INCONTROL

K110179 · Incontrol Medical, LLC · KPI · Feb 22, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K110179
• Device Name: INCONTROL
• Applicant: Incontrol Medical, LLC
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Feb 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InControl InTone device is a non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles, inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes. Federal (USA) law restricts this device to sale by or on the order of a physician.

Device Story

InControl InTone is a non-implanted electrical stimulator for female urinary incontinence. System comprises an intra-vaginal insertion probe with stainless steel electrodes and a hand-held control unit. Device delivers electrical stimulation to pelvic floor musculature and surrounding structures; provides air-pressure-based biofeedback for muscle re-education. Operated in clinic or home settings under physician direction. Patient controls session start/stop; clinician locks in current parameters. Device records and stores contraction data to assist in determining necessary stimulation levels. Output helps patients strengthen pelvic floor muscles and inhibit detrusor muscle activity, potentially improving urinary control.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing, confirming compliance with applicable standards.

Technological Characteristics

Non-implanted electrical stimulator. Materials: ABS plastic (housing), silicone/plastic (insertion probe), stainless steel (electrodes). Energy: Nickel metal hydride battery. Output: 1 channel, regulated voltage, dual-phase rectangular pulses (50 Hz, 200 µs/phase). Biofeedback: Air pressure (0-2 psi). Connectivity: Standalone. Software: Firmware-controlled with automatic overload/no-load trip and shut-off features. Moderate level of concern.

Indications for Use

Indicated for female patients with mixed urinary incontinence. Used for acute and ongoing treatment to strengthen pelvic floor muscles and inhibit detrusor muscle activity via reflexive mechanisms. Includes biofeedback for muscle re-education.

Regulatory Classification

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).

Predicate Devices

• Otto Bock STIWELL med (K080950)
• MyoTrac Infiniti (K053434)
• Hollister evadri (K050483)

Submission Summary (Full Text)

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## 510(k) Summary for InControl InTone

| Submitter: | | InControl Medical, LLC | | FEB 2 2 2012 |
|-------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------|-----------------|
| Address: | | | 3225 Gateway Road, Suite 250<br>Brookfield, Wisconsin 53045 | |
| Corporate Contact: | | InControl Medical, LLC | Herschel Peddicord, President | |
| Telephone: | | Ph: [phone] | | |
| Establishment Registration #: | | | to be registered following 510(k) | |
| Submission Contact: | | Michael J. Leigh, consultant<br>12715 Falcon Drive<br>Ph: [phone] | Brookfield, Wisconsin 53005 | |
| Trade Name: | InControl InTone | | | |
| Predicate Device: | Otto Bock STIWELL med, K080950<br>MyoTrac Infiniti, K053434<br>Hollister evadri, K050483 | | | |
| Common Name: | | | Stimulator, Electrical, Non-Implantable, for Incontinence | |
| Classification Name: | | | | |
| | | | | Device<br>Class |
| | | | Jon-implanted electrical continen | II |

### Device Description:

The device includes three parts; an insertion probe and a hand-held control unit. The insertion The device includes three parts, an inoortion provides more adaptable fit for intra-vaginal use. The probe includes stainless steel electrodes to deliver electro-stimulation. The hand-held control probe includes stainless steel clours and displays the results of electro-stimulation and patient and ulsplay device records, storos, and alspiary one to select and lock in the correct amount generated pervic noor excressor from to the contraction. It also stores data on contraction of current necessary to stimulate pervice noor ochination to select and lock in the correct amount of current necessary to stimulate pelvic floor contraction.

device

Intended Use:

d Use:
The InControl InTone device is a non-implanted indicated for use in the treatment of The InControl In One device is a non-inplanted electrical stimulation has and manufacture and female urinaly incontinence. It applies electrial only of mixed urinary incontinent surrounding structures. It is intended for active and strengthening of pelvic floor muscles and where the following results may improve unflary bonnery bonnel of the biofeedback feature can be used for muscle re-education purposes.

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Performance Data:

Complete EMC, electrical, mechanical, safety (operator and patient), temperature/humidity, and software testing demonstrate compliance with applicable standards. The results demonstrate that the InControl InTone device is in compliance with the guidelines and standards referenced in the FDA reviewer's guides, and that it performed within its specifications and functional requirements for the device.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with FDA requirements.

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| InControl InTone<br>(new device) | Otto Bock STIWELL med4<br>(K080950) | MyoTrac Infiniti<br>(K053434) | Hollister evadri<br>(K050483) | Comparison |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| The InControl device is a non-implanted<br>electrical stimulator indicated for use in<br>the treatment of female urinary<br>incontinence. It applies electrical<br>stimulation to the pelvic floor musculature<br>and surrounding structures. It is intended<br>for acute and ongoing treatment of mixed<br>urinary incontinence where the following<br>results may improve urinary control:<br>strengthening of pelvic floor muscles,<br>inhibition of the detrusor muscle through<br>reflexive mechanisms. The biofeedback<br>feature can be used for muscle re-<br>education purposes. | The STIWELL med4 is a neuromuscular<br>electronic stimulator for use under<br>medical supervision for adjunctive<br>therapy in the treatment of medical<br>diseases and conditions.<br><br>As a nonimplanted electrical continence<br>device the STIWELL med4 is indicated<br>for the following conditions:<br>Acute and ongoing treatment of<br>stress, urge, or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control: Inhibition of the<br>detruser muscles through reflexive<br>mechanisms and strengthening of<br>the pelvic floor muscles. Incontinence treatment for<br>assessing EMG activity of the<br>pelvic floor and accessory<br>muscles such as the abdominal<br>and the gluteus muscles. As a biofeedback device the STIWELL<br>med4 is indicated for the following<br>conditions:<br>Biofeedback, relaxation and<br>muscle re-education purposes. | Treatment of urinary incontinence<br>EMG biofeedback<br><br>The MyoTrac Infiniti system is indicated for<br>acute and ongoing treatment of stress, urge,<br>or mixed urinary incontinence and where the<br>following results may improve urinary<br>control: Inhibition of the detruser muscle<br>through reflexive mechanisms, strengthening<br>of pelvic floor muscle. It is also indicated<br>during incontinence treatment for assessing<br>EMG activity of the pelvic floor and<br>accessory muscles such as the abdominal or<br>gluteal muscles. | The evadri Bladder Control<br>System is intended to<br>provide electrical<br>stimulation or<br>electromyographic or<br>pressure biofeedback for the<br>treatment of urinary or fecal<br>(electromyographic<br>biofeedback) incontinence. | Equivalent |
| (see product labeling) | (see product labeling) | (see product labeling) | (see product labeling) | Equivalent |

Section 5 - 510(k) Summary.doc

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Section 5 - 510(k) Summary.doc

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| Method of line current<br>Solation | n/a (battery) | n/a (battery) | n/a (battery) | | Identical<br>(to Otto Bock,<br>MyoTrac) |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Patient leakage<br>current | n/a (battery) | n/a (battery) | n/a (battery) | | Identical<br>(to Otto Bock,<br>MyoTrac) |
| Number of output<br>modes | 1 | 1 | 1 | | Identical<br>(to all) |
| Number of output<br>channels | 1 | 1 | 1 | | Identical<br>(to all) |
| Regulated current or<br>Voltage? | Regulated voltage | Regulated current | Unknown | | Equivalent |
| Firmware controlled? | Yes | Yes | Yes | | Identical<br>(to all) |
| Automatic Overload<br>Trip? | Yes | Yes | Unknown | | Identical<br>(to Otto Bock) |
| Automatic No-Load<br>Trip? | Yes | Yes | Unknown | | Identical<br>(to Otto Bock) |
| Automatic Shut Off? | Yes | Yes | Unknown | | Identical<br>(to Otto Bock) |
| Indicator Display<br>On/Off Status<br>Low Battery | Yes | Yes | Yes | | Identical<br>(to Otto Bock,<br>MyoTrac) |
| Waveform, shape | dual phase, rectangular pulses | Biphasic symmetrical rectangular | asymmetric, balanced pulse | Balanced biphasic | Identical |
| Frequency<br>Mixed<br>Stress<br>Urge | 50 Hz | 35 Hz<br>10 Hz | 12.5, 50, 100, 200 Hz | 10, 12.5, 20, 50, 100, 200<br>Hz | Within range<br>(of MyoTrac,<br>Hollister) |
| Pulse width<br>Mixed<br>Stress<br>Urge | 200 µs/phase | 300 µs/phase<br>500 µs/phase | 0.2 ms | 0.3 or 1 ms | Within range |
| Time<br>On<br>Off | 20 secs<br>10 secs | 9 - 12 s for Stress, 13 s for Urge<br>7 - 9 s for Stress, 3 s for Urge | 2- 20 secs<br>2- 50 secs | 1 - 80 secs<br>0 - 80 secs | Equivalent |
| | | 5 - 25 mins | 0 - 120 mins | 1 - 30 mins | Within range |
| Total Session Time | 12 mins | | | | Identical<br>(to Otto Bock) |
| Max output voltage<br>(500Ω) | 50 Vdc | 50 Vdc | 30 Vdc | 30 Vdc | Identical |
| Max output current<br>(500Ω) | 100 mA | 100 mA | 100 mA | 100 mA | Identical<br>(to Otto Bock) |
| Maximum phase<br>charge (500Ω) | 50 µC | 50 μC | 60 µC | Unknown | Equivalent |
| Electrode surface area | 10.5 cm² x 2 | 21.2 cm² | Various, 1.53 cm² to 10.5 cm² | unknown | Identical<br>(to Otto Bock) |
| Max current density | 4.7 mA/cm² | 4.7 mA/cm² | Various, 4.7 mA/cm² to 32 mA/cm² | | Equivalent. |
| Maximum power<br>density (500Ω) | 14.3 µW/cm² | 23.5 µW/cm² | Various, 11.32 µW/cm² to 22.84 μW/cm² | Unknown | Equivalent |
| Biofeedback | Air pressure, 0-2 psi | EMG | EMG | EMG<br>pressure, 0 - 350 cm H₂O<br>or combination | Equivalent<br>(to Hollister) |
| Materials | | | | | |
| | | 175 x 95 x 30 mm | 102 x 152 x 51 mm | 100 x 70 x 130 mm | Equivalent |
| Dimensions | 8 x 5 x 4 inches | | | | |
| Control housing | ABS plastics | plastics | plastics | plastics | Equivalent |
| Insertion material | Silicone, plastics | plastics | plastics | plastics | Equivalent |
| Packaging or<br>Expiration Dating | 1 year for insertion unit | N/A | N/A | N/A | |
| Sterilization | N/A | N/A | N/A | N/A | |
| User Interaction and Software | | | | | |
| Operational Method:<br>Clinical Use<br>(e.g., ambulatory use, home use) | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Clinic or Home use, under direction of physician | Identical<br>(to all) |
| Patient Interaction:<br>Functions<br>Controllable | The patient can control the starting and stopping of each session. However, the device will stop on its own once the session in normally completed. | | | | Equivalent |
| An explanation of how the device interacts with the patient. | | | | | |
| Patient Interaction:<br>Programming<br>Capability | None, programming can only be changed by clinician | None, programming is locked by clinician | None, programming is locked by clinician | | Equivalent<br>(to Otto Bock, MyoTrac) |
| Whether the device can be programmed and to what extent | | | | | |
| Override | Yes | Yes | | | Identical<br>(to Otto Bock) |
| Patient Interaction:<br>Operator<br>Requirements | Intended as part of a complete therapy program with physician coaching. No special knowledge or training; instruction manual provided | Intended as part of a complete therapy program with physician coaching. No special knowledge or training; instruction manual provided | Intended as part of a complete therapy program with physician coaching. No special knowledge or training; instruction manual provided | Intended as part of a complete therapy program with physician coaching. No special knowledge or training; instruction manual provided | Identical<br>(to all) |
| Knowledge or training required of the operator | | | | | |
| Software Level of Concern | Moderate | | | | |
| A statement indicating the Level of Concern and a description of the rationale for that level | | | | | |
| Feature/ Function | InControl InTone<br>(new device) | Otto Bock STIWELL med4<br>(K080950) | MyoTrac Infiniti<br>(K053434) | Hollister evadri<br>(K050483) | Comparison |
| Technology, Engineering, and Performance | | | | | |
| Environmental<br>Specifications | For indoor use only | For indoor use only | For indoor use only | For indoor use only | Identical<br>(to all) |
| Power Source | Nickel metal hydride battery | Li-Ion battery | Four AAA 1.5V alkaline batteries | AC power supply | Equivalent |
| Number of output<br>modes | 1 | 1 | 1 | 1 | Identical<br>(to all) |
| Number of output<br>channels | 1 | 1 | 1 | 1 | Identical<br>(to all) |
| Regulated current of<br>voltage? | Regulated voltage | Regulated current | Unknown | Unknown | Equivalent |
| Firmware controlled? | Yes | Yes | Yes | Yes | Identical<br>(to all) |
| Automatic Overload<br>Trip? | Yes | Yes | Unknown | Unknown | Identical<br>(to Otto Bock) |
| Automatic Shut Off? | Yes | Yes | Unknown | unknown | Identical<br>(to Otto Bock) |
| Indicator Display<br>On/Off Status<br>Low Battery | Yes<br>Yes | Yes<br>Yes | Yes<br>Yes | unknown | Identical<br>(to Otto Bock,<br>MyoTrac) |
| Waveform, shape | dual phase, rectangular pulses | Biphasic symmetrical rectangular | asymmetric, balanced pulse | Balanced biphasic | Identical<br>(to Otto Bock,<br>Hollister) |
| Frequency<br>Mixed<br>Stress<br>Urge | 50Hz | 35 Hz<br>10 Hz | 12.5, 50, 100, 200 Hz | 10, 12.5, 20, 50, 100, 200<br>Hz | Identical<br>(to MyoTrac,<br>Hollister) |
| Pulse width<br>Mixed<br>Stress<br>Urge | 200 µs/phase | 300 µs/phase<br>500 µs/phase | 0.2 ms | 0.3 or 1 ms | Within range |
| Time<br>On<br>Off<br>Total Session Time | 20 secs<br>10 sccs<br>12 mins | 9 - 12 s for Stress, 13 s for Urge<br>7- 9 s for Stress, 3 s for Urge<br>5 - 25 mins | 2 - 20 sccs<br>2 - 50 secs<br>0 - 120 mins | 1 - 80 secs<br>0 - 80 secs<br>1 - 30 mins | Within range |
| Max output voltage<br>(500Ω) | 50 Vdc | 50 Vdc | 30 Vdc | 30 Vdc | Within range<br>Identical<br>(to Otto Bock) |
| Max output current<br>(500Ω) | 100 mA | 100 mA | 100 mA | 100 mA | Identical<br>(to Otto Bock) |
| Maximum phase<br>charge (500Ω) | 50 µC | 50 µC | 60 µC | Unknown | Identical |
| Electrode surface area | 10.5 cm² x 2 | 21.2 cm² | Various, 1.53 cm² to 10.5 cm² | unknown | Equivalent |
| Max current density | 4.7 mA/cm² | 4.7 mA/cm² | Various, 4.7 mA/ cm² to 32 mA/cm² | unknown | Identical |
| Maximum power<br>density (500Ω) | 14.3 µW/cm² | 23.5 µW/cm² | Various, 11.32 µW/ cm² to 22.84 µW/cm² | Unknown | Equivalent |
| Biofeedback | Air pressure, 0.2 psi | EMG | EMG | pressure, 0 - 350 cm H2O<br>or combination | Equivalent<br>(to Hollister) |

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Section 5 - 510(K) Summary.doc

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Section 5 - 510(k) Summary.doc

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

InControl Medical, LLC % Mr. Michael J. Leigh Consultant 12715 Falcon Drive BROOKFIELD WI 53005

FEB 2 2 2012

Re: K110179

Trade/Device Name: InControl InTone Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: January 24, 2011 Received: January 31, 2012

Dear Mr. Leigh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may were revelsions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de roo additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r load of act how a a determination that your device complies with other requirements of the Act that I DTPhas intatutes and regulations administered by other Federal agencies. You must or unf I edolul StatuteD and regurements, including, but not limited to: registration and listing confirs min an an and 110 room g (21 CFR Part 801); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Twichell

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K110179

InControl InTone Device Name:

Indications For Use:

The InControl InTone device is a non-implanted electrical stimulator indicated for use in the the incontrol in the devious is a non-mail.com income electrical stimulation to the pelvic floor treatment of lemale unnery incontinents. It is intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: mixed "unlary" incontinence" whole the religition of the detrusor muscle through reflexive strengthening of powle feature can be used for muscle re-education purposes.

Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Kohl

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110179

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