(29 days)
Not Found
No
The summary describes a standard electrotherapy device with a goniometer and mobile app control. There is no mention of AI or ML in the device description, intended use, or performance studies. The "closed loop feedback system" mentioned in the NMES mode description appears to be a basic control mechanism, not indicative of AI/ML.
Yes
The device is described as a "multifunctional electrotherapy device" with specific indications for use including "relaxation of muscle spasms," "retardation or prevention of disuse atrophy," "increasing local blood circulation," "re-educating muscles," "prevent venous thrombosis," "maintaining or increasing range of motion," and "symptomatic relief and management of chronic intractable pain." These are all therapeutic applications.
No
Explanation: The device is described as a "multifunctional electrotherapy device" used for therapy (NMES and TENS) to treat conditions like muscle spasms, disuse atrophy, pain relief, and to measure range of motion. It does not state that it is used to diagnose a medical condition or disease.
No
The device description explicitly lists multiple hardware components beyond just software, including a conductive garment with an integrated controller, electrodes, a goniometer, a charging cable, and a rechargeable battery pack. While it utilizes a mobile app for control, it is not solely software.
Based on the provided text, the CyMedica e-vive System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- CyMedica e-vive System Function: The description clearly states that the CyMedica e-vive System is an electrotherapy device that delivers electrical stimulation (NMES and TENS) to the body. It also includes a goniometer to measure joint range of motion.
- Intended Use: The intended uses listed are for therapeutic purposes (muscle stimulation, pain relief, range of motion measurement) and do not involve the analysis of biological specimens.
- Device Description: The components and operation described are consistent with an external electrotherapy device, not an IVD.
Therefore, the CyMedica e-vive System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, KQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data was submitted to demonstrate substantial equivalence. These tests focused on safety aspects including electrical safety, electromagnetic compatibility, usability, biocompatibility, and risk management. Performance of the BLE module for wireless co-existence was also evaluated. The device complied with all specified standards and requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are depicted in a single, continuous line. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
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
1
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,
Image /page/1/Picture/8 description: The image shows the name "Michael J. Hoffmann -A" in a large, sans-serif font. The text is black and appears to be centered on a white background. The name is written in a clear and legible manner.
- 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
2
Indications for Use
510(k) Number (if known) K163067
Device Name
CyMedica e-vive System; CY-1000
Indications for Use (Describe)
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
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K163067 510(k) Summary
CyMedica Orthopedics, Inc.
CyMedica e-vive™ System
1- SUBMITTER
| Manufacturer Name: | CyMedica Orthopedics, Inc.
19120 N. Pima Rd. Suite 135
Scottsdale, AZ 85255
Telephone (480) 664-1282
FAX (866) 296-2772 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kereshmeh Shahriari
19120 N. Pima Rd. Suite 135
Scottsdale, AZ 85255
kereshmeh@cymedicaortho.com
Telephone (480) 664-1282
FAX (866) 296-2772 |
| 510(k) Summary Preparation
Date | 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 (21
CFR 882.5890)
Goniometer, AC-powered (21 CFR 888.1500) |
| Product Codes: | Powered Muscle Stimulator or Neuromuscular Electrical
Stimulator (NMES); IPF
Transcutaneous Nerve Stimulator (TENS) for pain relief;
GZJ
Goniometer; KQX |
| Device Class: | Powered Muscle Stimulator & TENS: Class II
Goniometer: Class I, 510(k) Exempt |
4
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 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
5
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.
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:
6
-
- 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
The treatment programs for NMES Post-Op and NMES Strength are shown below.
| Treatment
| Program | 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 s | ||
| 2 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 s | ||
| 5 cycles | 1.4 s | 1, 2, 3, 4, 5, 6 |
The treatment program for TENS pain management is shown below .
| Treatment
Program | Pulse
shape | Duration | Frequency | Pulse
width | Duty
cycle | Work
cycle | Interphase
interval
time | Indications
numbers |
|-------------------------|--------------------------|----------|-----------|----------------|---------------|---------------|--------------------------------|------------------------|
| TENS Pain
Management | 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.
7
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 polymer | |||
| battery | Single H605060: 3.7V; | ||
| 2000mAh; Lithium ion | |||
| polymer 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 | Alternating | ||
| Transistor | Alternating | ||
| Transistor | |||
| 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? | Yes | ||
| Yes | |||
| No | Yes | ||
| Yes | |||
| No | |||
| 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
8
| 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 @500Ω | ||||||
| 15.5 @ 2 kΩ | |||||||
| 20.2 @10 kΩ | 8.4 @500Ω | ||||||
| @ 2 kΩ | |||||||
| @10 kΩ | 10.4 @500Ω | ||||||
| 17.1 @ 2 kΩ | |||||||
| 20.9 @10 kΩ | 9.3 @500Ω | ||||||
| 16.8 @ 2 kΩ | |||||||
| 21.9 @10 kΩ | 9.3 @500Ω | ||||||
| 16.6 @ 2 kΩ | |||||||
| 21.8 @10 kΩ | 10.2 @500Ω | ||||||
| 16.7 @ 2 kΩ | |||||||
| 19.8 @10 kΩ | |||||||
| Maximum Output Current (mA, rms) | 17.1 @500Ω | ||||||
| 7.7 @ 2 kΩ | |||||||
| 2.0 @10 kΩ | @500Ω | ||||||
| @ 2 kΩ | |||||||
| @10 kΩ | 20.9 @500Ω | ||||||
| 8.5 @ 2 kΩ | |||||||
| 2.1 @10 kΩ | 18.5 @500Ω | ||||||
| 8.4 @ 2 kΩ | |||||||
| 2.2 @10 kΩ | 18.6 @500Ω | ||||||
| 8.3 @ 2 kΩ | |||||||
| 2.2 @10 kΩ | 20.5 @500Ω | ||||||
| 8.3 @ 2 kΩ | |||||||
| 2.0 @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 NMES | ||||||
| POST-OP | e-vive NMES | ||||||
| STRENGTH | e-vive TENS | QB1 NMES | |||||
| POST-Op | QB1 NMES | ||||||
| STRENGTH | QB1 NMES | ||||||
| STRENGTH | |||||||
| Frequency (Hz) [or | |||||||
| Rate (pps)] | 50 | 50 | 100 | 50 | 50 | 100 | |
| For interferential | |||||||
| modes only: Beat | |||||||
| Frequency (Hz) | N/A | N/A | N/A | N/A | N/A | N/A | |
| For | |||||||
| multiphasi | |||||||
| c | |||||||
| waveform | |||||||
| s only: | Symmetrical | ||||||
| phases? | N/A | N/A | Yes | N/A | N/A | Yes | |
| Phase | |||||||
| duration | N/A | N/A | 1 ms | N/A | N/A | 1 ms | |
| Net Charge | |||||||
| (microcoulombs | |||||||
| (µC) per pulse) (If | |||||||
| zero, state method | |||||||
| of achieving zero | |||||||
| net charge.) | 342 @500Ω | 336 @500Ω | 0 @500Ω | ||||
| (Symmetric | |||||||
| Biphasic) | 371 @500Ω | 372 @500Ω | 0 @500Ω | ||||
| (Symmetric | |||||||
| Biphasic) | |||||||
| Maximum Phase | |||||||
| Charge, (µC) | 342 @500Ω | 336 @500Ω | 417 @500Ω | 371 @500Ω | 372 @500Ω | 409 @500Ω | |
| Maximum Current | |||||||
| Density (mA/cm², r.m.s.) | 0.66 @500Ω | 0.65 @500Ω | 0.81 @500Ω | 0.72 @500Ω | 0.72 @500Ω | 0.79 @500Ω | |
| Maximum Average | |||||||
| Current (average | |||||||
| absolute value), | |||||||
| mA | 17.1 @500Ω | 16.8 @500Ω | 20.9 @500Ω | 18.5 @500Ω | 18.6 @500Ω | 20.5 @500Ω | |
| Maximum Average | |||||||
| Power Density, | |||||||
| (W/cm²), (using | |||||||
| smallest electrode | |||||||
| conductive surface | |||||||
| area) | 0.005 @500Ω | 0.006 @500Ω | 0.009 | ||||
| @500Ω | 0.007 | ||||||
| @500Ω | 0.007 | ||||||
| @500Ω | 0.008 | ||||||
| @500Ω | |||||||
| Parameter | e-vive NMES | ||||||
| POST-OP | e-vive NMES | ||||||
| STRENGTH | e-vive TENS | QB1 NMES | |||||
| POST-Op | QB1 NMES | ||||||
| STRENGTH | QB1 NMES | ||||||
| STRENGTH | |||||||
| Burst | |||||||
| Mode | (a) Pulses | ||||||
| per burst | 150 | 50 | 150 | 50 | |||
| (b) Bursts | |||||||
| per second | 0.087 | 0.23 | 0.087 | 0.23 | |||
| (c) Burst | |||||||
| duration | |||||||
| (seconds) | 3 | 1 | 3 | 1 | N/A | ||
| (Continuous | |||||||
| Pulse) | |||||||
| (d) Duty | |||||||
| Cycle: Line | |||||||
| (b) x | |||||||
| Line (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, if | |||||||
| applicable) | N/A | N/A | N/A | N/A | N/A | N/A |
9
10
11
e-vive™ System differs from the QB1 System device in the following area:
| Difference Area | Equivalence Discussion |
|---|---|
| Technology; wireless and | |
| mobile app controlled vs. | |
| wired: | |
| e-vive™ system is a | |
| wireless and mobile app | |
| controlled device while | |
| QB1 system is a wired | |
| device. | The mobile app in e-vive system communicates the |
| User Interface Controller within the conductive | |
| garment via Bluetooth Low Energy, BLE 4.1 | |
| connection. The QB1 User Interface is connected to | |
| the treatment pod within the conductive garment using | |
| a cable. As shown in Section 18, the system has been | |
| fully tested per IEC 60601-1, 60601-1-2, 60601-1-6, | |
| 60601-1-11, 60601-2-10, and IEC 62366 and meets all | |
| standard requirements and FDA guidance requirements. | |
| It adequately controls the stimulator outputs to the | |
| allowable ranges and within the tolerance limits | |
| provided in the standards and guidance, evidenced in | |
| IEC 60601-2-10. Accordingly, the e-vive wireless and | |
| mobile app controlled system poses no new safety risks | |
| and 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
12
- 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
Page 10 of 12
13
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.
14
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.