(87 days)
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No
The device description details a simple pressure sensor and display with preset programs and sensitivity levels, with no mention of adaptive algorithms, learning, or complex data processing characteristic of AI/ML.
Yes
The device is intended to treat a medical condition (urinary incontinence) by helping to rehabilitate weak pelvic floor muscles, which aligns with the definition of a therapeutic device.
No
The device is intended for rehabilitation and biofeedback to strengthen pelvic floor muscles, not for diagnosing a medical condition.
No
The device description clearly outlines hardware components including a battery-powered machine, an inflatable pressure probe, a display panel with lights, and control switches.
Based on the provided information, the Contimed Pressure Biofeedback device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Contimed Device Function: The Contimed device measures the force of muscle contractions in vivo (within the living body) using a pressure probe inserted into the vagina or anus. It provides biofeedback to the patient based on this physical measurement.
- Intended Use: The intended use is for rehabilitation of weak pelvic floor muscles and treatment of urinary incontinence, which is a therapeutic and training purpose, not a diagnostic one based on analyzing a specimen.
The device description and intended use clearly indicate that it is a biofeedback device used for physical therapy and muscle training, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Contimed Pressure Biofeedback device is intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
Product codes
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Device Description
The Contimed Pressure Biofeedback device is intended to help strengthen pelvic floor muscles in the treatment of urinary incontinence The Contimed Pressure Biofeedback device is a battery powered machine which registers the force with which a patient contracts their pelvic floor muscles. The force is measured by using an anatomically shaped, inflatable pressure probe that is connected to the Contimed device. The latex probe (anal or vaginal) is inflated with air by using a syringe and is introduced into either the vagina or anus. The voluntary muscle contractions of the exercises compress the air inside the probe and register a reading on the display panel of the Contimed device. The visual display of contraction force gives the patient the ability to see and hear progress in the exercise session. The Contimed has a vertical column of lights. The number of the lights illuminated increases or decreases with an increase of contraction force. To reinforce the effect of the visual signal there is also an audible signal that can be turned on or off. The intensity of the tone increases or decreases in intensity depending on the contraction's force. Over time the exercise program will help the patient to improve the ability to control the pelvic floor muscles.
Three different duty cycles are preset to allow the caregiver the ability to choose a program that will help to strengthen the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device. Three sensitivity levels are available to accommodate different contraction strengths of the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device, there is also a slide switch for zero adjustment.
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 muscles
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).
0
APR 1 8 1996
Hollister Incorporated Contimed Pressure Biofeedback Device
Section VII
Safety and Effectiveness Summary
Hollister Incorporated represents that the proposed product is safe and effective for its intended use. A safety and effectiveness summary follows
1
Hollister Incorporated Contimed Pressure Biofeedback Device
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
- Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Joseph S. Tokarz Manager, Regulatory Affairs (847)680-2849 Ph -Fax (847)918-3860
Date Summary Prepared - January 18, 1996
2. Name of Device:
Hollister Contimed Pressure Biofeedback device
3. Name of Predicate Device(s)
- · Perineometer as described in 21 CFR 884.1425
- · InCare Contimed II Pressure Biofeedback device, K891774 (8/23/89).
4. Description of Device
The Contimed Pressure Biofeedback device is intended to help strengthen pelvic floor muscles in the treatment of urinary incontinence The Contimed Pressure Biofeedback device is a battery powered machine which registers the force with which a patient contracts their pelvic floor muscles. The force is measured by using an anatomically shaped, inflatable pressure probe that is connected to the Contimed device. The latex probe (anal or vaginal) is inflated with air by using a syringe and is introduced into either the vagina or anus. The voluntary muscle contractions of the exercises compress the air inside the probe and register a reading on the display panel of the Contimed device. The visual display of contraction force gives the patient the ability to see and hear progress in the exercise session. The Contimed has a vertical column of lights. The number of the lights illuminated increases or decreases with an increase of contraction force. To reinforce the effect of the visual signal there is also an audible signal that can be turned on or off. The intensity of the tone increases or decreases in intensity depending on the contraction's force. Over time the exercise program will help the patient to improve the ability to control the pelvic floor muscles.
Three different duty cycles are preset to allow the caregiver the ability to choose a program that will help to strengthen the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device. Three sensitivity levels are available to accommodate different contraction strengths of the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device, there is also a slide switch for zero adjustment. The chart below describes the parameters that are preset into the Contimed Pressure Biofeedback device of both.
2
Hollister Incorporated Contimed Pressure Biofeedback Device
| Work/Rest 3 Cycles (seconds) | 3 sensitivity levels expressed in millimeters of mercury | |
|---|---|---|
| Work | Rest | |
| 5s | 10s | 0- 25mm Hg |
| 10s | 20s | 0- 50mm Hg |
| 30s | 60s | 0-100mm Hg |
5. Statement of Intended Use
The Contimed Pressure Biofeedback device is intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
6. Statement of Technological Characteristics of the Device
a. The proposed Contimed device and the predicate device InCare Contimed II use piezoresistive (strain gauge) pressure sensors. The piezoresistive elements are connected in a Wheatstone bridge configuration. The pressure sensor used in the predicate device InCare Contimed II has internal temperature compensation and internal zeroing adjustment. The pressure sensor used in the proposed Contimed device does not have those two functions internal to its construction. These differences between the proposed and predicate device are not significant issues because: 1. The temperature range in which the devices are used is narrow (e.g. room temperature) and 2. The transducer zeroing is not a critical issue because these products are used for relative measurements. That is, any offsets and resting pressures are "zeroed out" by patient (using the zero button or slide potentiometer) when the exercise is started. However, the proposed Contimed device does have a calibration potentiometer on the circuit board which is used to adjust the pressure sensing circuitry during the manufacturing process.
b.
Comparison of the Similarities and Differences of InCare Contimed Pressure Biofeedback device and InCare Contimed II Biofeedback device, K891774 (8/23/89)
| Characteristic | Proposed device
Contimed Pressure Biofeedback
device | Predicate device
Contimed II Biofeedback device
K891774 (08/23/89) |
|--------------------|------------------------------------------------------------|--------------------------------------------------------------------------|
| Intended Use | Treatment of female urinary
incontinence | Treatment of female urinary
incontinence |
| Power Source | 9 Volt alkaline battery | 9 Volt alkaline battery |
| Sensitivity levels | 0-25mm Hg | 0-25cm H2O |
| | 0-50mm Hg | 0-50cm H2O |
| | 0-100mm Hg | 0-100cm H2O |
3
| Work Period (sec) | 5, 10, 30 (preset) | 5, 10, 30 (preset) or option of care-giver to set the patient's individual therapeutic needs. |
|---|---|---|
| Rest Period (sec) | 10, 20, 60 (preset) | 10, 20, 60 (preset) or option of care-giver to set the patient's individual therapeutic needs. |
| Session Length (min) | Labeling recommends no longer than 30 minutes | Labeling recommends no longer than 30 minutes, automatic shut-off after 15 minutes. |
| Recommended Probes | InCare Anal probe, Stock 9586 (K891774) | |
| InCare Vaginal probe, Stock 9585 (K891774) | InCare Anal probe, Stock 9586 (K891774) | |
| InCare Vaginal probe, Stock 9585 (K891774) | ||
| Indication of Contraction Force (Feedback Provided to User) | 1. Optional audio intensity increases or decreases with increase or decrease in contraction force. |
- Visual display - vertical column of lights. Number of lights illuminated increases or decreases with increase or decrease in contraction force. | 1. Optional audio intensity increases or decreases with increase or decrease in contraction force.
- Visual display - 30° angle of horizontal lights. Number of lights illuminated increases or decreases with increase or decrease in contraction force. |
| Machine Controls | Slide switch controls. | Membrane switch controls. |
| Patient data | Does not save patient data. | Has built in 30 day diary to monitor patient progress. |
| Pressure Zeroing Function | Slide potentiometer. | Membrane switch. (single press) |
| Transducer Type | Piezoresistive (strain gauge) | Piezoresistive (strain gauge), internal |
Hollister Incorporated Contimed Pressure Biofeedback Device
7. Conclusion
Based upon the information presented above it is concluded that the proposed Contimed
Pressure Biofeedback device is safe and effective for its intended use and instruction i Pressure Biofeedback device is safe and effective for its intended that the proposed Contined
Pressure Biofeedback device is safe and effective for its intended use and is su