InTone

K150180 · Incontrol Medical, LLC · KPI · Mar 16, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150180
• Device Name: InTone
• Applicant: Incontrol Medical, LLC
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Mar 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.

Device Story

InTone is a non-implanted electrical continence device used in clinic or home settings under physician direction. It consists of an insertion unit (inflatable probe with stainless steel electrodes and pressure sensor), a control unit, and a clinician software application. The patient inserts the probe and manually inflates it for a customized fit. The device delivers electrical stimulation to induce pelvic floor muscle contraction and monitors volitional contractions via manometric pressure sensing. The control unit provides visual biofeedback graphs to encourage muscle re-training and records session data for clinician review. Clinicians use the software to program the control unit and lock in stimulation levels. The device aims to strengthen pelvic floor muscles and inhibit detrusor muscle activity, potentially improving urinary control and reducing incontinence symptoms.

Clinical Evidence

No new clinical data was generated. Evidence relies on bench testing (electrical safety, EMC, biocompatibility) performed on predicate devices (K110179, K134020) and a clinical literature review. The literature review included a published article search and a MAUDE database search to support the safety and efficacy of electrical stimulation for female urinary incontinence.

Technological Characteristics

Non-implanted electrical muscle stimulator. Materials: ABS plastic (housing), silicone/plastic (insertion unit). Energy: 4/5 AA NiMH battery. Sensing: Manometric pressure sensor (0-2 psi). Output: Monophasic, alternating polarity, square pulses; 13 Hz/50 Hz frequency; 200 µs/phase pulse width. Connectivity: Clinician software application for programming. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-1. Software: Moderate level of concern.

Indications for Use

Indicated for female patients with urinary incontinence to provide electrical stimulation and/or visual biofeedback for pelvic floor muscle strengthening and 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

• InTone (K110179)
• InToneMV (K134020)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

InControl Medical, LLC. Jessica Andreshak Director of Quality Assurance/Regulatory Affairs 3225 Gateway Road, Ste. 250 Brookfield, Wisconsin 53045

Re: K150180 Trade/Device Name: InTone Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI, HIR Dated: January 26, 2015 Received: January 27, 2015

Dear Jessica Andreshak,

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 commerce prior 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 general controls provisions 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 may be subject to 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for 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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Image /page/2/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The address is 3225 Gateway Road, Ste. 250, Brookfield, WI 53045. The logo features the words "InControl" in a stylized font, with the word "MEDICAL" underneath.

Image /page/2/Picture/2 description: The image shows the logo for InTone. The logo is purple and features the word "InTone" in a sans-serif font. To the left of the word "InTone" is a circular design made up of curved lines. The logo is simple and modern.

## 6. Statement of Indications for Use

## 510(k) Number (if known):

### Device Name

InTone

## Indications for Use

InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.

Prescription Use _____X__ (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)

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Image /page/3/Picture/0 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl" in a sans-serif font, with the word "MEDICAL" in a smaller font below. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/3/Picture/2 description: The image shows the logo for InTone. The logo features the word "InTone" in a stylized font, with the "I" being larger than the other letters. To the left of the word is a circular design with curved lines. The color scheme is a muted purple.

# 7. 510(k) Summary

## Submission Date

January 26, 2015

## Submitter Information

Jessica Andreshak Director of Quality Assurance and Regulatory Affairs InControl Medical, LLC 3225 Gateway Road, Ste. 250, Brookfield, WI 53045 USA Phone: [phone] Fax: [phone] Email: [e-mail]

## Device Information

| Table 7.1 Device Information | |
|--------------------------------|-----------------------------------------------------------------------------------|
| Type of 510(k): | Traditional 510(k) |
| Common Name: | Pelvic Floor Muscle Stimulator |
| Trade Name (proprietary name): | InTone |
| Classification name: | Stimulator, Electrical, Non-Implantable, For Incontinence<br>Device, Perineometer |
| Classification Regulation: | 21 CFR 876.5320<br>21 CFR 884.1425 |
| Class: | Class II |
| Product Code: | KPI<br>HIR |

Table 7.1 Device Information

## Legally Marketed Device for Substantial Equivalence

| 510(k) | Name | Product Code | Manufacturer |
|---------|----------|--------------|-----------------------------------------------------------------------------------|
| K110179 | InTone | KPI | InControl Medical, LLC<br>3225 Gateway Road, Ste. 250<br>Brookfield, WI 53045 USA |
| K134020 | InToneMV | KPI/HCC | InControl Medical, LLC<br>3225 Gateway Road, Ste. 250<br>Brookfield, WI 53045 USA |

Table 7.2 Predicate Device Information

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Image /page/4/Picture/0 description: The image shows the logo for InControl Medical, followed by the address 3225 Gateway Road, Ste. 250, and the city, state, and zip code, Brookfield, WI 53045. The logo is a light blue circle with white lines inside, followed by the word "InControl" in dark gray. Below the word "InControl" is the word "Medical" in a smaller, light gray font. The address is in a dark gray font.

Image /page/4/Picture/2 description: The image shows the logo for InTone. The logo features the word "InTone" in a serif font, with the "I" and "T" capitalized. To the left of the word is a circular design with a pattern of curved lines. The color scheme is a light purple.

### Device Summary

The InTone device includes three parts: an Insertion Unit, a Control Unit, and a Software Application for clinicians. Each of these parts are summarized below:

- The Insertion Unit includes an inflation pump and an inflatable probe. The inflatable probe is inserted into the vagina and the inflation pump is used by the patient to manually inflate the probe, ensuring a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Biofeedback is monitored via a pressure sensor within the Insertion Unit which records changes in pressure related to volitional muscle contraction.
- The Control Unit includes user keys to initiate and control treatment sessions, and a visual biofeedback graph to encourage muscle re-training. The Control Unit is designed to record and store results of the electrical stimulation and biofeedback sessions for clinician review at follow-up visits.
- The Software Application is utilized by the clinician to program the Control Unit and display the results of electrical stimulation and biofeedback sessions. The Software Application allows the clinician to select and lock in the appropriate electrical stimulation level necessary to stimulate pelvic floor contraction.

## Intended Use

InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence.

#### Equivalence Comparison to the Predicate

Electrical muscle stimulation and biofeedback are the technological principles for InTone and the predicate devices. It is based on the use of the electrical muscle stimulator and/or biofeedback to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and different technological elements. The intended use, technology, engineering, performance and user interface for InTone is substantially equivalent to the predicate devices.

| Feature/ Function | InTone<br>(K110179) | InToneMV<br>(K134020) | InTone<br>(New Device) | Comparison | Impact on<br>Safety and<br>Performance |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------|
| Intended Use<br>An explicit<br>description of all<br>clinical functions<br>performed by the<br>device.<br>Indications for<br>Use<br>Explain when the<br>device is to be<br>clinically used and<br>the intended<br>patient population | The InControl device is a non-implanted<br>electrical stimulator indicated for use in the<br>treatment of female urinary incontinence.<br>It applies electrical stimulation to the pelvic<br>floor musculature and surrounding<br>structures. It is intended for acute and<br>ongoing treatment of mixed urinary<br>incontinence where the following results<br>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. | InToneMV is intended to provide<br>electrical stimulation and/or visual<br>biofeedback (via manometry) for<br>the treatment of male and female<br>urinary and fecal incontinence. | InTone is intended to provide<br>electrical stimulation and/or visual<br>biofeedback (via manometry) for<br>the treatment of female urinary<br>incontinence. | Substantially<br>equivalent | None |
| Feature/ Function | InTone<br>(K110179) | InToneMV<br>(K134020) | InTone<br>(New Device) | Comparison | Impact on<br>Safety and<br>Performance |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation<br>Visual Biofeedback | Delivery of electrical stimulation<br>Visual Biofeedback | Identical<br>to InToneMV | None |
| Warnings or<br>Precautions | (see product labeling) | (see product labeling) | (see product labeling) | Substantially<br>equivalent | None |
| Contraindications<br>Explain when the<br>device is not to be<br>clinically used | • This device is not intended for diagnostic<br>purposes or critical patient monitoring.<br>• The device is not defibrillator proof.<br>• The device should not be used on<br>patients with cardiac pacemaker,<br>implanted defibrillator, or other<br>implanted metallic or electronic device.<br>• Do not use if patient has a history of rate<br>or conductive disturbance.<br>• Do not use if patient has symptoms of an<br>active urinary tract infection.<br>• Do not use if the patient has vaginal<br>infections, localized lesions, or other<br>undiagnosed symptoms.<br>• Do not use if patient has undiagnosed<br>pain.<br>• Do not use if patient has a neurological<br>deficiency that does not permit proper<br>sensory perception or stimulation.<br>• Do not use if patient has diminished<br>mental capacity or physical competence<br>that limits use of the device or<br>interaction with the care provider<br>regarding the device settings.<br>• Do not use if patient is currently<br>pregnant or attempting to get pregnant.<br>• Do not use if patient has anatomical<br>vaginal structures that do not permit<br>proper and complete placement of the<br>Insertion Unit.<br>• Do not use if the patient has irregular<br>menstrual bleeding cycles.<br>• Do not use if the patient has a history or<br>symptoms of urinary retention.<br>• Do not use if the patient has extra-<br>urethra incontinence, (i.e. syrinx,<br>ectopic, urethra).<br>• Do not use if the patient has overflow<br>incontinence caused by evacuation<br>problems.<br>• Do not use if the patient has severe<br>urine retention in the upper urethras.<br>• Do not use if the patient has complete<br>peripheral denervation of the pelvic<br>floor.<br>• Do not use if the patient has an intestinal<br>clamp. | • Patients with a pacemaker or<br>implanted defibrillator require<br>cardiac clearance before<br>electrical stimulation is offered.<br>• Patients with symptoms of<br>active urinary tract infection,<br>vaginal infections, localized<br>lesions, or other undiagnosed<br>symptoms.<br>• Patient has extra-urethra<br>incontinence, (i.e. syrinx,<br>ectopic, urethra).<br>• Patient has overflow<br>incontinence caused by<br>evacuation problems.<br>• Patient has severe urine<br>retention in the upper urethra<br>or other symptoms of urine<br>retention.<br>• Patients with neurological<br>deficiency that does not permit<br>proper sensory perception of<br>stimulation or complete<br>denervation of the pelvic floor.<br>• Patients with cognitive<br>disabilities, i.e.; Alzheimer's<br>disease or dementia.<br>• Patients who are currently<br>pregnant or attempting to get<br>pregnant.<br>• Patients with anatomical pelvic<br>structures that do not permit<br>proper and complete placement<br>of the Insertion Unit.<br>• Patients with active pelvic<br>malignancy.<br>• Patients with an intestinal<br>clamp.<br>• Patients should be 6 weeks post-<br>pelvic surgery or vaginal<br>childbirth.<br>• Device should not be used for<br>diagnostic purposes or critical<br>patient monitoring.<br>• Device is not (external)<br>defibrillator-proof. | • Patients with a pacemaker or<br>implanted defibrillator require<br>cardiac clearance before<br>electrical stimulation is offered.<br>• Patients with symptoms of<br>active urinary tract infection,<br>vaginal infections, localized<br>lesions, or other undiagnosed<br>symptoms.<br>• Patient has extra-urethra<br>incontinence, (i.e. syrinx,<br>ectopic, urethra).<br>• Patient has overflow<br>incontinence caused by<br>evacuation problems.<br>• Patient has severe urine<br>retention in the upper urethra<br>or other symptoms of urine<br>retention.<br>• Patients with neurological<br>deficiency that does not permit<br>proper sensory perception of<br>stimulation or complete<br>denervation of the pelvic floor.<br>• Patients with cognitive<br>disabilities, i.e.; Alzheimer's<br>disease or dementia.<br>• Patients who are currently<br>pregnant or attempting to get<br>pregnant.<br>• Patients with anatomical pelvic<br>structures that do not permit<br>proper and complete placement<br>of the Insertion Unit.<br>• Patients with active pelvic<br>malignancy.<br>• Patients with an intestinal<br>clamp.<br>• Patients should be 6 weeks post-<br>pelvic surgery or vaginal<br>childbirth.<br>• Device should not be used for<br>diagnostic purposes or critical<br>patient monitoring.<br>• Device is not (external)<br>defibrillator-proof. | Identical<br>to InToneMV | None |
| Labeling<br>Summary<br>Clarity to insure<br>safer or more<br>effective use | User Manual | User Manual | User Manual | Substantially<br>equivalent | None |
| Environmental<br>Specifications | For indoor use only | For indoor use only | For indoor use only | Identical | None |
| Power Source | 4/5 AA nickel metal hydride battery | 4/5 AA nickel metal hydride<br>battery | 4/5 AA nickel metal hydride<br>battery | Identical | None |
| Method of line<br>current isolation | n/a (battery) | n/a (battery) | n/a (battery) | Identical | None |
| Feature/ Function | InTone<br>(K110179) | InToneMV<br>(K134020) | InTone<br>(New Device) | Comparison | Impact on<br>Safety and<br>Performance |
| Patient leakage<br>current | n/a (battery) | n/a (battery) | n/a (battery) | Identical | None |
| Number of output<br>modes | । | 1 | 1 | Identical | None |
| Number of output<br>channels | 1 | 1 | 1…