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K Number
K960496
Device Name
LIBERTY LITE PFS SYSTEM
Manufacturer
UTAH MEDICAL PRODUCTS, INC.
Date Cleared
1996-06-27

(147 days)

Product Code
KPI
Regulation Number
876.5320
Type
Traditional
Panel
GU
Reference & Predicate Devices
K943250,K891773
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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.

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.

AI/ML Overview

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:

  1. A table of acceptance criteria and reported device performance.
  2. Details on any specific study (sample size, data provenance, retrospective/prospective).
  3. Information on experts or ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance data.
  7. Type of ground truth used.
  8. 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.

§ 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).