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.

Device Description

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 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.

AI/ML Overview

This document describes the regulatory submission for the ApexMV device, which is a non-implantable muscle stimulator for treating urinary and/or fecal incontinence in adult women.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the determination of substantial equivalence to previously cleared predicate devices. The reported "device performance" is primarily qualitative, stating that the device "successfully passed all of this testing" and is "safe and effective."

Below is a table summarizing the tests performed and the reported outcomes, which implicitly serve as the device meeting the acceptance criteria for regulatory clearance:

Acceptance Criteria (Implied by Test Completion)	Reported Device Performance (Qualitative)
Software Verification and Validation Testing (Adherence to FDA Guidance for Software in Medical Devices for "moderate" level of concern)	Documentation was provided as recommended. The software met the requirements for a "moderate" level of concern. Testing data found in Appendix 4 – Risk Management File.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing (Compliance with IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, and IEC 60601-1-2 standards)	The ApexMV device complies with all specified IEC standards for safety and EMC. Testing data found in Appendix 7 – SGS EMC and Electrical Safety.
Biocompatibility Testing (Compliance with ISO 10993-1 for tissue-contacting parts < 24 hours)	Not re-tested for ApexMV directly due to identical materials and manufacturing processes as cleared predicates (ApexM, InToneMV, InTone). Biocompatibility testing for predicates included: Cytotoxicity, Sensitization, Irritation. Previously submitted with K150183 and K134020, demonstrating equivalent safety.
Human Factors Usability Study (Ability of user/subject to self-identify incontinence, self-limit usage, use safely with labeling/manuals, and complete critical tasks successfully for OTC use)	Study objectives were met. Subjects successfully self-identified incontinence. Labeling and packaging supported safe OTC use. Study feedback supported availability of training video. Results found in Appendix 9 – Clinical Literature and Human Factors Usability Study Test.
Performance Validation (Implied by equivalence comparison, specifically stating "The stimulation output characteristics as noted above will be replicated identical to the predicate devices.")	Successfully passed all performance validation testing. (Specific quantitative performance data is not provided in this excerpt, but it is stated to be identical or substantially equivalent to predicates.)
Risk Management (Evaluation and reduction of risks to AS-Low-As-Reasonably-Practicable (ALARP) as per ISO 14971)	Risks were reduced to ALARP. Risk/benefit analysis was acceptable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- For the Human Factors Usability Study, the document states "the subject/end users were able to properly self-identify...". However, it does not specify the exact number of participants (sample size) in this study.
- For other tests (Software, Electrical Safety, EMC), sample sizes are not applicable in the same way as clinical studies. These typically involve testing the device itself or its components against a set of standards.
- For clinical literature evaluation, no specific sample size from a new study is mentioned; instead, it's a review of existing literature on predicate devices.
Data Provenance:
- Human Factors Usability Study: Prospective study, conducted specifically for the ApexMV device. The country of origin for the study is not explicitly stated, but the submitter is InControl Medical, LLC, located in Brookfield, WI, USA, suggesting the study was likely conducted in the US.
- Clinical Literature Evaluation: Retrospective (review of existing literature). The origin of this data would be diverse, based on the studies reviewed.
- Software, Electrical Safety, EMC, Biocompatibility: These are engineering and bench tests, not directly involving patient data. For biocompatibility, the data used was retrospective from previous predicate device submissions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Human Factors Usability Study: The document states that the study was "conducted with collaboration with a supervising physician." This indicates at least one physician was involved in supervising and possibly establishing the ground truth regarding patient self-identification and safe device use based on labeling. Specific qualifications (e.g., years of experience, specialty beyond "physician") are not detailed.
Clinical Literature Evaluation: An "appraisal of each article was completed." This implies experts reviewed the literature, but the number or specific qualifications of these experts are not provided.
Other tests: Ground truth establishment by experts as described for medical image analysis is not directly applicable to these engineering and bench tests. Compliance with standards is the "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the Human Factors Usability Study. The assessment seems to be based on whether participants "were able to properly self-identify" and "complete critical tasks successfully" with the guidance of the supervising physician. For the clinical literature review, an "appraisal" was done but no specific adjudication process is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The ApexMV device is a muscle stimulator, not an AI software intended to assist human readers in interpreting medical images. The primary evaluation method was substantial equivalence to existing predicate devices and direct testing of the device's adherence to safety and performance standards, and user interaction.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The ApexMV is a direct-to-consumer medical device used by the patient. Its "standalone performance" refers to its electrical stimulation characteristics and biofeedback capabilities operating as designed, independent of a clinician's direct real-time intervention for each session. The software and electrical safety tests can be considered evaluations of its standalone functional performance against specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Human Factors Usability Study: The ground truth was established by the performance of the test subjects in self-identifying and successfully using the device, as assessed by a supervising physician and the study protocol. The "ground truth" for self-identification was based on the subjects' actual condition and their ability to determine it based on the provided labeling.
For Electrical Safety, EMC, Software, Biocompatibility: The "ground truth" is adherence to established international and FDA-recognized standards and internal specifications. For biocompatibility, the ground truth was established from previous testing on identical materials in predicate devices.
Clinical Literature Review: The ground truth here is the evidence for safety and efficacy of similar electrical stimulation technologies as established and published in existing clinical literature.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI models. This device is an electrical stimulator, not an AI/ML diagnostic or assistive tool, so a training set in that sense is not applicable. The device's design and features are based on the established technology of predicate devices and general engineering principles.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and performance claims is established through compliance with regulatory standards, engineering principles, and demonstration of substantial equivalence to already-cleared devices.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K182022

Device Name ApexMV

Indications for Use (Describe)

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)

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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, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA
K150183	ApexM	KPI	InControl Medical, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA

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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

· 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.

Indications for Use

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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 byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
Intended UseAn explicitdescription ofall clinicalfunctionsperformed bythe deviceIndications forUseExplain whenthe device is tobe clinicallyused and theintendedpatientpopulation	InToneMV is intendedto provide electricalstimulation and/orvisual biofeedback(via manometry) forthe treatment ofmale and femaleurinary and fecalincontinence	ApexM is a non-implanted musclestimulator designedto treat, stress, urge,and/or mixed urinaryincontinence inwomen. It appliesstimulation to thepelvic floor musclesto improve strengthand support.	ApexMV is a non-implantable musclestimulator intended toprovide electricalstimulation and/orvisual biofeedback (viamanometry) for thetreatment of stress,urge, or mixed urinaryincontinence and/orfecal incontinence inadult women.	Substantiallyequivalent	None:These devicesapply the sameelectricalstimulation tostrengthen thepelvic floormuscles, assupported byliterature.
PrimaryFunction	Delivery of electricalstimulationVisual biofeedback	Delivery of electricalstimulation	Delivery of electricalstimulationVisual biofeedback	Identical toInToneMV	None
Warnings orPrecautions	(See product labeling)	(See productlabeling)	(See product labeling)	Substantiallyequivalent	None:ApexMVwarnings andprecautions areidentical toApexM andInToneMV,which were
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
					defined inaccordancewith the FDAguidancedocument andvalidatedthrough theHuman FactorsUsabilityTesting.
ContraindicationsExplain whenthe device isnot to beclinically used	• Patients with apacemaker orimplanteddefibrillator requirecardiac clearancebefore electricalstimulation isoffered.• Patients withsymptoms of activeurinary tractinfection, vaginalinfections, localizedlesions, or otherundiagnosedsymptoms.• Patient has extra-urethraincontinence, (i.e.syrinx, ectopic,urethra).• Patient hasoverflowincontinencecaused byevacuationproblems.• Patient has severeurine retention inthe upper urethraor other symptomsof urine retention	• Do not use if youare pregnant• Do not use if youare attempting toget pregnant• Do not use if youhave a cardiacdemandpacemaker orimplanteddefibrillator• Do not use if youhave symptoms ofactive urinary tractinfection, vaginalinfections, orlocalized lesions• Do not use if youhave a diagnosis ofextra-urethral oroverflowincontinence• Do not use if youhave severe urineretention• Do not use if youhave poorsensation in thepelvic region• Do not use if youhave cognitivedisabilities, i.e.:	• Do not use if you arepregnant• Do not use if you areattempting to getpregnant• Do not use if youhave a cardiacdemand pacemakeror implantedelectrical device• Do not use if youhave symptoms ofactive urinary tractinfection, vaginalinfections, orlocalized lesions• Do not use if youhave a diagnosis ofextra-urethral oroverflowincontinence• Do not use if youhave severe urineretention• Do not use if youhave poor sensationin the pelvic region• Do not use if youhave cognitivedisabilities, i.e.;Alzheimer's diseaseor dementia	SubstantiallyEquivalent	None
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
	• Patients withneurologicaldeficiency that doesnot permit propersensory perceptionof stimulation orcompletedenervation of thepelvic floor.• Patients withcognitivedisabilities, i.e.;Alzheimer's diseaseor dementia.• Patients who arecurrently pregnantor attempting to getpregnant.• Patients withanatomical pelvicstructures that donot permit properand completeplacement of theInsertion Unit.• Patients with activepelvic malignancy.• Patients with anintestinal clamp.• Patients should be 6weeks post-pelvicsurgery or vaginalchildbirth.• Device should notbe used fordiagnostic purposesor critical patientmonitoring.• Device is not(external)defibrillator-proof.	Alzheimer's diseaseor dementia• Do not use if youare unable toproperly insert thedevice perinstructions• Do not use if youhave active pelviccancer• Do not use if youhave an intestinalclamp• You must be 6weeks post-pelvicsurgery or vaginalchildbirth to usethis device• Do not use thisdevice fordiagnosticpurposes or criticalpatient monitoring• This device is not(external)defibrillator-proof	• Do not use if youhave active pelviccancer• Do not use if youhave an intestinalclamp• You must be 6weeks post-pelvicsurgery or vaginalchildbirth to use thisdevice
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
LabelingSummaryClarity toensure safer ormore effectiveuse	User Manual andQuick ReferencePatient Guide Card	User Manual andQuick ReferencePatient Guide Card	User Manual andQuick ReferencePatient Guide Card	Identical topredicates	None:ApexMV UserManual andQuickReferencePatient GuideCard user werebased on thelabeling anduse for ApexMfor Over-The-Counter useand wasvalidatedthrough theHuman FactorsUsabilityTesting.
EnvironmentalSpecifications	For indoor use only	For indoor use only	For indoor use only	Identical topredicates	None
Power Source	4/5 AA nickel metalhydride battery	4-AAA Alkalinebattery	4 -AA Alkaline battery	Substantiallyequivalent	None
Method of linecurrentisolation	N/A (battery)	N/A (battery)	N/A (battery)	Identical topredicates	None
Patientleakagecurrent	N/A (battery)	N/A (battery)	N/A (battery)	Identical topredicates	None
Number ofoutput modes	1	1	1	Identical topredicates	None
Number ofoutputchannels	1	1	1	Identical topredicates	None
Regulatedcurrent orvoltage?	Regulated voltage	Regulated voltage	Regulated voltage	Identical topredicates	None
Firmwarecontrolled?	Yes	Yes	Yes	Identical topredicates	None
AutomaticOverload Trip?	No	No	No	Identical topredicates	None
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
Automatic No-Load Trip?	No	No	No	Identical topredicates	None
AutomaticShut Off?	Yes	Yes	Yes	Identical topredicates	None
IndicatorDisplay• On/OffStatus• LowBattery	Yes (via displayillumination)Yes	Yes (via displayillumination)No	YesYes (via on screenwarning)	Substantiallyequivalent toInToneMV	None
Waveform,shape	Monophasic,alternating polarity,square pulse	Monophasic,alternating polarity,square pulse	Monophasic,alternating polarity,square pulse	Identical topredicates	None
WaveformFrequency• Urge• Stress• Mixed	13 Hz - UrgeIncontinence50 Hz - StressIncontinence13/50 Hz - Mixed	13 Hz - UrgeIncontinence50 Hz - StressIncontinence13/50 Hz - Mixed	13 Hz - UrgeIncontinence50 Hz - StressIncontinence13/50 Hz - Mixed	Identical topredicates	None
WaveformPulse width	200 µs/phase	200 µs/phase	200 µs/phase	Identicalpredicates	None
WaveformPattern	1 second at 50 Hz2 seconds nostimulation2 seconds at 13 Hz2 second nostimulation	1 second at 50 Hz2 seconds nostimulation2 seconds at 13 Hz2 second nostimulation	1 second at 50 Hz2 seconds nostimulation2 seconds at 13 Hz2 second nostimulation	Identical topredicates	None

Table 7.3: Substantial Equivalence Comparison Table

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Image /page/6/Picture/1 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 "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".

Image /page/6/Picture/3 description: The image shows the logo for ApexMV. The logo is in gray and features a stylized flower above the letters "exMV". The flower has a green color.

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K182022
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Image /page/7/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a stylized font, with the word "InControl" in a larger, bolder font than the word "Medical." There is a circular graphic to the left of the company name. Below the logo is the address "3225 Gateway Road, Ste. 250".

Traditional 510(k) Submission

Image /page/7/Picture/3 description: The image contains the word "Submission" at the top. Below that is the logo for apexMV, which is written in a sans-serif font. The "M" and "V" are slightly larger than the "apex" part of the logo. Above the "apex" part of the logo is a green flower-like design.

3225 Gateway Road, Ste. 250 Brookfield, WI 53045

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Image /page/8/Picture/1 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl" in a stylized font, with the word "Medical" below it. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/8/Picture/3 description: The image shows the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font. Above the text is a green, stylized flower-like graphic with six petals and a small droplet at the bottom.

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Image /page/9/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a bold, sans-serif font, with the word "InControl" in a darker shade and "Medical" in a lighter shade. To the left of the company name is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".

Brookfield, WI 53045

Image /page/9/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 shade of gray and the "MV" portion in a darker shade of gray. Above the "apex" portion of the text is a green floral design with a water droplet in the center.

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K182022
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Image /page/10/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a stylized font, with the word "InControl" in a larger font than the word "Medical". There is also an address listed below the logo, which reads "3225 Gateway Road, Ste. 250".

Image /page/10/Picture/3 description: The image shows the logo for apexMV. The logo is in gray and features a stylized flower above the 'x' in 'apex'. The flower has six petals and a small droplet in the center.

	MEDICA
3225 Gateway Road, Ste. 250
Brookfield, WI 53045

Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
Total SessionTime	Total session time ofapproximately 12minutes2 minutes ofvolitionalstimulation5 minutes ofmusclesstimulation5 minutes ofvolitionalcontractions.	Total session time of10-15 minutes5-10 minuteselectricalstimulation5 minutes self-directedcontractions(recommended)	Total session time ofapproximately 11minutes7 minutes ofelectricalstimulation3.5 minutes ofself-directedcontractions(recommended)	Substantiallyequivalent topredicates	None
Max outputvoltage (500Ω)	40.0 V peak	40.0 V peak	40.0 V peak	Identical topredicates	None
Max outputcurrent (500Ω)	80.0 mA peak	80.0 mA peak	80.0 mA peak	Identical topredicates	None
Maximumphase charge(500Ω)	16.0 µC	16.0 µC	16.0 µC	Identical topredicates	None
Electrodesurface area	2.5 cm² ± 0.1 cm² x 2	5.9 cm² ± 0.1 cm² x 2	3.9 cm² ± 0.1 cm² x 2	Substantiallyequivalent topredicates	None
Max currentdensity	32.0 mA/cm²	13.6 mA/cm²	20.5 mA/cm²	Substantiallyequivalent topredicates	None
Max averagepower density(500Ω)	12.8 mW/ cm²	5.4 mW/cm²	8.2 mW/cm² peak	Substantiallyequivalent topredicates	None
Biofeedback	Manometric Airpressure, .01 - 2 psi	None	Manometric Airpressure, .01 - 2 psi	Substantiallyequivalent topredicates	None
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
Dimensions(Insertion Unit)	Control Unit: 4.8" x2.4" x 1.1" (+/- 0.1")Inflation bulb: 7.7" x2.3" x 3.9" (+/- 0.1")Uninflated Probe:2.7" x 0.5" x 0.9" (+/-0.1")Inflated Probe (2.0PSI):2.4" x 1.4" x 1.7" (+/-0.1")Tubing: 40.0" (+/-1.0") long	Overall InsertionUnit: 11.8"x 2.3"x3.9" (+/- 0.1")Uninflated Probe:5.1" x 1.2" x 1.5" (+/-0.1")Inflated Probe: 5.0" x1.6" x 2.1" (+/- 0.1")	Control Unit:6.2"x3.3"x 1.8" (+/-0.1")Uninflated Probe: 4.1"x 0.5" x 0.8" (+/- 0.1")Inflated Probe: 3.9" x1.4" x 1.7" (+/- 0.1")Tubing: 40.0" (+/-1.0") long	Substantiallyequivalent toInToneMV	None
Controlhousingmaterial	ABS plastics	N/A	ABS plastics, TPE overmolded gaskets andhand grip	Substantiallyequivalent	A TPE overmolded gasketwas added tothe plastichousing tocomply withelectrical safetystandards forhome usedevices (H20ingress).
Insertion probematerial	Silicone, stainlesssteel	Silicone, stainlesssteel	Silicone, stainless steel	Identical	None
ExpirationDating	N/A	N/A	N/A for the ApexMVinsertion unit.4 year shelf life for theelectrode gel	Identical	The electrodegel supplied inthe kits forInToneMV,ApexM andApexMV has a4 year shelf lifethat was notstated in theoriginalsubmissions.
Overall DeviceWeight	~ 0.8lbs.	~ 0.8 lbs.	~ 0.8 lbs.	Identical	None
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
Packaging(OverallWeight)	~ 2.6 lbs.	~ 2.0 lbs.	~ 2.2 lbs.	Substantiallyequivalent	The InToneMV,ApexM and theApexMV are allpackaged withthe samecustomizedfoam thatsurrounds thedevice, andsamecorrugatedcardboardexterior box forthe PatientUnit.
Sterilization	N/A	N/A	N/A	Identical topredicates	None
OperationalMethod:Clinical Usee.g.,ambulatoryuse, home use	Clinic or Home use,under direction of aPhysician or healthcare provider.	Home use, Over-the-counter	Home use, Over-the-counter	Identical toApexM	None
OperatingConditions:	Temperature: 32 -130°F (0-54°C)Relative Humidity:15-95%, non-condensing	Temperature: 32 -130°F (0-54°C)Relative Humidity:15-95%, non-condensing	Temperature: 41 - 104°F (5-40°C)Relative Humidity: 15-95%, non-condensing	Substantiallyequivalent topredicates	None
Storage andTransportationConditions:	Temperature: -4-150°F (-20 -65°C)Relative Humidity:10-95%, non-condensing	Temperature: -4-150°F (-20 -65°C)Relative Humidity:10-95%, non-condensing	Temperature: -13 -158°F (-25 -70°C)Relative Humidity: 10-95%, non-condensing	Substantiallyequivalent topredicates	None
Feature/Function	K134020 InToneMV(Predicate)manufactured byInControl Medical,LLC.	K150183 ApexM(Predicate)manufactured byInControl Medical,LLC.	ApexMV	Comparison	Impact onSafety andPerformance
PatientInteraction:FunctionsControllable:An explanationof how thedeviceinteracts withthe patient.	The patient cancontrol the startingand stopping of eachsession. However, thedevice will stopautomatically on itsown once the sessionis complete.	The end user cancontrol the electricalstimulation levelsand the duration ofthe stimulationsession.	The end user cancontrol the electricalstimulation levels andthe starting andstopping of eachsession. However, thedevice willautomatically stop onits own once thesession is complete.	Substantiallyequivalent tothe predicates	None
PatientInteraction:ProgrammingCapabilityWhether thedevice can beprogrammedand to whatextent	None, stimulationlevel settings can onlybe changed by aPhysician or healthcare provider.	Electrical stimulationlevels are set by theend user	Electrical stimulationlevels are set by theend user	Identical toApexM	None
Override	Yes	No	Yes	Identical toInToneMV	None
PatientInteraction:OperatorRequirementsKnowledge ortrainingrequired of theoperator,	Intended as part of acomplete therapyprogram withphysician coaching.No special knowledgeor training;instruction manualprovided	Over-the-counterdevice. No specialknowledge ortraining required;instruction manualprovided	Over-the-counterdevice. No specialknowledge or trainingrequired; instructionmanual provided	Identical toApexM	None
Software Levelof Concern	Moderate	Moderate	Moderate	ldentical topredicates	None

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Image /page/11/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a gray sans-serif font, with the word "InControl" in a larger font size than the word "Medical." To the left of the company name is a light blue circle with a series of curved lines inside. Below the logo is the address "3225 Gateway Road, Ste. 250".

Brookfield, WI 53045

Image /page/11/Picture/3 description: The image shows the logo for ApexMV. The logo consists of the word "apexMV" in a sans-serif font. Above the "x" in "apex" is a green flower-like symbol with a water droplet in the center.

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Image /page/12/Picture/1 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 "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".

Image /page/12/Picture/3 description: The image shows the logo for ApexMV. The logo features the text "apexMV" in a sans-serif font, with the "apex" portion in a lighter shade of gray and the "MV" portion in a darker shade of gray. Above the "apex" portion of the text is a stylized flower-like graphic in a teal color.

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Image /page/13/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. To the left of the words is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".

Brookfield, WI 53045

Traditional 510(k) Submission

Image /page/13/Picture/3 description: The image shows the logo for apexMV. The logo features a stylized flower or asterisk-like symbol in a teal color above the text "apexMV" in a gray sans-serif font. The logo appears to be clean and modern in design.

ApexMV Design Modifications Compared To Predicates

1. The modifications to the insertion unit includes: a longer in length inflatable probe of 4.0 inches in place of the 2.7 inch probe on the InToneMV (K134020) device. The inflatable probe is inserted into either the vagina or rectum and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the probe to induce a contraction of the pelvic floor muscles. This portion of the device has been modified from the predicate device, InToneMV (K134020).

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Image /page/14/Picture/1 description: The image shows the logo for InControl Medical. The logo features the company name in a bold, sans-serif font, with the word "InControl" in a larger size than the word "Medical". To the left of the company name is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".

Image /page/14/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 darker shade of gray and the "MV" portion in a lighter shade of gray. Above the "apex" portion of the text is a green, stylized flower-like graphic with a droplet shape in the center.

Brookfield, WI 53045
- 2. The attached hand-held control unit includes user keys to initiate and control the treatment sessions. The control unit is designed to provide the stimulation pulses as well as visual biofeedback response. The modifications to the hand-held control unit include:
  - Use of a new microprocessor. The stimulation output will operate under the o same specifications as the previous InToneMV device (use of the same frequency (13/50Hz), pulse width (200uS), maximum voltage (40V), and maximum current (80mA). The pulse delivery on/off time shall also be identical.
  - The stimulation output characteristics as noted above will be replicated o identical to the predicate devices. The electrode surface area of the ApexMV falls between the InToneMV (smaller surface area) and the ApexM (larger surface area) making the ApexMV substantially equivalent in current density compared to the predicates.
  - Addition of an LED indicator that will illuminate when the stimulation is active O on the electrodes. The LEDs will only illuminate when sufficient current is conducting from one electrode to another, or will require tissue to bridge between the electrodes (create a current conducing path) in order to illuminate the LEDs.
  - Addition of an OLED display allows users to see the following visual cues: o
    - I Timer for duration of stimulation session
    - . Pressure gauge to illustrate the optimal balloon pressure range to begin the self-directed contractions to maximize the LED biofeedback bar graph response.
    - Visual cues during the self-directed contractions to guide the user when to contract and relax, as well as an integrated timer to illustrate length of contraction/relaxation.
  - o Omission of audio, no verbal session guidance will be offered for the ApexMV.

These changes do not change the fundamental technology, operating principle or primary function of the ApexMV device. Software/Firmware verification, electrical safety and EMC testing, Human Factors Usability Study and performance validation was performed in accordance with InControl Medical's risk management process and external standards. A summary of the results from this testing is found in Testing Summary, pages 21-22 of this document.

The table below is a summary of why each predicate was chosen for the ApexMV device design.

Attribute	Predicate
Smaller in size Probe	InToneMV
Visual Biofeedback	InToneMV
Over-the-Counter Use	ApexM
Fecal and Urinary Incontinence in menand women	InToneMV
Stress, Urge or Mixed UrinaryIncontinence in women	ApexM
End user sets their own stimulation	ApexM

Table 7.4: Substantial Equivalence Comparison Table

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Image /page/15/Picture/1 description: The image shows the logo for InControl Medical, with the company name in a stylized font. Below the logo is the address "3225 Gateway Road, Ste. 250 Brookfield, WI 53045".

Image /page/15/Picture/3 description: The image shows the logo for ApexMV. The logo consists of the word "apexMV" in a light gray sans-serif font. Above the "x" in "apex" is a green, stylized flower-like design with six petals and a small drop in the center. The overall design is clean and modern.

The ApexMV was designed with the smaller insertion probe, substantially equivalent to the InToneMV to accommodate anal insertion for urinary or fecal incontinence and for certain women who have smaller physical anatomies. The smaller probe aids in either rectal or vaginal insertion. The visual biofeedback that was added to the ApexMV, is substantially equivalent to the predicate, InToneMV. It allows the end user of the ApexMV to visually see the LED bars illuminate when they contract their pelvic floor muscles against the inflated balloon during the self-directed contraction portion of the session, which aids in their treatment.

By combining the smaller probe with the biofeedback, the ApexMV device is then able to treat stress, urge or mixed urinary and/or fecal incontinence in adult women as the electrical technology is identical to the predicates. The over-the-counter use allows the end user to self-diagnose their own incontinence and use the device to specifically treat that incontinence, same as the ApexM. Where as the InToneMV had data review and a controlled treatment session by the clinician/medical professional. The ApexMV doesn't have this data review or controlled treatment session by a clinician/medical professional. The end user of the ApexMV set's their own stimulation as they can with ApexM.

The device labeling and packaging (which includes an educational consumer-focused box, detailed IFU/user manual, laminated quick reference guide/patient card and an instructional video included in the packaging and available via InControl Medical's website) allows the end user to accurately self-diagnose and use the product. ApexMV labeling and packaging is substantially equivalent to the predicate, ApexM (K150183), and is therefore safe for over-thecounter use. This intended use is substantially equivalent to the predicate devices, ApexM (K150183) and InToneMV (K134020). The ApexMV labeling and the predicate labeling for ApexM (150183) and InToneMV (K134020) is found in Appendix 11 – Predicate and ApexMV Labeling.

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Image /page/16/Picture/1 description: The image shows the logo and address of InControl Medical. The logo features the text "InControl Medical" in a stylized font, with a circular graphic to the left. Below the logo is the address "3225 Gateway Road, Ste. 250, Brookfield, WI 53045".

Image /page/16/Picture/3 description: The image contains the logo for apexMV. The logo is gray, and there is a green flower above the 'x' in apexMV. The flower has six petals and a water droplet in the center.

Testing Summary

The following testing is provided in support of the substantial equivalence. The testing for ApexMV included software/firmware verification, electrical safety and EMC, Human Factors Usability Study and performance validation, in which the ApexMV device successfully passed all of this testing. Since the ApexMV device uses the same grade, type, color, and manufacturing processes for the silicone parts as the predicates and the previously cleared InTone device (K150180), manufactured by InControl Medical, LLC, the biocompatibility testing was not performed for the ApexMV device to demonstrate the equivalent safety and effectiveness. The biocompatibility testing was previously submitted with the ApexM submission under K150183 and with the InToneMV submission under K134020, there for the data is not attached to this submission for ApexMV.

Software Verification and Validation Testing:

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the end user. Testing data is found in Appendix 4 – Risk Management File.

Electrical Safety and Electromagnetic Compatibility Testing:

Electrical safety and EMC testing was conducted. The ApexMV device complies with the IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, and IEC 60601-1-2 standards for safety and the standard for EMC. Testing data is found in Appendix 7 – SGS EMC and Electrical Safety.

Biocompatibility Testing:

The biocompatibility evaluation was completed and submitted previously as stated above under the Testing Summary, therefore it was not tested for the ApexMV device. Above, under Testing Summary, contains the rationale. When the biocompatibility testing was performed for the predicates, it was conducted in accordance with International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by the FDA. The inflatable probe on the ApexMV device and predicates is considered tissue contacting for a duration of less than 24 hours. The biocompatibility testing included the following tests:

Cytotoxicity
Sensitization
. Irritation

Clinical Testing:

A clinical literature evaluation was conducted on the predicates ApexM (150183) and InToneMV (K134020) to provide evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence and treatment of male urinary or fecal incontinence. An appraisal of each article was completed as part of the literature evaluation. The appraisal included an assessment of suitability of each article, a device performance assessment and a device safety assessment.

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Image /page/17/Picture/1 description: The image shows the logo and address of InControl Medical. The logo features the company name in a stylized font, with the word "InControl" in a larger, bolder font and the word "Medical" in a smaller font below. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/17/Picture/3 description: The image contains the logo for ApexMV. The logo features the text "apexMV" in a simple, sans-serif font. The "apex" portion of the text is in a lighter color, while the "MV" portion is in a darker shade of gray. Above the text is a small, stylized graphic that resembles a flower or asterisk in a teal color.

A Human Factors Usability Study was conducted on the ApexMV device to assess the safety for over-the-counter use. The Human Factors Usability Study objectives were to: 1) determine if a user/subject can self-identify as having urinary and / or fecal incontinence using package labeling, 2) self-limit usage, if a contraindication is present, 3) safely use the ApexMV device using only package labeling, manual and patient card, and 4) determine subject's ability to complete critical tasks successfully. The study was conducted with collaboration with a supervising physician to ensure the product labeling, IFU, and video provided were suitable for over-the-counter use. The study objectives were met as the subject/end users were able to properly self-identify as having either urinary incontinence (either stress, urge, and/or mixed) or fecal incontinence. The labeling and packaging for the ApexMV device is substantially equivalent to the predicates ApexM (K150183) and InToneMV (K134020). The study feedback supported the availability of a training video. The Clinical Literature Review and Human Factors Usability Study results are found in Appendix 9 – Clinical Literature and Human Factors Usability Study Test.

Risk Management Summary

ApexMV has been designed according to InControl Medical's internal procedures with traceability between the design inputs, design outputs, verification and validation activities.

ApexMV has been evaluated for risks according to InControl Medical's internal procedures based on ISO14971. The risks associated with ApexMV were reduced to as low as possible and the risk/benefit analysis was acceptable.

Conclusion

The non-clinical data on the predicate devices support the safety of the ApexMV device. The software verification, performance validation, electrical safety, EMC testing and Human Factors Usability Study demonstrates that the ApexMV device is safe and effective for an over-thecounter treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
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).(b)
Classification. Class II (performance standards).