The CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

Indications for Use:

As an NMES device, indications are for the following conditions:
Relaxation of muscle spasms
Retardation or prevention of disuse atrophy
Increasing local blood circulation
Re-educating muscles
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

Symptomatic relief and management of chronic intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain

Device Description

The CyMedica e-vive™ System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The e-vive™ system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.

The e-vive device is equipped with a goniometer (Class I, 510(k) Exempt), which is intended to measure and record joint range of motion.

e-vive™ electrical stimulation technology is based on the electrical stimulation technology developed for CyMedica QB1™ system. K150413. The e-vive™ electrotherapy programs are delivered to the patient directly by a User Interface controller integrated in a conductive garment. The stimulation programs are managed wirelessly using a mobile application developed for use on smart phones or tablets that interact with the User Interface controller.

The e-vive™ system are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

In NMES mode, the e-vive™ system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The evive™ NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas.

In NMES mode, the e-vive™ system consists of a knee conductive garment with an incorporated Controller, docking receptacle, range of motion sensor, three electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device.

As a TENS device, the e-vive TENS treatment is a safe and effective method of providing a drug-free method of pain relief. Patients with recurring pain, can utilize the e-vive TENS treatment program for immediate and long-term pain relief.

The e-vive™ TENS system consists of a conductive garment with an incorporated Controller. docking receptacle, two electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device.

The e-vive electrogoniometer (battery powered goniometer) is capable of measuring and recording the joint range of motion by using two sensors to detect the knee range of motion. One sensor is located on the Controller board and the second sensor is located within the sensor pod, on a small electronic board. The sensor pod is contained within the conductive garment below the knee area opening. The sensor pod is connected wirelessly to the Controller using a BLE connection. The sensor data from the sensor pod and the Controller sensor is conveyed to the mobile device real time. The sensors can detect the knee extension/flexion angles, and associated range of motion angle through the use of the e-vive mobile app when initiated by the patient or healthcare provider.

The e-vive™ System incorporates a Bluetooth Low Energy, BLE 4.1 connection module to enable wireless communication and can be paired with a Bluetooth enabled mobile device running the e-vive™ App, available from the App stores. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.

The Controller is connected to the conductive garment via a 16-pin interface. The Controller contains the primary safety controls for operation of the device and a push button is available for switching the unit on or off. The power button remains active and can be used in the event of loss of Bluetooth connection to power on/off the device or start/stop stimulation while performing stimulation sessions. The e-vive™ system contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and Bluetooth™ activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

AI/ML Overview

The document provided is a 510(k) Summary for the CyMedica e-vive™ System, which focuses on demonstrating substantial equivalence to a predicate device (QB1 NMES & TENS System K150413) rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding a study design (sample size, expert qualifications, adjudication, MRMC study, standalone performance) is not available in these documents.

However, the document does list various non-clinical performance data and standards compliance to demonstrate safety and effectiveness.

Here's a breakdown of the available information:

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

The document implicitly uses compliance with recognized standards and substantial equivalence to a predicate device as its acceptance criteria. No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided for efficacy, as this is a non-clinical submission.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance
Electrical Safety	Compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012	Complies (Tested)
	Compliance with IEC 60601-2-10:2012	Complies (Tested)
	Compliance with IEC 60601-1-11:2015	Complies (Tested)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014, 4th Edition	Complies (Tested)
	Compliance with BLE module wireless standards (FCC 47CFR PT 15-C, RSS 210, ICES 003, ETSI EN 300 328, ETSI EN 301 489-1, ETSI EN 301 489-17)	Met all specified requirements (Certified by supplier)
Software	Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)	Validated, meets design requirements
	Compliance with IEC 62304:2006	Validated
Usability/Human Factors	Compliance with IEC 60601-1-6:2010	Complies (Tested), results support instructions
	Compliance with IEC 62366:2007	Complies (Tested), results substantiate risk acceptability
Biocompatibility	Compliance with ISO 10993-1:2009	Tested
	Compliance with ISO 10993-5:2009	Tested
	Compliance with ISO 10993-10:2010	Tested
Risk Management	Compliance with ISO 14971:2007	Tested
Battery Safety	Compliance with IEC 62133:2012	Complies (Tested)
Functional Equivalence	Substantial equivalence to predicate device (QB1 System, K150413) in intended use, design, materials, and functional characteristics for NMES and TENS.	Demonstrated through comparison of technical characteristics and compliance with guidance document (FDA Final Guidance Document for Powered Muscle Stimulator 510(k), June 9, 1999).

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. The document describes non-clinical bench testing and compliance with standards, not a clinical study with a test set of patient data.
Data Provenance: Not applicable.

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

Not applicable, as this was a non-clinical submission.

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

Not applicable, as this was a non-clinical submission.

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, an MRMC study was not done. This device is an electrotherapy device, not an AI-assisted diagnostic tool involving human readers.

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

The document implies that the device's electrical stimulation output parameters were tested independently to ensure they fall within safe and effective ranges as per relevant standards (IEC 60601-2-10). The goniometer's accuracy in measuring range of motion was also assessed independently. This could be considered standalone performance for the specific functions of stimulation delivery and goniometry.

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

For the electrical safety and performance parameters, the "ground truth" was defined by recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FCC, ETSI) and an FDA guidance document for powered muscle stimulators.
For the goniometer, the ground truth would be accepted methods of measuring flexion/extension angles.

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a training set in the traditional sense. The software validation involved testing against design requirements.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2016

CyMedica Orthopedics, Inc. % Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K163067

Trade/Device Name: CyMedica e-vive™ System; CY-1000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, KQX Dated: October 31, 2016 Received: November 2, 2016

Dear Mark Job:

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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

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for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K163067

Device Name

CyMedica e-vive System; CY-1000

Indications for Use (Describe)

Indications for Use:

As an NMES device, indications are for the following conditions:
Relaxation of muscle spasms
Retardation or prevention of disuse atrophy
Increasing local blood circulation
Re-educating muscles
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

Symptomatic relief and management of chronic intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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K163067 510(k) Summary

CyMedica Orthopedics, Inc.

CyMedica e-vive™ System

1- SUBMITTER

Manufacturer Name:	CyMedica Orthopedics, Inc.19120 N. Pima Rd. Suite 135Scottsdale, AZ 85255Telephone (480) 664-1282FAX (866) 296-2772
Official Contact:	Kereshmeh Shahriari19120 N. Pima Rd. Suite 135Scottsdale, AZ 85255kereshmeh@cymedicaortho.comTelephone (480) 664-1282FAX (866) 296-2772
510(k) Summary PreparationDate	November 30, 2016
2- DEVICE
Trade/Proprietary Name:	CyMedica e-vive™ System; CY-1000
Common Name:	Muscle stimulator & Electrogoniometer
Classification Names:	Powered muscle stimulator (21 CFR 890.5850)Transcutaneous Electrical Nerve Stimulator for Pain Relief (21CFR 882.5890)Goniometer, AC-powered (21 CFR 888.1500)
Product Codes:	Powered Muscle Stimulator or Neuromuscular ElectricalStimulator (NMES); IPFTranscutaneous Nerve Stimulator (TENS) for pain relief;GZJGoniometer; KQX
Device Class:	Powered Muscle Stimulator & TENS: Class IIGoniometer: Class I, 510(k) Exempt

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CyMedica e-vive™ System K163067

NMES and TENS devices are reviewed by the Division of Neurological and Physical Medicine Devices (DNPMD).

3- PREDICATE DEVICE

Name & 510(k) Number:

K150413 QB1 NMES & TENS System CyMedica Orthopedics, Inc.

4- DEVICE DESCRIPTION

The e-vive device is equipped with a goniometer (Class I, 510(k) Exempt), which is intended to measure and record joint range of motion.

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download from the App Store onto a patient's mobile device.

5- INDICATIONS FOR USE

The e-vive™ System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

Indications for Use:

As an NMES device, indications are for the following conditions:

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1. Relaxation of muscle spasms
1. Retardation or prevention of disuse atrophy
1. Increasing local blood circulation
1. Re-educating muscles
1. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
1. Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

1. Symptomatic relief and management of chronic intractable pain
1. Adjunctive treatment for post-surgical and post-trauma acute pain

The treatment programs for NMES Post-Op and NMES Strength are shown below.

TreatmentProgram	Pulse shape	Duration	Frequency	Pulse width	Duty cycle	Work cycle	Relaxation time	Contraction time	Rest time	Indications numbers
NMES Post-Op	Monophasic	20 min	50 pps	5 ms	25%	13 s	10 s	3 s2 cycles	3.4 s	1, 2, 3, 4, 5, 6
NMES Strength	Monophasic	20 min	50 pps	5 ms	25%	12 s	10 s	1 s5 cycles	1.4 s	1, 2, 3, 4, 5, 6

The treatment program for TENS pain management is shown below .

TreatmentProgram	Pulseshape	Duration	Frequency	Pulsewidth	Dutycycle	Workcycle	Interphaseintervaltime	Indicationsnumbers
TENS PainManagement	Biphasic,symmetrical	20 min	100 pps	1 ms	20%	Continuous	4 ms	7, 8

6- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

CyMedica Orthopedics, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the e-vive™ System is substantially equivalent to the predicate device, QB1 System, K150413. The data included in this submission demonstrates substantial equivalence to the predicate device listed above.

The intended use, design, materials and functional characteristics of the e-vive™ NMES and TENS System and the QB1 predicate device are substantially the same. The subject device and predicate device provide neuromuscular electrical stimulation therapy, are portable, hand-held, and for home healthcare environment use. Similar to the predicate device, the power in e-vive™ device is derived from a rechargeable battery that is pre-installed in the User Interface Controller. There are two channels of stimulation in both devices. In both devices, the user needs to select the desired treatment program and adjust the intensity. Both devices employ a ramp-up, work, and rest phases.

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CyMedica e-vive™ System K163067

The data included in this submission demonstrates substantial equivalence to the predicate device listed above. The intended use, design, and functional characteristics of the e-vive electrogoniometer are within the limitations of exemption in 21 CFR 888.9, applicable to goniometers which are Class I, 510(k) exempt. The goniometer in the e-vive system measures and records joint range of motion similar to other goniometers under 21 CFR 888.1500. The goniometer is battery operated and uses accelerometers to measure the flexion and extension angles. An embedded software in the e-vive system calculates the range of motion using the measured flexion and extension angles data.

	Parameter	e-vive	QB1
	510(k) Number	K163067	K150413
	Device Name and Mode	e-vive	QB1
	Manufacturer	CyMedica Orthopedics	CyMedica Orthopedics
	Power Source(s)†	Single VD434053:3.7V; 1000mAh;Lithium ion polymerbattery	Single H605060: 3.7V;2000mAh; Lithium ionpolymer battery
-	Method of Line Current Isolation	No line connection	No line connection
-	Patient Leakage Current††	---	---
-	Normal Condition(µA)	4.88	1.5
-	Single Fault Condition (µA)	8.00	2.6
	Number of Output Modes †††	3	3
	Number of Output Channels ††††: Synchronous or Alternating? Method of Channel Isolation	AlternatingTransistor	AlternatingTransistor
	Regulated Current or Regulated Voltage?	Regulated Power	Regulated Power
	Software/Firmware/Microprocessor Control?	Yes	Yes
	Automatic Overload Trip?	No	No
	Automatic No-Load Trip?	No	No
	Automatic Shut Off?	Yes	Yes
	User Override Control?	Yes Stop Buttons	Yes Stop Button
	Indicator Display:On/Off Status?Low Battery?Voltage/Current Level?	YesYesNo	YesYesNo
	Timer Range (minutes)	20-open	20-open
	Compliance with Voluntary Standards?	Yes.IEC 60601-2-10:2012 Part 2-10;IEC 60601-1-11:2015 Part 1-11;IEC 60601-1-6:2010;ISO 10993-1:2009 Part 1	Yes.IEC 60601-2-10:2012 Part 2-10;IEC 60601-1-11:2010 Part 1-11;IEC 60601-1-6:2010;ISO 10993-1:2009 Part 1
	Compliance with 21 CFR 898?	Yes	Yes
	Weight (lbs., oz.)	1.76 oz. (50g)	8.6 oz (243.8g)

Comparison of Technology to Predicate

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Parameter	e-vive	QB1
Dimensions (in.) [W x H x D]	1.93" x 0.64" x 3.28"	3.15" x 0.88" x 5.84"
Housing Materials and Construction	Molded PC\ABS	Molded PC\ABS
	Plastic	Plastic
	Bayblend FR3010	Bayblend FR3010

Parameter	e-vive NMES POST-OP	e-vive NMES STRENGTH	e-vive TENS	QB1 NMES POST-Op	QB1 NMES STRENGTH	QB1 NMES STRENGTH
510(k) Number	K163067	K163067	K163067	K150413	K150413	K150413
Mode or Program Name	NMES POST-OP	NMES STRENGTH	TENS	NMES POST-OP	NMES STRENGTH	TENS
Waveform (e.g., pulsed monophasic, biphasic)	Pulsed Monophasic	Pulsed Monophasic	Symmetric Biphasic	Pulsed Monophasic	Pulsed Monophasic	Symmetric Biphasic
Shape (e.g., rectangular, spike, rectified sinusoidal)	Complex	Complex	Complex	Complex	Complex	Complex
Maximum Output Voltage (volts, rms)	8.5 @500Ω15.5 @ 2 kΩ20.2 @10 kΩ	8.4 @500Ω@ 2 kΩ@10 kΩ	10.4 @500Ω17.1 @ 2 kΩ20.9 @10 kΩ	9.3 @500Ω16.8 @ 2 kΩ21.9 @10 kΩ	9.3 @500Ω16.6 @ 2 kΩ21.8 @10 kΩ	10.2 @500Ω16.7 @ 2 kΩ19.8 @10 kΩ
Maximum Output Current (mA, rms)	17.1 @500Ω7.7 @ 2 kΩ2.0 @10 kΩ	@500Ω@ 2 kΩ@10 kΩ	20.9 @500Ω8.5 @ 2 kΩ2.1 @10 kΩ	18.5 @500Ω8.4 @ 2 kΩ2.2 @10 kΩ	18.6 @500Ω8.3 @ 2 kΩ2.2 @10 kΩ	20.5 @500Ω8.3 @ 2 kΩ2.0 @10 kΩ
Duration of primary (depolarizing) phase (µsec)	5000	5000	N/A (Continuous)	5000	5000	N/A (Continuous)
Pulse Duration (µsec)	5000	5000	1000	5000	5000	1000
Parameter	e-vive NMESPOST-OP	e-vive NMESSTRENGTH	e-vive TENS	QB1 NMESPOST-Op	QB1 NMESSTRENGTH	QB1 NMESSTRENGTH
Frequency (Hz) [orRate (pps)]	50	50	100	50	50	100
For interferentialmodes only: BeatFrequency (Hz)	N/A	N/A	N/A	N/A	N/A	N/A
Formultiphasicwaveforms only:	Symmetricalphases?	N/A	N/A	Yes	N/A	N/A	Yes
	Phaseduration	N/A	N/A	1 ms	N/A	N/A	1 ms
Net Charge(microcoulombs(µC) per pulse) (Ifzero, state methodof achieving zeronet charge.)	342 @500Ω	336 @500Ω	0 @500Ω(SymmetricBiphasic)	371 @500Ω	372 @500Ω	0 @500Ω(SymmetricBiphasic)
Maximum PhaseCharge, (µC)	342 @500Ω	336 @500Ω	417 @500Ω	371 @500Ω	372 @500Ω	409 @500Ω
Maximum CurrentDensity (mA/cm², r.m.s.)	0.66 @500Ω	0.65 @500Ω	0.81 @500Ω	0.72 @500Ω	0.72 @500Ω	0.79 @500Ω
Maximum AverageCurrent (averageabsolute value),mA	17.1 @500Ω	16.8 @500Ω	20.9 @500Ω	18.5 @500Ω	18.6 @500Ω	20.5 @500Ω
Maximum AveragePower Density,(W/cm²), (usingsmallest electrodeconductive surfacearea)	0.005 @500Ω	0.006 @500Ω	0.009@500Ω	0.007@500Ω	0.007@500Ω	0.008@500Ω
	Parameter	e-vive NMESPOST-OP	e-vive NMESSTRENGTH	e-vive TENS	QB1 NMESPOST-Op	QB1 NMESSTRENGTH	QB1 NMESSTRENGTH
BurstMode	(a) Pulsesper burst	150	50		150	50
	(b) Burstsper second	0.087	0.23		0.087	0.23
	(c) Burstduration(seconds)	3	1		3	1	N/A(ContinuousPulse)
	(d) DutyCycle: Line(b) xLine (c)	0.26	0.23		0.26	0.23
	ON Time(seconds)	312	276	Continuous	312	276	Continuous
	OFF Time(seconds)	888	924	Continuous	888	924	Continuous
	Additional Features(specify, ifapplicable)	N/A	N/A	N/A	N/A	N/A	N/A

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e-vive™ System differs from the QB1 System device in the following area:

Difference Area	Equivalence Discussion
Technology; wireless andmobile app controlled vs.wired:e-vive™ system is awireless and mobile appcontrolled device whileQB1 system is a wireddevice.	The mobile app in e-vive system communicates theUser Interface Controller within the conductivegarment via Bluetooth Low Energy, BLE 4.1connection. The QB1 User Interface is connected tothe treatment pod within the conductive garment usinga cable. As shown in Section 18, the system has beenfully tested per IEC 60601-1, 60601-1-2, 60601-1-6,60601-1-11, 60601-2-10, and IEC 62366 and meets allstandard requirements and FDA guidance requirements.It adequately controls the stimulator outputs to theallowable ranges and within the tolerance limitsprovided in the standards and guidance, evidenced inIEC 60601-2-10. Accordingly, the e-vive wireless andmobile app controlled system poses no new safety risksand is substantially equivalent to the predicate.

Difference Area

Equivalence Discussion

Technology; wireless andmobile app controlled vs.wired:e-vive™ system is awireless and mobile appcontrolled device whileQB1 system is a wireddevice.

The mobile app in e-vive system communicates theUser Interface Controller within the conductivegarment via Bluetooth Low Energy, BLE 4.1connection. The QB1 User Interface is connected tothe treatment pod within the conductive garment usinga cable. As shown in Section 18, the system has beenfully tested per IEC 60601-1, 60601-1-2, 60601-1-6,60601-1-11, 60601-2-10, and IEC 62366 and meets allstandard requirements and FDA guidance requirements.It adequately controls the stimulator outputs to theallowable ranges and within the tolerance limitsprovided in the standards and guidance, evidenced inIEC 60601-2-10. Accordingly, the e-vive wireless andmobile app controlled system poses no new safety risksand is substantially equivalent to the predicate.

Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or effectiveness.

7- PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence.

To demonstrate the safety, the e-vive™ system was tested for electrical safety, electromagnetic compatibility, usability, biocompatibility, and risk management requirements.

To demonstrate the safety, the e-vive™ System was tested per the following standards:

AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012 Medical electrical equipment -. Part 1: General requirements for basic safety and essential performance
. IEC 60601-1-2: 2014, 4th Edition. Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility requirements
IEC 60601-2-10: 2012, 2nd Edition, Medical electrical equipment- Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulator

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IEC 60601-1-11: 2015, 2nd Edition, Medical electrical equipment- Part 1-11: General . requirements for basic safety and essential performance- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. IEC 60601-1-6: 2010, 3rd Edition, Medical electrical equipment- Part 1-6: General requirements for basic safety and essential performance- Collateral standard: Usability including IEC 62366: Application of usability engineering to medical devices
IEC 62366: 2007, 1st Edition, Medical devices -- Application of usability engineering to medical devices
IEC 62304: 2006, 15T Edition, Medical device software Software life cycle processes ●
ISO 10993-1: 2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010, Biological evaluation of medical devices- Part 10: Tests for ● irritation and skin sensitization
. ISO 14971: 2007, Application of risk management to medical devices

In addition, the performance of e-vive™ BLE module for wireless co-existence was evaluated and certified by the supplier of the module in an environment with equipment operating in the ISM band i.e. Bluetooth and Wi-Fi devices, cellphones, cordless phones etc. The device met all specified requirements.

BLE module testing was conducted in accordance with the following standards:

FCC 47CFR PT 15-C, Issued:2007/10/01 Title 47 CFR Part 15 Subpart C: Intentional . Radiators [FCC §15.247]
FCC 47CFR PT 15 SPT B. Issued: 2013/01/28 Title 47 CFR Part 15 Subpart B: . Unintentional Radiators, FCC Part 15, Subpart B [FCC §15.107 & FCC §15.109]
. RSS 210, Issue:2010/12/01 Issue:8 Low Power License-Exempt Radio communication Devices (All Frequency Bands) - Category I Equipment
ICES 003 Issued: 2012/08/01Spectrum Management and Telecommunications . Interference-Causing Equipment Standard
. ETSI EN 300 328, Issued: 2012/06/08 V. 1.8.1 Electromagnetic Compatibility. & Radio Spectrum Matters; Wideband Trans. Systems; Data Trans. Equip. Operating in the 2.4

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GHz ISM Band & Using Wideband Modulation Techniques; Harmon. EN Covering Essen. Req. Under Art. 3.2-R&TTE Directive

ETSI EN 301 489-1, Issued: 2011/09/22 V1.9.2 Electromagnetic Compatibility & Radio . Spectrum Matters (ERM); Electromagnetic Compatibility (EMC) Radio Equipment & Services; Prt 1: Common Technical Requirements
ETSI EN 301 489-17, Issue:2009/05/12 Electromagnetic Compatibility And Radio . Spectrum Matters (Erm); Electromagnetic Compatibility (EMC) Standard For Radio Equipment; Part 17: Specific Conditions For Broadband Data Transmission Systems -V2.1.1

Battery testing was conducted in accordance with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications.

To demonstrate the e-vive system effectiveness and performance substantial equivalency of the subject device, e-vive system and the predicate device OB1 System (K150413) were tested according to the following FDA guidance document:

. FDA Final Guidance Document for Powered Muscle Stimulator 510(k), June 9, 1999

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the e-vive system and complies with the IEC 60601-1, IEC 60601-2-10, and 60601-11 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification & Validation Testing

The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and IEC 62304: 2006, 180 Edition, Medical device software – Software life cycle processes. The software validation tests demonstrated that the software version meets its design requirements.

Human Factors and Usability

The human factors and usability study was conducted to validate the usability of the e-vive system in the home environment. The results of the study support the instructions for successfully using the device as intended. The results of human factors and usability study substantiates the acceptability of the risks identified during the risk assessment activities. The evive system complies with the IEC 60601-1-6: 2010 for usability and IEC 62366: Application of usability engineering to medical devices.

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8- CONCLUSION

Based on the performance testing and the supporting documentation, it can be concluded that the e-vive NMES and TENS system is safe, effective, and substantially equivalent to the predicate devices. The e-vive device output pulse parameters provide a safe and effective treatment for the NMES and TENS applications.

Based on the acceptable bench test results and e-vive compliance with the applicable standards, the e-vive NMES and TENS therapies are considered safe and as effective as the predicate device, QB1 System (K150413) for its intended uses and indications for use. The e-vive NMES and TENS pulse parameters and waveform are selected and designed so they would provide a safe and effective treatment for the indications for use.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).