MyoCycle Home, MyoCycle Pro

K170132 · Myolyn, LLC · GZI · Apr 25, 2017 · Neurology

Device Facts

• Record ID: K170132
• Device Name: MyoCycle Home, MyoCycle Pro
• Applicant: Myolyn, LLC
• Product Code: GZI · Neurology
• Decision Date: Apr 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyoCycle is intended for general rehabilitation for: 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion

Device Story

MyoCycle is a stationary functional electrical stimulation (FES) cycle ergometer; consists of motorized ergometer, FES controller, stimulation cables, and cutaneous electrodes (up to 12). Used in home or clinical settings by patients with impaired lower extremity movement; operated by patients or clinicians. System provides active cycling via FES-evoked muscle contractions and passive cycling via motor power. Motor maintains constant 35 r/min (isokinetic cycling); automatically assists or resists based on patient torque. Software manages stimulation parameters and user data (Pro mode for multiple users; Home mode for single user). Output allows patients to perform cycling exercises despite motor impairment; benefits include muscle spasm reduction, atrophy prevention, improved circulation, and range of motion maintenance.

Clinical Evidence

No clinical trials; evidence based on bench testing and validation studies. System testing verified performance against specifications and consensus standards (IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11). Validation included usability testing with five lay operators (simulated patient), seven clinician operators (six spinal cord injured patients), and five spinal cord injured patients (unassisted).

Technological Characteristics

Stationary FES cycle ergometer; mains powered. Uses embedded microcontrollers with custom software. Stimulation: 0-126 mA charge-balanced stimulator. Connectivity: supports unique user ID codes. Standards: IEC 60601-2-10, AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11. Form factor: motorized ergometer allowing use from existing seating (e.g., wheelchair).

Indications for Use

Indicated for general rehabilitation in patients requiring relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, and maintenance/increase of range of motion. Prescription use only.

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• RT300-S (K050036)

Submission Summary (Full Text)

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

April 25. 2017

Myolyn, LLC Matthew Bellman Chief Technology Officer 7731 W. Newberry Rd., Suite A-2 Gainesville, Florida 32606

Re: K170132

Trade/Device Name: Myocycle Home, Myocycle Pro Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: March 21, 2017 Received: March 23, 2017

Dear Mr. Bellman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director

Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170132

Device Name MyoCycle Home, MyoCycle Pro

Indications for Use (Describe)

The MyoCycle is intended for general rehabilitation for:

- 1. Relaxation of muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Maintaining or increasing range of motion

| 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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Image /page/3/Picture/1 description: The image shows the word "MYOLYN" in a stylized font. The letters are all capitalized and in a thin, sans-serif font. The "O" in the word is replaced by a circular graphic containing a complex, branching pattern resembling a neuron or nerve cell. The overall design is clean and modern.

# 510(k) Summary

- (1) Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

| Company: | MYOLYN, LLC<br>7731 W. Newberry. Rd., Suite A-2<br>Gainesville, FL 32606<br>Phone: [phone] |
|----------|---------------------------------------------------------------------------------------------------|
| | |

Contact person: Matthew Bellman, PhD Chief Technology Officer Phone: [phone] E-mail: [e-mail]

Date prepared: 04-12-2017

- (2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name:

| Proprietary name: | MyoCycle Home, MyoCycle Pro |
|------------------------------|---------------------------------------------------------|
| Common name: | Functional electrical stimulation (FES) cycle ergometer |
| Classification name: | External functional neuromuscular stimulator |
| Device class: | 2 |
| Classification product code: | GZI |
| Classification panel: | Neurology |
| Regulation number: | 882.5810 |

- (3) Identification of the legally marketed device to which the submitter claims equivalence:
Manufacturer: Restorative Therapies Inc. Product: RT300-S 510(k) number: K050036 Device class: ನ

#### (4) A description of the device that is subject of the premarket notification submission:

The MyoCycle is a stationary FES cycle ergometer which is composed of:

- 1. a motorized cycle ergometer
- 2. an FES controller / stimulator
- 3. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 channels)
- 4. cutaneous electrodes

This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside

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Image /page/4/Picture/1 description: The image shows the word "MYOLYN" in a stylized font. The "O" in the word is replaced by a circular graphic containing a neuron-like structure. The letters are all in uppercase and have a minimalist, geometric design. The overall design is clean and modern.

the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient. The system software operates in two modes:

- 1. Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
- 2. Home mode only stores data for one user

### (5) Indications for Use Statement:

The MyoCycle's Indications for Use (IFU) Statement is substantially equivalent to that of the predicate device, the RT300-S (K050036), as described in the table below. The MyoCycle does not have the same IFU Statement as the RT300-SP (pediatric version).

| MyoCycle IFU Statement | RT300-S (K050036) IFU Statement |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| The MyoCycle is intended for general<br>rehabilitation for: | The RT300-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for: |
| 1. Relaxation of muscle spasms | 1. Relaxation of muscle spasms |
| 2. Prevention or retardation of disuse atrophy | 2. Prevention or retardation of disuse atrophy |
| 3. Increasing local blood circulation | 3. Increasing local blood circulation |
| 4. Maintaining or increasing range of motion | 4. Maintaining or increasing range of motion |
| | The RT300-SP (pediatric version), is intended for population ages 4 to 12 years. |

The MyoCycle is for prescription use only.

#### (6) Technological Characteristics

The function of the MyoCycle is substantially equivalent to the predicate device; however, there are certain technological similarities and differences, as described below:

| Technology | MyoCycle | RT300-S (K050036) |
|-------------------------------|--------------------------------------------------------------|--------------------------------------------------|
| Power source (energy used) | Mains power | Mains power |
| Controller | Uses embedded<br>microcontrollers running<br>custom software | Based on Pocket PC<br>running custom<br>software |
| Stimulator (energy delivered) | 0-126 mA charge<br>balanced stimulator | 0-140 mA charge<br>balanced stimulator |

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Image /page/5/Picture/0 description: The image shows the word "MYOLYN" in a stylized font. The letters are all in uppercase and are black. The "O" in the word is replaced by a circle containing a black neuron-like structure, adding a biological or medical theme to the design. The overall design is clean and modern.

| Flywheel | Uses motor to create<br>flywheel effect with<br>reduced weight and<br>space | Uses motor to create<br>flywheel effect with<br>reduced weight and<br>space |
|-----------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Seating | Allows user to remain in<br>their own seating, e.g.<br>wheelchair eliminating<br>the need for transfer | Allows user to remain in<br>their own seating, e.g.<br>wheelchair eliminating<br>the need for transfer |
| Passive cycling | Utilizes motor to provide<br>assistance during<br>passive cycling | Utilizes motor to provide<br>assistance during<br>passive cycling |

## (b) Performance data

Testing to determine equivalence has been primarily composed of the following tests:

| Test or procedure | Description |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Review of user documentation for<br>predicate device | Ensure that equivalent functionality is<br>specified and implemented in the new<br>device. |
| Review of 510(k) submission for<br>predicate device | Confirm technical specifications for<br>completion of predicate details in<br>comparison tables. |
| Output characteristic measurement of<br>new device | Confirm technical specifications for<br>completion of new device details in<br>comparison tables. |
| Conduct of system testing | Conduct system testing to verify<br>performance to specification. |
| Testing with lay operators | The MyoCycle was validated with five lay<br>operators using the device with an able<br>bodied, simulated patient. |
| Testing with clinician operators | The MyoCycle was validated with seven<br>clinician operators using the device with six<br>spinal cord injured patients. |
| Testing with patient operators | The MyoCycle was validated with five<br>spinal cord injured patients using the<br>device without assistance. |

As part of the system testing described above, the MyoCycle met the following recognized consensus standards:

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Image /page/6/Picture/0 description: The image shows the word "MYOLYN" in a stylized font. The letters are all capitalized and made of thin lines. The "O" in the word is replaced by a circle containing a black neuron-like structure with branching dendrites, adding a biological or scientific element to the design.

| Recognition<br>Number | Standards<br>Organization | Standard Designation<br>Number and Date | Title of Standard |
|-----------------------|---------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 17-11 | IEC | 60601-2-10 Edition 2.0<br>2012-06 | Medical Electrical Equipment -- Part<br>2-10: Particular Requirements For<br>The Basic Safety And Essential<br>Performance Of Nerve And Muscle<br>Stimulators |
| 19-4 | AAMI ANSI | ES60601-<br>1:2005/(R)2012 And<br>A1:2012 | C1:2009/(R)2012 And<br>A2:2010/(R)2012 (Consolidated Text)<br>Medical Electrical Equipment - Part<br>1: General Requirements For Basic<br>Safety And Essential Performance<br>(IEC 60601-1:2005, MOD) |
| 19-8 | IEC | 60601-1-2 Edition 4.0<br>2014-02 | Medical Electrical Equipment - Part<br>1-2: General Requirements For Basic<br>Safety And Essential Performance -<br>Collateral Standard: Electromagnetic<br>Disturbances - Requirements And<br>Tests |
| 19-14 | IEC | 60601-1-11 Edition 2.0<br>2015-01 | Medical Electrical Equipment - Part<br>1-11: General Requirements For<br>Basic Safety And Essential<br>Performance - Collateral Standard:<br>Requirements For Medical Electrical<br>Equipment And Medical Electrical<br>Systems Used In The Home<br>Healthcare Environment |
| 19-16 | AAMI ANSI | HA60601-1-11:2015 | Medical Electrical Equipment -- Part<br>1-11: General Requirements For<br>Basic Safety And Essential<br>Performance -- Collateral Standard:<br>Requirements For Medical Electrical<br>Equipment And Medical Electrical<br>Equipment And Medical Electrical<br>Systems Used In The Home<br>Healthcare Environment (IEC 60601-<br>1-11:2015 MOD) |

#### MYOLYN concludes that:

The intended use of the MyoCycle is substantially equivalent to that of the predicate device.

The MyoCycle has similar output characteristics to those of the predicate device. The different technological characteristics do not raise new questions of safety and effectiveness.

MYOLYN's performance testing has demonstrated that the MyoCycle is as safe and effective for the intended use as the predicate device and is therefore substantially equivalent.