LIBERTY LITE PFS SYSTEM

K960496 · Utah Medical Products, Inc. · KPI · Jun 27, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960496
• Device Name: LIBERTY LITE PFS SYSTEM
• Applicant: Utah Medical Products, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Each session lasts for 15 to 30 minutes without the need for active involvement of the patient or the physician.

Device Story

Battery-operated electrostimulation device; intravaginal applicator with electrode pair; delivers electrical stimulation to pelvic floor neuromuscular tissue. Used by female patients at home; 15-30 minute sessions, 1-2 times daily. Device trains tissue to improve/restore urinary continence; requires no active patient or physician involvement during session. Simplified user interface compared to predicate; equivalent stimulation waveforms; equivalent anatomical placement and active surface area.

Technological Characteristics

Battery-operated electrostimulation; intravaginal applicator; single electrode pair; non-implanted. Materials equivalent to predicate InCare Applicator. No software/algorithm details provided.

Indications for Use

Indicated for females with urinary incontinence requiring neuromuscular pelvic floor training. Contraindications not specified.

Regulatory Classification

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).

Predicate Devices

• UMP Liberty System (K943250)
• Hollister InCare Applicator (K891773)

Submission Summary (Full Text)

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UTAH MEDICAL PRODUCTS INC.
K960496
JUN 27 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. Each 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 Lite 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.

Materials used in the Liberty Lite Applicator that contact the vaginal tissues are equivalent to materials used in the InCare Applicator.

Kevin L. Cornwell
President & CEO

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UTAH MEDICAL PRODUCTS, INC • 7043 South 300 West • Midvale, Utah 810171018 • 801/566-1200 • FAX#[phone]