Myocene

DEN230051 · Myocene · SDX · Jan 17, 2025 · Neurology

Device Facts

• Record ID: DEN230051
• Device Name: Myocene
• Applicant: Myocene
• Product Code: SDX · Neurology
• Decision Date: Jan 17, 2025
• Decision: DENG
• Submission Type: Direct
• Regulation: 21 CFR 882.1871
• Device Class: Class 2

Intended Use

The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue.

Device Story

Myocene system evaluates muscle fatigue in healthy athletes; utilizes powered muscle stimulator to induce quadriceps contractions alongside voluntary contractions; sensors measure force of contraction; device computes objective fatigue metrics; used in sports practice settings by coaches and athletes; output informs athletic training decisions; helps optimize training loads; prevents over-training or musculoskeletal injury.

Clinical Evidence

No clinical data provided; safety and effectiveness supported by non-clinical performance testing, including characterization of neuromuscular stimulation parameters and sensor accuracy, electrical/thermal/mechanical safety testing, and software verification/validation.

Technological Characteristics

Neuromuscular stimulator and evaluation system; includes powered muscle stimulator and force sensors; parameters include waveforms, output modes, voltage, current, pulse duration, frequency, and charge density; requires biocompatibility for tissue-contacting components; subject to electrical, thermal, and mechanical safety standards; software-controlled.

Indications for Use

Indicated for healthy athletes, 15 years of age or older, to evaluate quadriceps muscle fatigue via voluntary and stimulated knee extensor contractions to inform athletic training decisions.

Regulatory Classification

Identification

The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue.

Special Controls

In combination with the general controls of the FD&C Act, the neuromuscular stimulator and evaluation system is subject to the following special controls: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Characterization of the neuromuscular stimulation parameters. For electrical stimulation, these parameters including the following: waveforms; output modes; maximum output voltage and maximum output current; pulse duration; frequency; net charge per pulse; maximum phase charge, maximum current density, maximum average current, and maximum average power density; and (ii) Characterization of the device sensor(s) used to quantify muscle response, including sampling frequency, accuracy, and measurement range. (2) Performance data must demonstrate the electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety of the device for its intended environment(s) of use. (3) Software verification, validation, and hazard analysis must be performed. (4) The tissue-contacting components of the device must be demonstrated to be biocompatible. (5) A human factors and usability evaluation, including a use-related risk analysis (URRA), must be performed. (6) Labeling must include: (i) Summaries of stimulation output and other performance parameters, and (ii) Interpretation of the device’s output measures.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 17, 2025

Myocene
Jean-Yves Mignolet
CEO
Quai Banning 6
Liège, 4000
Belgium

Re: DEN230051
Trade/Device Name: Myocene
Regulation Number: 21 CFR 882.1871
Regulation Name: Neuromuscular stimulator and evaluation system
Regulatory Class: Class II
Product Code: SDX
Dated: July 27, 2023
Received: July 27, 2023

Dear Jean-Yves Mignolet:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your De Novo request for classification of the Myocene, a prescription device under 21 CFR Part 801.109 with the following indications for use:

The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue.

FDA concludes that this device should be classified into Class II. This order, therefore, classifies the Myocene, and substantially equivalent devices of this generic type, into Class II under the generic name neuromuscular stimulator and evaluation system.

FDA identifies this generic type of device as:

**Neuromuscular stimulator and evaluation system.** A neuromuscular stimulator and evaluation system is a device that applies neuromuscular stimulation and measures a neuromuscular response, for the purpose of evaluating exercise capacity and performance or informing athletic training decisions.

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

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DEN230051 - Jean-Yves Mignolet
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Section 513(f)(2) of the Food, Drug and Cosmetic Act (the FD&C Act) was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. This law provides two options for De Novo classification. First, any person who receives a "not substantially equivalent" (NSE) determination in response to a 510(k) for a device that has not been previously classified under the Act may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act. On December 13, 2016, the 21st Century Cures Act removed a requirement that a De Novo request be submitted within 30 days of receiving an NSE determination. Alternatively, any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the Act without first submitting a 510(k). FDA shall, within 120 days of receiving such a request, classify the device. This classification shall be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing the classification.

On July 27, 2023, FDA received your De Novo requesting classification of the Myocene. The request was submitted under section 513(f)(2) of the FD&C Act. In order to classify the Myocene into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the De Novo request, FDA has determined that, for the previously stated indications for use, the Myocene can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type. The identified risks to health and corresponding mitigation measures associated with the device type are summarized in the following table:

| Risks to Health | Mitigation Measures |
| --- | --- |
| Adverse tissue reaction | Biocompatibility evaluation |
| Skin irritation and burns | Non-clinical performance testing
Labeling |
| Muscle or soft tissue injury due to muscle over-activation | Non-clinical performance testing
Software verification, validation, and hazard analysis
Labeling |
| Athletic over-training or musculoskeletal injury due to inaccurate or misinterpreted device output measures | Non-clinical performance testing
Electrical, thermal, and mechanical safety testing
Electromagnetic compatibility (EMC) testing
Software verification, validation, and hazard analysis
Human factors and usability evaluation
Labeling |

In combination with the general controls of the FD&C Act, the neuromuscular stimulator and evaluation system is subject to the following special controls:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:

(i) Characterization of the neuromuscular stimulation parameters. For electrical stimulation, these parameters including the following: waveforms; output modes; maximum output voltage and maximum output current; pulse duration; frequency; net charge per pulse; maximum phase

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DEN230051 - Jean-Yves Mignolet
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charge, maximum current density, maximum average current, and maximum average power density; and

(ii) Characterization of the device sensor(s) used to quantify muscle response, including sampling frequency, accuracy, and measurement range.

(2) Performance data must demonstrate the electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety of the device for its intended environment(s) of use.

(3) Software verification, validation, and hazard analysis must be performed.

(4) The tissue-contacting components of the device must be demonstrated to be biocompatible.

(5) A human factors and usability evaluation, including a use-related risk analysis (URRA), must be performed.

(6) Labeling must include:

(i) Summaries of stimulation output and other performance parameters, and
(ii) Interpretation of the device’s output measures.

In addition, this is a prescription device and must comply with 21 CFR 801.109.

Although this letter refers to your product as a device, please be aware that some granted products may instead be combination products. If you have questions on whether your product is a combination product, contact [e-mail].

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device type. FDA has determined premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device type and, therefore, the device is not exempt from the premarket notification requirements of the FD&C Act. Thus, persons who intend to market this device type must submit a premarket notification containing information on the neuromuscular stimulator and evaluation system they intend to market prior to marketing the device.

Please be advised that FDA's decision to grant this De Novo request does not mean that FDA has made a determination that your device complies with other requirements of the FD&C Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the FD&C 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 FD&C Act; 21 CFR 1000-1050).

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All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System Rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation are on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and are available for inspection between 9 a.m. and 4 p.m., Monday through Friday.

As a result of this order, you may immediately market your device as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

For comprehensive regulatory information about medical devices and radiation-emitting products, 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).

If you have any questions concerning the contents of the letter, please contact Zach B. McKinney, PhD at [e-mail] or [phone].

Sincerely,

David P. Mc

Mullen -S

Digitally signed by David P. Mc

Mullen -S

Date: 2025.01.17 17:07:02 -05'00'

David McMullen, MD

Director

OHT5: Office of Neurological and

Physical Medicine Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health