) | 0-30, 1 minute increments | 0-30, 1 minute increments |
| Programmable Features | By physician: Pulse width, Frequency, Duty cycle, Session length (none by patient) | By physician: Pulse width, Frequency, Duty cycle, Session length (none by patient) |
| Current Density (Probe 9595) | 0.003 amperes/cm² | 0.003 amperes/cm² |
| Current Density (Probe 9596) | 0.018 amperes/cm² | 0.018 amperes/cm² |
| Power Density (Probe 9595) | 0.047 watts/cm² | 0.047 watts/cm² |
| Power Density (Probe 9596) | 0.239 watts/cm² | 0.239 watts/cm² |
| EMI | Meets IEC 601-1, IEC 601-1-1, IEC 601-2-10 (except Para 36), EN 60601-1-2/IEC 601-1-2, EN 55011/CISPR 11, EN60801-2/IEC 801-2, IEC 801-3, IEC 801-4, IEC 801-5 | Meets IEC 601-1, IEC 601-1-1, IEC 601-2-10 (except Para 36), EN 60601-1-2/IEC 601-1-2, EN 55011/CISPR 11, EN60801-2/IEC 801-2, IEC 801-3, IEC 801-4, IEC 801-5 |
| Biofeedback Characteristics | ||
| Intended Use | Treatment of Urinary Incontinence | Treatment of Urinary Incontinence |
| Measurement Channels | Adjustable, 2 channels EMG, 2 channels pressure, or combination | Adjustable, 2 channels EMG, 2 channels pressure, or combination |
| EMG Sensitivity (microvolts) | 0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500 | 0-5, 0-10, 0-25, 0-50, 0-100, 0-250, 0-500 |
| EMG Bandwidth | 100-500 Hz | 100-500 Hz |
| EMG Signal Processing | Root Mean Squared (RMS) | Root Mean Squared (RMS) |
| EMG Detection | Bipolar | Bipolar |
| Pressure Sensitivity (cm-H2O) | 0-10, 0-25, 0-50, 0-100 | 0-10, 0-25, 0-50, 0-100 |
| Work Period (sec) | 1-80 in 1 second increments | 1-80 in 1 second increments |
| Rest Period (sec) | 0-80 in 1 second increments | 0-80 in 1 second increments |
| Session Duration (min) | 1-60 in 1 minute increments | 1-60 in 1 minute increments |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a substantial equivalence submission based on device specifications comparison, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth was established by experts for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method described as no clinical performance study 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 is not an AI-assisted device, and no MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for treatment/biofeedback, not an algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As noted, this submission is driven by substantial equivalence to a predicate device based on technical specifications rather than a clinical study requiring ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" for this application is the established safety and effectiveness of the predicate device and the demonstration that the new device remains within those bounds.
8. The sample size for the training set
Not applicable. This submission doesn't involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This submission doesn't involve machine learning or a training set.
§ 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).