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 Description

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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Apex device, a non-implanted muscle stimulator for treating female stress urinary incontinence. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to a predicate device (InTone K110179) and ensuring safety for over-the-counter use.

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

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

The document does not present explicit "acceptance criteria" in a quantitative performance table (e.g., Sensitivity X%, Specificity Y%). Instead, it focuses on demonstrating substantial equivalence to a predicate device and confirming safety and intended performance through various tests for its over-the-counter use.

The "Acceptance Criteria" implicitly stem from comparability to the predicate and compliance with relevant standards and usability requirements for an OTC device. "Reported Device Performance" is presented in terms of compliance with these standards and successful completion of the studies.

Acceptance Criteria (Implicitly based on Predicate Equivalence and OTC Safety)	Reported Device Performance (Apex)
Intended Use Equivalence: Treat female stress urinary incontinence by applying stimulation to pelvic floor muscles.	Substantially equivalent to InTone (K110179). Both apply electrical stimulation to strengthen pelvic floor muscles. Apex specifically designed for female stress urinary incontinence.
Primary Function Equivalence: Delivery of electrical stimulation.	Identical to InTone (K110179).
Warnings/Precautions Equivalence & Clarity: Improve end-user understanding for OTC use.	Substantially equivalent to InTone (K110179). Reworded for Apex to improve end-user understanding for OTC use. Validated through Human Factors and Usability Testing.
Contraindications Equivalence & Clarity: Improve end-user understanding for OTC use and ensure proper self-limitation.	Substantially equivalent to InTone (K110179). Reworded and reordered for Apex to improve end-user understanding for OTC use. Validated through collaboration with the supervising physician from the Human Factors and Usability Testing.
Labeling Summary Clarity: Improve end-user understanding.	Substantially equivalent to InTone (K110179). User manual reworded for Apex to improve end-user understanding for OTC use. Manual validated through collaboration with the supervising physician from Human Factors and Usability Testing. Enhanced labeling includes educational consumer-focused box, detailed IFU, quick reference guide, and instructional video.
Electrical Safety Standards Compliance: Meet IEC 60601-1 and IEC 60601-2-10 standards.	The device complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety.
Electromagnetic Compatibility (EMC) Standards Compliance: Meet IEC 60601-1-2 standard.	The device complies with the IEC 60601-1-2 standard for EMC.
Biocompatibility: Meet ISO 10993-1 for tissue contact.	Biocompatibility evaluation conducted per ISO 10993-1. Insertion Unit is tissue contacting for <24 hours. Completed Cytotoxicity, Sensitization, and Irritation tests.
Software Verification & Validation: Adhere to FDA guidance for "moderate" level of concern.	Software verification and validation conducted per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "moderate" level of concern. Passed all testing.
Human Factors/Usability (OTC specific): Enable self-identification of SUI, self-limitation if contraindicated, and safe use based on provided instructions.	A human factors/usability study was conducted. Objectives: 1) determine if a subject can self-identify as having SUI using package labeling, 2) self-limit usage if a contraindication is present, 3) safely use Apex using only the IFU. Results were favorable, leading to further labeling enhancements (educational box, detailed IFU, quick reference guide, inspirational video).
Risk Management: Risks reduced to as low as reasonably practicable, with acceptable risk/benefit analysis.	Evaluated for risks per ISO 14971. Risks reduced to as low as possible, and risk/benefit analysis was acceptable.
Technological Equivalence (Key Parameters):	Apex Performance compared to InTone (Predicate):- Power Source: 4 AAA Alkaline battery vs. 4/5 AA NiMH. Substantially equivalent; both battery powered, operate at 3.3V/5V. AAA chosen for ease of use/acquisition; battery insertion validated via HF/Usability. - Automatic Overload Trip: No vs. Yes. Substantially equivalent; Apex circuit design does not introduce safety risks, max stimulation is self-limiting. - Automatic No-Load Trip: No vs. Yes. Substantially equivalent; Apex circuit design does not introduce safety risks, max stimulation is self-limiting. - Indicator Display (Low Battery): No vs. Yes. Substantially equivalent; not a safety risk as device powers off when battery is too low. - Time On Off: 1s at 50Hz, 2s no stimulation (Apex) vs. 1s at 50Hz, 2s no stim & 2s at 13Hz, 2.1s no stim (InTone). Substantially equivalent; identical for 50Hz treatment algorithm. - Total Session Time: 10-15 minutes (5-10min stim, 5min self-directed cont.) vs. 12 minutes. Substantially equivalent; small variances allowed for end user preferences. - Max Output Voltage (500Ω): 34.2 V vs. 34.7 V. Substantially equivalent; slightly lower, 1% deviation within circuit component tolerance. - Max Output Current (500Ω): 68.2 mA vs. 69.1 mA. Substantially equivalent; slightly lower, 1% deviation within circuit component tolerance. - Maximum Phase Charge (500Ω): 13.6 µC vs. 13.8 µC. Substantially equivalent; slightly lower, 1% deviation within circuit component tolerance. - Max Current Density: 11.6 mA/cm² vs. 11.8 mA/cm². Substantially equivalent; slightly lower, <2% deviation within circuit component tolerance. - Max Average Power Density (500Ω): 3.95 mW/cm² vs. 4.05 mW/cm². Substantially equivalent; slightly lower, <2% deviation within circuit component tolerance. - Biofeedback: None vs. Air pressure, 0-2 psi. Feature removed; not a safety concern as biofeedback is an enhanced feature and its omission does not adversely impact safety. - Control housing material: N/A vs. ABS plastics. Feature removed; Apex is a single unit, control unit not present. - Packaging or Expiration Dating: NA vs. 1 year for insertion unit. Substantially equivalent; not needed due to material stability. - Operational Method: Home use, Over-the-counter vs. Clinic or Home use, under direction of physician. Substantially equivalent; OTC indication does not impact safety as stimulation is end-user controlled; additional safety features (max frequency, auto shut-off) built-in. - Patient Interaction (Override): No vs. Yes. Substantially equivalent; Apex is a single unit, designed for ease of use (powering off resets stimulation to 0).

2. Sample sized used for the test set and the data provenance

Human Factors / Usability Study (Test Set): The document mentions that a human factors/usability study was "conducted to assess the safety of the Apex device for over-the-counter use." However, it does not specify the sample size used for this study.
Data Provenance: The document does not explicitly state the country of origin for the human factors/usability study or whether it was retrospective or prospective. Given the FDA submission, it implicitly refers to a study conducted to support the US market. The nature of a usability study suggests it would be prospective (new data collected on actual users).
Clinical Literature Evaluation: This involved evaluating existing literature, so it's a retrospective review of published studies. No specific sample size for a "test set" applies here as it's a review, not primary data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Human Factors / Usability Study: The document states that "InControl Medical collaborated with the supervising physician from the Human Factors and Usability Testing" for labeling enhancements and validation of contraindication understanding. This implies at least one supervising physician served as an expert. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "supervising physician."
Clinical Literature Evaluation: This involved an "appraisal of each article," which would typically be done by qualified individuals, but the document does not specify the number of experts or their qualifications for this appraisal.

4. Adjudication method for the test set

For the Human Factors / Usability Study, the document mentions "collaboration with the supervising physician" for validating understanding of contraindications and refining labeling. This suggests an expert review/adjudication process for the usability and labeling aspects, but a formal (e.g., 2+1, 3+1) adjudication method is not explicitly described.

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 Apex device is an electrical muscle stimulator, not an AI-assisted diagnostic device that would typically involve human readers interpreting images. The study focuses on the device's direct performance, safety for OTC use, and equivalence to a predicate device.

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

Again, this question is more relevant to AI/diagnostic algorithms. For the Apex device, the "standalone" performance relates to its electrical stimulation characteristics, which were tested for compliance with electrical safety and EMC standards. The electrical stimulation parameters and safety features (e.g., self-limiting output, auto shut-off) represent the device's "standalone" functional performance, which were verified through the "Electrical Safety and Electromagnetic Compatibility Testing" and presented in the equivalence table.

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

Human Factors / Usability Study: The "ground truth" for this study was the correct understanding and safe application of the device by the end-user based on the provided instructions and labeling, as verified by the supervising physician. It's effectively a form of user performance/behavioral data assessed against safety and usability benchmarks.
Clinical Literature Evaluation: The ground truth for efficacy and safety was established by the peer-reviewed scientific literature on electrical stimulation for stress urinary incontinence. This relies on the outcomes data and conclusions from those published studies.
Engineering/Electrical Testing: The ground truth was defined by international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which the device demonstrated compliance with.

8. The sample size for the training set

The document does not mention a traditional "training set" as would be used for machine learning. The studies described are for verification and validation of a hardware device and its usability, not for training a model.

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

As there's no mention of a traditional machine learning "training set," this question is not applicable in the context of this device's submission.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: (262) 373.0422 Fax: (262) 373.0463 Email: jandreshak@incontrolmedical.com

Device Information

Table 4. Device Information

Type of 510(k):	Traditional 510(k)
Common Name:	Pelvic Floor Muscle Stimulator
Trade Name (proprietary name):	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, LLC3225 Gateway Road, Ste. 250Brookfield, 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

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(Predicate)	Apex(New Device)	Comparison	Impact on Safety andPerformance
Intended UseAn explicit description of allclinical functions performed bythe device,Indications for UseExplain when the device is to beclinically used and the intendedpatient population	The InControl device is a non-implantedelectrical stimulator indicated for use inthe treatment of female urinaryincontinence. It applies electricalstimulation to the pelvic floormusculature and surrounding structures.It is intended for acute and ongoingtreatment of mixed urinary incontinencewhere the following results may improveurinary control: strengthening of pelvicfloor muscles, inhibition of the detrusormuscle through reflexive mechanisms.The biofeedback feature can be used formuscle re-education purposes.	Apex is a non-implanted musclestimulator designed to treatfemale stress urinary incontinence.It applies stimulation to the pelvicfloor muscles to improve strengthand support.	Substantiallyequivalent	None:Both devices apply electricalstimulation to strengthen thepelvic floor muscles, assupported by literature, seeAppendix 13.
Primary Function	Delivery of electrical stimulation	Delivery of electrical stimulation	Identical	None
Feature/ Function	K110179 InTone(Predicate)	Apex(New Device)	Comparison	Impact on Safety andPerformance
Warnings or Precautions	(see product labeling)	(see product labeling)	Substantiallyequivalent	None:The warnings and precautionswere based on the predicate,InTone, but were reworded forApex to improve end userunderstanding for over-the-counter use. The warning andprecautions were re-definedaccording to the FDA guidancedocument and validatedthrough the Human Factors andUsability Testing.
ContraindicationsExplain when the device is notto be clinically used	• This device is not intended fordiagnostic purposes or critical patientmonitoring.• The device is not defibrillator proof.• The device should not be used onpatients with cardiac pacemaker,implanted defibrillator, or otherimplanted metallic or electronic device.• Do not use if patient has a history ofrate or conductive disturbance• Do not use if patient has symptoms ofan active urinary tract infection• Do not use if the patient has vaginalinfections, localized lesions, or otherundiagnosed symptoms.• Do not use if patient has undiagnosedpain.• Do not use if patient has a neurologicaldeficiency that does not permit propersensory perception or stimulation• Do not use if patient has diminishedmental capacity or physicalcompetence that limits use of thedevice or interaction with the careprovider regarding the device settings.• Do not use if patient is currentlypregnant or attempting to getpregnant.• Do not use if patient has anatomicalvaginal structures that do not permitproper and complete placement of theInsertion Unit• Do not use if the patient has irregularmenstrual bleeding cycles• Do not use if the patient has a historyor symptoms of urinary retention.• Do not use if the patient has extra-urethra incontinence, (i.e. syrinx,ectopic, urethra).• Do not use if the patient has overflowincontinence caused by evacuationproblems.• Do not use if the patient has severeurine retention in the upper urethras.• Do not use if the patient has completeperipheral denervation of the pelvicfloor.• Do not use if the patient has anintestinal clamp.	• Do not use if you are pregnant• Do not use if you are attemptingto get pregnant• Do not use if you have a cardiacdemand pacemaker orimplanted defibrillator• Do not use if you havesymptoms of active urinary tractinfection, vaginal infections, orlocalized lesions• Do not use if you have adiagnosis of extra-urethral oroverflow incontinence• Do not use if you have severeurine retention• Do not use if you have poorsensation in the pelvic region• Do not use if you have cognitivedisabilities, i.e.; Alzheimer'sdisease or dementia• Do not use if you are unable toproperly insert the device perinstructions• Do not use if you have activepelvic cancer• Do not use if you have anintestinal clamp• You must be 6 weeks post-pelvicsurgery or vaginal childbirth touse this device• Do not use this device fordiagnostic purposes or criticalpatient monitoring• This device is not (external)defibrillator-proof	Substantiallyequivalent	None:The contraindications are basedon the predicate, InTone, butwere reworded and reorderedfor Apex to improve end userunderstanding for over-the-counter use. The ability tounderstand thecontraindications was validatedthrough collaboration with thesupervising physician from theHuman Factors and UsabilityTesting.
Feature/ Function	K110179 InTone(Predicate)	Apex(New Device)	Comparison	Impact on Safety andPerformance
Labeling SummaryClarity to insure safer or moreeffective use	User Manual	User Manual	Substantiallyequivalent	None:The user manual is based on thepredicate, InTone, but wasreworded for Apex to improveend user understanding forover-the-counter use. Themanual was validated throughcollaboration with thesupervising physician from theHuman Factors and UsabilityTesting.
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	Substantiallyequivalent	None:Both devices are batterypowered. Both devices operateat 3.3V (processor) and 5V(waveform generator);however, the Apex deviceleverages 4 AAA Alkalinebatteries for ease of use andacquisition for the end user.Battery insertion was validatedthrough the Human Factors andUsability Testing.
Method of line currentisolation	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	Substantiallyequivalent	None:Although there is no overloadtrip, Apex does not introduceany safety risks because of thecircuit design. The maximumlevel of stimulation is self-limiting and will not cause enduser injury if maximum outputis applied.
Automatic No-Load Trip?	Yes	No	Substantiallyequivalent	None:Although there is no no-loadtrip, Apex does not cause anysafety risks because of thecircuit design. The maximumlevel of stimulation is self-limiting and will not cause enduser injury if powered with noload.
Automatic Shut Off?	Yes	Yes	Identical	None
Indicator Display• On/Off Status• Low Battery	YesYes	Yes (via display illumination)No	Substantiallyequivalent	None:Apex does not have a lowbattery indicator. This does notintroduce a safety risk becausethe device will power off whenthe battery power is too low.
Waveform, shape	Monophasic, alternating polarity, squarepulse	Monophasic, alternating polarity,square pulse	Identical	None
Feature/ Function	K110179 InTone(Predicate)	Apex(New Device)	Comparison	Impact on Safety andPerformance
				incontinence as supported byliterature, see Appendix 13.
Pulse width	200 $\mu$ s/phase	200 $\mu$ s/phase	Identical	None
TimeOn Off	1 second at 50 Hz2 seconds no stimulation2 seconds at 13 Hz2.1 second no stimulation	1 second at 50 Hz2 seconds no stimulation	Substantiallyequivalent	None:The time on and time off areidentical for the 50Hz treatmentalgorithm.
Total Session Time	12 minutes	Total session time of 10-15minutes5-10 minutes electricalstimulation 5 minutes self-directedcontraction (recommended)	Substantiallyequivalent	None:With Apex, small variances insession time are allowed due toend user preferences.
Max output voltage (500Ω)	34.7 V	34.2 V	Substantiallyequivalent	None:Apex has a slightly lower outputvoltage than the predicate. A1% deviation from the predicateis within the variation of circuitcomponent tolerance.
Max output current (500Ω)	69.1 mA	68.2 mA	Substantiallyequivalent	None:Apex has a slightly lower maxoutput current than thepredicate. A 1% deviation fromthe predicate is within thevariation of circuit componenttolerance.
Maximum phase charge (500Ω)	13.8 $\mu$ C	13.6 $\mu$ C	Substantiallyequivalent	None:Apex has a slightly lower maxphase charge than thepredicate. A 1% deviation fromthe predicate is within thevariation of circuit componenttolerance.
Electrode surface area	5.88 cm²	5.88 cm²	Identical	None
Max current density	11.8 mA/cm²	11.6 mA/cm²	Substantiallyequivalent	None:Apex has a slightly lower maxcurrent density than thepredicate. Less than 2%deviation from the predicate iswithin the variation of circuitcomponent tolerance.
Max average power density(500Ω)	4.05 mW/cm²	3.95 mW/cm²	Substantiallyequivalent	None:Apex has a slightly lower maxaverage power density than thepredicate. Less than 2%deviation from the predicate iswithin the variation of circuitcomponent tolerance.
Biofeedback	Air pressure, 0 - 2 psi	None	Featureremoved	None:Biofeedback is strictly anenhanced feature forneuromuscular re-educationand the omission of this featuredoes not adversely impact thesafety of the device.
Dimensions (Insertion Unit)	Overall Insertion Unit: 12.2"x 2.5"x 4.0"	Overall Insertion Unit: 12.2"x 2.5"x4.0"	Identical	None
Control housing material	ABS plastics	N/A	FeatureRemoved	None:Apex does not include a controlunit. The control unit is
Feature/ Function	K110179 InTone(Predicate)	Apex(New Device)	Comparison	Impact on Safety andPerformance
Insertion material	Silicone, plastics	Silicone, plastics	Identical	None
Packaging or Expiration Dating	1 year for insertion unit	NA	Substantiallyequivalent	None:Expiration dating is not neededbased on the stability of thematerials chosen.
Sterilization	N/A	N/A	Identical	None
Operational Method: ClinicalUsee.g., ambulatory use, home use	Clinic or Home use, under direction ofphysician	Home use, Over-the-counter	Substantiallyequivalent	None:An over-the-counter indicationdoes not impact safety becausethe stimulation is controlled bythe end user per end userresponse. Additional safetyfeatures are built into thedesign of the device for themaximum frequency andautomatic shut-off.
Patient Interaction: FunctionsControllable: An explanation ofhow the device interacts withthe patient.	The patient can control the starting andstopping of each session. However, thedevice will stop on its own once thesession in normally completed.	The end user can control theelectrical stimulation levels and theduration of the stimulation session.	Substantiallyequivalent	None:Stimulation is controlled by theend user per individualresponse. Additional safetyfeatures are built into thedesign of the device for themaximum frequency andautomatic shut-off.
Patient Interaction:Programming CapabilityWhether the device can beprogrammed and to whatextent	None, programming can only be changedby clinician	Electrical stimulation levels are setby the end user	Substantiallyequivalent	None:Stimulation is controlled by theend user per individualresponse. Additional safetyfeatures are built into thedesign of the device for themaximum frequency andautomatic shut-off.
Override	Yes	No	Substantiallyequivalent	None:The predicate, InTone, includestwo units (control unit andinsertion unit) and has anoverride feature so that thepatient can pause the sessionon the control unit withoutpowering the unit off. Apex is asingle unit device (insertion unitonly) and therefore does nothave an override option forsuspending the stimulationfunction. Apex is designed to bepowered off by the end user tostop stimulation and improveease of use. Powering off thedevice resets the stimulationlevel to 0.
Patient Interaction: OperatorRequirementsKnowledge or training requiredof the operator,	Intended as part of a complete therapyprogram with physician coaching. Nospecial knowledge or training; instructionmanual provided	Over-the-counter device. Nospecial knowledge or trainingrequired; instruction manualprovided	Substantiallyequivalent	None:The Apex device has beendesigned to be more intuitivefor use by the end user withoutphysician oversight. In bothcases, no special knowledge or
Feature/ Function	K110179 InTone(Predicate)	Apex(New Device)	Comparison	Impact on Safety andPerformance
				training is required. End userinteraction was validated by theHuman Factors and UsabilityValidation.
Software Level of Concern	Moderate	Moderate	Identical	None

Table 6. Substantial Equivalence Comparison Table

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Image /page/5/Picture/0 description: The image shows the logo for InControl Medical. The logo features the text "InControl" in a bold, sans-serif font, with the word "Medical" in a smaller font below. The logo also includes the address "3225 Gateway Road, Ste. 250".

Image /page/5/Picture/2 description: The image contains the word "apex" in a blue sans-serif font. To the right of the word is a stylized flower-like design in a light orange color. The flower has six petals arranged in a circular pattern.

Brookfield, WI 53045

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Image /page/6/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the company name in a gray, sans-serif font, with the word "MEDICAL" in a smaller font size below "CONTROL". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/6/Picture/2 description: The image shows the word "apex" in a blue sans-serif font. To the right of the word is a light orange flower-like design. The flower has six petals and a small circle in the center.

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Image /page/7/Picture/0 description: The image shows the logo for InControl Medical, followed by their address. The logo is a light green circle with the word "InControl" in dark gray letters. Below the logo is the word "Medical" in smaller, dark gray letters. The address is 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/7/Picture/2 description: The image shows the word "apex" in a sans-serif font. The word is in lowercase letters and is a teal color. To the right of the word is a light orange flower-like design.

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Image /page/8/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 underneath. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/8/Picture/2 description: The image shows the word "apex" in a sans-serif font. The word is in a teal color. To the right of the word is a flower-like design in a light orange color.

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Image /page/9/Picture/0 description: The image shows the logo and address of InControl Medical. 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.

Testing Summary

The following performance testing was provided in support of the substantial equivalence. The testing for Apex included software, electrical safety, biocompatibility and clinical. Apex successfully passed all testing.

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 as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the end user.

Electrical Safety and Electromagnetic Compatibility Testing:

Electrical safety and EMC testing were conducted on Apex. The device complies with the IEC 60601-1 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.

Biocompatibility Testing:

The biocompatibility evaluation for Apex 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 FDA. The Insertion Unit is considered tissue contacting for a duration of less than 24 hours. The biocompatibility testing completed included the following tests:

Cytotoxicity
Sensitization
. Irritation

Clinical Testing:

A clinical literature evaluation was conducted to provide evidence of the safety and efficacy of electrical stimulation for the treatment of female stress urinary 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.

A human factors / usability study was conducted to assess the safety of the Apex device for over-the-counter use. The human factors / usability study objectives were to: 1) determine if a subject can self-identify as having stress urinary incontinence using package labeling 2) self-limit usage if a contraindication is present 3) safely use the Apex device using only the instructions for use (IFU) provided. The results were favorable leveraging the original packaging and IFU; however, InControl Medical collaborated with the supervising physician to make further labeling

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Image /page/10/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the word "InControl" in a stylized font, with the word "Medical" underneath. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.

Image /page/10/Picture/2 description: The image shows the word "apex" in a sans-serif font. The letters are a light blue color. To the right of the word is a light orange flower-like design. The design has six petals.

enhancements including an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video.

Risk Management Summary

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

Apex has been evaluated for risks according to InControl Medical's internal procedures based on ISO 14971. The risks associated with Apex were reduced to as low as possible and the risk/benefit analysis was acceptable.

Conclusion

The non-clinical data supports the safety of the device, and the hardware and software verification and validation demonstrates that Apex performs as intended in the specified use conditions. The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of electrical stimulation as an effective treatment of stress urinary incontinence in women. Given that Apex is intended for over-the-counter use, whereas the predicate is intended for prescription use, a human factors / usability study was completed to support the safety of the product labeling for self-diagnosis and use. The data included within this submission supports the use of Apex for over-the-counter as safe and effective.

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).