(90 days)
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No
The description focuses on electrical stimulation and the physical components of the device, with no mention of AI or ML algorithms for data analysis, decision-making, or personalized treatment.
Yes
The device applies electrical stimulation to neuromuscular tissue to help train pelvic floor muscles for improvement or restoration of urinary continence, which is a therapeutic purpose.
No
Explanation: The device is described as an electrostimulation device used to train pelvic floor muscles, not to diagnose a condition.
No
The device description explicitly states it consists of an injection molded thermoplastic applicator with stainless steel electrode rings and a cable, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help train the pelvic floor muscles using electrical stimulation." This is a therapeutic or training function, not a diagnostic one.
- Device Description: The device applies electrical stimulation to neuromuscular tissue. This is a direct interaction with the body for a physiological effect, not for analyzing a sample from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.
Product codes
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Device Description
The device consists of 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 in men and women. The electrical stimulation energy is conducted to the electrodes via a two conductor cable and connector that plugs into the Liberty Stimulator.
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
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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)
Laboratory tests of the UMP PFS-043 probe and the ICAA applicator demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles.
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
Not Found
§ 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
K964526
Image /page/0/Picture/1 description: The image shows the logo for Utah Medical Products Inc. The logo features the company's name in a simple, sans-serif font at the top. Below the name is a stylized emblem that resembles a rounded letter 'U' or an omega symbol, with a thick, bold outline. The entire logo is presented in black and white.
FEB 1 0 1997
510(k) Summary
November 8, 1996
Trade Name: Common Name: Classification:
Liberty Rectal Pelvic Floor Exerciser Electrical Pelvic Floor Stimulation System Nonimplanted Electrical Continence Device. 21 CFR §876.5320
The Utah Medical Products, Inc. (UMP) Liberty Rectal Pelvic Floor Exerciser (PFS-043) is substantially equivalent to the UMP Liberty Probe (PFS-041), cleared for marketing under K960496, and to the Hollister InCare Anal Applicator (ICAA), cleared for marketing under K891773.
The device consists of 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 in men and women. The electrical stimulation energy is conducted to the electrodes via a two conductor cable and connector that plugs into the Liberty Stimulator.
The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.
The technological characteristics of the UMP PFS-043 probe are substantially equivalent to the UMP PFS-041 probe and the ICAA applicator. There are differences in the size and placement of the stainless steel electrodes and in the thermoplastic materials used to mold the applicators, however, the PFS-043 probe and the ICAA applicator both utilize a single electrode pair with equivalent anatomical placement. The new device and the predicate devices are all manufactured using biocompatible materials.
Laboratory tests of the UMP PFS-043 probe and the ICAA applicator demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles.
Ki-J. Cornell
evin L. Cornwell President & CEO