MyoCycle MC-2 (Home / Home + / Pro / Pro +)

K213925 · Myolyn, LLC · GZI · Apr 25, 2022 · Neurology

Device Facts

• Record ID: K213925
• Device Name: MyoCycle MC-2 (Home / Home + / Pro / Pro +)
• Applicant: Myolyn, LLC
• Product Code: GZI · Neurology
• Decision Date: Apr 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 5. Muscle re-education

Device Story

MyoCycle MC-2 is a stationary functional electrical stimulation (FES) cycle ergometer; assists patients with impaired lower extremity movement. Device comprises motorized ergometer, FES controller, stimulation cables, and cutaneous electrodes (up to 10 channels). Operates in active (FES-evoked muscle contractions) or passive (motor-driven) modes; maintains isokinetic cycling at 35 r/min. Motor automatically assists or resists based on patient-applied torque. Used in home or clinical settings; operated by patient or clinician. System includes touchscreen GUI for therapy settings and session logs. Provides muscle stimulation to quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, abdominals, and erector spinae. Benefits include improved circulation, spasm reduction, and muscle re-education.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified via system testing against recognized consensus standards including ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, and IEC 60601-2-10.

Technological Characteristics

Mains-powered FES cycle ergometer. Features: 0-140 mA charge-balanced stimulator, 5-100 Hz frequency, 20-500 microsecond pulse width, up to 10 stimulation channels. Embedded microcontrollers with Android OS interface. 10-inch touchscreen GUI. Connectivity: 802.11 a/b/g/n/ac Wi-Fi, Bluetooth, BLE. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10.

Indications for Use

Indicated for individuals with impaired lower extremity movement requiring general rehabilitation, including relaxation of muscle spasms, prevention/retardation of disuse atrophy, increased local blood circulation, maintenance/increase of range of motion, and muscle re-education. 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

• MyoCycle MC-HP-1 (K170132)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

April 25, 2022

Myolyn, LLC
Matthew Bellman
Chief Technology Officer
6931 NW 22nd Street, Suite A
Gainesville, Florida 32653-1231

Re: K213925
Trade/Device Name: MyoCycle MC-2 (Home / Home + / Pro / Pro +)
Regulation Number: 21 CFR 882.5810
Regulation Name: External Functional Neuromuscular Stimulator
Regulatory Class: Class II
Product Code: GZI
Dated: January 7, 2022
Received: January 10, 2022

Dear Matthew 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. 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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K213925 - Matthew Bellman
Page 2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Amber T. Ballard -S

Amber Ballard, PhD
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}

FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K213925 | |
| Device Name MyoCycle MC-2 (Home / Pro / Home + / 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 5. Muscle re-education | |
| 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 [e-mail] | |
| "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}

MYOLYN
MyoCycle MC-2 Traditional 510(k)Submission

# 510(k) Summary

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

Company: MYOLYN, INC
6931 NW 22ND Street, Suite A
Gainesville, FL 32653
Phone: [phone]

Contact person: Matthew Bellman, PhD
Chief Technology Officer
Phone: [phone] x101
E-mail: [e-mail]

Date prepared: April 25, 2022

(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 MC-2 (Home / Home + / Pro / Pro +) |
| --- | --- |
| Common name: | Functional electrical stimulation |
| 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: MYOLYN
Product: MyoCycle MC-HP-1 (Home / Pro)
510(k) number: K170132
Device class: 2

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

The MyoCycle is a stationary Functional electrical stimulation (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 20 cutaneous electrodes for 10 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

Page 1 of 5

{4}

MYOLYN
MyoCycle MC-2 Traditional 510(k)Submission

(utilizing power developed by the ergometer's motor). The electric motor inside 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 has four different configurations:

1. Pro – allows for multiple users by storing unique user data that can be accessed by a unique user identification code; extended FES parameter adjustability; up to six channels of stimulation
2. Home – only stores data for one user; limited FES parameter adjustability; up to six channels of stimulation
3. Pro Plus (+) – same as Pro but allows for up to ten channels of stimulation and uses patient cabling with additional leads
4. Home Plus (+) – same as Home but allows for up to ten channels of stimulation and uses patient cabling with additional leads

(5) Indications for Use Statement:

The MyoCycle MC-2 device's Indications for Use (IFU) Statement is substantially equivalent to that of the predicate device, the MyoCycle MC-HP-1 (K170132), as described in the table below.

| MyoCycle MC-2 IFU Statement | MyoCycle MC-HP-1 (K170132) IFU Statement |
| --- | --- |
| The MyoCycle is intended for general rehabilitation for: | The MyoCycle is 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 |
| 5. Muscle re-education | |

NOTE: THE SAME INDICATIONS FOR USE AS THE EXISTING MYOCYCLE ARE PROPOSED HOWEVER THE MUSCLE RE-EDUCATION INDICATION FROM FDA'S POWERED MUSCLE STIMULATOR GUIDANCE DOCUMENT HAS BEEN ADDED.

The MyoCycle is for prescription use only.

Page 2 of 5

{5}

MYOLYN

MyoCycle MC-2 Traditional 510(k)Submission

# (6) Technological Characteristics

The function of the MyoCycle MC-2 is substantially equivalent to the predicate device; however, there are certain technological similarities and differences, as described below:

| Technology | MyoCycle MC-2 | MyoCycle MC-HP-1 (K170132) |
| --- | --- | --- |
| Power source (energy used) | Mains power | Mains power |
| Controller | Uses embedded microcontrollers running custom software with an Android OS interface | Uses embedded microcontrollers running custom software |
| Stimulator (energy delivered) | 0-140 mA charge balanced stimulator | 0-126 mA charge balanced stimulator |
| Stimulation pulse width | 20 to 500 microseconds | Not publicly available |
| Stimulation frequency | 5 to 100 Hz | Not publicly available |
| Stimulation channels | Up to 10 channels | Up to 6 channels |
| Muscles available for stimulation | Bilateral quadriceps, hamstrings, gluteals, gastroc, anterior tibialis, abdominals, erector spinae | Not publicly available |
| Flywheel | Uses motor to create flywheel effect with reduced weight and space | Uses motor to create flywheel effect with reduced weight and space |
| Seating | Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer | Allows user to remain in their own seating, e.g. wheelchair eliminating the need for transfer |
| Passive cycling | Utilizes motor to provide assistance during passive cycling | Utilizes motor to provide assistance during passive cycling |
| Touchscreen interface | Utilizes a 10-inch touchscreen graphical user interface (GUI) | Not publicly available |
| Wireless communications | Utilizes an integrated 802.11 a/b/g/n/ac WLAN (Wi-Fi), Bluetooth, and Bluetooth Low Energy (BLE) module | Not publicly available |
| Database interface | Utilizes database interface for storage and retrieval of | |

{6}

MYOLYN
MyoCycle MC-2 Traditional 510(k)Submission

patient therapy settings and storage of session logs. Not publicly available

## (b) Performance data

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

| Test or procedure | Description |
| --- | --- |
| Review of user documentation for predicate device | Ensure that equivalent functionality is specified and implemented in the new device. |
| Review of 510(k) submission for predicate device | Confirm technical specifications for completion of predicate details in comparison tables. |
| Output characteristic measurement of new device | Confirm technical specifications for completion of new device details in comparison tables. |
| Conduct of system testing | Conduct system testing to verify performance to specification. |

The system testing described above made general use of the following recognized consensus standards to ensure specific risks were reduced to acceptable levels:

| Recognition Number | Standards Organization | Standard Designation Number and Date | Title of Standard |
| --- | --- | --- | --- |
| 19-4 | ANSI AAMI | ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| 19-36 | IEC | 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic |

Page 4 of 5

{7}

MYOLYN
MyoCycle MC-2 Traditional 510(k)Submission

| | | | disturbances - Requirements and tests |
| --- | --- | --- | --- |
| 5-132 | IEC | 60601-1-6 Edition 3.2
2020-07 CONSOLIDATED VERSION | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 19-38 | IEC | 60601-1-11 Edition 2.1
2020-07 CONSOLIDATED VERSION | 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 |
| 17-16 | IEC | 60601-2-10 Edition 2.1
2016-04 | Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |

## Discussion

The intended use of the MyoCycle MC-2 is substantially equivalent to that of the predicate device MyoCycle MC-HP-1 (K170132). The MyoCycle MC-2 has an indication for use, namely, "muscle re-education," which the predicate device does not claim. However, this indication is a standard indication for use for Powered Muscle Stimulators according to the guidance document entitled, "Guidance Document for Powered Muscle Stimulator 510(k)s," dated June 9, 1999. Furthermore, the addition of this indication with respect to the predicate does not raise any new questions of safety and effectiveness.

The MyoCycle MC-2 has similar technological characteristics and output specifications to those of the predicate device MyoCycle MC-HP-1 (K170132). Specifically, the MC-2 device has up to four additional stimulation channels with a wider range of stimulation parameters and a larger touchscreen interface. The different characteristics and specifications do not raise new questions of safety and effectiveness. MYOLYN's non-clinical testing, including bench testing against recognized consensus standards, have demonstrated that the MC-2 device is as safe and effective as the predicate device and is therefore substantially equivalent.

## 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.

Page 5 of 5