(134 days)
This device is intended as therapeutic aid in the conservative treatment of stress incontinence, urge incontinence or mixed stress and urge incontinence in women. Patients appropriate for this therapy should be selected using the following criteria:
Indications:
- Good general health, both mentally and physically. .
- Urge incontinence due to detrusor instability or of idiopathic origin. .
- Stress incontinence not associated with intrinsic sphincter deficiency. ●
- Mixed incontinence. .
- Ability of patient to understand and demonstrate understanding of the use of the Liberty Plus . System.
- . Willingness to comply with the therapy plan.
Contraindications:
- Use of a cardiac pacemaker, or a history of rate or conductive disturbances. .
- Neurological deficiency that would not permit proper sensory perception or stimulation. .
- . Currently pregnant or attempting to get pregnant.
- Anatomical vaginal structure that does not permit proper and complete placement of the . vaginal probe.
- . Irregular menstrual bleeding cycles.
- Any urinary or vaginal infections, localized lesions or other undiagnosed symptoms. .
- . History of urinary retention or current symptoms.
The device consists of a hand held electrostimulation unit and an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence for women. The applicator includes a pressure transducer that provides biofeedback relations of the pelvic floor muscles. The electrical stimulation energy and the power for the transducer are conducted to the electrodes via a six conductor cable and connector that plugs into the PFS-300. The transducer output signal is conducted back to an LCD graphical display by the same cable.
The PFS-300 is indicated for use to help train the pelvic floor muscles using electrical stimulation and biofeedback. The PFS-044 is a vaginal applicator that is used with the PFS-300. The PFS-300 is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the PFS-044 applicator.
The provided text is a 510(k) summary for the Liberty Plus System (PFS-300), a non-implanted electrical continence device. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices and does not describe acceptance criteria, a specific study proving device performance against those criteria, or the detailed aspects of a clinical trial.
Therefore, I cannot extract the requested information based on the provided text. The document states that "Laboratory tests of the PFS-300 and the PFS-200 have demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles" and that "The PFS-300 and the Cardio Design Pty Ltd. PFX both display readings of the pressures generated by contractions of the pelvic floor muscles." However, it does not provide details about these laboratory tests, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
§ 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).