(183 days)
The itouch Sure is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women
The itouch Sure is a small lightweight battery powered single channel neuromuscular stimulation device supplied with a vaginal two electrode stimulation probe. The probe connects to the control unit by cable and plug. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has four preset treatment programs, an adjustable treatment timer, a compliance monitor, and open circuit detectors.
The TensCare itouch Sure Pelvic Floor Exerciser (K103698) is a Class II device intended to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles to treat stress, urge, and mixed urinary incontinence in women.
The submission does not include a separate study that establishes acceptance criteria and proves the device meets them in the way clinical performance studies with specific endpoints would. Instead, the FDA's "substantial equivalence" determination for this 510(k) submission is based on a technological comparison to predicate devices. This means the device is deemed safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed, and any differences do not raise new questions of safety or effectiveness.
Therefore, the "acceptance criteria" here are inherent to the regulatory process for substantial equivalence, focusing on whether the new device is as safe and effective as its predicates based on a comparison of their features and performance characteristics.
Here’s an interpretation of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit numerical targets from a performance study but rather the demonstration that the TensCare itouch Sure's technical specifications and safety profile are comparable to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported TensCare itouch Sure Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: Treatment of urinary incontinence | "The itouch Sure is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women." (Same as predicates) |
| Technological Equivalence (Key Parameters): | (See detailed comparison table in the "Technological Comparison" section of the 510(k) summary) |
| Frequency (Hz) | 10/20/35/50 (Comparable to predicates, e.g., K941911: 12.5/50; K81480: 2-100) |
| Pulse Width (uS) | 200/250/300 (Comparable to predicates, e.g., K941911: 300; K81480: 50-450) |
| Output Current/Voltage | 0-45V = 0-90mA over 500 Ohm; Constant current 160-500 Ω, Constant voltage 500-1500 Ω (Comparable to predicates, e.g., K941911: 0-60mA (100mA override); K81480: 0-90 mA nominal) |
| Waveform Type & Shape | Bi-phasic, Rectangular at positive (Substantially equivalent to Kegel 8; difference in negative phase not clinically significant) |
| Biocompatibility: Probe materials are safe for patient contact. | Materials (ABS, Stainless Steel) are the same as Kegel 8 probe. Biocompatibility tests (ISO 10993-5:2009 and -10:2002) showed no cytotoxicity, negligible vaginal irritation, no sensitization. |
| Safety: Compliance with relevant safety standards, controlled output energy, no new safety hazards. | Designed to comply with recognized consensus standards. Output energy controlled within safety/effectiveness ranges. Test results, Risk Analysis, FMEA show it is safe. Device controls output at constant voltage > 500 Ω and pseudo-constant current |
§ 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).