(90 days)
The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.
The InMode System is a computerized device intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. . The System consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The single use vTone Applicator is connected to the console via pulse generator adaptor.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
The System emits an electrical signal of rectangular bi-phasic wave, and allows selecting intensity level of stimulation pulses from 1 to 50 intensity levels (equivalent to 5-54V). The system pulse width ranges from 50 to 450usec.
The system pulse frequency ranges from 3 to 100Hz. In addition, the device emits the pulses in bursts of 1-60 sec, with a succeeding relaxation time of 1-60 sec, depending on the intensity level chosen by the user.
The System supports the following components:
- LCD display touch screen ●
- Audio loudspeaker ●
- 48V AC/DC power supply ●
- . Controller
- Fans
The System operates while connected to the following applicator:
- · vTone Applicator
The InMode System with vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for clinical performance in terms of specific thresholds for efficacy. Instead, the device establishes substantial equivalence to a predicate device (Kegel8, K081480) by demonstrating similar indications for use, mechanism of action, and comparable performance specifications, alongside compliance with relevant safety standards and satisfactory non-clinical testing.
Therefore, the "acceptance criteria" are implied to be demonstration of substantial equivalence to the predicate device as outlined in the comparative table, and compliance with recognized safety and performance standards through bench testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1. Substantial Equivalence to Predicate Device (K081480) | Demonstrated through a detailed comparison highlighting similar Indications for Use, Target Population, Anatomical Sites, Environment Used, Mechanism of Action, Electrical Type, Number of Output Modes, Number of Output Channels (similar concept for a single channel device), Waveform, Pulse Shape, Net Charge @ 500 ohms, Maximum Phase Charge, Standards Met, and Compatibility with Environment and Other Devices. Minimal differences in some specs (e.g., power source, maximum voltage/current, other specific metrics like timer range, on/off time) were deemed not to alter safety or effectiveness. The predicate device uses a 9V PP3 battery while the subject device uses an AC line power. |
| 2. Compliance with Recognized Safety and Performance Standards | A. IEC 60601-1 (Basic Safety and Essential Performance): Tested and complies. |
| B. IEC 60601-1-2 (Electromagnetic Compatibility - EMC): Tested and complies. | |
| C. IEC 60601-2-10 (Nerve and Muscle Stimulators - Performance): Tested and complies. | |
| D. IEC 60601-1-6 (Usability): Tested and complies. | |
| 3. Non-Clinical (Bench) Performance Data for Device Functionality | Bench testing conducted to validate output waveform, basic unit characteristics, and output specifications. Results demonstrated the device performs as expected under anticipated conditions of use. |
| 4. Biocompatibility of Patient-Contacting Materials (vTone Applicator) | Biocompatibility tests performed according to ISO 10993-1:2018 and FDA Guidance. |
| * Cytotoxicity Study: Non-toxic (no evidence of cell lysis or toxicity). | |
| * ISO Acute Systemic Toxicity Study: Non-toxic (no evidence of systemic toxicity in mice). | |
| * ISO Guinea Pig Maximization Sensitization Test: No irritation/sensitization (no evidence of delayed dermal contact sensitization). | |
| * ISO Vaginal Irritation Sensitization in Rabbit: No irritation (non-irritant to vaginal tissue). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There was no clinical study involving human subjects or patient data to generate a "test set" for efficacy. The assessment was based on non-clinical (bench) testing and a comparison to a predicate device.
- Data Provenance: Not applicable. The data is from laboratory (bench) testing conducted by the manufacturer, InMode Ltd., and its consultants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As there was no clinical test set involving human subjects to evaluate efficacy, no experts were used to establish ground truth for this purpose. The assessment relied on engineering and scientific principles for device design, safety, and functionality, and comparison to a legally marketed predicate device. Biocompatibility testing was outsourced to independent labs.
4. Adjudication Method for the Test Set
Not applicable. No test set involving expert adjudication was conducted.
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 stimulation device for pelvic floor muscle rehabilitation, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. Performance was assessed through engineering bench tests of its electrical and mechanical properties, and compliance with safety standards.
7. The type of ground truth used
The concept of "ground truth" in the clinical efficacy sense (e.g., pathology, outcomes data) is not directly applicable here. The "truth" for this submission is established through:
- Compliance with recognized consensus standards: Demonstrating that the device meets established safety and performance benchmarks for medical electrical equipment and nerve/muscle stimulators.
- Bench Test Results: Verification that the device's electrical output, physical characteristics, and biocompatibility meet its design specifications and regulatory requirements.
- Substantial Equivalence: The foundation of the 510(k) submission is showing that the new device is as safe and effective as a legally marketed predicate device (Kegel8, K081480), which previously gained clearance. The "ground truth" for the predicate device's safety and effectiveness was established during its original clearance process.
8. The sample size for the training set
Not applicable. As there was no machine learning or AI component, there was no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
May 5, 2020
InMode Ltd. % Amit Goren, Ph.D. Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel
Re: K200293
Trade/Device Name: InMode System with vTone Applicator Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: January 30, 2020 Received: February 5, 2020
Dear Amit Goren:
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. 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.
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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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidanceregulatory-information/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-devices/medical-devicesafety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200293
Device Name InMode System with vTone Applicator
Indications for Use (Describe)
The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
THE INMODE SYSTEM WITH THE VTONE APPLICATOR
510(k) Number K200293
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar YokneamYokneam 20692IsraelTel: +972-4-9097470Fax: +972-4-9097471E-mail: amit@asteinrac.com |
| Contact Person: | Amit Goren |
| Official Correspondent:Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102Kfar Saba 4442520 IsraelTel: +972-9-7670002Fax: +972-9-7668534E-mail: amit@asteinrac.com |
| Date Prepared: | April 21, 2020 |
| Trade Name: | The InMode System with vTone Applicator |
| Classification Name: | CFR Classification section 876.5320;(Product code: KPI)Nonimplanted Electrical Continence Device |
| Classification: | Class II Medical Device |
Predicate Device:
The InMode System with vTone Applicator is substantially equivalent to the following predicate device.
| Predicate | Manufacturer | 510(k) No. |
|---|---|---|
| Kegel8 device | Mantra International (HK) Ltd | K081480 |
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Device Description:
The InMode System is a computerized device intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women. . The System consists of an AC/DC power supply unit, controller and user interface including an LCD touch screen. The single use vTone Applicator is connected to the console via pulse generator adaptor.
The delivery of the electrical energy is controlled by a Start/Stop button positioned on the LCD screen.
The System emits an electrical signal of rectangular bi-phasic wave, and allows selecting intensity level of stimulation pulses from 1 to 50 intensity levels (equivalent to 5-54V). The system pulse width ranges from 50 to 450usec.
The system pulse frequency ranges from 3 to 100Hz. In addition, the device emits the pulses in bursts of 1-60 sec, with a succeeding relaxation time of 1-60 sec, depending on the intensity level chosen by the user.
The System supports the following components:
- LCD display touch screen ●
- Audio loudspeaker ●
- 48V AC/DC power supply ●
- . Controller
- Fans
The System operates while connected to the following applicator:
- · vTone Applicator
Following are The InMode System with vTone Applicator specifications:
| Main Line Frequency (nominal): | 50-60 Hz |
|---|---|
| Input Voltage (nominal): | 100-240 VAC |
| Input Current (rms): | 2A |
| Dimensions: | |
| Console | 35cm W x 35cm D x 100cm H |
| [W x H x D] | [18.2" W x 18.2" D x 40" H] |
| vTone Applicator | 8.8cm L x 2.8cm D |
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| [L x D] | [3.5'' L x 1.1'' D] |
|---|---|
| Console Weight: | 20 Kg (44 lbs) |
| vTone Applicator Weight: | 0.11 Kg [0.25 lbs.] |
| vTone electrode material | Chrome coated plastic |
| vTone electrode size | 9.58cm2 |
| Platform modules | Converts AC input voltage (100-240VAC) to |
| AC/DC power supply | 48Vdc, 300W |
| Waveform | Biphasic |
| Shape | Rectangular |
| Intensity (output Voltage) | Up to 50 intensity level (=54 Vpeak) |
| Pulse Width | 50 to 450 usec |
| Frequency | 3 to 100 Hz |
Intended Use/Indication for Use:
The InMode System with the vTone Applicator is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women.
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Performance Standards:
The InMode System with vTone Applicator has been tested and complies with the following FDA recognized consensus standards:
- · IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005 Edition 3rd, MOD)
- · IEC 60601-1-2: Medical electrical equipment; Part 1-2: Collateral Standard: Electromagnetic compatibility - Requirements and tests, Edition 4.0 (2014). Environment of intended uses: Professional Healthcare Facility Environment
- · IEC 60601-2-10 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10 Edition 2.1 2016-04) IEC 60601-2-10: 2012, AMD1:2016 for use in conjunction with IEC 60601-1:2005/AMD1:2016
- · IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability (60601-1-6 Edition 3.1 2013-10, AMD1:2013)
Non-Clinical (Bench) Performance Data:
Bench testing was conducted to demonstrate that the InMode System with vTone Applicator performs as expected under anticipated conditions of use and to verify that the device performance meets the device design requirements. The device was tested for validation of output waveform, basic unit characteristics, and output specifications.
The bench testing results demonstrated that the device performs as expected under anticipated conditions of use
The biocompatibility of the vTone Applicator outer components (handle and electrodes) was verified in a set of Biocompatibility Tests in accordance with the Biocompatibility classification set forth in ISO 10993-1:2018 and in compliance with the FDA Guidance Document on Medical Device Biocompatibility; "Use of International Standard ISO
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10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Issued June 16, 2016.
The following biocompatibility tests were performed as part of the biocompatibility assessment:
| Test | Test Summary | Conclusions |
|---|---|---|
| Cytotoxicity Study Using the ISOElution Method | The test article extractshowed no evidence ofcausing cell lysis ortoxicity | Non-toxic |
| ISO Acute Systemic Toxicity Studyin Mice | The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization in theguineapig. | Non-toxic |
| ISO Guinea Pig MaximizationSensitization Test | There was no mortality orevidence of systemictoxicity from the extractsinjected into mice | No irritation/sensitization |
| ISO Vaginal Irritation sensitizationin rabbit | The test article extract wasconsidered a nonirritant tovaginal tissue of the rabbit | No irritation |
Pre-Clinical (Animal) Performance Data:
Non-Applicable.
Clinical Performance Data:
Non-Applicable.
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Substantial Equivalence:
The below table summarizes the main comparison aspects between the InMode System with vTone Applicator and the proposed predicate devices; The InMode System with the vTone Applicator is substantially equivalent to the previously FDA cleared Kegel 8 device (manufactured by Mantra International (HK) Ltd.), subject of 510(k) files no. K081480
| Characteristic | Subject Device | Predicate |
|---|---|---|
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System withvTone Applicator | Kegel8 |
| Equivalence | Platform vTone Applicator | NA Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Prescription/OTC | Prescription | Prescription |
| Class, ProductCode. | Class IIKPI | Class IIKPI |
| Indications forUse | The InMode System withthe vTone Applicator isintended to provideelectrical stimulation andneuromuscular re-education for the purposeof rehabilitation of weakpelvic floor muscles forthe treatment of stress,urge, and mixed urinaryincontinence in women | The 'Kegel8' Pelvic MuscleTrainer is intended to provideelectrical stimulation andneuromuscular re-education forthe purpose of rehabilitation ofweak pelvic floor muscles forthe treatment of stress urge andmixed urinary incontinence inwomen |
| TargetPopulation | Adult Population whichrequire treatment asspecified in the indicationfor use | Idem |
| AnatomicalSites | Body parts requiringtreatment as specified inthe indication for use | Idem |
| EnvironmentUsed | Hospital or Clinic setting | Idem |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System withvTone Applicator | Kegel8 |
| Equivalence | • Platform• vTone Applicator | • NA• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Design: | The InMode System withvTone Applicator consistsof an AC/DC powersupply unit, controller anduser interface includingan LCD touch screen. Thedelivery of the electricalenergy is controlled by aStart/Stop buttonpositioned on the frontpanel.The System support thefollowing components:• LCD display touchscreen• Audio loudspeaker• 48V AC/DC powersupply• ControllerThe System operateswhile connected to thefollowing applicator:• vTone Applicator | The Kegel8 Pelvic MuscleTrainer is a small lightweightbattery powered dualchannel neuromuscularstimulation device supplied witha vaginal two electrodestimulation probe.The probe connects to thecontrol unit by cable and plug. |
| Mechanism ofAction | Muscle contraction byelectrical pulsing | Idem |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System withvTone Applicator | Kegel8 |
| Equivalence | • Platform• vTone Applicator | • NA• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| - ComponentsConsole | The InMode Systemconsists of the followingcomponents:• Console, including apower supply unit,controller and userinterface including anLCD touch screen.• vTone Applicatorconnected to theconsole via a cable. | The Kegel 8 treatment unitconsists of the followingcomponents:• 9V PP3 Battery, userinterface and LCD display• Probe and lead |
| DimensionsConsole[W x H x D] | 35cm W x 35cm D x100cm H[18.2" W x 18.2" D x40" H] | 6.2cm W x 2.3cm D x 10.8cm H[2.4" W x 0.9" D x 4.25" H] |
| Applicator[L x D] | 8.8cm L x 2.8cm D[3.5" L x 1.1" D] | 8.7 cm L x 2.6 cm D[3.41" L x 1.01" D] |
| Weight Console | 20.0 Kg [44 lbs.] | 0.07 Kg without battery, 0.1KGwith battery |
| Weightapplicator | 0.11 Kg [0.25 lbs.] | Not publicly available |
| Performance Specifications: System | ||
| PowerSource(s) | Main Line Frequency(nominal)50-60HzInput Voltage (nominal)100-240VACInput Current (rms)2A | 9V PP3 |
| Method of LineCurrentIsolation | Independent transformerisolated | NA - Battery powered |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System withvTone Applicator | Kegel8 |
| Equivalence | • Platform• vTone Applicator | • NA• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Electrical Type | Type BF | Type BF |
| Patient LeakageCurrent -NormalCondition (μΑ) | <100 μΑ | NA – Battery powered |
| Patient LeakageCurrent - SingleFault Condition(μΑ) | <500 μΑ | NA – Battery powered |
| Number ofOutput Modes | 1 | 1 |
| Number ofOutputChannels | 1 | 2 |
| Synchro–nous orAlternating | NA – 1 Channel | Synchronous/ Alternating |
| Method–ofChannelIsolation | NA – 1 Channel | Individually isolated circuits |
| RegulatedCurrent orRegulatedVoltage (outputsignals only) | Regulated Voltage withcurrent limit | Regulated Current |
| Software/Firmware/Microprocessor Control | Yes | Yes |
| AutomaticOverload Trip | No | Not publicly available |
| Automatic No-Load Trip | Yes | Not publicly available |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System withvTone Applicator | Kegel8 |
| Equivalence | • Platform• vTone Applicator | • NA• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| Automatic Shut Off | Yes, On/off switch | Yes |
| Patient Override Control | No | Not publicly available |
| Indicator Display:- On/Off Status- Battery | YesNoYes | YesYesYes |
| Voltage/Current level | ||
| Timer Range (Minutes) | Up to 60 | Up to 90 |
| Performance Specifications: Applicator | ||
| Applicator Name | vTone Applicator | Kegel8 Applicator |
| Output Specifications: Waveform | Biphasic | Biphasic |
| Pulse Shape | Rectangular | Rectangular |
| Maximum Output Voltage (± 10%) | 45V @500Ω54V @2 kΩ54V @10kΩ | 45V @ 500 Ω100V @ 2 kΩ190V @ 10 kΩ |
| Maximum Output Current (± 10%) | 90 mA @ 500 Ω current limit28 mA @ 2 kΩ5.6 mA @ 10 kΩ | 90mA @ 500 Ω50mA @ 2 kΩ19mA @ 10 kΩAnd thus, shuts off |
| Pulse Width (μsec.) - The output active positive pulse width | 50 to 450 [μsec] | 50 to 450 [μsec]Program dependent |
| Characteristic | Subject Device | Predicate |
| 510(k) file No. | K200293 | K081480 |
| Device Name | InMode System withvTone Applicator | Kegel8 |
| Equivalence | • Platform• vTone Applicator | • NA• Applicator |
| Manufacturer | InMode Ltd. | Mantra International (HK) Ltd |
| PulseFrequency (Hz) | 3 to 100 $[Hz]$ | 2 to 100 $[Hz]$ |
| Net Charge @500 ohms | 0 $[μC] @ 500Ω$ | 0 $[μC] @ 500Ω$ |
| $[μC/pulse]$ | ||
| MaximumPhase Charge | 40.5 $μC @ 500Ω$ | 40.5 $μC @ 500Ω$ |
| $[μC]$ | ||
| MaximumCurrent (RMS)Density | 9.4 $[mA/cm²]$ | 14.1 $[mA/cm²]$ |
| $[mA/cm²]$ | ||
| MaximumPower Density | 33.8 $[mW/cm²]$ | 57 $[mW/cm²]$At maximum frequencyof 100Hz, pulse width450µS and current of 90mAPC Electrode area: 6.4 cm² |
| $[mW/cm²]$ | ||
| On Time (sec.) | 1-60 | Not publicly available |
| Off Time (sec.) | 1-60 | Not publicly available |
| Standards Met | IEC 60601-1 for basicsafety and essentialperformanceIEC 60601-1-2 forelectromagneticcompatibilityIEC 60601-2-10 forperformance | IEC 60601-1 for basic safety andessential performanceIEC 60601-1-2 forelectromagnetic compatibility |
| CompatibilitywithEnvironmentand OtherDevices | The InMode System iscompliant with the IEC60601-1-2 (EMC Safety)standard. | The kegel8 device is compliantwith the IEC 60601-1-2 (EMCSafety) standard. |
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The InMode System with vTone Applicator indications for use are substantially equivalent to the indications for use of the predicate device. The predicate device possesses the same design, mode of action, mode of operation and similar technological specifications. The Kegel8 device (K081480) has a slightly different design to the subject device. It is operated by a 9V PP3 battery instead of an AC lined power as with the subject device. Apart from that, it bears similar design features to the subject device; main control unit that operates the system functions, user interface, pulse generator and a vaginal applicator with a pair of electrodes to emit the electrical currents as with the subject device. All of the subject device performance specifications are in range or equal to those of its predicate devices. The minor differences in technical specifications should not alter the device safety and effectiveness. Furthermore, the subject device had underwent the required performance testing and validation testing and demonstrates its conformance with device design requirements and with applicable standards. The safety features and compliance with safety standards of the subject device are similar to the safety features and compliance with safety standards of the predicate device. All user-contacting materials were tested for biocompatibility and found to comply with the ISO 10993-1 standard. Furthermore, the design and development phases of the subject device were validated throughout a set of performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1 standard, electromagnetic compatibility testing according to IEC 60601-1-2 standard, safety and essential performance of nerve and muscle stimulators testing according to IEC 60601-2-10 standard, and bench performance tests. All in all, these performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
Consequently, it can be concluded that the InMode System with vTone Applicator is substantially equivalent to its predicate devices and can be sold in the US market.
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Conclusions:
Based on the comparison to the predicate devices and on the non-clinical performance testing results demonstrating that The InMode System with vTone Applicator is as safe and effective as the predicate devices, it can be concluded that The InMode System with vTone Applicator is substantially equivalent to the predicate devices; the Kegel8 device cleared under 510(k) K081480 and therefore, may be legally marketed in the USA.
§ 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).