ApexM

K150183 · Incontrol Medical, LLC · KPI · Apr 9, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150183
• Device Name: ApexM
• Applicant: Incontrol Medical, LLC
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Apr 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

Device Story

ApexM is a hand-held, home-use device for female urinary incontinence. It features an inflatable probe inserted vaginally and manually inflated by the user for a customized fit. Stainless steel electrodes on the probe deliver electrical stimulation to pelvic floor muscles. High-frequency stimulation (50 Hz) targets specific muscles to encourage contraction and strengthening; low-frequency stimulation (13 Hz) inhibits the detrusor muscle to reduce urgency. The user controls stimulation levels via push-button controls. The device provides a 10-15 minute session (5-10 minutes stimulation, 5 minutes self-directed contraction). It benefits patients by training pelvic floor muscles to hold contractions longer and reducing urge symptoms. The device is intended for over-the-counter use; no physician oversight is required. Users rely on provided labeling, instructions, and educational materials to self-identify suitability.

Clinical Evidence

No new clinical trials were conducted. Evidence consists of a clinical literature evaluation supporting the safety and efficacy of electrical stimulation for female urinary incontinence. A human factors/usability study performed on the predicate Apex (K141158) demonstrated that users can safely self-diagnose and operate the device using provided labeling and instructions.

Technological Characteristics

Non-implanted electrical muscle stimulator. Materials: Silicone and plastics (insertion unit). Energy source: 4 AAA alkaline batteries. Output: Monophasic, alternating polarity, square pulse; 13 Hz and 50 Hz frequencies; 200 µs/phase pulse width. Regulated voltage. Connectivity: Standalone. Software: Firmware-controlled, moderate level of concern. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-1.

Indications for Use

Indicated for women with stress, urge, and/or mixed urinary incontinence to improve pelvic floor muscle strength and support. Contraindicated for pregnant women, those attempting pregnancy, patients with cardiac demand pacemakers or implanted defibrillators, active urinary tract or vaginal infections, localized lesions, extra-urethral or overflow incontinence, severe urine retention, poor pelvic sensation, cognitive disabilities (e.g., Alzheimer's, dementia), active pelvic cancer, intestinal clamps, or those unable to properly insert the device. Must be 6 weeks post-pelvic surgery or vaginal childbirth.

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)
• Apex (K141158)

Reference Devices

• InToneMV (K131420)

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right.

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

April 9, 2015

InControl Medical, LLC Jessica Andreshak Director of Quality Assurance and Regulatory Affairs 3225 Gateway Road, Suite. 250 Brookfield, WI 53045

Re: K150183 Trade/Device Name: ApexM Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: KPI 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,

Benjamin R. Fisher -S

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 logo features the word "InControl" in a gray 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.

## 6. Statement of Indications for Use

## 510(k) Number (if known) K150183

### Device Name

ApexM

## Indications for Use

ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

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

Over-The-Counter Use ____X (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 for InControl Medical, along with their address. The logo features the company name in a stylized font, with the word "InControl" in a larger font than "Medical". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

## 510(k) Summary

## Submission Date

January 26th, 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): | ApexM |
| 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

| 510(k) | Name | Product Code | Manufacturer |
|---------|--------|--------------|-----------------------------------------------------------------------------------|
| K110179 | InTone | KPI | InControl Medical, LLC<br>3225 Gateway Road, Ste. 250<br>Brookfield, WI 53045 USA |
| K141158 | Apex | KPI | 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, along with their address. The logo features the word "InControl" in a dark gray font, with the word "MEDICAL" in a smaller font below it. To the left of the word "InControl" is a light blue circle with white lines inside. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

## Device Summary

ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user 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. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

### Intended Use

ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.

## Equivalence Comparison to the Predicate

Electrical muscle stimulation is the technological principle for ApexM and the predicate devices. It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and unique technological elements between ApexM and the predicate devices. The intended use, technology, engineering, performance and user interface for ApexM is substantially equivalent to the predicate devices.

| Feature/ Function | K110179 InTone<br>(Predicate) | K141158 Apex<br>(Predicate) | ApexM<br>(New Device) | Comparison | Impact on Safety and<br>Performance |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>An explicit<br>description of all<br>clinical functions<br>performed by the<br>device<br><br>Indications for Use<br>Explain when the<br>device is to be<br>clinically used and<br>the intended patient<br>population | The InControl device is a non-<br>implanted electrical<br>stimulator indicated for use in<br>the treatment of female<br>urinary incontinence. It<br>applies electrical stimulation<br>to the pelvic floor<br>musculature and surrounding<br>structures. It is intended for<br>acute and ongoing treatment<br>of mixed urinary incontinence<br>where the following results<br>may improve urinary control. | Apex is a non-implanted<br>muscle stimulator designed to<br>treat female stress urinary<br>incontinence. It applies<br>stimulation to the pelvic floor<br>muscles to improve strength<br>and support. | ApexM is a non-implanted<br>muscle stimulator designed to<br>treat stress, urge and/or<br>mixed urinary incontinence in<br>women. It applies stimulation<br>to the pelvic floor muscles<br>and surrounding structures to<br>improve strength and<br>support. | Substantially<br>equivalent | None:<br>These devices apply<br>electrical stimulation to<br>strengthen the pelvic floor<br>muscles, as supported by<br>literature. |
| Feature/ Function | K110179 InTone<br>(Predicate) | K141158 Apex<br>(Predicate) | ApexM<br>(New Device) | Comparison | Impact on Safety and<br>Performance |
| | strengthening of pelvic floor<br>muscles, inhibition of the<br>detrusor muscle through<br>reflexive mechanisms. The<br>biofeedback feature can be<br>used for muscle re-education<br>purposes. | | | | |
| Primary Function | Delivery of electrical<br>stimulation | Delivery of electrical<br>stimulation | Delivery of electrical<br>stimulation | Identical | None |
| Warnings or<br>Precautions | (see product labeling) | (see product labeling) | (see product labeling) | Identical to<br>Apex | None:<br>ApexM warnings and<br>precautions are identical to<br>Apex, which were defined<br>according to the FDA<br>guidance document and<br>validated through the<br>Human Factors and<br>Usability Testing. |
| Contraindications<br>Explain when the<br>device is not to be<br>clinically used | • This device is not intended<br>for diagnostic purposes or<br>critical patient monitoring.<br>• The device is not<br>defibrillator proof.<br>• The device should not be<br>used on patients with<br>cardiac pacemaker,<br>implanted defibrillator, or<br>other implanted metallic or<br>electronic device. Do not<br>use if patient has a history<br>of rate or conductive<br>disturbance<br>• Do not use if patient has<br>symptoms of an active<br>urinary tract infection<br>• Do not use if the patient<br>has vaginal infections,<br>localized lesions, or other<br>undiagnosed symptoms.<br>• Do not use if patient has<br>undiagnosed pain.<br>• Do not use if patient has a<br>neurological deficiency that<br>does not permit proper<br>sensory perception or<br>stimulation<br>• Do not use if patient has<br>diminished mental capacity<br>or physical competence<br>that limits use of the device<br>or interaction with the care<br>provider regarding the<br>device settings.<br>• Do not use if patient is<br>currently pregnant or<br>attempting to get<br>pregnant. | • Do not use if you are<br>pregnant<br>• Do not use if you are<br>attempting to get pregnant<br>• Do not use if you have a<br>cardiac demand pacemaker<br>or implanted defibrillator<br>• Do not use if you have<br>symptoms of active urinary<br>tract infection, vaginal<br>infections, or localized<br>lesions<br>• Do not use if you have a<br>diagnosis of extra-urethral<br>or overflow incontinence<br>• Do not use if you have<br>severe urine retention<br>• Do not use if you have poor<br>sensation in the pelvic<br>region<br>• Do not use if you have<br>cognitive disabilities, i.e.;<br>Alzheimer's disease or<br>dementia<br>• Do not use if you are<br>unable to properly insert<br>the device per instructions<br>• Do not use if you have<br>active pelvic cancer<br>• Do not use if you have an<br>intestinal clamp<br>• You must be 6 weeks post-<br>pelvic surgery or vaginal<br>childbirth to use this device<br>• Do not use this device for<br>diagnostic purposes or<br>critical patient monitoring<br>• This device is not (external)<br>defibrillator-proof | • Do not use if you are<br>pregnant<br>• Do not use if you are<br>attempting to get pregnant<br>• Do not use if you have a<br>cardiac demand pacemaker<br>or implanted defibrillator<br>• Do not use if you have<br>symptoms of active urinary<br>tract infection, vaginal<br>infections, or localized<br>lesions<br>• Do not use if you have a<br>diagnosis of extra-urethral<br>or overflow incontinence<br>• Do not use if you have<br>severe urine retention<br>• Do not use if you have poor<br>sensation in the pelvic<br>region<br>• Do not use if you have<br>cognitive disabilities, i.e.;<br>Alzheimer's disease or<br>dementia<br>• Do not use if you are<br>unable to properly insert<br>the device per instructions<br>• Do not use if you have<br>active pelvic cancer<br>• Do not use if you have an<br>intestinal clamp<br>• You must be 6 weeks post-<br>pelvic surgery or vaginal<br>childbirth to use this device<br>• Do not use this device for<br>diagnostic purposes or<br>critical patient monitoring<br>• This device is not (external)<br>defibrillator-proof | Identical to<br>Apex | None:<br>ApexM contraindications<br>are identical to Apex, which<br>were validated through the<br>Human Factors and<br>Usability Testing. |
| Feature/ Function | K110179 InTone<br>(Predicate) | K141158 Apex<br>(Predicate) | ApexM<br>(New Device) | Comparison | Impact on Safety and Performance |
| | anatomical vaginal<br>structures that do not<br>permit proper and<br>complete placement of the<br>Insertion Unit<br>• Do not use if the patient<br>has irregular menstrual<br>bleeding cycles<br>• Do not use if the patient<br>has a history or symptoms<br>of urinary retention.<br>• Do not use if the patient<br>has extra-urethra<br>incontinence, (i.e. syrinx,<br>ectopic, urethra).<br>• Do not use if the patient<br>has overflow incontinence<br>caused by evacuation<br>problems.<br>• Do not use if the patient<br>has severe urine retention<br>in the upper urethras.<br>• Do not use if the patient<br>has complete peripheral<br>denervation of the pelvic<br>floor.<br>• Do not use if the patient<br>has an intestinal clamp. | | | | |
| Labeling Summary<br>Clarity to insure safer<br>or more effective use | User Manual | User Manual | User Manual | Substantially<br>equivalent | None:<br>ApexM user manual was<br>based on the predicate,<br>Apex, which was validated<br>through the Human<br>Factors/Usability testing. |
| 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<br>battery | 4 AAA Alkaline battery | 4 AAA Alkaline battery | Identical to<br>Apex | None:<br>ApexM battery is identical<br>to Apex, which leverages 4<br>AAA Alkaline batteries for<br>ease of use and acquisition<br>for the end user. Battery<br>insertion was validated<br>through the Apex Human<br>Factors and Usability<br>Testing. |
| Method of line<br>current isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None |
| Patient leakage<br>current | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None |
| Number of output<br>modes | 1 | 1 | 1 | Identical | None |
| Number of output<br>channels | 1 | 1 | 1 | Identical | None |
| Regulated current or<br>voltage? | Regulated voltage | Regulated voltage…