(147 days)
The UMP Liberty Lite PFS System is a battery operated electrostimulation device with an intravaginal applicator that applies electrical stimulation through electrodes on the applicator, to help train neuromuscular tissue in the pelvic floor in order to improve or restore urinary continence in females.
The UMP Liberty Lite PFS System is a battery operated electrostimulation device with an intravaginal applicator that applies electrical stimulation through electrodes on the applicator, to help train neuromuscular tissue in the pelvic floor in order to improve or restore urinary continence in females. The patient uses the system once or twice per day at home. Fach session lasts for 15 to 30 minutes without the need for active involvement of the patient or the physician.
This 510(k) summary for the K960496 Liberty Lite System does not contain the information requested about acceptance criteria and a study that proves the device meets those criteria.
The document is a marketing clearance summary that describes the device, its intended use, and claims substantial equivalence to previously cleared devices (UMP Liberty System K943250 and Hollister InCare Applicator K891773). It focuses on:
- Device Description: Battery-operated electrostimulation device with an intravaginal applicator for pelvic floor muscle training to improve urinary continence in females.
- Substantial Equivalence Claims: Argues that the Liberty Lite Stimulator has equivalent waveforms to the UMP Liberty System, and the Liberty Lite Applicator has equivalent anatomical placement and active surface area to the InCare Applicator, despite physical construction differences. It also mentions material equivalence.
- Marketing Focus: Highlights the device's cost-effectiveness and user-friendliness.
It does not provide:
- A table of acceptance criteria and reported device performance.
- Details on any specific study (sample size, data provenance, retrospective/prospective).
- Information on experts or ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone performance data.
- Type of ground truth used.
- Training set details or how its ground truth was established, as this appears to be a medical device clearance, not an AI/algorithm-based product as commonly implied by these questions.
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UN 2 7 1996
SMDA 510(k) Summary
Trade Name: Liberty Lite System Common Name: Electrical Pelvic Floor Stimulation System Classification: Nonimplanted Electrical Continence Device. 21 CFR §876.5320.
The UMP Liberty Lite PFS System is a battery operated electrostimulation device with an intravaginal applicator that applies electrical stimulation through electrodes on the applicator, to help train neuromuscular tissue in the pelvic floor in order to improve or restore urinary continence in females. The patient uses the system once or twice per day at home. Fach session lasts for 15 to 30 minutes without the need for active involvement of the patient or the physician.
Liberty Lite is substantially equivalent to the UMP Liberty System cleared for marketing under 510(k) K943250 and the Hollister InCare Applicator cleared for marketing under 510(k) K891773. Although the Liberty Lite Stimulator utilizes a simplified user interface, the stimulation output has equivalent waveforms. The Liberty Litc Applicator and the InCare Applicator have some differences in their physical construction and dimensions, however, they both utilize a single electrode pair with equivalent anatomical placement and active surface area. Liberty Lite is designed to be more cost effective and user friendly than currently marketed devices.
Matcrials used in the Liberty Lite Applicator that contact the vaginal tissues are equivalent to materials used in the InCare Applicator.
Kevin J. Criswell
evin L. Cornwell President & CEO
UTAH MEDICAL PRODUCTS, INC . 7043 South 300 West . Midwile, Utah 840171048 . 801566-1200 . FAX#801566-2062
§ 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).