APEX

K141158 · Incontrol Medical, LLC · KPI · Nov 26, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141158
• Device Name: APEX
• Applicant: Incontrol Medical, LLC
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Nov 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.

Device Story

Apex is a hand-held, home-use device for treating female stress urinary incontinence. It consists of 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 to induce contractions, strengthening muscles and improving support. The user controls stimulation levels via manual push-button controls. The device is intended for over-the-counter use; users self-diagnose and operate the device using provided educational materials, instructions, and quick reference guides. By training muscles to hold contractions, the device helps users recognize and activate pelvic floor muscles, potentially reducing incontinence symptoms. The device is a single unit, powered by 4 AAA alkaline batteries, and features automatic shut-off.

Clinical Evidence

Clinical evidence includes a literature evaluation supporting the safety and efficacy of electrical stimulation for female stress urinary incontinence. A human factors/usability study was conducted to validate the safety of OTC use, confirming that users can accurately self-identify stress urinary incontinence, identify contraindications, and safely operate the device using provided instructions.

Technological Characteristics

Non-implanted electrical muscle stimulator. Materials: Silicone and plastics. Energy source: 4 AAA alkaline batteries. Waveform: Monophasic, alternating polarity, square pulse (200 µs/phase). Output: Regulated voltage, 1 channel. Standards: IEC 60601-1, IEC 60601-2-10 (safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility). Software: Moderate level of concern, firmware-controlled.

Indications for Use

Indicated for female patients with stress urinary incontinence to improve pelvic floor muscle strength and support. Contraindicated in pregnancy, cardiac demand pacemakers, 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 if less than 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)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

November 26, 2014

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

Re: K141158 Trade/Device Name: Apex Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: Class II Product Code: KPI Dated: October 13, 2014 Received: October 23, 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. 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 Fisher 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 bold, 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)

K141158

Device Name

Арех

### Indications for Use

Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles 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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### 7. 510(k) Summary

### Submission Date

May 2nd, 2014

### 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 4. Device Information

| Type of 510(k): | Traditional 510(k) |
|--------------------------------|-----------------------------------------------------------|
| Common Name: | Pelvic Floor Muscle Stimulator |
| Trade Name (proprietary name): | Apex |
| 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 |

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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, Brookfield, WI 53045. The logo is in gray and features the text "InControl" above the word "Medical". To the left of the text is a circular design with curved lines.

Image /page/4/Picture/1 description: The image shows the text "Traditional 510(k) Submission" in a bold, sans-serif font. The text is centered on the image and appears to be the title or heading of a document. The words are arranged on a single line, with "Traditional" being the first word and "Submission" being the last.

#### Device Summary

Apex is a hand-held, home-use device designed to treat female stress 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, stimulation is delivered to specific muscles to encourage their contraction. This contraction strengthens the muscles and also helps the end user recognize which muscles to activate during self-directed contractions. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

#### Intended Use

Apex is a non-implanted muscle stimulator designed to treat female stress urinary incontinence. It applies stimulation to the pelvic floor muscles to improve strength and support.

Apex for over-the-counter use was evaluated for safety through a human factors / usability study. The device labeling and packaging (which includes an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video) allow the end user to accurately self-diagnose and use the product to treat stress urinary incontinence.

### Equivalence Comparison to the Predicate

Electrical muscle stimulation is the technological principle for both Apex and the predicate device, InTone (K110179). It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles. The chart below summarizes the shared and unique technological elements between the InTone and Apex devices. The intended use, technology, engineering, performance and user interface for Apex is substantially equivalent to the predicate devices.

| Feature/ Function | K110179 InTone<br>(Predicate) | Apex<br>(New Device) | Comparison | Impact on Safety and<br>Performance |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>An explicit description of all<br>clinical functions performed by<br>the device,<br>Indications for Use<br>Explain when the device is to be<br>clinically used and the intended<br>patient population | 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<br>musculature and surrounding structures.<br>It is intended for acute and ongoing<br>treatment of mixed urinary incontinence<br>where the following results may improve<br>urinary control: strengthening of pelvic<br>floor muscles, inhibition of the detrusor<br>muscle through reflexive mechanisms.<br>The biofeedback feature can be used for<br>muscle re-education purposes. | Apex is a non-implanted muscle<br>stimulator designed to treat<br>female stress urinary incontinence.<br>It applies stimulation to the pelvic<br>floor muscles to improve strength<br>and support. | Substantially<br>equivalent | None:<br>Both devices apply electrical<br>stimulation to strengthen the<br>pelvic floor muscles, as<br>supported by literature, see<br>Appendix 13. |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation | Identical | None |
| Feature/ Function | K110179 InTone<br>(Predicate) | Apex<br>(New Device) | Comparison | Impact on Safety and<br>Performance |
| Warnings or Precautions | (see product labeling) | (see product labeling) | Substantially<br>equivalent | None:<br>The warnings and precautions<br>were based on the predicate,<br>InTone, but were reworded for<br>Apex to improve end user<br>understanding for over-the-<br>counter use. The warning and<br>precautions were re-defined<br>according to the FDA guidance<br>document and validated<br>through the Human Factors and<br>Usability Testing. |
| Contraindications<br>Explain when the device is not<br>to be clinically used | • This device is not intended for<br>diagnostic purposes or critical patient<br>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<br>rate or conductive disturbance<br>• Do not use if patient has symptoms of<br>an 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<br>competence that limits use of the<br>device or interaction with the care<br>provider regarding the device settings.<br>• Do not use if patient is currently<br>pregnant or attempting to get<br>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<br>or 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<br>intestinal clamp. | • Do not use if you are pregnant<br>• Do not use if you are attempting<br>to get pregnant<br>• Do not use if you have a cardiac<br>demand pacemaker or<br>implanted defibrillator<br>• Do not use if you have<br>symptoms of active urinary tract<br>infection, vaginal infections, or<br>localized lesions<br>• Do not use if you have a<br>diagnosis of extra-urethral or<br>overflow incontinence<br>• Do not use if you have severe<br>urine retention<br>• Do not use if you have poor<br>sensation in the pelvic region<br>• Do not use if you have cognitive<br>disabilities, i.e.; Alzheimer's<br>disease or dementia<br>• Do not use if you are unable to<br>properly insert the device per<br>instructions<br>• Do not use if you have active<br>pelvic cancer<br>• Do not use if you have an<br>intestinal clamp<br>• You must be 6 weeks post-pelvic<br>surgery or vaginal childbirth to<br>use this device<br>• Do not use this device for<br>diagnostic purposes or critical<br>patient monitoring<br>• This device is not (external)<br>defibrillator-proof | Substantially<br>equivalent | None:<br>The contraindications are based<br>on the predicate, InTone, but<br>were reworded and reordered<br>for Apex to improve end user<br>understanding for over-the-<br>counter use. The ability to<br>understand the<br>contraindications was validated<br>through collaboration with the<br>supervising physician from the<br>Human Factors and Usability<br>Testing. |
| Feature/ Function | K110179 InTone<br>(Predicate) | Apex<br>(New Device) | Comparison | Impact on Safety and<br>Performance |
| Labeling Summary<br>Clarity to insure safer or more<br>effective use | User Manual | User Manual | Substantially<br>equivalent | None:<br>The user manual is based on the<br>predicate, InTone, but was<br>reworded for Apex to improve<br>end user understanding for<br>over-the-counter use. The<br>manual was validated through<br>collaboration with the<br>supervising physician from the<br>Human Factors and Usability<br>Testing. |
| Environmental Specifications | For indoor use only | For indoor use only | Identical | None |
| Power Source | 4/5 AA nickel metal hydride battery | 4 AAA Alkaline battery | Substantially<br>equivalent | None:<br>Both devices are battery<br>powered. Both devices operate<br>at 3.3V (processor) and 5V<br>(waveform generator);<br>however, the Apex device<br>leverages 4 AAA Alkaline<br>batteries for ease of use and<br>acquisition for the end user.<br>Battery insertion was validated<br>through the Human Factors and<br>Usability Testing. |
| Method of line current<br>isolation | N/A (battery) | N/A (battery) | Identical | None |
| Patient leakage current | N/A (battery) | N/A (battery) | Identical | None |
| Number of output modes | 1 | 1 | Identical | None |
| Number of output channels | 1 | 1 | Identical | None |
| Regulated current or voltage? | Regulated voltage | Regulated voltage | Identical | None |
| Firmware controlled? | Yes | Yes | Identical | None |
| Automatic Overload Trip? | Yes | No | Substantially<br>equivalent | None:<br>Although there is no overload<br>trip, Apex does not introduce<br>any safety risks because of the<br>circuit design. The maximum<br>level of stimulation is self-<br>limiting and will not cause end<br>user injury if maximum output<br>is applied. |
| Automatic No-Load Trip? | Yes | No | Substantially<br>equivalent | None:<br>Although there is no no-load<br>trip, Apex does not cause any<br>safety risks because of the<br>circuit design. The maximum<br>level of stimulation is self-<br>limiting and will not cause end<br>user injury if powered with no<br>load. |
| Automatic Shut Off? | Yes | Yes…