Who is the manufacturer of INTONEMV?

Incontrol Medical, LLC filed the 510(k) submission for INTONEMV (K134020).

What is the FDA product code for INTONEMV?

KPI. It is classified under 21 CFR 876.5320 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for INTONEMV?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INTONEMV?

InTone (K110179); evadri Bladder Control Systems (K050483).

Who can help prepare an FDA 510(k) submission like INTONEMV?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INTONEMV

K134020 · Incontrol Medical, LLC · KPI · Feb 25, 2014 · Gastroenterology, Urology

Device Facts

Record ID	K134020
Device Name	INTONEMV
Applicant	Incontrol Medical, LLC
Product Code	KPI · Gastroenterology, Urology
Decision Date	Feb 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5320
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

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

Device Story

InToneMV is a pelvic floor muscle stimulator for treating urinary and fecal incontinence. The device consists of an insertion unit (inflatable probe with stainless steel electrodes and internal pressure sensor), a control unit, and clinician software. The patient inserts the probe into the vagina or rectum and manually inflates it for a customized fit. The device delivers electrical stimulation to induce pelvic floor muscle contraction and uses manometry to provide visual biofeedback on a graph via the control unit. Used in clinics or at home under physician direction. The control unit stores session data for clinician review at follow-up visits. The software allows clinicians to program the control unit and display session results. The device aids in muscle re-training and strengthening, potentially improving patient urinary and fecal control.

Clinical Evidence

Clinical evaluations were completed to support safety and effectiveness. No specific quantitative clinical metrics (e.g., p-values, sensitivity) were provided in the summary; however, the device passed all performance, software, electrical safety, EMC, and biocompatibility bench testing.

Technological Characteristics

Device uses dual-phase rectangular pulses (0-50 Hz, 200 µs/phase) for electrical stimulation. Materials include ABS plastics for the control housing, silicone and plastics for the insertion unit, and silicone for tubing. Powered by 4/5 AA nickel metal hydride battery. Features manometric biofeedback (0-2 psi). Software-controlled with moderate level of concern. Operates via regulated voltage (max 50 Vdc, 100 mA).

Indications for Use

Indicated for male and female patients suffering from urinary and fecal incontinence requiring electrical stimulation or visual manometric biofeedback for muscle re-education and treatment.

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)
evadri Bladder Control Systems (K050483)

Submission Summary (Full Text)

{0}------------------------------------------------ FEB 25 2014 ### Traditional 510(k) Submission IN TONE MV INCON 3225 Gateway Road, Ste. 2 Brookfield, WI 53045 ## 7. 510(k) Summary ### Submission Date December 27th, 2013 ### Submitter Information Jessica Andreshak Director of Quality Assurance and Regulatory Affairs InControl Medical, LLC 3225 Gateway Road, Ste. 250, Brookfield, WI 53045 USA Phone: (262) 373.0422 Fax: (262) 373.0463 Email: jandreshak@incontrolmedical.com ### Device Information #### Table 4. Device Information | Type of 510(k): | Traditional 510(k) | |--------------------------------|-----------------------------------------------------------| | Common Name: | Pelvic Floor Muscle Stimulator | | Trade Name (proprietary name): | InToneMV | | Classification name: | Stimulator, Electrical, Non-Implantable, For Incontinence | | Classification Regulation: | 21 CFR 876.5320 | | Class: | Class II | | Product Code: | KPI | ### Legally Marketed Device for Substantial Equivalence | Table 5. Predicate Device Information | | | | | | |---------------------------------------|--|--|--|--|--| |---------------------------------------|--|--|--|--|--| | 510(k) | Name | Product Code | Manufacturer | |---------|-----------------------------------|--------------|-----------------------------------------------------------------------------------| | K110179 | InTone | KPI | InControl Medical, LLC 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 USA | | K050483 | evadri Bladder Control Systems | KPI | HOLLISTER, Inc. 2000 Hollister Dr. Libertyville, IL 60048 USA | {1}------------------------------------------------ 3225 Gateway Road, Brookfield, WI 53045 Traditional 510(k) Submission IN TONEMV #### Device Summary The InToneMV device includes three parts: an insertion unit, control unit, and a software application for clinicians. Each of these parts are summarized below: - The insertion unit includes (1) an inflation bulb, (2) the customizable inflatable probe, . and (3) the flexible tubing connecting the inflation bulb and the inflatable probe. The inflatable probe is inserted into the vagina or rectum and manually inflated by the patient to ensure 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 provide 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. #### Intended Use InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence. ### Equivalence Comparison to the Predicate The intended use, technology, engineering, performance and user interface for InToneMV is substantially equivalent to the predicate devices as summarized in the chart below. | Feature/ Function | InTone (K110179) | evadri Bladder Control Systems (K050483) | InToneMV (New Device) | Comparison | Impact on Safety and Performance | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------| | Intended Use An explicit description of all clinical functions performed by the device, Indications for Use Explain when the device is to be clinically used and the intended patient population | The InControl 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. | The evadri Bladder Control System is intended to provide electrical stimulation or electromyographic or pressure feedback for the treatment of urinary and fecal (electromyographic biofeedback) incontinence. | InToneMV is intended to be used in males and females for the treatment of urinary and fecal incontinence. | Substantially equivalent | None | | Feature/ Function | InTone (K110179) | evadri Bladder Control Systems (K050483) | InToneMV (New Device) | Comparison | Impact on Safety and Performance | | Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation EMG Biofeedback | Delivery of electrical stimulation Visual Biofeedback | Substantially equivalent | None | | Warnings or Precautions | (see product labeling) | (see product labeling) | (see product labeling) | Substantially equivalent | None | | Labeling Summary Clarity to insure safer or more effective use | User Manual | User Manual | User Manual | Substantially equivalent | None | | Environmental Specifications | For indoor use only | For indoor use only | For indoor use only | Identical | None | | Power Source | 4/5 AA nickel metal hydride battery | Isolated AC to DC power adapter, 115/230VAC switchable input to 6VDC output | 4/5 AA nickel metal hydride battery | Substantially equivalent | None | | Method of line current isolation | n/a (battery) | Unknown | n/a (battery) | Substantially equivalent | None | | Patient leakage current | n/a (battery) | Unknown | n/a (battery) | Substantially equivalent | None | | Number of output modes | 1 | 1 | 1 | Substantially equivalent | None | | Number of output channels | 1 | 1 | 1 | Substantially equivalent | None | | Regulated current or voltage? | Regulated voltage | Unknown | Regulated voltage | Substantially equivalent | None | | Firmware controlled? | Yes | Yes | Yes | Identical | None | | Automatic Overload Trip? | Yes | Unknown | N/A | Substantially equivalent | None | | Automatic No-Load Trip? | Yes | Unknown | N/A | Substantially equivalent | None | | Automatic Shut Off? | Yes | Unknown | Yes | Substantially equivalent | None | | Indicator Display On/Off Status Low Battery | Yes Yes | Unknown | Yes (via display illumination) Yes | Substantially equivalent | None | | Waveform, shape | Dual phase, rectangular pulses | Balanced biphasic, no DC component | Dual phase, rectangular pulses | Substantially equivalent | None | | Frequency Mixed Stress Urge | 50 Hz | 10, 12.5, 20, 50, 100, 200 HZ | 0 - 50 Hz | Substantially equivalent | None | | Pulse width Mixed Stress Urge | 200 µs/phase | 0.3, 1 ms | 200 µs/phase | Substantially equivalent | None | | Time On Off | 20 seconds 10 seconds | 1-80 seconds 0-80 seconds | 0 - 20 seconds 0 - 20 seconds | Substantially equivalent | None | | Total Session Time | 12 mins | 1 - 30 minutes | 0-30 minutes | Substantially equivalent | None | | Max output voltage (5000) | 50 Vdc | 0-30 Vdc | 50 Vdc | Substantially equivalent | None | | Feature/ Function | InTone (K110179) | evadri Bladder Control Systems (K050483) | InToneMV (New Device) | Comparison | Impact on Safety and Performance | | Max output current (500Ω) | 100 mA | 100 Vdc | 100 mA | Substantially equivalent | None | | Maximum phase charge (500Ω) | 50 μC | Unknown | 50 μC | Substantially equivalent | None | | Electrode surface area | 10.5 cm² x 2 | Various | 2.5 cm² ± 0.5 cm² (x 2) | Substantially equivalent | None | | Max current density | 4.7 mA/ cm² | Unknown | 20 mA/ cm² | Substantially equivalent | None | | Max average power density (500Ω) | 2.38 mW/cm² | Unknown | 10 mW/cm² | Substantially equivalent | None | | Biofeedback | Air pressure, 0 - 2 psi | EMG Pressure, 0 - 350 cm H2O or combination | Manometric Air pressure, 0 - 2 psi | Substantially equivalent | None | | Dimensions | 8 x 5 x 4 inches (Inflatable Probe, uninflated) | 100 x 70 x 130 mm | Control Unit: 4.8" x 2.4" x 1.1" (+/- 1.0") Inflation bulb: 7.7" x 2.3" x 3.9" (+/- 2.0") Inflatable Probe (with handle): 4.8" x 1.0" x 1.5" (+/- 1.5") Tubing: Maximum 41" long | Substantially equivalent | None | | Control housing material | ABS plastics | Plastics | ABS plastics | Substantially equivalent | None | | Insertion material | Silicone, plastics | Plastics | Silicone, plastics | Substantially equivalent | None | | Tubing Material | NA | N/A | Silicone | Substantially equivalent | None | | Packaging or Expiration Dating | 1 year for insertion unit | N/A | N/A | Substantially equivalent | None | | Sterilization | N/A | N/A | N/A | Identical | None | | Operational Method: Clinical Use e.g., ambulatory use, home use | Clinic or Home use, under direction of physician | Unknown | Clinic or Home use, under direction of physician | Substantially equivalent | None | | Patient Interaction: Functions Controllable: An explanation of how the device interacts with the patient. | 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. | Unknown | 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. | Substantially equivalent | None | | Patient Interaction: Programming Capability Whether the device can be programmed and to what extent | None, programming can only be changed by clinician | Unknown | None, programming can only be changed by clinician | Substantially equivalent | None | | Override | Yes | Unknown | Yes | Substantially equivalent | None | | Patient Interaction: Operator Requirements Knowledge or training required of the operator, | 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 | Substantially equivalent | None | | Software Level of | Moderate | Unknown | Moderate | Substantially equivalent | None | Confidential {2}------------------------------------------------ # INCONTRONT ### Traditional 510(k) Submission IN TONE MV . .... K134020 Page 3 of 5 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 11 | Page : " · ( {3}------------------------------------------------ INCONT 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 ### Traditional 510(k) Submission K134020 Page 4 of 5 INTONE MV : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : - : 12 | P a g e {4}------------------------------------------------ INCON 3225 Gateway Road, Ste Brookfield, WI 53045 N TONEMV ### Testing Summary The testing for InToneMV included performance, software, electrical safety, EMC and biocompatibility. InToneMV successfully passed all testing. Clinical evaluations for InToneMV have been completed to support the device as safe and effective according to the intended use. #### Risk Management Summary InToneMV has been designed according to InControl Medical's internal procedures with clear traceability between the design inputs, design outputs verification and validation activities. InToneMV has been evaluated for risks according to InControl Medical's internal procedures based on ISO 14971. The risks associated with InToneMV were reduced to as low as possible and the risk/benefit analysis was acceptable. ### Conclusion InTone is substantially equivalent to the predicate devices. The data collected and documented throughout this submission provides objective evidence that InToneMV performs as well as or better than the predicate devices for the treatment of incontinence. {5}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 25, 2014 InControl Medical, LLC Jessica Andreshak Director of Quality Assurance and Regulatory Affairs 3225 Gateway Road, Suite 250 Brookfield, WI 53045 - Re: K134020 Trade/Device Name: InToneMV Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI, HCC Dated: January 4, 2014 Received: February 5, 2014 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. {6}------------------------------------------------ Page 2 - Jessica Andreshak 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 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/gefault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/6/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a simple, sans-serif font. The letters are black against a white background, creating a clear contrast. The "P. Lerner" part of the name is stylized with some decorative elements around the letters. The overall impression is clean and professional. 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo and address of InControl Medical. The logo features the company name in bold, capitalized letters, with the word "MEDICAL" in smaller font beneath "CONTROL". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045. ### 6. Statement of Indications for Use ### 510(k) Number (if known): K134020 Device Name InToneMV ### Indications for Use InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal 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) # Herbert P. Lerne 2014.02.25 1

INTONEMV

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Submission Summary (Full Text)

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Submission Summary (Full Text)

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