(98 days)
Not Found
No
The description focuses on the mechanical and electrical components of the device and its operational modes, with no mention of AI or ML algorithms for data analysis, control, or adaptation.
Yes
The device is described with specific pathological conditions it aims to address (e.g., relaxation of muscle spasms, prevention of disuse atrophy) and operates through physical or electrical means (FES evoked muscle contractions) to achieve therapeutic effects, fitting the definition of a therapeutic device.
No
The device is described as a stationary FES cycle ergometer intended for rehabilitation purposes such as muscle relaxation, atrophy prevention, increasing blood circulation, and maintaining/increasing range of motion. It does not perform any diagnostic functions like detecting, identifying, or monitoring a disease or condition.
No
The device description explicitly lists multiple hardware components including a motorized cycle ergometer, an FES controller/stimulator, stimulation cables, and cutaneous electrodes. While it includes software, it is an integral part of a larger hardware system.
Based on the provided information, the MyoCycle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The MyoCycle's intended use and device description clearly indicate it is a physical rehabilitation device that applies electrical stimulation and provides cycling exercise. It does not analyze any biological specimens.
- The intended use focuses on physical rehabilitation outcomes such as muscle relaxation, preventing atrophy, increasing blood circulation, and maintaining range of motion. These are not diagnostic purposes.
- The device description details a mechanical and electrical system for exercise and stimulation, not a system for analyzing biological samples.
Therefore, the MyoCycle falls under the category of a physical therapy or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
The MyoCycle is for prescription use only.
- Maintaining or increasing range of motion
Product codes
GZI
Device Description
The MyoCycle is a stationary 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 12 cutaneous electrodes for 6 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 operates in two modes:
-
- Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
-
- Home mode only stores data for one user
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D).
MyoCycle Pro allows for multiple users by storing unique user data that can be accessed by a unique user identification code.
MyoCycle Home only stores data for one user.
The MyoCycle was validated with five lay operators using the device with an able bodied, simulated patient.
The MyoCycle was validated with seven clinician operators using the device with six spinal cord injured patients.
The MyoCycle was validated with five spinal cord injured patients using the device without assistance.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing to determine equivalence has been primarily composed of the following tests:
- Test or procedure: Review of user documentation for predicate device; Description: Ensure that equivalent functionality is specified and implemented in the new device.
- Test or procedure: Review of 510(k) submission for predicate device; Description: Confirm technical specifications for completion of predicate details in comparison tables.
- Test or procedure: Output characteristic measurement of new device; Description: Confirm technical specifications for completion of new device details in comparison tables.
- Test or procedure: Conduct of system testing; Description: Conduct system testing to verify performance to specification.
- Test or procedure: Testing with lay operators; Description: The MyoCycle was validated with five lay operators using the device with an able bodied, simulated patient.
- Test or procedure: Testing with clinician operators; Description: The MyoCycle was validated with seven clinician operators using the device with six spinal cord injured patients.
- Test or procedure: Testing with patient operators; Description: The MyoCycle was validated with five spinal cord injured patients using the device without assistance.
As part of the system testing described above, the MyoCycle met the following recognized consensus standards:
- IEC 60601-2-10 Edition 2.0 2012-06: Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
- AAMI ANSI 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)
- IEC 60601-1-2 Edition 4.0 2014-02: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- IEC 60601-1-11 Edition 2.0 2015-01: 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
- AAMI ANSI HA60601-1-11:2015: Medical Electrical Equipment -- Part 1-11: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment (IEC 60601-1-11:2015 MOD)
Key results:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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:
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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
7731 W. Newberry. Rd., Suite A-2
Gainesville, FL 32606
Phone: (352) 354-2749 |
|----------|---------------------------------------------------------------------------------------------------|
| | |
Contact person: Matthew Bellman, PhD Chief Technology Officer Phone: (850) 832-1842 E-mail: mjbellman@myolyn.com
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:
-
- a motorized cycle ergometer
-
- an FES controller / stimulator
-
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 12 cutaneous electrodes for 6 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
4
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:
-
- Pro mode allows for multiple users by storing unique user data that can be accessed by a unique user identification code
-
- 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 | |
| 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 | |
| microcontrollers running | ||
| custom software | Based on Pocket PC | |
| running custom | ||
| software | ||
| Stimulator (energy delivered) | 0-126 mA charge | |
| balanced stimulator | 0-140 mA charge | |
| 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
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 |
(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. | |
| Testing with lay operators | The MyoCycle was validated with five lay |
| operators using the device with an able | |
| bodied, simulated patient. | |
| Testing with clinician operators | The MyoCycle was validated with seven |
| clinician operators using the device with six | |
| spinal cord injured patients. | |
| Testing with patient operators | The MyoCycle was validated with five |
| spinal cord injured patients using the | |
| 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
Number | Standards
Organization | Standard Designation
Number and Date | Title of Standard |
|-----------------------|---------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 17-11 | IEC | 60601-2-10 Edition 2.0
2012-06 | Medical Electrical Equipment -- Part
2-10: Particular Requirements For
The Basic Safety And Essential
Performance Of Nerve And Muscle
Stimulators |
| 19-4 | AAMI ANSI | 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) |
| 19-8 | IEC | 60601-1-2 Edition 4.0
2014-02 | Medical Electrical Equipment - Part
1-2: General Requirements For Basic
Safety And Essential Performance -
Collateral Standard: Electromagnetic
Disturbances - Requirements And
Tests |
| 19-14 | IEC | 60601-1-11 Edition 2.0
2015-01 | 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 |
| 19-16 | AAMI ANSI | HA60601-1-11:2015 | Medical Electrical Equipment -- Part
1-11: General Requirements For
Basic Safety And Essential
Performance -- Collateral Standard:
Requirements For Medical Electrical
Equipment And Medical Electrical
Equipment And Medical Electrical
Systems Used In The Home
Healthcare Environment (IEC 60601-
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.