(72 days)
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
This document, K150183 for the ApexM device, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study for the new device itself. The information provided is primarily a comparison between the new device (ApexM) and two predicate devices (InTone and Apex) to show that the ApexM is equally safe and effective.
Therefore, many of the requested elements for acceptance criteria and a study proving the device meets them cannot be directly extracted as if a new, standalone performance study was conducted for ApexM with specific quantitative acceptance criteria. Instead, the document relies on comparing features and prior testing of predicate devices.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, explicit "acceptance criteria" for the new device's performance (e.g., "device must achieve X% sensitivity") are not stated in the provided text. The "reported device performance" is essentially that its features and technical specifications are substantially equivalent to the predicates, which have presumably met their own performance and safety requirements.
We can, however, extrapolate the implicit "acceptance criteria" as being "identical or substantially equivalent to the predicate device Apex (K141158) or InTone (K110179) without introducing new safety or effectiveness concerns." The "reported device performance" is that it meets this equivalence across various characteristics.
| Feature/Function | Implicit Acceptance Criterion (based on predicate) | Reported Device Performance (ApexM) |
|---|---|---|
| Intended Use | Treat female urinary incontinence (stress, urge, mixed, or a combination thereof) | Treat stress, urge and/or mixed urinary incontinence in women. Identical to Apex (K141158) in its application of stimulation, but broader in the types of incontinence treated compared to Apex alone. Substantially equivalent. |
| Primary Function | Delivery of electrical stimulation | Delivery of electrical stimulation. Identical. |
| Warnings/Precautions | Identical to Apex (K141158) | Identical to Apex. No new safety concerns. |
| Contraindications | Identical to Apex (K141158) | Identical to Apex. No new safety concerns. |
| Labeling Summary (User Manual) | User manual based on predicate Apex, adequate for safe and effective use. | User manual based on predicate Apex, which was validated through Human Factors/Usability testing. Substantially equivalent. |
| Environmental Specifications | For indoor use only. | For indoor use only. Identical. |
| Power Source | 4 AAA Alkaline battery (identical to Apex) | 4 AAA Alkaline battery. Identical to Apex, leveraging ease of use and acquisition for end user. |
| Method of line current isolation | N/A (battery) | N/A (battery). Identical. |
| Patient leakage current | N/A (battery) | N/A (battery). Identical. |
| Number of output modes/channels | 1 mode, 1 channel. | 1 mode, 1 channel. Identical. |
| Regulated current or voltage? | Regulated voltage. | Regulated voltage. Identical. |
| Firmware controlled? | Yes. | Yes. Identical. |
| Automatic Overload Trip? | No (identical to Apex) | No. Identical to Apex. Circuit design ensures self-limiting max stimulation, no injury. |
| Automatic No-Load Trip? | No (identical to Apex) | No. Identical to Apex. Circuit design ensures self-limiting max stimulation, no injury. |
| Automatic Shut Off? | Yes. | Yes. Identical. |
| Indicator Display (On/Off, Low Battery) | On/Off via display illumination (Yes), Low Battery (No). Identical to Apex. | Yes (via display illumination), No. Identical to Apex. Device powers off with low battery, so no safety risk. |
| Waveform, shape | Monophasic, alternating polarity, square pulse (identical to Apex) | Monophasic, alternating polarity, square pulse. Identical to Apex. Dual phase and monophasic alternating polarity both provide balanced positive/negative alternating waveforms. |
| Frequency (Mixed, Stress, Urge) | 50 Hz for stress (Apex); 50 Hz mixed (InTone). New frequency 13Hz is added for urge. | 13, 50 Hz. Combination of frequencies supported by literature for stress, urge, and mixed incontinence. Substantially equivalent. |
| Pulse width | 200 µs/phase. | 200 µs/phase. Identical. |
| Time (On, Off) | 1 second On, 2 seconds Off (for 50Hz, identical to Apex). Additional on/off times for 13Hz. | 1 second at 50 Hz, 2 seconds no stimulation; 2 seconds at 13 Hz, 2 seconds no stimulation. Substantially equivalent, with added times for the new frequency. |
| Total Session Time | 10-15 minutes (identical to Apex) | 10-15 minutes (5-10 minutes stimulation, 5 minutes self-directed). Identical to Apex. Small variances allowed. |
| Max output voltage (500Ω) | 40 Vdc (identical to Apex), meets IEC60601-2-10. | 40 Vdc. Identical to Apex, meets IEC60601-2-10. |
| Max output current (500Ω) | 80 mA (identical to Apex), meets IEC60601-2-10. | 80 mA. Identical to Apex, meets IEC60601-2-10. |
| Maximum phase charge (500Ω) | 16 µC (identical to Apex), meets IEC60601-2-10. | 16 µC. Identical to Apex, meets IEC60601-2-10. Pulse width identical. |
| Electrode surface area | 6.00 cm² ± 0.5 cm² (x 2) (identical to Apex). | 6.00 cm² ± 0.5 cm² (x 2). Identical to Apex. |
| Max current density | 13.3 mA/cm² (identical to Apex), meets IEC60601-2-10. | 13.3 mA/cm². Identical to Apex, meets IEC60601-2-10. Electrode surface area is identical. |
| Max average power density (500Ω) | 5.33 mW/cm² (identical to Apex), meets IEC60601-2-10. | 5.33 mW/cm². Identical to Apex, meets IEC60601-2-10. Electrode surface area, pulse width, max frequency identical. |
| Biofeedback | None (Identical to Apex, removed feature). | None. Biofeedback is a removed feature on both Apex and ApexM; omission does not adversely impact safety. |
| Dimensions (Insertion Unit) | Insertion Unit (overall): 12.2" x 2.5" x 4.0"; Inflatable Probe (avg. inflated): 5.5" x 2.2" x 2.5". Identical to Apex. | Insertion Unit (overall): 12.2" x 2.5" x 4.0"; Inflatable Probe (avg. inflated): 5.5" x 2.2" x 2.5". Identical. |
| Control housing material | N/A (identical to Apex; no separate control unit). | N/A. Identical to Apex. No separate control unit, as ApexM is OTC and controlled by end user. |
| Insertion material | Silicone, plastics. | Silicone, plastics. Identical. |
| Packaging or Expiration Dating | N/A (identical to Apex). | N/A. Identical to Apex. No expiration date needed as components are stable. |
| Sterilization | N/A. | N/A. Identical. |
| Operational Method: Clinical Use | Home use, Over-the-counter (identical to Apex). | Home use, Over-the-counter. Identical to Apex. Over-the-counter indication does not impact safety due to user control, safety features. |
| Patient Interaction: Functions Controllable | End user controls electrical stimulation levels and duration (identical to Apex). | End user controls electrical stimulation levels and duration. Identical to Apex. Stimulation controlled by end user per response, with safety features. |
| Patient Interaction: Programming Capability | Electrical stimulation levels set by end user (identical to Apex). | Electrical stimulation levels set by end user. Identical to Apex. Stimulation controlled by end user per response, with safety features. |
| Override | No (identical to Apex). | No. Identical to Apex. Device is single unit, powered off to stop stimulation and reset. |
| Patient Interaction: Operator Requirements | Over-the-counter device. No special knowledge or training required; instruction manual provided (identical to Apex). | Over-the-counter device. No special knowledge or training required; instruction manual provided. Identical to Apex. Designed for intuitive use without physician oversight, validated by Apex Human Factors study. |
| Software Level of Concern | Moderate. | Moderate. Identical. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For ApexM specifically: No new separate clinical or human factors study was conducted for ApexM. Its "test set" and provenance are based on the studies or evaluations of its predicate devices.
- For the predicate Apex (K141158): A human factors/usability study was conducted.
- Sample size: Not explicitly stated but the study was designed for a "general population of women."
- Data provenance: Not specified in terms of country of origin but was a prospective "human factors / usability study."
- For predicate InTone (K110179) and InToneMV (K131420): Biocompatibility testing was performed on InToneMV, and electrical safety and EMC testing for InTone and Apex. These are generally lab-based tests, not human subject studies with a "test set" in the sense of clinical performance endpoints.
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)
- The document mentions "InControl Medical collaborated with the supervising physician to make further labeling enhancements" for the predicate Apex's human factors study.
- Number of experts: At least one "supervising physician" mentioned.
- Qualifications: "Supervising physician" implies medical expertise, but specific qualifications (e.g., years of experience, specialty) are not detailed.
- No other expert involvement for "ground truth" on test sets is mentioned for ApexM or its predicates in the context of device performance, as the studies are focused on usability, safety, and technical equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The human factors/usability study for Apex was not a clinical trial requiring adjudication of outcomes by multiple experts. It assessed self-diagnosis, self-limiting usage based on contraindications, and safe use based on instructions. The results were deemed "favorable."
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
Not applicable. This device is an electrical muscle stimulator, not an AI-assisted diagnostic tool or imaging device that would involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a muscle stimulator used by a human user. Software verification and validation were performed for algorithms within the device (if any, as it's firmware controlled), but not a standalone "algorithm only" performance study in the AI sense. The "standalone performance" is covered by the electrical safety, EMC, and biocompatibility testing of the hardware components which demonstrated compliance with relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the human factors/usability study on predicate Apex: The "ground truth" was whether users could successfully self-diagnose, self-limit usage, and use the device safely as intended based on their understanding of the labeling. This implicitly relies on the medical accuracy of the diagnostic criteria presented in the labeling, which would be based on established medical knowledge and expert input in the development of those materials.
- For the clinical literature evaluation: The "ground truth" was derived from "evidence of the safety and efficacy of electrical stimulation for the treatment of female urinary incontinence" from published scientific literature, which would be based on clinical outcomes data from those studies.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device's technical specifications and safety parameters comes from engineering design, adherence to standards, and prior testing of predicate devices.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device with a training set. The "ground truth" for the underlying principles of electrical stimulation and device safety were established through decades of medical and engineering science, published literature, and regulatory standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
InControl Medical, LLC Jessica Andreshak Director of Quality Assurance and Regulatory Affairs 3225 Gateway Road, Suite. 250 Brookfield, WI 53045
Re: K150183 Trade/Device Name: ApexM Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: KPI Dated: January 26, 2015 Received: January 27, 2015
Dear Jessica Andreshak,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the word "InControl" in a gray sans-serif font, with the word "MEDICAL" in a smaller font below. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
6. Statement of Indications for Use
510(k) Number (if known) K150183
Device Name
ApexM
Indications for Use
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ____X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the company name in a stylized font, with the word "InControl" in a larger font than "Medical". The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
510(k) Summary
Submission Date
January 26th, 2015
Submitter Information
Jessica Andreshak Director of Quality Assurance and Regulatory Affairs InControl Medical, LLC 3225 Gateway Road, Ste. 250, Brookfield, WI 53045 USA Phone: (262) 373.0422 Fax: (262) 373.0463 Email: jandreshak@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): | ApexM |
| Classification name: | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Classification Regulation: | 21 CFR 876.5320 |
| Class: | Class II |
| Product Code: | KPI |
Legally Marketed Device for Substantial Equivalence
| 510(k) | Name | Product Code | Manufacturer |
|---|---|---|---|
| K110179 | InTone | KPI | InControl Medical, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA |
| K141158 | Apex | KPI | InControl Medical, LLC3225 Gateway Road, Ste. 250Brookfield, WI 53045 USA |
Table 7.2: Predicate Device Information
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Image /page/4/Picture/0 description: The image shows the logo for InControl Medical, along with their address. The logo features the word "InControl" in a dark gray font, with the word "MEDICAL" in a smaller font below it. To the left of the word "InControl" is a light blue circle with white lines inside. The address is listed as 3225 Gateway Road, Ste. 250, Brookfield, WI 53045.
Device Summary
ApexM is a hand-held, home-use device designed to treat female urinary incontinence. The device includes an inflatable probe. The inflatable probe is inserted into the vagina and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is used to improve the ability of muscles to hold a contraction for an extended period of time and is a treatment for urinary incontinence. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.
Intended Use
ApexM is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
Equivalence Comparison to the Predicate
Electrical muscle stimulation is the technological principle for ApexM and the predicate devices. It is based on the use of the electrical muscle stimulator to strengthen the pelvic floor muscles and surrounding structures. The chart below summarizes the shared and unique technological elements between ApexM and the predicate devices. The intended use, technology, engineering, performance and user interface for ApexM is substantially equivalent to the predicate devices.
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety andPerformance |
|---|---|---|---|---|---|
| Intended UseAn explicitdescription of allclinical functionsperformed by thedeviceIndications for UseExplain when thedevice is to beclinically used andthe intended patientpopulation | The InControl device is a non-implanted electricalstimulator indicated for use inthe treatment of femaleurinary incontinence. Itapplies electrical stimulationto the pelvic floormusculature and surroundingstructures. It is intended foracute and ongoing treatmentof mixed urinary incontinencewhere the following resultsmay improve urinary control. | Apex is a non-implantedmuscle stimulator designed totreat female stress urinaryincontinence. It appliesstimulation to the pelvic floormuscles to improve strengthand support. | ApexM is a non-implantedmuscle stimulator designed totreat stress, urge and/ormixed urinary incontinence inwomen. It applies stimulationto the pelvic floor musclesand surrounding structures toimprove strength andsupport. | Substantiallyequivalent | None:These devices applyelectrical stimulation tostrengthen the pelvic floormuscles, as supported byliterature. |
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety andPerformance |
| strengthening of pelvic floormuscles, inhibition of thedetrusor muscle throughreflexive mechanisms. Thebiofeedback feature can beused for muscle re-educationpurposes. | |||||
| Primary Function | Delivery of electricalstimulation | Delivery of electricalstimulation | Delivery of electricalstimulation | Identical | None |
| Warnings orPrecautions | (see product labeling) | (see product labeling) | (see product labeling) | Identical toApex | None:ApexM warnings andprecautions are identical toApex, which were definedaccording to the FDAguidance document andvalidated through theHuman Factors andUsability Testing. |
| ContraindicationsExplain when thedevice is not to beclinically used | • This device is not intendedfor diagnostic purposes orcritical patient monitoring.• The device is notdefibrillator proof.• The device should not beused on patients withcardiac pacemaker,implanted defibrillator, orother implanted metallic orelectronic device. Do notuse if patient has a historyof rate or conductivedisturbance• Do not use if patient hassymptoms of an activeurinary tract infection• Do not use if the patienthas vaginal infections,localized lesions, or otherundiagnosed symptoms.• Do not use if patient hasundiagnosed pain.• Do not use if patient has aneurological deficiency thatdoes not permit propersensory perception orstimulation• Do not use if patient hasdiminished mental capacityor physical competencethat limits use of the deviceor interaction with the careprovider regarding thedevice settings.• Do not use if patient iscurrently pregnant orattempting to getpregnant. | • Do not use if you arepregnant• Do not use if you areattempting to get pregnant• Do not use if you have acardiac demand pacemakeror implanted defibrillator• Do not use if you havesymptoms of active urinarytract infection, vaginalinfections, or localizedlesions• Do not use if you have adiagnosis of extra-urethralor overflow incontinence• Do not use if you havesevere urine retention• Do not use if you have poorsensation in the pelvicregion• Do not use if you havecognitive disabilities, i.e.;Alzheimer's disease ordementia• Do not use if you areunable to properly insertthe device per instructions• Do not use if you haveactive pelvic cancer• Do not use if you have anintestinal clamp• You must be 6 weeks post-pelvic surgery or vaginalchildbirth to use this device• Do not use this device fordiagnostic purposes orcritical patient monitoring• This device is not (external)defibrillator-proof | • Do not use if you arepregnant• Do not use if you areattempting to get pregnant• Do not use if you have acardiac demand pacemakeror implanted defibrillator• Do not use if you havesymptoms of active urinarytract infection, vaginalinfections, or localizedlesions• Do not use if you have adiagnosis of extra-urethralor overflow incontinence• Do not use if you havesevere urine retention• Do not use if you have poorsensation in the pelvicregion• Do not use if you havecognitive disabilities, i.e.;Alzheimer's disease ordementia• Do not use if you areunable to properly insertthe device per instructions• Do not use if you haveactive pelvic cancer• Do not use if you have anintestinal clamp• You must be 6 weeks post-pelvic surgery or vaginalchildbirth to use this device• Do not use this device fordiagnostic purposes orcritical patient monitoring• This device is not (external)defibrillator-proof | Identical toApex | None:ApexM contraindicationsare identical to Apex, whichwere validated through theHuman Factors andUsability Testing. |
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety and Performance |
| anatomical vaginalstructures that do notpermit proper andcomplete placement of theInsertion Unit• Do not use if the patienthas irregular menstrualbleeding cycles• Do not use if the patienthas a history or symptomsof urinary retention.• Do not use if the patienthas extra-urethraincontinence, (i.e. syrinx,ectopic, urethra).• Do not use if the patienthas overflow incontinencecaused by evacuationproblems.• Do not use if the patienthas severe urine retentionin the upper urethras.• Do not use if the patienthas complete peripheraldenervation of the pelvicfloor.• Do not use if the patienthas an intestinal clamp. | |||||
| Labeling SummaryClarity to insure saferor more effective use | User Manual | User Manual | User Manual | Substantiallyequivalent | None:ApexM user manual wasbased on the predicate,Apex, which was validatedthrough the HumanFactors/Usability testing. |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | For indoor use only | Identical | None |
| Power Source | 4/5 AA nickel metal hydridebattery | 4 AAA Alkaline battery | 4 AAA Alkaline battery | Identical toApex | None:ApexM battery is identicalto Apex, which leverages 4AAA Alkaline batteries forease of use and acquisitionfor the end user. Batteryinsertion was validatedthrough the Apex HumanFactors and UsabilityTesting. |
| Method of linecurrent isolation | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None |
| Patient leakagecurrent | N/A (battery) | N/A (battery) | N/A (battery) | Identical | None |
| Number of outputmodes | 1 | 1 | 1 | Identical | None |
| Number of outputchannels | 1 | 1 | 1 | Identical | None |
| Regulated current orvoltage? | Regulated voltage | Regulated voltage | Regulated voltage | Identical | None |
| Firmwarecontrolled? | Yes | Yes | Yes | Identical | None |
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety andPerformance |
| Automatic OverloadTrip? | Yes | No | No | Identical toApex | None:ApexM overload trip isidentical to Apex. Althoughthere is no overload trip,ApexM does not introduceany safety risks because ofthe circuit design. Themaximum level ofstimulation is self-limitingand will not cause end userinjury if maximum output isapplied. |
| Automatic No-LoadTrip? | Yes | No | No | Identical toApex | None:ApexM no-load trip isidentical to Apex. Althoughthere is no no-load trip,ApexM does not cause anysafety risks because of thecircuit design. Themaximum level ofstimulation is self-limitingand will not cause end userinjury if powered with noload. |
| Automatic Shut Off? | Yes | Yes | Yes | Identical | None |
| Indicator Display● On/Off Status● Low Battery | YesYes | Yes (via display illumination)No | Yes (via display illumination)No | Identical toApex | None:ApexM indicator display isidentical to Apex. This doesnot introduce a safety riskbecause the device willpower off when the batterypower is too low. |
| Waveform, shape | Dual phase, rectangularpulses | Monophasic, alternatingpolarity, square pulse | Monophasic, alternatingpolarity, square pulse | Identical toApex | None:ApexM waveform shape isidentical to Apex. Thesquare/rectangular shapedefines the DC componentcommon with bothwaveforms. The dual phaseand monophasic alternatingpolarity waveform deliveryboth provide a balancedpositive/negativealternating waveformdelivery. |
| Frequency● Mixed● Stress● Urge | 50 Hz-- | 50 Hz-- | 13, 50 Hz-- | Substantiallyequivalent | None:ApexM has a combinationof 50Hz and 13Hzfrequency. Thesefrequencies treat stress,urge and mixed urinaryincontinence as supportedby literature. |
| Pulse width | 200 µs/phase | 200 µs/phase | 200 µs/phase | Identical | None |
| Time● On● Off | 20 seconds10 seconds | 1 second at 50 Hz2 seconds no stimulation | 1 second at 50 Hz2 seconds no stimulation2 seconds at 13 Hz2 second no stimulation | Substantiallyequivalent | None:ApexM time on and off isidentical to Apex for the50Hz frequency. Theadditional time on and off isto account for a secondfrequency of 13Hz. |
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety andPerformance |
| Total Session Time | 12 minutes | Total session time of 10-15minutes• 5-10 minutes electricalstimulation• 5 minutes self-directedcontraction(recommended) | Total session time of 10-15minutes• 5-10 minutes electricalstimulation• 5 minutes self-directedcontraction(recommended) | Identical toApex | None:ApexM session time isidentical to Apex. Smallvariances in session timeare allowed due to end userpreferences. |
| Max output voltage(500Ω) | 50 Vdc | 40 Vdc | 40 Vdc | Identical toApex | None:This value is identical toApex and IEC60601-2-10requirements are met. |
| Max output current(500Ω) | 100 mA | 80 mA | 80 mA | Identical toApex | None:This value is identical toApex and IEC60601-2-10requirements are met. |
| Maximum phasecharge (500Ω) | 20 μC | 16 µC | 16 µC | Identical toApex | None:This value is based on theoutput current which meetsIEC60601-2-10requirements. The pulsewidth is identical to thepredicates. |
| Electrode surfacearea | 10.5 cm² x 2 | 6.00 cm² ± 0.5 cm² (x 2) | 6.00 cm² ± 0.5 cm² (x 2) | Identical toApex | None:ApexM electrode size is thesame as Apex. |
| Max current density | 9.5 mA/cm² | 13.3 mA/cm² | 13.3 mA/cm² | Identical toApex | None:This value is based on theoutput current which meetsIEC60601-2-10requirements. Theelectrode surface area isidentical to Apex. |
| Max average powerdensity (500Ω) | 4.8 mW/cm² | 5.33 mW/cm² | 5.33 mW/cm² | Identical toApex | None:This value is based on theoutput current which meetsIEC60601-2-10requirements. Theelectrode surface area,pulse width and maxfrequency are identical toApex. |
| Biofeedback | Air pressure, 0 - 2 psi | None | None | Identical toApex | None:Biofeedback is a removedfeature on both Apex andApexM. Biofeedback isstrictly an enhanced featurefor neuromuscular re-education and the omissionof this feature does notadversely impact the safetyof the device. |
| Dimensions(Insertion Unit) | Insertion Unit (overall): 12.2"x 2.5" x 4.0"Inflatable Probe (avg.inflated): 5.5" x 2.2" x 2.5" | Insertion Unit (overall): 12.2"x 2.5" x 4.0"Inflatable Probe (avg.inflated): 5.5" x 2.2" x 2.5" | Insertion Unit (overall): 12.2"x 2.5" x 4.0"Inflatable Probe (avg.inflated): 5.5" x 2.2" x 2.5" | Identical | None |
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety andPerformance |
| Control housingmaterial | ABS plastics | N/A | N/A | Identical toApex | None:ApexM does not include acontrol unit, identical toApex. The control unit isintended to store andreview data collected and toset stimulation levels by theclinician. Since ApexM isOTC, there is no need for acontrol unit. |
| Insertion material | Silicone, plastics | Silicone, plastics | Silicone, plastics | Identical | None |
| Packaging orExpiration Dating | 1 year for Insertion Unit | N/A | N/A | Identical toApex | None:The expiration date forApexM is identical to Apex.There is no need for anexpiration date since thecomponents are stable. |
| Sterilization | N/A | N/A | N/A | Identical | None |
| OperationalMethod: Clinical Usee.g., ambulatory use,home use | Clinic or Home use, underdirection of physician | Home use, Over-the-counter | Home use, Over-the-counter | Identical toApex | None:ApexM operation methodfor clinical use is identical toApex. An over-the-counterindication does not impactsafety because thestimulation 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: Anexplanation of howthe device interactswith the patient. | The patient can control thestarting and stopping of eachsession. However, the devicewill stop on its own once thesession in normallycompleted. | The end user can control theelectrical stimulation levelsand the duration of thestimulation session. | The end user can control theelectrical stimulation levelsand the duration of thestimulation session. | Identical toApex | None:ApexM patient controlledfunctions are identical toApex. Stimulation iscontrolled by the end userper individual response.Additional safety featuresare built into the design ofthe device for the maximumfrequency and automaticshut-off. |
| Patient Interaction:ProgrammingCapabilityWhether the devicecan be programmedand to what extent | None, programming can onlybe changed by clinician | Electrical stimulation levelsare set by the end user | Electrical stimulation levelsare set by the end user | Identical toApex | None:ApexM patientprogramming capability isidentical to Apex.Stimulation is controlled bythe end user per individualresponse. Additional safetyfeatures are built into the design of the device for the maximum frequency and automatic shut-off. |
| Feature/ Function | K110179 InTone(Predicate) | K141158 Apex(Predicate) | ApexM(New Device) | Comparison | Impact on Safety andPerformance |
| Override | Yes | No | No | Identical toApex | None:ApexM override is identicalto Apex. The predicate,InTone, includes two units(Control Unit and InsertionUnit) and has an overridefeature so that the patientcan pause the session onthe Control Unit withoutpowering the unit off. Apexand ApexM are single unitdevices (Insertion Unit only)and therefore do not havean override option forsuspending the stimulationfunction. Apex and ApexMare designed to be poweredoff by the end user to stopstimulation and improveease of use. Powering offthe devices reset thestimulation level to 0. |
| Patient Interaction:OperatorRequirementsKnowledge ortraining required ofthe operator, | Intended as part of acomplete therapy programwith physician coaching. Nospecial knowledge or training;instruction manual provided | Over-the-counter device. Nospecial knowledge or trainingrequired; instruction manualprovided | Over-the-counter device. Nospecial knowledge or trainingrequired; instruction manualprovided | Identical toApex | None:ApexM operatorrequirements are identicalto Apex. The ApexM devicehas been designed to bemore intuitive for use bythe end user withoutphysician oversight. In bothcases, no special knowledgeor training is required. Enduser interaction wasvalidated by the ApexHuman Factors andUsability Validation. |
| Software Level ofConcern | Moderate | Moderate | Moderate | Identical | None |
Table 7.3: Substantial Equivalence Comparison Table
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Image /page/5/Picture/0 description: The image contains the logo for InControl Medical. The logo features the word "InControl" in a large, serif font, with the word "MEDICAL" in a smaller font underneath. To the left of the word "InControl" is a light blue circle. Below the logo is the text "3225 Gateway Road, Ste. 250".
K110179 InTone
Traditional 510(k) Submission
ApexM
apexM
Impact on Safety and
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
K141158 Apex
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Image /page/6/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 size underneath. To the left of the text is a circular graphic with a series of curved lines. Below the logo is the text "2225 Gateway Road, Ste. 250".
Image /page/6/Picture/2 description: The image shows the logo for apexM. The text "apex" is in a blue sans-serif font, and the "M" is in a similar font but slightly larger. Above the "ex" in apex is a pink flower with five petals.
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
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Image /page/7/Picture/0 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 light blue circle with curved lines inside. Below the logo is the address "3225 Gateway Road, Ste. 250".
Brookfield, WI 53045
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Image /page/8/Picture/0 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" stacked above 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".
3225 Gateway Road, Ste. 250 Brookfield, WI 53045
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Image /page/9/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 it. To the left of the text is a circular graphic with a series of curved lines. Below the logo is the address "3225 Gateway Road, Ste. 250".
Brookfield, WI 53045
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ApexM has the same internal electronics and hardware as the predicate Apex (K141158). ApexM has the same patient contacting materials as InToneMV (K134020).
The predicate device, Apex (K141158), was evaluated for safety when supplied over-the-counter 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 as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the educational materials was found to be appropriate for this kind of self-identification in a general population of women. ApexM labeling and packaging is substantially equivalent to Apex (K14158). Users of ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis. Therefore, ApexM is also safe for over-the-counter use.
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Testing Summary
The following performance testing was provided in support of the substantial equivalence. The testing for ApexM included software verification and validation, and ApexM successfully passed the testing. As a result of the similar features between ApexM and the predicates, this claim of substantial equivalence references the electrical safety, and EMC testing performed on the predicates InTone and Apex, and the biocompatibility testing performed on InToneMV (K131420). New electrical safety, EMC, and biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of ApexM.
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.
Electrical Safety and Electromagnetic Compatibility Testing:
Electrical safety and EMC testing was conducted on the predicates InTone and 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. New electrical safety and EMC testing did not need to be performed to demonstrate the equivalent safety and effectiveness of ApexM.
Biocompatibility Testing:
The biocompatibility evaluation was completed for InToneMV (K131420). Testing 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 inflatable probe on the Insertion Unit is considered tissue contacting for a duration of less than 24 hours. The biocompatibility testing included the following tests:
- . Cytotoxicity
- Sensitization .
- . Irritation
New biocompatibility testing did not need to be performed to demonstrate the equivalent safety and effectiveness of ApexM.
Clinical Testing:
A clinical literature evaluation was conducted to provide evidence of the safety and efficacy of electrical stimulation for the treatment of female 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 on the predicate device Apex (K141158) to assess the safety for over-the-counter use. The human factors / usability study objectives were to: 1) determine if a subject can self-diagnose using package labeling, 2) self-limit usage if a
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contraindication is present, and 3) safely use the device referencing 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 enhancements including an educational consumer-focused box, detailed instructions for use, laminated quick reference guide and instructional video. The human factors / usability study can be applied to ApexM since women using ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis. The labeling and packaging for ApexM is substantially equivalent to Apex (K141158).
Risk Management Summary
ApexM has been designed according to InControl Medical's internal procedures with traceability between the design inputs, design outputs, verification and validation activities.
ApexM has been evaluated for risks according to InControl Medical's internal procedures based on ISO14971. The risks associated with ApexM 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 device, and the software verification and validation demonstrates that ApexM 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 urinary incontinence in women. Like the predicate device Apex (K141158), ApexM is intended for overthe-counter use. The usability study completed for the Apex device was designed to ensure that potential users could self-identify as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the educational materials was found to be appropriate for this kind of self-identification in a general population of women. Since users of ApexM will be able to properly self-identify as having urinary incontinence (either stress, urge, and/or mixed) as they will not have to exclude themselves from any specific diagnosis, a new human factors / usability study did not need to be performed. The labeling and packaging between ApexM and Apex (K14158) is substantially equivalent, supporting the safety of product labeling for selfdiagnosis and use. The data included within this submission supports ApexM as an over-thecounter treatment for stress, urge and/or mixed urinary incontinence in women as safe and effective.
§ 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).