Who is the manufacturer of ApexMV?

Incontrol Medical, LLC filed the 510(k) submission for ApexMV (K182022).

What is the FDA product code for ApexMV?

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 ApexMV?

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

What are the predicate devices for ApexMV?

InToneMV (K134020); ApexM (K150183).

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

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.

ApexMV

K182022 · Incontrol Medical, LLC · KPI · Mar 15, 2019 · Gastroenterology, Urology

Device Facts

Record ID	K182022
Device Name	ApexMV
Applicant	Incontrol Medical, LLC
Product Code	KPI · Gastroenterology, Urology
Decision Date	Mar 15, 2019
Decision	SESK
Submission Type	Traditional
Regulation	21 CFR 876.5320
Device Class	Class 2
Attributes	Therapeutic

Intended Use

ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.

Device Story

ApexMV is a non-implantable muscle stimulator for home use by adult women to treat urinary and fecal incontinence. The device consists of a handheld control unit connected via flexible tubing to a customizable inflatable probe. The user inserts the probe vaginally or rectally and manually inflates it for a customized fit. The device delivers electrical stimulation via stainless steel electrodes on the probe to strengthen pelvic floor muscles (high frequency) and calm the detrusor muscle (low frequency). It also provides visual biofeedback via manometry, displaying pressure and contraction/relaxation cues on an OLED screen. The user controls stimulation levels and session start/stop via push-button controls. The device automatically stops after an approximately 11-minute session. By strengthening pelvic floor muscles and providing biofeedback, the device helps users improve muscle control, potentially reducing incontinence symptoms. It is distributed as an OTC kit including the control unit, probe, electrode gel, and instructional materials.

Clinical Evidence

No clinical trials were performed. Evidence includes a clinical literature evaluation of the predicate devices (ApexM and InToneMV) supporting the safety and efficacy of electrical stimulation for urinary and fecal incontinence. A Human Factors Usability Study was conducted to validate OTC use, confirming that users could self-identify conditions, identify contraindications, and safely operate the device using provided labeling and instructions.

Technological Characteristics

Materials: Silicone, stainless steel, ABS plastics, TPE. Energy: 4-AA Alkaline batteries. Stimulation: Monophasic, alternating polarity, square pulse; 13/50 Hz frequency; 200 µs/phase pulse width; 40V/80mA max output. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, IEC 60601-1-2. Software: Moderate level of concern. Sterilization: N/A.

Indications for Use

Indicated for adult women with stress, urge, or mixed urinary incontinence and/or fecal incontinence. Contraindications include pregnancy, attempting pregnancy, cardiac demand pacemaker or implanted electrical device, active urinary tract infection, 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 clamp, or less than 6 weeks post-pelvic surgery/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

InToneMV (K134020)
ApexM (K150183)

Related Devices

K150183 — ApexM · Incontrol Medical, LLC · Apr 9, 2015
K141158 — APEX · Incontrol Medical, LLC · Nov 26, 2014
K134020 — INTONEMV · Incontrol Medical, LLC · Feb 25, 2014
K142506 — TensCare KegelFit · Tenscare, Ltd. · Apr 20, 2015
K191312 — Perfect PFE · Tenscare, Ltd. · Nov 1, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 15, 2019 InControl Medical, LLC Jennifer Koch Director of Quality & Regulatory Affairs 3225 Gateway Road Suite 250 Brookfield. WI 53045 K182022 Re: Trade/Device Name: ApexMV Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI Dated: February 5, 2019 Received: February 7, 2019 Dear Jennifer Koch: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Glenn B. Bell -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182022 Device Name ApexMV Indications for Use (Describe) ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence in adult women. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | | Prescription Use (Part 21 CFR 801 Subpart D) |X | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for InControl Medical, followed by their address. The address is 3225 Gateway Road, Ste. 250 in Brookfield, WI 53045. The logo is a light blue circle with the word "InControl" in dark blue letters. The word "MEDICAL" is in smaller, dark blue letters to the right of "InControl". Image /page/3/Picture/3 description: The image contains the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font, with the "apex" portion in a lighter gray and the "MV" portion in a darker gray. Above the "apex" portion of the text is a green, stylized flower-like graphic with six petals. # 7. 510(k) Summary ## Date Prepared Friday, March 15th, 2019 ## Submitter Information Corey Olson Regulatory Affairs Manager InControl Medical, LLC 3225 Gateway Road, Suite 250, Brookfield, WI 53045 USA Phone: (262) 373.0422 Fax: (262) 373.0463 Email: colson@incontrolmedical.com ## Device Information Table 7.1: Device Information | Type of 510(k): | Traditional 510(k) | |--------------------------------|-------------------------------------------| | Common Name: | Pelvic Floor Muscle Stimulator | | Trade Name (proprietary name): | ApexMV | | Classification name: | Nonimplanted Electrical Continence Device | | Classification Regulation: | 21 CFR 876.5320 | | Class: | Class II | | Product Code: | KPI | ## Legally Marketed Device for Substantial Equivalence Table 7.2: Predicate Device Information | 510(k) | Name | Product Code | Owner | |---------|----------|--------------|-----------------------------------------------------------------------------------| | K134020 | InToneMV | KPI | InControl Medical, LLC 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 USA | | K150183 | ApexM | KPI | InControl Medical, LLC 3225 Gateway Road, Ste. 250 Brookfield, WI 53045 USA | {4}------------------------------------------------ # Traditional 510(k) Subm Image /page/4/Picture/2 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl MEDICAL" in a serif font, with the word "MEDICAL" in a smaller font size. The address is "3225 Gateway Road, Ste. 250 Brookfield, WI 53045". #### Device Summary The ApexMV device is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women for Over-the-Counter use. The ApexMV device is to be distributed as a kit that contains the following items: - · 1 ApexMV device - 1 4 pack of AA batteries - · 1 2 oz. tube of InControl Medical Electrode Gel** - 1 ApexMV IFU/ User Manual - · 1 ApexMV Quick Reference Card - 1 Screw driver - 1 Travel Bag - 1 Animation Video **The InControl Medical Electrode Gel is privately labeled for InControl Medical. It is a Pre-Amendment Class II Medical Device under D039725. The kit contents are substantially equivalent to the ApexM (K150183) and InToneMV (K134020) that are distributed on the market by InControl Medical. The inclusion of the screw driver in the ApexMV kit is for the screw that holds the battery cover panel in place on the back side of the control unit. The ApexMV device consists of a hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing. The customizable inflatable probe is inserted vaginally or rectally 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 also used to improve the ability of the muscles to hold a contraction for an extended period of time for the treatment of stress, urge, or mixed urinary and/or fecal incontinence in adult women. 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. ## Indications for Use ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for InControl Medical, with the words "InControl" in large, bold letters and the word "Medical" in smaller letters below. The logo also includes a circular design with curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250". Image /page/5/Picture/3 description: The image shows the logo for ApexMV. The logo is in a light gray color, with the letters "apexMV" written in a simple, sans-serif font. Above the "x" in "apex" is a small, stylized flower or starburst design in a teal color. The logo is clean and modern in appearance. Brookfield, WI 53045 # Equivalence Comparison to the Predicate Electrical muscle stimulation is the technological principle for ApexMV and the predicate devices, ApexM (K150183) and InToneMV (134020). It is based on the use of electrical muscle stimulation to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and unique technological elements between ApexMV and the predicate devices, ApexM (K150183) and InToneMV (K134020). The intended use, technology, engineering, and performance for the ApexMV is substantially equivalent to the predicate devices, ApexM (K150183) and InToneMV (134020). | Feature/ Function | K134020 InToneMV (Predicate) manufactured by InControl Medical, LLC. | K150183 ApexM (Predicate) manufactured by InControl Medical, LLC. | ApexMV | 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 | InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence | 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 to improve strength and support. | ApexMV is a non- implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women. | Substantially equivalent | None: These devices apply the same electrical stimulation to strengthen the pelvic floor muscles, as supported by literature. | | Primary Function | Delivery of electrical stimulation Visual biofeedback | Delivery of electrical stimulation | Delivery of electrical stimulation Visual biofeedback | Identical to InToneMV | None | | Warnings or Precautions | (See product labeling) | (See product labeling) | (See product labeling) | Substantially equivalent | None: ApexMV warnings and precautions are identical to ApexM and InToneMV, which were | | Feature/ Function | K134020 InToneMV (Predicate) manufactured by InControl Medical, LLC. | K150183 ApexM (Predicate) manufactured by InControl Medical, LLC. | ApexMV | Comparison | Impact on Safety and Performance | | | | | | | defined in accordance with the FDA guidance document and validated through the Human Factors Usability Testing. | | Contraindications Explain when the device is not to be clinically used | • Patients with a pacemaker or implanted defibrillator require cardiac clearance before electrical stimulation is offered. • Patients with symptoms of active urinary tract infection, vaginal infections, localized lesions, or other undiagnosed symptoms. • Patient has extra- urethra incontinence, (i.e. syrinx, ectopic, urethra). • Patient has overflow incontinence caused by evacuation problems. • Patient has severe urine retention in the upper urethra or other symptoms of urine retention | • Do not use if you are pregnant • Do not use if you are attempting to get pregnant • Do not use if you have a cardiac demand pacemaker or implanted defibrillator • Do not use if you have symptoms of active urinary tract infection, vaginal infections, or localized lesions • Do not use if you have a diagnosis of extra-urethral or overflow incontinence • Do not use if you have severe urine retention • Do not use if you have poor sensation in the pelvic region • Do not use if you have cognitive disabilities, i.e.: | • Do not use if you are pregnant • Do not use if you are attempting to get pregnant • Do not use if you have a cardiac demand pacemaker or implanted electrical device • Do not use if you have symptoms of active urinary tract infection, vaginal infections, or localized lesions • Do not use if you have a diagnosis of extra-urethral or overflow incontinence • Do not use if you have severe urine retention • Do not use if you have poor sensation in the pelvic region • Do not use if you have cognitive disabilities, i.e.; Alzheimer's disease or dementia | Substantially Equivalent | None | | Feature/ Function | K134020 InToneMV (Predicate) manufactured by InControl Medical, LLC. | K150183 ApexM (Predicate) manufactured by InControl Medical, LLC. | ApexMV | Comparison | Impact on Safety and Performance | | | • Patients with neurological deficiency that does not permit proper sensory perception of stimulation or complete denervation of the pelvic floor. • Patients with cognitive disabilities, i.e.; Alzheimer's disease or dementia. • Patients who are currently pregnant or attempting to get pregnant. • Patients with anatomical pelvic structures that do not permit proper and complete placement of the Insertion Unit. • Patients with active pelvic malignancy. • Patients with an intestinal clamp. • Patients should be 6 weeks post-pelvic surgery or vaginal childbirth. • Device should not be used for diagnostic purposes or critical patient monitoring. • Device is not (external) defibrillator-proof. | Alzheimer's disease or dementia • Do not use if you are unable to properly insert the device per instructions • Do not use if you have active pelvic cancer • Do not use if you have an intestinal clamp • You must be 6 weeks post-pelvic surgery or vaginal childbirth to use this device • Do not use this device for diagnostic purposes or critical patient monitoring • This device is not (external) defibrillator-proof | • Do not use if you have active pelvic cancer • Do not use if you have an intestinal clamp • You must be 6 weeks post-pelvic surgery or vaginal childbirth to use this device | | | | Feature/ Function | K134020 InToneMV (Predicate) manufactured by InControl Medical, LLC. | K150183 ApexM (Predicate) manufactured by InControl Medical, LLC. | ApexMV | Comparison | Impact on Safety and Performance | | Labeling Summary Clarity to ensure safer or more effective use | User Manual and Quick Reference Patient Guide Card | User Manual and Quick Reference Patient Guide Card | User Manual and Quick Reference Patient Guide Card | Identical to predicates | None: ApexMV User Manual and Quick Reference Patient Guide Card user were based on the labeling and use for ApexM for Over-The- Counter use and was validated through the Human Factors Usability Testing. | | Environmental Specifications | For indoor use only | For indoor use only | For indoor use only | Identical to predicates | None | | Power Source | 4/5 AA nickel metal hydride battery | 4-AAA Alkaline battery | 4 -AA Alkaline battery | Substantially equivalent | None | | Method of line current isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical to predicates | None | | Patient leakage current | N/A (battery) | N/A (battery) | N/A (battery) | Identical to predicates | None | | Number of output modes | 1 | 1 | 1 | Identical to predicates | None | | Number of output channels | 1 | 1 | 1 | Identical to predicates | None | | Regulated current or voltage? | Regulated voltage | Regulated voltage | Regulated voltage | Identical to predicates | None | | Firmware controlled? | Yes | Yes | Yes | Identical to predicates | None | | Automatic Overload Trip? | No | No | No | Identical to predicates | None | | Feature/ Function | K134020 InToneMV (Predicate) manufactured by InControl Medical, LLC. | K150183 ApexM (Predicate) manufactured by InControl Medical, LLC. | ApexMV | Comparison | Impact on Safety and Performance | | Automatic No- Load Trip? | No | No | No | Identical to predicates | None | | Automatic Shut Off? | Yes | Yes | Yes | Identical to predicates | None | | Indicator Display • On/Off Status • Low Battery | Yes (via display illumination) Yes | Yes (via display illumination) No | Yes Yes (via on screen warning) | Substantially equivalent to InToneMV | None | | Waveform, shape | Monophasic, alternating polarity, square pulse | Monophasic, alternating polarity, square pulse…

ApexMV

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

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Predicate Devices

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