(130 days)
The MyoCycle is intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
- Muscle re-education
The MyoCycle is a stationary Functional electrical stimulation (FES) cycle ergometer which is composed of:
- a motorized cycle ergometer
- an FES controller /stimulator
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 20 cutaneous electrodes for 10 channels)
- 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 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:
- 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
- Home – only stores data for one user; limited FES parameter adjustability; up to six channels of stimulation
- Pro Plus (+) – same as Pro but allows for up to ten channels of stimulation and uses patient cabling with additional leads
- Home Plus (+) – same as Home but allows for up to ten channels of stimulation and uses patient cabling with additional leads
The provided document is an FDA 510(k) clearance letter for the MyoCycle MC-2 device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics (numerical results), details about a test set (sample size, provenance), expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance data.
The document primarily focuses on demonstrating substantial equivalence through:
- Comparison of Indications for Use: Showing the MyoCycle MC-2 has substantially equivalent indications to the predicate device, with an added "muscle re-education" indication that is standard for this type of device and does not raise new safety/effectiveness questions.
- Comparison of Technological Characteristics: Highlighting similarities and minor differences (e.g., increased stimulation channels, wider parameter range, larger touchscreen, wireless communication, database interface) that do not raise new safety/effectiveness questions.
- Performance Data (Bench Testing): Stating that testing was conducted to ensure equivalent functionality and verify performance to specifications, primarily through a review of documentation and bench testing against recognized consensus standards (e.g., electrical safety, EMC, usability).
Therefore, I cannot populate most of the requested sections as the information is not present in the provided text.
Here's what can be extracted based on the document:
Acceptance Criteria and Study Details for MyoCycle MC-2
The FDA 510(k) submission for the MyoCycle MC-2 primarily relies on demonstrating substantial equivalence to a predicate device (MyoCycle MC-HP-1, K170132) rather than presenting new clinical performance data with numeric acceptance criteria for specific outcomes. The "performance data" referred to in the document pertains to bench testing against recognized consensus standards to ensure safety and functionality, not a clinical study to evaluate device effectiveness in patients.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes no specific quantitative acceptance criteria or reported device performance metrics in a clinical context (e.g., "device achieved X% accuracy," "device improved range of motion by Y degrees"). Instead, the "acceptance criteria" are implied to be the successful demonstration of:
- Substantially equivalent Indications For Use.
- Similar technological characteristics that do not raise new questions of safety or effectiveness.
- Compliance with recognized consensus standards for device safety and electrical performance.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Indications for Use Equivalence | "The MyoCycle MC-2 device's Indications for Use (IFU) Statement is substantially equivalent to that of the predicate device... addition of this indication... does not raise any new questions of safety and effectiveness." |
| Technological Characteristics Equivalence | "The MyoCycle MC-2 has similar technological characteristics and output specifications to those of the predicate device... The different characteristics and specifications do not raise new questions of safety and effectiveness." |
| Safety and Functional Performance | "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." |
| Stimulator Output | Output characteristic measurement of new device confirmed technical specifications: 0-140 mA charge balanced stimulator (predicate: 0-126 mA). |
| Compliance with Standards | System testing made general use of recognized consensus standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set in the conventional sense of a patient-based clinical study. The "testing" mentioned is primarily non-clinical bench testing and review of documentation. Therefore, information on sample size and data provenance for a clinical test set is not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no clinical test set requiring expert ground truth or adjudication is described.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technological characteristics and bench testing, not on comparative clinical effectiveness with human readers/users.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The MyoCycle MC-2 is a physical medical device (an FES cycle ergometer) rather than a software algorithm intended for standalone diagnostic or interpretive performance. Its functionality is tied to its interaction with a user.
7. The Type of Ground Truth Used
For the bench testing and design verification, the "ground truth" would be established by the specifications defined for the device and the requirements of the recognized consensus standards. For example, an electrical safety standard dictates specific performance criteria that the device must meet, and this standard serves as the "ground truth" for compliance. There is no mention of patient-level "ground truth" (e.g., pathology, outcomes data) for clinical efficacy.
8. The Sample Size for the Training Set
Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described.
FDA 510(k) Clearance Letter - MyoCycle MC-2
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.04.32
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
Page 2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 3
FORM FDA 3881 (6/20) Page 1 of 1
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:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
- 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
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."
Page 4
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: (352) 354-2749
Contact person: Matthew Bellman, PhD
Chief Technology Officer
Phone: (352) 204-9066 x101
E-mail: mjbellman@myolyn.com
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:
- a motorized cycle ergometer
- an FES controller /stimulator
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 20 cutaneous electrodes for 10 channels)
- 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 5
(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:
- 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
- Home – only stores data for one user; limited FES parameter adjustability; up to six channels of stimulation
- Pro Plus (+) – same as Pro but allows for up to ten channels of stimulation and uses patient cabling with additional leads
- 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:1. Relaxation of muscle spasms2. Prevention or retardation of disuse atrophy3. Increasing local blood circulation4. Maintaining or increasing range of motion5. Muscle re-education | The MyoCycle is intended for general rehabilitation for:1. Relaxation of muscle spasms2. Prevention or retardation of disuse atrophy3. Increasing local blood circulation4. Maintaining or increasing range of motion |
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 6
(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 | Not publicly available |
Page 7
| | patient therapy settings and storage of session logs. | |
(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 8
| 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.
§ 882.5810 External functional neuromuscular stimulator.
(a)
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.(b)
Classification. Class II (performance standards).