(59 days)
Not Found
No
The summary describes a standard electrical muscle stimulator with a closed-loop feedback system, which is a common control mechanism and does not inherently indicate AI/ML. There are no mentions of AI, ML, deep learning, training data, or test data.
Yes
The device is intended to strengthen muscles and provide temporary pain relief associated with knee arthritis by applying electrical current, which are therapeutic functions.
No
The device is described as an over-the-counter electrical muscle stimulator for pain relief and muscle strengthening, not for diagnosing conditions.
No
The device description explicitly states it is an "electrical muscle stimulator" and describes applying an electrical current through a "power regulated output closed-loop feedback NMES system." This indicates the presence of hardware components beyond just software. The performance studies also include testing for electrical safety, electromagnetic compatibility, and biocompatibility of physical components like the wrap and electrodes, further confirming it is not software-only.
Based on the provided information, the Motive™ Knee Wrap device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to strengthen the quadriceps muscle stimulation for symptomatic temporary pain relief associated with knee arthritis. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as an electrical muscle stimulator (NMES therapy) that applies electrical current to the muscle. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The Motive™ Knee Wrap device's function is to directly stimulate a muscle for therapeutic benefit.
N/A
Intended Use / Indications for Use
The Motive™ Knee Wrap device is intended to strengthen the quadriceps muscle stimulation to provide symptomatic temporary pain relief associated with knee arthritis.
The Motive™ Knee Wrap device is indicated for adults of 22 years of age and older.
Product codes (comma separated list FDA assigned to the subject device)
IPF
Device Description
The Motive Knee Wrap device (Motive device) is an over-the-counter (OTC) electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) for relief of knee pain associated with knee arthritis. The Motive device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with arthritis. The stimulator continuously contracts quadricep muscle groups for strengthening of the muscles and knee pain relief. The stimulator is placed over the thigh muscle and just above the knee.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
quadriceps muscle, knee, thigh muscle
Indicated Patient Age Range
adults of 22 years of age and older.
Intended User / Care Setting
User, Home-use
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)
To demonstrate the safety, the Motive device was tested for electrical safety, electromagnetic compatibility, usability, biocompatibility, and risk management 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/2 description: The image shows the logo for 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 acronym and name on the right. The FDA part of the logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
May 12, 2022
CyMedica Orthopedics, Inc. Kereshmeh Shahriari Vice President, Regulatory, Clinical, & Quality 2120 East 6th Street Tempe, Arizona 85281
Re: K220738
Trade/Device Name: Motive Knee Wrap Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: March 7, 2022 Received: March 14, 2022
Dear Kereshmeh Shahriari:
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.
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
1
801); medical device reporting of medical device-related 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/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-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,
For: CDR Jitendra Virani, MS. Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220738
Device Name Motive™ Knee Wrap Device
Indications for Use (Describe)
The Motive™ Knee Wrap device is intended to strengthen the quadriceps muscle stimulation to provide symptomatic temporary pain relief associated with knee arthritis.
The Motive™ Knee Wrap device is indicated for adults of 22 years of age and older.
| 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) |
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
510(k) Summary Motive™ Knee Wrap CyMedica Orthopedics, Inc.
| 1 Regulatory Information | |
|---|---|
| 1.1 Trade/Proprietary Name: | Motive™ Knee Wrap |
| 1.2 Common Name: | Powered muscle stimulator |
| 1.3 Regulation Names & Numbers: | Powered muscle stimulator, 21 CFR 890.5850 |
| Product Codes: | |
| Code- IPF; Powered muscle stimulator | |
| 1.4 Classification: | Powered muscle stimulator: II |
| 1.5 Manufacturer Name: | CyMedica Orthopedics, Inc. |
| 2120 East 6th Street, Suite 8 | |
| Tempe, AZ 85281 | |
| Telephone (480) 664-1282 | |
| FAX (866) 296-2772 |
These devices are reviewed by the Division of Neurological and Physical Medicine Devices.
2 Submission Information
| Submission Number: | K220738 |
|---|---|
| Date: | March 31, 2022 |
| Contact: | Kereshmeh Shahriari |
| 2120 East 6th Street, Suite 8 | |
| Tempe, AZ 85281 | |
| kereshmeh@cymedicaortho.com | |
| Telephone (480) 664-1282 | |
| FAX (866) 296-2772 |
4
3 Indications for Use
The Motive Knee Wrap device is intended to strengthen the quadriceps muscle using powered muscle stimulation to provide symptomatic temporary pain relief associated with knee arthritis. The Motive Knee Wrap device is indicated for adults of 22 years of age and older.
4 Device Description
The Motive Knee Wrap device (Motive device) is an over-the-counter (OTC) electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) for relief of knee pain associated with knee arthritis. The Motive device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with arthritis. The stimulator continuously contracts quadricep muscle groups for strengthening of the muscles and knee pain relief. The stimulator is placed over the thigh muscle and just above the knee.
4.1 Electrical Muscle Stimulator (NMES therapy)
The device is used to apply a patented unique waveform by means of an electrical current through a power regulated output and closed-loop feedback system to provide relief of knee pain associated with arthritis. The stimulator continuously contracts quadricep muscle groups for strengthening of the muscles and for knee pain relief. Electrical stimulation waveform is generated using a pulse generator or Controller. Electrical stimulation is delivered non-invasively to the treatment site (quadricep muscles of the knee joint) using connected electrodes placed directly on the skin.
4.2 Mobile Application (App)
The electrical stimulation therapy is initiated and managed wirelessly by the User using a mobile application (App) developed for use on smart phones or tablets that interact with the system's pulse generator or Controller.
4.3 Wrap with Smart Panel
The electrical muscle stimulator along with the cutaneous electrodes and wires are incorporated in a Wrap with a Smart Panel™ placed on the thigh and above the knee. Wrap with Smart Panel is worn on the thigh covering quadriceps muscles to apply the NMES therapy. The Wrap is comprised of a modular design including a textile-based wrap and a Smart Panel. The modular Smart Panel is attached to the Wrap by means of a hook and loop interface or other mechanisms. The Smart Panel is an assembly of a Controller (NMES pulse generator), cradle, plastics for hosting the electronics, and four skin contacting snap type electrodes. The Wrap with Smart Panel design is a single size for all size Users and intended for a bilateral use (right and left thigh use independently).
4.4 Wireless Communications
The Motive device incorporates a Bluetooth Low Energy, BLE 4.2 connection module to enable wireless communication that can be paired with a Bluetooth enabled mobile device running the 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 Smart Panel via a multi-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
5
of loss of Bluetooth connection to power on/off the device or start/stop stimulation while performing stimulation sessions. The Controller 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.
4.5 Software
The Motive device utilizes an embedded Controller firmware, App software, and Web Services software.
The treatment program embedded software is a fundamental component of the system that supports the selection, adjustment, and delivery of the treatment program. The embedded software runs on the Controller and is interfaced with the stimulation pulse generator and App.
The App runs on a mobile platform operating system and communicates with the Controller over a BLE 4.2 connection. The free Motive App is downloaded by the Users from their respective App Stores. The Motive device allows the User to control the NMES therapy program in an easy and intuitive way. It allows the User to select, administer, and adjust the NMES therapy intensities, and manage their health and wellness conditions related to their therapy.
4.6 Controller and the App
The Controller's main function is the NMES therapy stimulation generator and communicating therapy metrics to the App. The Controller contains the primary safety controls for operation of the device. A push button is available for powering the unit on/off or pausing/resuming stimulation. The push button "Stop" control remains active at all times during stimulation and can be used in the event of loss of Bluetooth connection.
Once the App is installed and a wireless connection is established between the Controller and the mobile device (User's phone or tablet), the User can interact with all of the device features. The App downloaded on the User's mobile device provides the graphical user interface and governs the interactions between the controller and the User. The screens and user interface are designed to be intuitive and interactive. Improved User's engagement and compliance through the App are significant design features of the device.
Help and informational screens are provided throughout the App and on specific screens where a User needs to be aware of a feature or condition. Upon downloading the App, the User is guided through chronological screens on the App to perform the following tasks:
- Reading and accepting the Motive App Terms of Use and Conditions ●
- Creating a User profile
- Pairing the App with the Controller ●
- Starting the treatment
- Managing the treatment
- Reviewing User's related data and information on the App
4.7 Web Services (API, Database)
A Medical Device Data System (MDDS), the CyMedica Web Services allows for the electronic transfer, storage, retrieval, and display of data sent or received by the Users' App
6
and Controller. Web Services includes an encrypted database hosted on secure cloud-based servers and an Application Programming Interface (API) allowing the App to send and receive data to read or write to the database and execute logic tasks. Web Services provides persistent storage and retrieval of data.
5 General Electrical Muscle Stimulation Device Features and Output Characteristics
The following two Tables represent the Motive device electrical stimulation features and the neuromuscular electrical stimulation (NMES) therapy output specifications.
Table 1- Motive device Therapy Program General Electrical Stimulation Features
| No. of Output Modes | 1 |
|---|---|
| No. of Output Channels | 2 |
| Regulated Current, Voltage, or Power | Regulated Power |
| Software/Firmware/Microprocessor Control? | Yes |
| Automatic shut off? | Yes |
| Patient device control? | Yes |
| Indicator display- Low Battery? | Yes |
| Indicator display- Voltage/Current Level? | Yes |
| Timer range (minutes) | 20 minutes |
Table 2- Motive device NMES Therapy Program Output Specifications
| Waveform | Monophasic |
|---|---|
| Shape | Asymmetrical, Complex |
| Pulse width | 5 ms |
| Frequency | 50 pps |
| Maximum current density @ 500Ω | 0.7 mA/cm² (rms) |
| Maximum power density (using smallest electrode conductive | |
| surface area) @ 500Ω | 0.006 W/cm² |
| Maximum phase charge @ 500Ω | 359.8 μC |
| Maximum output voltage (VRMS) (±10%) @ 500Ω | 9.0 V |
| Maximum output current (IRMS) (±10%) @ 500Ω | 18 mA |
| Power source | Li-Polymer Battery |
| 950mAh 3.7 VDC | |
| Contraction time | 1.0 s |
| Relaxation time | 1.4 s |
| Treatment session | 20 minutes |
6 NMES Waveform
The NMES treatment program pulse parameters are defined below, Table 3:
7
| Table 3- Motive NMES Waveform Pulse parameters | ||
|---|---|---|
| Pulse shape | Asymmetrical, monophasic, and complex | |
| Treatment duration | 20 minutes | |
| Frequency | 50 pps | |
| Pulse width | 5 ms | |
| Duty cycle | 25% | |
| Work cycle | 12 s | |
| Relaxation time | 10 s | |
| Contraction time | 5 cycles | 1 s |
| Rest time | 1.4 s |
In the treatment program, the work cycle consists of the combination of five cycles of contraction and rest. Contraction time is the actual stimulation contraction period. Rest time is the period between contractions to wait to oscillate the stimulation between the two channels. Relaxation time is a period of no stimulation between the work cycles.
7 Recommended Usage
Motive device NMES therapy is recommended to be used twice a day for a minimum of 5 days per week. Each session of NMES therapy is 20 minutes. The therapy is recommended to be applied as long as the knee pain relief is sustained.
8 Summary of Non-Clinical/ Bench Studies
To demonstrate the safety, the Motive device was tested for electrical safety, electromagnetic compatibility, usability, biocompatibility, and risk management requirements.
To demonstrate the safety, the Motive device was tested per the following standards:
- IEC 60601-1: 2005, 3rd Edition, Medical electrical equipment- General requirements for ● basic safety and essential performance + CORR. 1:2006 + CORR. 2:2007 + A1:2012
- IEC 60601-1-2: 2014-02, 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
- 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
8
- IEC 60601-1-6: 2010+ A1:2013, 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+ A1: 2014, 1st Edition, Medical devices -- Application ofusability . engineering to medical devices
- IEC 62304: 2006, 15T Edition, Medical device software Software life cycleprocesses ●
- 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
In addition, the performance of BLE module for wireless co-existence was tested 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 CFR47 Part 15, Subpart C, July 2019, Intentional Radiator, §15.247, Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-5850MHz
- FCC 47CFR PT 15 SPT B, August 2018 Title 47 CFR Part 15 Subpart B: Unintentional ● Radiators, FCC Part 15, Subpart B [FCC $15.107 & FCC §15.109]
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.
9 Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Motive device 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.
10 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, 15" Edition, Medical device software - Software life cycle processes. The software validation tests demonstrated that the software version meets its design requirements.
Cybersecurity Controls 11
Cybersecurity related activities included system assessment and mitigations for potential
9
cybersecurity hazards and risks on the Motive device performance and data security. Information related to system design features, processes, testing, and controls to manage and mitigate the risks are included in this submission.
Cybersecurity information and supporting documents created and submitted according to the requirements of FDA guidance documents, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2, 2014 and Postmarket Management of Cybersecurity in Medical Devices, December 28, 2016.
12 Human Factors and Usability
A self-selection study and human factors study including usability assessment was conducted to validate the usability of the Motive device as an over-the-counter device and for home use. The results of the study support the labeling content and User's Manual instructions for successfully using the device as intended. The results of the human factors and usability study substantiates the acceptability of the risks identified during the risk assessment activities.
Human Factors information and supporting documents created and submitted according to the requirements of FDA guidance documents, FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016.
Additionally, the Motive device complies with the IEC 60601-1-6: 2010 for usability and IEC 62366: Application of usability engineering to medical devices.
13 Biocompatibility/ Material
The patient contacting materials used in the Motive device components include the Wrap with Smart Panel, electrodes, and electrode gel. The biocompatibility of the Wrap, electrodes, and electrode gel were previously evaluated and cleared under 510(K) submission K163067. The biocompatibility testing had been conducted according to the requirements of ISO 10993: 2009 and tested as a surface contact/ >24 hour to 30 days prolonged exposure. From the evaluation and submitted information, the components of the Motive device were found to be biocompatible for its use.
14 Shelf life/ Sterility
The non-invasive nature of the device obviates the need for sterile components; however, patientcontacting surfaces should be capable of being cleaned as needed. The Motive device is provided for single person use and does not require any of the components to be sterilized by the end user. It is intended for external use only. The electrodes are disposable and can be replaced as needed.
15 Performance Testing- Bench Testing of Electrical Muscle Stimulation (NMES) Waveform
All features and output specifications of the device, including those identified in Tables 1 and 2, were verified by individual pulse output waveform tracings for loads of 500, 2k, and 10k ohms, to simulate conditions that the device could counter during use.
10
16 Comparison of Technological Characteristics with the Predicate Device
CyMedica Orthopedics, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Motive device is substantially equivalent in design principles to the predicate device, CyMedica Orthopedics, Inc. IntelliHab System, K210604, the primary predicate device. The data included in this submission demonstrates design substantial equivalence to the predicate device, IntelliHab System. Both devices utilize the same NMES therapy electrical stimulation waveform and electrodes to deliver the therapy to the quadriceps muscles of the knee. Both devices are indicated for the treatment of knee pain and strengthening of the quadriceps muscle.
The primary predicate IntelliHab system is intended for prescription use and the subject Motive device is intended for over-the-counter (OTC) use. However, both devices are intended for home-use. Data from a self-selection study and human factors study were provided to support the Motive device safety for the OTC use. Additionally, a second predicate device is included, RelieforMe TENS/EMS Device Model UPK-GE01 (K192733) as an OTC device.
The intended use, design, materials, and functional characteristics of the Motive device and the primary predicate device are substantially the same. The subject device and primary predicate device are both intended as home-based use devices. Both devices have the same general purpose and function. Both devices are intended for the same general health population. Both devices utilize the same electrical stimulation therapy to strengthen the quadricep muscle to provide symptomatic temporary knee pain relief. Similar to the primary predicate device, Motive device provides the same NMES waveform, protocol, and pulse amplitude for the purpose of muscle strengthening and knee pain relief. Similar to the primary predicate device, Motive device includes a Wrap. Controller (pulse generator), RF communications, electrodes, and an App for delivery of the NMES therapy.
The Motive device is substantially equivalent in design and labeling to the primary predicate device and secondary predicate device. Nonclinical testing including self-selection study and human factors study performed on the Motive device are sufficient to demonstrate that the subject device is as safe and effective as the legally marketed predicate devices. The technological and labeling differences do not raise new or different questions about safety or effectiveness. Motive device is substantially equivalent to the predicate devices.
The following table demonstrates the similarities and differences between the subject Motive device and the predicate devices, IntelliHab System and RelieforMe TENS/EMS Device.
11
| TABLE 4-
Substantial
Equivalence
Comparison | Proposed Subject Device, Motive™ Knee
Wrap (Motive device), K220738
CyMedica Orthopedics, Inc. | Primary Predicate Device, IntelliHab™
System, K210604
CyMedica Orthopedics, Inc. | 2nd Predicate Device, RelieforMe TENS/EMS
Device Model UPK-GE01, K192733
UMEHEAL Ltd. |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The Motive Knee Wrap device is intended to
strengthen the quadriceps muscle using powered
muscle stimulation to provide symptomatic
temporary pain relief associated with knee
arthritis.
The Motive Knee Wrap device is indicated for
adults of 22 years of age and older. | The IntelliHab system is intended to strengthen
the quadricep muscle using powered muscle
stimulation to provide symptomatic temporary
pain relief associated with knee osteoarthritis and
improvement of the knee joint mobility when the
recommended treatment regimens are followed.
In addition, the Intellihab System is indicated for
the following:
• Retardation or prevention of disuse atrophy
• Evaluation of joint mobility by measuring and
recording range of motion.
The IntelliHab System is indicated for adults of
22 years of age and older. | TENS:
- It is intended for temporary relief of
pain associated with sore and aching
muscles in the shoulder, neck, back,
waist, abdomen, lower extremities (legs),
upper extremities (arms) due to strain
from exercise or normal household and
work activities. - It is also intended for symptomatic relief
and management of chronic, intractable pain
and relief of pain associated with arthritis.
EMS: - To stimulate healthy muscles to
improve and facilitate muscle performance.
To be used for the improvement of muscle
tone and firmness, and for strengthening
muscles in the intended areas onthe body. - To be used for relaxation of muscle
spasm, increase of blood flow circulation,
prevention or retardation of disuse
atrophy, muscle re-education, maintaining
or increasing range of motion, and
immediate post-surgical stimulation of
calf muscles to prevent venous thrombosis |
| Intended Use | Over-the-Counter (OTC)
Home-use | Prescription
Home-use | OTC
Home-use |
| Regulation
names and
numbers | Powered muscle stimulator, 21 CFR 890.5850 | Powered muscle stimulator, 21 CFR 890.5850
Goniometer, AC-powered, 21 CFR 888.1500 | Powered muscle stimulator, 21 CFR 890.5850
TENS, 21 CFR 882.5890 |
| Product codes
and
classifications | Powered muscle stimulator, IPF, Class II | Powered muscle stimulator, IPF, Class II
Goniometer, AC-powered, KQX, Class I | Powered muscle stimulator, IPF, Class II
TENS, GZJ and NUH, Class II |
| TABLE 4-
Substantial
Equivalence
Comparison | Proposed Subject Device, Motive™ Knee
Wrap (Motive device), K220738
CyMedica Orthopedics, Inc. | Primary Predicate Device, IntelliHab™
System, K210604
CyMedica Orthopedics, Inc. | 2nd Predicate Device, RelieforMe TENS/EMS
Device Model UPK-GE01, K192733
UMEHEAL Ltd. |
| Product
identifications | Powered muscle stimulator, 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. | Powered muscle stimulator, 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.
Goniometer, AC-powered, A goniometer is an
AC-powered or battery powered device intended
to evaluate joint function by measuring and
recording ranges of motion, acceleration, or
forces exerted by a joint. | Powered muscle stimulator, 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.
TENS, A transcutaneous electrical nerve
stimulator for pain relief is a device used to
apply an electrical current to electrodes on a
patient's skin to treat pain. |
| Electrical
stimulation
modalities | NMES "Strength" program therapy | NMES "Strength" program therapy | NMES and TENS therapies |
| System
components | Controller, Controller changing cable, App,
Wrap with Smart Panel, electrodes, and
electrode gel | Controller, Controller changing cable, App,
conductive wrap, electrodes, and electrode gel | Controller and electrodes |
| Controller and
PCBA | Controller (pulse generator) consists of a
printed-circuit board within a plastic enclosure
that docks in a wrap docking receptacle via a 16-
pin interface. The Controller is the stimulation
generator and the tactile control device for the
system. The User can establish a wireless
connection between the Controller and their
mobile device. | Same | Unknown |
| Wrap | The Wrap design includes a modular design of a
basic textile-based wrap and a removable Smart
Panel where all the electronics, wires, and
electrodes are included in the Smart Panel.
Wrap with Smart Panel is single size.A single Wrap with Smart Panel can
provide treatment for both right and left
knees (not simultaneously). | The Wrap is one piece only and includes
integrated electronics, wires, and accelerometers
Wrap is not washable.
Wrap comes in different sizes.Two designated right and left wraps are
required to provide the treatment for the
right knee or left knee (not
simultaneously). | No wrap |
| TABLE 4-
Substantial
Equivalence
Comparison | Proposed Subject Device, Motive™ Knee
Wrap (Motive device), K220738
CyMedica Orthopedics, Inc. | Primary Predicate Device, IntelliHabTM
System, K210604
CyMedica Orthopedics, Inc. | 2nd Predicate Device, RelieforMe TENS/EMS
Device Model UPK-GE01, K192733
UMEHEAL Ltd. |
| Electrodes | Three snap type connected electrodes integrated
with the Smart Panel of the Wrap. One 2"
diameter electrode is required to activate the
Vastous Medialis Oblique (VMO) muscle and
two 2" x 3.5" electrodes for Rectus Femoris (RF)
muscle.
Although only three electrodes are required to
provide the therapy, in the Motive device setup
steps, Users are instructed to install 4 electrodes
(2 VMO electrodes) so they can apply the right
and left knee therapies when desired. | Three wire connected or pigtail electrodes
integrated with the conductive wrap. One 2x2"
electrode for VMO muscle and two 2" x 3.5"
electrodes for RF muscle. | Unknown |
| User Interface | The User's App serves as the primary user
interface and communication link between the
Controller and UI. The App includes screens for
application of NMES therapy, changing
intensities, starting, pausing, and stopping a
treatment. The App includes screens for creating
a profile, initial device setup guide, Help, and
reminders related to critical tasks such as
changing electrodes.
Additionally, the App improves therapy
compliance through a multi-faceted approach of
incentivizing User engagement through a
motivational User Dashboard, therapy reminders
and a rewards system. | Same UI design | Unknown |
| Stimulation
pulse
characteristics | The patented waveform is a unique,
asymmetrical, complex, and monophasic shaped
pulse which is designed to provide optimized
therapeutic benefits while maximizing comfort
and compliance.
The unique design features including a longer
pulse width (5 ms), monophasic polarity, work
cycles, and regulated power output provide a
longer duration of muscle contraction within a
20 minute treatment session. These unique
waveform characteristics lead to the therapeutic
benefits of the device reducing the knee pain and | Same | Unknown |
| TABLE 4-
Substantial
Equivalence
Comparison | Proposed Subject Device, Motive™ Knee
Wrap (Motive device), K220738
CyMedica Orthopedics, Inc. | Primary Predicate Device, IntelliHab™
System, K210604
CyMedica Orthopedics, Inc. | 2nd Predicate Device, RelieforMe TENS/EMS
Device Model UPK-GE01, K192733
UMEHEAL Ltd. |
| | improving knee joint functionality.
The Moive NMES stimulation pulses have three
distinct phases:
Phase 1: Pulse Spike (Rise Time, Peak,
and Decay)
Phase 2: Pulse Mesa
Phase 3: Recharge (off period) | | |
| Regulated
power output | Using a proprietary technology, the output of
stimulation circuit delivers energy to the User at
a constant power, independent of the load
impedance, hence power regulation during the
mesa portion of the pulse. | Same | Unknown |
| Closed loop
feedback
system | The stimulation circuit employs a proprietary
closed loop feedback technology to regulate
energy transferred to the User for stimulation
sensation comfort. | Same | None |
| Waveform | Asymmetrical, monophasic, complex | Same | Unknown |
| Pulse width
(µsec) | 5000 µsec | Same | 250-400 µs, NMES
4-300 µs, TENS |
| Pulse Train | 50 Hz | Same | 1-100 Hz, NMES
1-1200, TENS |
| Maximum
Output Voltage
(volts, rms) (+/-
%) @ 2k Ω | 16.7 V | Same | 65 V |
| Maximum
Output Current
(mA, rms) (+/-
%) @ 2k Ω | 8.3 mA | Same | 32.5 mA |
| Net Charge
(microcoulombs
(µC) per pulse) | 359.8 µC @500Ω | Same | Unknown |
| TABLE 4-
Substantial
Equivalence
Comparison | Proposed Subject Device, Motive™ Knee
Wrap (Motive device), K220738
CyMedica Orthopedics, Inc. | Primary Predicate Device, IntelliHab™
System, K210604
CyMedica Orthopedics, Inc. | 2nd Predicate Device, RelieforMe TENS/EMS
Device Model UPK-GE01, K192733
UMEHEAL Ltd. |
| Maximum
Phase Charge,
(μC) | 359.8 μC @500Ω | Same | 48.8 μC @500Ω, NMES
36.6 μC @500Ω, TENS |
| Maximum
Current
Density
(mA/cm²,r.m.s.) | 0.9 mA @500Ω | Same | Unknown |
| Maximum
Average Power
Density,
(W/cm²), (using
smallest
electrode
conductive
surface area) | 0.009 W/cm² @500Ω | Same | Unknown |
| Integrated
digital
goniometer | No goniometer | In addition to an electrical muscle stimulator,
IntelliHab System includes an integrated digital
goniometer for measurement of knee joint range
of motion (ROM) to evaluate joint mobility. The
device includes two accelerometers located in a
conductive wrap and IntelliHab Controller
allowing for the measurement of knee joint
extension and flexion degrees or range of motion
measurement. The measured flexion, extension,
and ROM angles are displayed and stored in the
IntelliHab patient's App. | No goniometer |
| Embedded
software | The treatment program embedded software is a
fundamental component of the system that
supports the selection, adjustment, and delivery of
the treatment program. The embedded software
runs on the Controller and is interfaced with the
stimulation pulse generator and App.
The Controller software drives the stimulation
circuits to generate appropriate waveforms for the
prescribed protocols and deliver them to the | Same | Unknown |
| TABLE 4-
Substantial
Equivalence
Comparison | Proposed Subject Device, Motive™ Knee
Wrap (Motive device), K220738
CyMedica Orthopedics, Inc. | Primary Predicate Device, IntelliHab™
System, K210604
CyMedica Orthopedics, Inc. | 2nd Predicate Device, RelieforMe TENS/EMS
Device Model UPK-GE01, K192733
UMEHEAL Ltd. |
| | electrode interface. The power button, with
integrated LED indicator, on the Controller is
used for powering the Controller On/Off and
Pause/Resume an active treatment; the button is
always active and can be used in the event of loss
of Bluetooth connection to the mobile device to
pause or abort therapy. The Controller
communicates collected data and commands in
real-time to the App wirelessly over Bluetooth
communications. | | |
| Wireless
communications | Motive device incorporates a Bluetooth Low
Energy, BLE 4.2 connection module to enable
wireless communication that can be paired with
a Bluetooth enabled mobile device running the
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 Smart Panel
via a multi-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 Controller 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. | Same | None |
| Parameter | Motive Knee Wrap | IntelliHab System | RelieforMe |
| 510(k) Number | K220738 | K210604 | K192733 |
| Device Name and Mode | Motive NMES | Intellihab NMES | RelieforMe TENS/EMS |
| Manufacturer | CyMedica Orthopedics | Same | UMEHEAL Ltd. |
| Power Source(s)† | Single
VD434053:
3.7V;
1000mAh;
Lithium ion
polymer battery | Same | Battery powered |
| - Method of Line Current Isolation | No line
connection | Same | Unknown |
| - Patient Leakage Current | --- | --- | --- |
| - Normal Condition(µA) | 4.88 | Same | Unknown |
| - Single Fault Condition (μΑ) | 8.00 | Same | Unknown |
| Number of Output Modes | One (NMES) | Same | 2 |
| Number of Output Channels ††††: | 1, Alternating | Same | 1 |
| | 1, Transistor | Same | 1 |
| Regulated Current or Regulated Voltage? | Regulated Power | Same | Voltage |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes |
| Automatic Overload Trip? | No | No | No |
| Automatic No-Load Trip? | No | No | No |
| Automatic Shut Off? | Yes | Yes | Yes |
| User Override Control? | Yes, Stop Buttons | Yes | Yes, Off button stops
treatment
immediately |
| Indicator Display: | On/Off Status?
Yes
Low Battery?
Yes
Voltage/Current
Level?
No | Yes
Yes
No | Yes
Yes
No |
| Timer Range (minutes) | 20-open | Same | Unknown |
| 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, Same
standards | Unknown |
| Weight (lbs., oz.) | 1.76 oz.
(50g) | Same | Unknown |
| Dimensions (in.) [W x H x D] | 1.93" x 0.64" x
3.28" | Same | Unknown |
| Housing Materials and Construction | Molded PC\ABS
Plastic Bayblend
FR3010 | Same | Unknown |
12
13
14
15
16
17
The following table summarizes the subject Motive device and the predicated devices, IntelliHab System and RelieforMe technological characteristics:
Table 5- Technological characteristics of the subject device and predicate devices
18
19
The following table summarizes the subject Motive device, IntelliHab System therapy waveform characteristics:
| Table 6- Motive NMES Waveform & IntelliHab NMES Waveform Parameters | ||||
|---|---|---|---|---|
| NMES Waveform Parameters | Subject device, Motive NMES program | Predicate device, IntelliHab NMES program, K210604 | Discussion of similarities and differences | |
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed Monophasic | Pulsed Monophasic | Same | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Complex | Complex | Same | |
| Maximum Output Voltage (volts, rms) (+/- ______ %) | 9.3 @500Ω | 9.0 @500Ω | Similar | |
| 16.7 @ 2 k Ω | 16.2 @ 2 k Ω | Similar | ||
| 21.8 @10 k Ω | 21.1 @10 k Ω | Similar | ||
| Maximum Output Current (mA, rms) (+/- ______%) | 18.6 @500Ω | 18.0 @500Ω | Similar | |
| 8.3 @ 2 k Ω | 8.1 @ 2 k Ω | Similar | ||
| 2.2 @10 k Ω | 2.1 @10 k Ω | Similar | ||
| Duration of primary (depolarizing) phase (μsec) | 5000 | 5000 | Same | |
| Pulse Duration (μsec) | 5000 | 5000 | Same | |
| Frequency (Hz) [or Rate (pps)] | 50 | 50 | Same | |
| For interferential modes only: Beat Frequency (Hz) | N/A | N/A | N/A | |
| For multiphasic waveforms only: | Symmetrical phases? | N/A | N/A | N/A |
| Phase duration | N/A | N/A | N/A | |
| Net Charge (microcoulombs (µC) per pulse) (If zero, state method of achieving zero net charge.) | 359.8 @500Ω | 359.8 @500Ω | Same | |
| Maximum Phase Charge, (µC) | 359.8 @500Ω | 359.8 @500Ω | Same | |
| Maximum Current Density (mA/cm², r.m.s.) | 0.9 @500Ω | 0.7 @500Ω | Similar | |
| Maximum Average Current (average absolute value), | ||||
| mA | 18.6 @500Ω | 18.0 @500Ω | Similar | |
| Maximum Average Power Density, (W/cm²), (using | ||||
| smallest electrode conductive surface area) | 0.009 @500Ω | 0.006 @500Ω | Similar | |
| Burst Mode | (a) Pulses per burst | 50 | 50 | Same |
| (b) Bursts per second | 0.23 | 0.23 | Same | |
| (c) Burst duration (seconds) | 1 | 1 | Same | |
| (d) Duty Cycle: Line (b) x Line (c) | 0.23 | 0.23 | Same | |
| ON Time (seconds) | 276 | 276 | Same | |
| OFF Time (seconds) | 924 | 924 | Same | |
| Additional Features (specify, if applicable) | N/A | N/A | N/A |
20
21
Summary of Clinical Study 17
Subject Motive device utilizes the same NMES waveform and protocol as the predicate device CyMedica IntelliHab System, K210604. Clinical data submitted in the predicate device application, IntelliHab System, K210604 applies to the subject Motive device.
18 Conclusion
The basis for substantial equivalence for the Motive device and the predicate devices is nonclinical data, a self-selection study, human factors test data, and conformity with recognized standards. The hardware and software verification and validation demonstrate that the subject device performs comparably to the predicate devices that are marketed for the same intended use. Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the Motive device is as safe and effective as, and substantially equivalent to, the predicate devices.