← Product Code [IPF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF) · K210604
# Intellihab System (K210604)
_Cymedica Orthopedics, Inc. · IPF · Jun 3, 2021 · Physical Medicine · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K210604
## Device Facts
- **Applicant:** Cymedica Orthopedics, Inc.
- **Product Code:** [IPF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF.md)
- **Decision Date:** Jun 3, 2021
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5850
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine
- **Attributes:** Therapeutic
## Indications for Use
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.
## Device Story
Intellihab System is a remote-monitoring NMES device for knee osteoarthritis. It uses a conductive wrap with electrodes and two 6-axis accelerometers (one in the controller, one in the wrap) to deliver electrical stimulation and measure knee range of motion (ROM). The patient uses a smartphone app to control therapy, track activity, and report outcomes (VAS, KOOS, WOMAC). Data is transmitted via Bluetooth to the app and then to a cloud-based provider portal for remote monitoring. The system provides quadriceps strengthening to reduce compressive joint loads and alleviate pain. It is intended for home use by patients, with data review by healthcare providers. Benefits include improved muscle strength, pain relief, and joint mobility.
## Clinical Evidence
Randomized, sham-controlled, double-blind, multi-center trial (N=156). Primary endpoint: change in VAS Nominated Activity at 12 weeks. ITT analysis showed clinically meaningful pain reduction (38.5% PCFB) but no statistically significant difference vs. sham. PPTC (therapy-compliant) analysis (N=45) showed statistically significant improvements in pain (WOMAC pain p=0.038, KOOS JR pain p=0.010), stiffness (WOMAC stiffness p=0.002), and function (WOMAC function p=0.029) compared to sham. Adverse events were rare (0.016% of sessions) and non-serious.
## Technological Characteristics
Materials: Molded PC/ABS plastic (Bayblend FR3010). Sensing: Two 6-axis Accelerometer/Gyroscope units. Energy: 3.7V 950mAh Li-Po battery. Connectivity: Bluetooth Low Energy (BLE) 4.2, cloud-based API. Waveform: Asymmetrical, monophasic, complex pulse; 50 pps; 5 ms pulse width. Software: Embedded controller firmware, mobile app, web-based portal. Sterilization: Non-sterile, single-person use, cleanable.
## Regulatory 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.
## Predicate Devices
- CyMedica e-vive® System ([K163067](/device/K163067.md))
## Submission Summary (Full Text)
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June 3, 2021
CyMedica Orthopedics, Inc. Kereshmeh Shahriari Vice President, Regulatory, Clinical, & Quality 19120 N. Pima Rd. Scottsdale, Arizona 85331
Re: K210604
Trade/Device Name: Intellihab System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, KQX Dated: May 7, 2021 Received: May 7, 2021
### 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
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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 (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 Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### K210604
Device Name
Intellihab™ System Indications for Use (Describe)
The Intellihab system is intended to strengthen the quadricep 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.
| 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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FORM FDA 3881 (6/20)
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# 510(k) Summary Intellihab™ System CyMedica Orthopedics, Inc.
| 1 | Regulatory Information | |
|-----|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.1 | Trade/Proprietary Name: | Intellihab™ System |
| 1.2 | Common Name: | Powered muscle stimulator |
| 1.3 | Regulation Names & Numbers: | Powered muscle stimulator, 21 CFR 890.5850
Goniometer, 21 CFR 888.1500
Product Codes:
Primary Code- Powered muscle stimulator: IPF
Secondary Code- Goniometer, AC-powered: KQX |
| 1.4 | Classification: | Powered muscle stimulator: II
Goniometer: I |
| 1.5 | Manufacturer Name: | CyMedica Orthopedics, Inc.
19120 N. Pima Rd. Suite 135
Scottsdale, AZ 85255
Telephone (480) 664-1282
FAX (866) 296-2772 |
These devices are reviewed by the Division of Neurological and Physical Medicine Devices.
#### Submission Information 2
| Submission Number: | K210604 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 2, 2021 |
| Contact: | Kereshmeh Shahriari
19120 N. Pima Rd. Suite 135
Scottsdale, AZ 85255
kereshmeh@cymedicaortho.com
Telephone (480) 664-1282
FAX (866) 296-2772 |
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#### 3 Indications for Use
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.
#### 4 Device Description
Intellihab System is a remote monitoring electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements. Intellihab 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 osteoarthritis. The stimulator is intended for medical purposes that continuously contracts muscle groups for an intended therapeutic application and allows for remote monitoring of therapeutic data by the healthcare Providers. The stimulator is provided with an integrated battery powered digital goniometer that allows for measurement of knee joint range of motion. The stimulator along with the digital goniometer is placed over or in proximity to affected joint. The Intellihab System includes a provider portal allowing for remote monitoring of collected patient data through Intellihab mobile app and API interface.
#### 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 osteoarthritis. The electrical muscle stimulator is intended for medical purposes that continuously contracts muscle groups for an intended therapeutic application and allows for remote monitoring of therapeutic data by the healthcare providers. Electrical stimulation waveform is generated using a Controller. Electrical stimulation is delivered non-invasively to the treatment site (quadriceps muscles of the knee joint) using three connected electrodes placed directly on the skin.
#### 4.2 Mobile Application (App)
The electrical stimulation therapy is initiated and managed wirelessly by the patient using a mobile application (app) developed for use on smart phones or tablets that interact with the Intellihab Controller.
In addition, the app includes features that would allow to track patient's activity level and allow the patients to report their knee joint osteoarthritis related clinical outcomes including pain level using CyMedica Intellihab app based Visual Analog Scale (VAS) pain measuring instrument. VAS measures are stored in the app. Other knee-specific measuring instruments including KOOS questionnaire (Knee Injury and Osteoarthritis Outcome Score) and WOMAC questionnaire (Western Ontario and McMaster Universities Arthritis Index) are provided in the Intellihab app, allowing the patients to report their knee related outcomes. KOOS and WOMAC scores are calculated and stored in the app. The Intellihab app can improve therapy compliance through a multi-faceted approach of incentivizing patient engagement through a motivational Patient Dashboard, therapy reminders and a rewards system. The app serves as the primary user
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interface and communication link between the Intellihab system and Provider portal as discussed below.
#### 4.3 Digital Goniometer for Range of Motion Measurement
Intellihab includes an integrated digital goniometer for measurement of knee joint range of motion (ROM) to evaluate joint mobility. The device includes two accelerometers, some located in a conductive wrap and the other in the 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 app.
#### 4.4 Conductive Garment or Wrap
The electrical muscle stimulator along with the cutaneous electrodes, wires, and ROM accelerometers are incorporated in a conductive wrap placed over or in proximity to the knee joint. The Intellihab system utilizes a conductive smart garment to actively communicate to the NMES Controller the patient's tibial sensor kinematics data, Controller docking status and garment identification data to the patient's mobile device. Additionally, the garment provides mild compression and warming benefits to the patient.
#### 4.5 Web-based Provider Portal for Remote Patient Monitoring
A Medical Device Data System (MDDS), CyMedica web-based healthcare Provider portal is available to allow for the electronic transfer, storage, and display of data sent from the patients' mobile app.
CyMedica web-based portal allows the healthcare Providers to monitor patient's app-based therapy compliance and other collected health related data (ROM. PROs. activity) remotely. The portal is hosted on a secure cloud-based server that connects with an internal database using an API communication.
#### 5 Wireless Communications
The Intellihab System 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 Intellihab 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 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 and the unit can be recharged by using the supplied USB cable.
#### 6 Proposed software
The Intellihab system utilizes an embedded Controller/ROM software, mobile application 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 mobile app.
The mobile application (app) runs on a mobile platform operating system and communicates with the
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Controller over a BLE 4.2 connection. The free mobile application is downloaded by the patients from the respective App Stores. The Intellihab system allows the patient to control the NMES therapy program in an easy and intuitive way. It allows the patient to select, administer, and adjust the NMES therapy intensities, perform a range of motion test, and manage their health and wellness conditions related to their therapy.
In addition, the app provides other tools to engage the patients with their NMES treatment and tracking of patient outcomes that may be valuable to their healthcare providers.
#### 7 Controller and the Mobile App
The Controller's main function is the NMES therapy stimulation generator and communicating therapy and range of motion metrics to the mobile app. The Controller contains the primary safety controls for operation of the device. A push button is available for switching the unit on or off. The "Stop" control remains active at all times during stimulation and can be used in the event of loss of Bluetooth connection.
Once the mobile app is installed and a wireless connection is established between the Controller and the mobile device, the patient can interact with all of the device features. The mobile app downloaded on the patient's mobile device provides the graphical user interface and governs the interactions between the Controller and the patient. The screens and user interface are designed to be intuitive and interactive. Improved patient engagement and compliance through the mobile app are significant design features of the device.
Help and informational screens are provided throughout the app and on specific screens where a patient needs to be aware of a feature or condition. Upon downloading the mobile app, the patient is guided through chronological screens on the app to perform the following tasks:
- Reading and accepting the app Terms of Use and Conditions
- Creating a patient profile
- Pairing the mobile app on a smart device with the Intellihab conductive garment
- Starting the treatment
- Managing the treatment
- Completing Patient Reported Outcomes (PROs)
- Reviewing patient related data and information on the app
#### 8 Joint Range of Motion Measure Function
The Intellihab system uses two 6-axis Accelerometer/Gyroscope (AG) to detect the knee range of motion. One accelerometer is located on the Controller board and the second accelerometer is located within a small plastic enclosure in the conductive garment knee opening area. The two accelerometers are connected using wires embedded in the garment. The data from the accelerometers is conveyed to the mobile device in real-time. The accelerometers detect the knee extension and flexion angles, and associated range of motion angle through the use of the Intellihab mobile app when initiated by the patient.
#### 9 Remote Patient Monitoring
A cloud-based database and services are designed to allow for secure transfer, storage, and display
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of the data reported by patient's mobile app through a Web Application Programming Interface (API) or Web API. Intellihab mobile app makes specific API calls to perform a desired task, save data to the central remote storage (cloud) or to retrieve data back. Intellihab Web Services provide a way for the mobile app to communicate with CyMedica cloud database and services.
In addition, a healthcare Provider facing portal is designed to allow for remote patient monitoring by the Providers. Through appropriate credentialing processes, healthcare providers are capable of viewing their patients reported data including the therapy compliance, knee range of motion, patient reported knee pain levels, and knee-specific outcomes surveys including KOOS JR. and WOMAC scores.
Image /page/7/Figure/2 description: The image shows a diagram of the modes of operation for the CyMedica system. The system consists of CyMedica hosted data servers, a cloud service, and a CyMedica provider portal. The system has two modes of operation: NMES mode and charging mode. The NMES mode includes an Intellihab system controller, a dock, electrodes, and a ROM sensor, while the charging mode includes an Intellihab system controller and a wall charger. The system connects to a smartphone via WiFi, LTE, and Bluetooth, and is used in the patient's home or clinic.
Figure 1- Intellihab system including electrical muscle stimulation therapy (NMES), conductive wrap, range of motion test function, mobile application, and a Provider web-portal for patient monitoring
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#### General Electrical Muscle Stimulation Device Features and Output Characteristics 10
The following two Tables, Tables 1 and 2, represent the Intellihab electrical stimulation device features and the neuromuscular electrical stimulation (NMES) therapy output specifications.
| 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 1- Intellihab NMES Therapy Program General Electrical Stimulation Device Features
Table 2- Intellihab 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 |
#### 11 NMES Waveform
The NMES treatment program pulse parameters are defined below, Table 3:
| Table 3- Intellihab 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 |
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| 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.
The following graphs show the individual pulses and pulse train. The waveform is a unique, asymmetrical, complex, and monophasic shaped pulse which is designed to provide optimized therapeutic benefits.
Image /page/9/Figure/3 description: The image shows two oscilloscope plots. The top plot shows two signals, one in blue and one in red, that appear to be square waves with a voltage of approximately 60V. The bottom plot shows a signal that appears to be a series of pulses with a voltage of approximately 60V. The time scale for the top plot is in milliseconds, and the time scale for the bottom plot is also in milliseconds.
Figure 2- Intellihab NMES Pulse Plots- Pulse train and single pulse
#### Recommended Usage 12
Intellihab 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
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knee pain relief and joint functionality or mobility improvements are sustained.
### 13 Intellihab System NMES Therapy Mechanism of Action for Treatment of Knee Osteoarthritis Symptoms
Studies have suggested quadriceps weakness or atrophy plays a significant role in the knee osteoarthritis disease initiation and progression. Other publications suggest muscle atrophy as an underlying cause for early stage osteoarthritis. Regardless, the quadriceps muscle is critical to dynamic joint stability, and weakness of this muscle group is related to pain and poor functional outcomes in knee osteoarthritis patients - The involvement of quadriceps weakness in the development or progression of the knee osteoarthritis may be linked to the role of quadriceps during gait, where an eccentric contraction of the quadriceps is responsible for providing the shock absorption at the knee. The inability to adequately attenuate large compressive forces at the knee can result in impulsive loading, which has been attributed to quadriceps and inactivity and may be responsible for knee osteoarthritis changes. In addition, the decline in quadriceps strength has been attributed to the central nervous system lack of ability to fully volitionally activate the muscles (voluntary activation deficit). It is theorized that the voluntary activation deficit is caused by progressive joint degeneration that results in abnormal articular afferent information being sent to the motor neurons, thereby reducing theiractivation1-6.
Therefore, therapies or modalities that improve quadriceps strength are important in managing knee osteoarthritis symptoms including pain relief and joint mobility improvements. Many recent clinical studies have shown that the addition of an at home NMES therapy system is a promising intervention to use in managing knee osteoarthritis symptoms712. NMES therapy may override activation deficit which would increase the quadriceps strength and ultimately reduce the compressive loads on the knee joint.
The results of isometric quadriceps strength test in the CyMedica NMES clinical study demonstrated an increase in quadricep strength by application of the NMES treatment over time at weeks 4, 8, and 12 post intervention. With the application of CyMedica NMES treatment the quadriceps strength gradually increased at week 4 by 30.5%, week 8 by 47.8%, and week 12 by 81.5% as compared to the baseline for the compliant patients.
#### 14 Summary of Non-Clinical/ Bench Studies
To demonstrate the safety, the Intellihab system was tested for electrical safety, electromagnetic compatibility, usability, biocompatibility, and risk management requirements.
To demonstrate the safety, the Intellihab system 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 ●
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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
- 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, 18 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
In addition, the performance of Intellihab 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.
### 15 Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the Intellihab 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.
### 16 Software Verification & Validation Testing
The device's software has been validated in accordance with the requirements set forth in the
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FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and IEC 62304: 2006, 150 Edition, Medical device software – Software life cycle processes. The software validation tests demonstrated that the software version meets its design requirements.
#### 17 Cybersecurity Controls
Cybersecurity related activities included system assessment and mitigations for potential cybersecurity hazards and risks on the Intellihab System 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.
### 18 Human Factors and Usability
The human factors including usability study was conducted to validate the usability of the Intellihab system in the home environment. The results of the study support the 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. The Intellihab system complies with the IEC 60601-1-6: 2010 for usability and IEC 62366: Application of usability engineering to medical devices.
#### 19 Biocompatibility/ Material
The patient contacting materials used in the Intellihab system components include the conductive garment or wrap, electrodes, and electrode gel. The biocompatibility of the conductive garment, 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 contacting/skin contact/ >24 hour to 30 days prolonged exposure. From the evaluation and submitted information, the components of the Intellihab device were found to be biocompatible for its use.
### 20 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 Intellihab system 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. Cleaning instructions are provided in the User Manual for safe handling and proper care of the device.
#### 21 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.
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## 22 Comparison of Technological Characteristics with the Predicate Device
CyMedica Orthopedics, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Intellihab System is substantially equivalent in design principles to the predicate device, which has been determined by FDA to be substantially equivalent to CyMedica Orthopedics. Inc. CyMedica e-vive® System. K163067. The data included in this submission demonstrates design substantial equivalence to the predicate device. CyMedica e-vive.
The design, materials, and functional characteristics of the Intellihab System and the predicate device are substantially the same. The subject device and predicate device provide neuromuscular electrical stimulation therapy, are for prescription use, portable, hand-held, and for home healthcare environment use. Similar to the predicate device. Intellihab System provides NMES therapy for the purpose of muscle strengthening. Similar to the predicate device, Intellihab System includes an integrated battery powered goniometer for measurement of knee range of motion and intended to evaluate joint function.
However, the indications for use for the subject Intellihab system are different than the predicate device. Submitted clinical data shows that the proposed indications for use does not result into a new intended use and supports the basis for assessment of safety and effectiveness.
The following table demonstrates the similarities and differences between the subject Intellihab system and the predicate device, CyMedica e-vive system.
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| Table 4- Product Features
Comparison | CyMedica Intellihab™ System (K210604) | CyMedica e-vive® System (K163067) | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Intended Use | The Intellihab system is intended for strengthening of the
muscles by application of neuromuscular electrical stimulation
(NMES) therapy. | The CyMedica e-vive System is intended for strengthening of
the muscles by application of neuromuscular electrical
stimulation (NMES) therapy. | |
| Indications for use | 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. | Indications for Use:
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
In addition, the e-vive device is intended to evaluate joint
function by measuring and recording range of motion. | |
| Regulation names and
numbers | Powered muscle stimulator, 21 CFR 890.5850
Goniometer, 21 CFR 888.1500 | Powered muscle stimulator, 21 CFR 890.5850
Goniometer, 21 CFR 888.1500
TENS, 21 CFR 882.5890 | |
| Product codes and
classifications | Powered muscle stimulator, IPF, Class II
Goniometer, AC-powered, KQX, Class I | Powered muscle stimulator, IPF, Class II
Goniometer, AC-powered, KQX, Class I
TENS, GZJ, Class II | |
| Table 4- Product Features
Comparison | CyMedica Intellihab™ System (K210604) | CyMedica e-vive® System (K163067) | |
| 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, 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. | Goniometer, 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. | |
| | | 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 | NMES Strength,
NMES POST-OP, and
TENS | |
| System functions | NMES therapy for knee osteoarthritis pain relief and treatment of disuse atrophy Knee range of motion measurement | NMES therapy for treatment of disuse atrophy, muscle spasms, increasing local blood, circulation, re-educating muscles, post-surgical prevention of venous thrombosis, and increasein ROM Knee range of motion measurement TENS | |
| System components | Controller, mobile app, conductive garment, electrodes, and
electrode gel | Same | |
| TENS therapy | No TENS included | Includes TENS | |
| Muscle stimulator (NMES
therapy) | | | |
| | Table 4- Product Features Comparison | CyMedica Intellihab™ System (K210604) | CyMedica e-vive® System (K163067) |
| - | 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, Figure 2. 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 minutes treatment session. These unique waveform characteristics lead to the therapeutic benefits of Intellihab therapy reducing the knee pain and improving knee joint functionality. The Intellihab stimulation pulses have three distinct phases: - Phase 1: Pulse Spike (Rise Time, Peak, and Decay) - Phase 2: Pulse Mesa - Phase 3: Recharge (off period) | Same |
| - | Regulated power output | Using a proprietary technology, the output of Intellihab stimulation circuit delivers energy to the patient at a constant power, independent of the load impedance, hence power regulation during the mesa portion of the pulse. | Same |
| - | Closed loop feedback system | The Intellihab stimulation circuit employs a proprietary closed loop feedback technology to regulate energy transferred to the patient for stimulation sensation comfort. | Same |
| - | Waveform | Asymmetrical, monophasic, complex | Same |
| - | Pulse width | The Intellihab electrical muscle stimulation (NMES) pulse width (including spike and mesa) is 5ms, longer than other muscle stimulation devices which range 300 to 500 μs. | Same for NMES Strength program only |
| - | Pulse Train | The Intellihab muscle electrical stimulation (NMES) pulse train consist of individual monophasic stimulation pulses of 50 pulses-per-second. | Same for NMES Strength program only |
| - | Integrated digital goniometer…
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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K210604](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IPF/K210604)
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