(147 days)
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No
The summary describes a standard electrostimulation device and does not mention any AI or ML components or functionalities.
Yes
The device is intended to 'improve or restore urinary continence in females' through electrical stimulation, which directly addresses a medical condition, classifying it as therapeutic.
No
The device description states its purpose is to "help train neuromuscular tissue in the pelvic floor in order to improve or restore urinary continence in females" through electrical stimulation, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "battery operated electrostimulation device with an intravaginal applicator that applies electrical stimulation through electrodes on the applicator," indicating it includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The UMP Liberty Lite PFS System is an electrostimulation device that applies electrical stimulation directly to the pelvic floor muscles. It is a therapeutic device used to train and strengthen muscles, not to analyze biological samples.
- Intended Use: The intended use is to "help train neuromuscular tissue in the pelvic floor in order to improve or restore urinary continence in females." This is a therapeutic goal, not a diagnostic one.
The device description and intended use clearly indicate that it is a physical therapy/rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
21 CFR §876.5320
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
pelvic floor, vaginal tissues
Indicated Patient Age Range
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Intended User / Care Setting
patient (at home)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/4 description: The image shows the logo for Utah Medical Products Inc. The logo features the company name in all caps at the top, with a line underneath. Below the name is a large, stylized letter 'U' that also resembles an 'M'. The logo is black and white.
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