PERINEOMETER

K960311 · Hollister, Inc. · HIR · Apr 18, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K960311
• Device Name: PERINEOMETER
• Applicant: Hollister, Inc.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Apr 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Continued 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.

Device Story

Battery-powered biofeedback device for pelvic floor muscle strengthening. Input: air pressure changes within an inflatable anal or vaginal probe during voluntary muscle contractions. Operation: pressure changes registered by piezoresistive strain gauge sensor; signal processed to drive visual (vertical column of lights) and audible (variable intensity tone) feedback. User: patient performs exercises; caregiver selects preset duty cycles (work/rest intervals) and sensitivity levels via slide switches. Output: real-time visual/audible feedback of contraction force. Benefit: enables patient to monitor and improve pelvic floor muscle control through biofeedback. Device does not store patient data.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Piezoresistive (strain gauge) pressure sensor; Wheatstone bridge configuration. 9V alkaline battery powered. Form factor: handheld unit with slide switch controls, vertical LED column display, and inflatable latex probes (anal/vaginal). Calibration potentiometer on circuit board. No internal temperature compensation or automatic zeroing.

Indications for Use

Indicated for patients requiring rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

Regulatory Classification

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.

Predicate Devices

• Perineometer (21 CFR 884.1425)
• InCare Continued II Pressure Biofeedback device (K891774)

Submission Summary (Full Text)

{0}

K960311
APR 18 1996
K960311

Hollister Incorporated
Continued 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.

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K960311

# Hollister Incorporated
## Continued Pressure Biofeedback Device

# Safety and Effectiveness Summary

## 1. Submitter's name, Address and Contact Person

| Submitter | Contact Person |
| --- | --- |
| Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048 | Joseph S. Tokarz
Manager, Regulatory Affairs
Ph [phone]
Fax [phone] |

Date Summary Prepared - January 18, 1996

## 2. Name of Device:

Hollister Continued Pressure Biofeedback device

## 3. Name of Predicate Device(s)

- Perineometer as described in 21 CFR 884.1425
- InCare Continued II Pressure Biofeedback device, K891774 (8/23/89).

## 4. Description of Device

The Continued Pressure Biofeedback device is intended to help strengthen pelvic floor muscles in the treatment of urinary incontinence. The Continued 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 Continued 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 Continued device. The visual display of contraction force gives the patient the ability to see and hear progress in the exercise session. The Continued has a vertical column of lights. The number of the lights illuminated increases or decreases with an increase or decrease 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 Continued Pressure Biofeedback device of both.

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Hollister Incorporated
Continued 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 Continued 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 Continued device and the predicate device InCare Continued 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 Continued II has internal temperature compensation and internal zeroing adjustment. The pressure sensor used in the proposed Continued 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 Continued 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 Continued Pressure Biofeedback device and InCare Continued II Biofeedback device, K891774 (8/23/89)

| Characteristic | Proposed device
Continued Pressure Biofeedback device | Predicate device
Continued 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 |

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# Hollister Incorporated
## Continued Pressure Biofeedback Device

| 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.
2. 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.
2. 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 temperature with compensation and zeroing adjustment |

## 7. Conclusion

Based upon the information presented above it is concluded that the proposed Continued Pressure Biofeedback device is safe and effective for its intended use and is substantially equivalent to the predicate device.