SENTIO MMG Gen 2
Device Facts
| Record ID | K173526 |
|---|---|
| Device Name | SENTIO MMG Gen 2 |
| Applicant | Medos International SARL |
| Product Code | PDQ · Ear, Nose, Throat |
| Decision Date | Apr 5, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
Indications for Use
This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.
Device Story
SENTIO MMG Gen 2 is a multichannel surgical nerve stimulator/locator used in clinical settings by surgeons. It utilizes a single-use sterile probe to deliver electrical stimulation (monopolar, bipolar, or train-of-four) to surgical sites. The device captures mechanical muscle activity (MMG) via non-sterile 3D accelerometer sensors attached to the skin. The system processes these signals to detect nerve activation resulting from intentional stimulation or unintentional mechanical factors like retraction or compression. Output is displayed on a touchscreen tablet, providing real-time feedback to the surgeon regarding nerve location and status. This information assists in nerve identification and monitoring throughout surgical interventions, potentially reducing the risk of nerve injury by alerting the surgeon to nerve proximity or impact.
Clinical Evidence
Bench testing only. Testing included electrical safety, electromagnetic compatibility, hardware/disposable functionality, and signal acquisition equivalence. Comparative performance evaluation used clinically relevant MMG signal simulation to demonstrate high agreement with the primary predicate. Biocompatibility, shelf-life, sterilization, packaging integrity, and software validations were performed.
Technological Characteristics
Multichannel system with touchscreen tablet and control unit. Stimulation: constant current, monophasic square pulse. Sensors: 3D digital accelerometers (1.8V). Connectivity: 3.5mm stereo plug for sensors, 1.5mm touch-proof connector (DIN 42-802) for ground patch. Power: Delta MDS-060AAS12 B. Biocompatible materials used for patient-contacting components (probe, sensors, ground patch).
Indications for Use
Indicated for use in surgical procedures to assist in locating and mapping motor nerves in patients requiring neurophysiologic status assessment via MMG signals and electrical nerve stimulation.
Regulatory Classification
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Predicate Devices
- SENTIO MMG (K131304)
- NuVasive Next Generation NVM5 System (K162313)
- STIMPOD NMS450 Nerve Stimulator (K102084)
Reference Devices
Submission Summary (Full Text)
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April 5, 2018 Medos International, SARL % Anna D'lima Senior Regulatory Affairs Program Lead DePuy Synthes 325 Paramont Drive Raynham, Massachusetts 02767
## Re: K173526
Trade/Device Name: SENTIO MMG Gen 2 Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: March 1, 2018 Received: March 5, 2018
Dear Anna D'lima:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2018.04.05 16:43:21 -04'00'
for Carlos L. Peña, PhD, MS 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) K173526
Device Name SENTIO MMG Gen 2
Indications for Use (Describe)
This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------|--|
| <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |
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# 510(K) SUMMARY K173526
#### A. Submitter Information
| Manufacturer: | Medos International SARL<br>Chemin-Blanc 38<br>2400 Le Locle, Switzerland |
|-------------------|---------------------------------------------------------------------------|
| Submitter: | DePuy Spine, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Contact Person: | Anna D'Lima<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Telephone number: | 508-977-3896 |
| Fax number: | 508-828-3797 |
| Email: | adlima@its.jnj.com |
#### B. Date Prepared
April 02, 2018
#### C. Device Name
| Trade/Proprietary Name: | SENTIO MMG® Gen 2 |
|------------------------------------------|------------------------------------------------------------|
| Common/Usual Name: | Surgical Nerve Stimulator/Locator |
| Device Classification<br>and Regulation: | Class II per 21 CFR §874.1820 |
| Product Code and Description: | PDQ; Neurosurgical Nerve Locator<br>ETN; Stimulator, Nerve |
#### D. Predicate Device Name
| Primary: | SENTIO MMG (K131304) |
|----------------------|----------------------------------------------------------------------------------------------|
| Other: | NuVasive Next Generation NVM5 System (K162313), STIMPOD<br>NMS450 Nerve Stimulator (K102084) |
| Reference<br>Device: | NIM-Spine (K031510), predicate to original SENTIO MMG<br>submission (K100992) |
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#### E. Device Description
SENTIO MMG Gen 2 is a multichannel device for locating, mapping and assessing the status of motor nerves during surgical procedures. SENTIO MMG Gen 2 alerts the user of recorded mechanical activity (termed mechanomyography, or MMG) from muscles innervated by affected nerves, which may originate from operator applied electrical stimulus or unintentional innervation of the nerve as a result of nerve impact, retraction, compression, or other mechanical factors. The device will assist with nerve identification and assessment by alerting the surgeon when monitored nerves are activated. The device will also assist with tracking the status of monitored nerves throughout the course of surgical intervention. The Sentio MMG Gen 2 system consists of capital equipment and disposable devices, both sterile and non-sterile.
| Stimulus Modes | Standard<br>(Monopolar) | Bipolar | Train of Four |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|
| Current Ranges | 0-20 mA | 0-2 mA | 20-80 mA |
| Current<br>Adjustment | 1 mA | 0.1 mA | 5 mA |
| Stimulation<br>Voltages | 115 V | 27 V | 350 V |
| Waveform | Monophasic<br>square pulse | Monophasic<br>square pulse | Monophasic<br>square pulse |
| Pulse Width | 50-250 µs | 50-250 µs | 100-200 µs |
| Pulse Rate | 4 Hz, Continuous | 4 Hz, Continuous | 2 Hz, 4 Pulse burst |
| Nerve Mapping<br>Probe | Single-use, sterile accessory used to provide electrical<br>stimulation to the surgical site | | |
| MMG Sensor | Single-use, non-sterile three-dimensional accelerometer<br>designed to provide feedback for locating and mapping motor<br>nerves | | |
| AC Power Supply | Delta MDS-060AAS12 B | | |
| Weight | Tablet: 0.68 Kg<br>Control Unit: 0.72 Kg | | |
| Dimensions | Tablet: 291 mm (D) x 193 mm (W) x 8 mm (H)<br>Control Unit: 220 mm (D) x 140 mm (W) x 40 mm (H) | | |
#### E. Technological Characteristics
#### G. Indications for Use / Intended Use
This device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device provides information directly to the surgeon to help assess a patient's neurophysiologic status by measuring and comparing MMG signals throughout a surgical procedure.
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### H. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The intended use and technological characteristics, including material, design, and performance, of SENTIO MMG Gen 2 are consistent with those of the predicate device. The different user interface and enhanced MMG signal acquisition do not raise new questions of safety and effectiveness based on results of bench testing and comparative performance evaluation.
| Attribute | Substantial Equivalence Evaluation |
|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Substantially equivalent - The indications for use statement for the<br>SENTIO MMG Gen 2 is a combination of the primary and secondary<br>predicate devices. The differences do not change the intended use as<br>a surgical nerve stimulator / locator, nor raise new questions of safety<br>or effectiveness as demonstrated by results of the risk-based<br>verification and validation testing. |
| Capital<br>Equipment:<br>Control Unit<br>and<br>PC/Display<br>Capital<br>Equipment:<br>Control Unit<br>and<br>PC/Display<br>(continued) | Number of Channels - Enhanced signal acquisition in comparison to<br>primary predicate - Substantially equivalent to secondary predicates<br>for same purpose of detecting a muscle event as evidenced by<br>comparative performance evaluation.<br>User interface - Touchscreen Tablet PC - Same as the primary<br>predicate, substantially equivalent to secondary predicates with the<br>same functional specification (system operation).<br>Display Size - Substantially equivalent - Subject device meets the<br>same acceptance criteria and conforms to the same consensus<br>standards as the primary predicate device.<br>Weight - Substantially equivalent - Subject device meets the same<br>acceptance criteria and conforms to the same consensus standards<br>as the primary predicate device.<br>Audio - Same as primary predicate and substantially equivalent to<br>secondary predicates. |
| System<br>Stimulation | Type Constant - Constant Current (mA) - Same as primary predicate.<br>Stimulus Range - Standard (monopolar), Bipolar Mode, Train of Four<br>- Substantially equivalent - Ranges are the same, or within, the<br>ranges of the primary predicate device, secondary predicates, or<br>reference device and have the same intended function.<br>Control - Digitally controlled, incremental adjustment - Standard<br>(monopolar), Bipolar Mode, Train of Four, or selectable range via<br>touchscreen - Same as primary predicate.<br>Maximum Stimulation Voltage - Substantially equivalent - Maximums<br>are within the limit settings of the primary predicate device, secondary<br>predicates, or reference device and have the same intended function.<br>Waveform - Monophasic square pulse - Same as primary predicate.<br>Pulse Width - Standard (monopolar), Bipolar Mode, Train of Four -<br>Same as primary predicate - Substantially equivalent - Ranges are<br>the same, or within, the ranges of the primary predicate device,<br>secondary predicates, or reference device and have the same<br>intended function.<br>Stimulation Rate - Same as the primary predicate and the same or<br>less than the secondary predicates and reference device. |
| Attribute | Substantial Equivalence Evaluation |
| Activation - Touchscreen or hand switch - Same as the primary<br>predicate. | |
| Sensors | Signal (electromechanical) - Same as primary predicate.<br>Attachment Site - Skin surface - Same as primary predicate.<br>Size - Reduced size for smaller site attachment - Same performance<br>criteria with reduced site attachment.<br>Connector type - 3.5mm Stereo plug - Substantially Equivalent -<br>3.5mm plug is independent of orientation. Same performance<br>requirements.<br>Technology - Digital - Substantially Equivalent as evidenced by<br>comparative performance evaluation.<br>Operating Voltage - 1.8V compared to 3.3V - Substantially Equivalent<br>- lower power consumes less energy for operation yet meets the<br>same performance. |
| Stimulator<br>Probe | Same as primary predicate. |
| Ground<br>Patch | Attachment Site - Skin surface - Same as primary predicate.<br>Size - Same as primary predicate.<br>Connector Type - 1.5mm touch proof - Industry standard DIN 42-802. |
| Materials | Capital equipment is comprised of materials evidenced to be suited<br>for their specified purpose.<br>Stimulator Probe is biocompatible and the same as the primary<br>predicate.<br>Sensors are biocompatible and comprised of the same, or proven<br>equivalent materials.<br>Ground Patch is biocompatibility and comprised of the same, or<br>proven equivalent materials. |
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#### l. Performance Data
Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The test results demonstrate that the device performs as well as the predicate devices and/or conform to recognized consensus standards for the compared design inputs, including, but not limited to; operating conditions, electrical safety, electromagnetic compatibility, hardware and disposable device functionality, signal acquisition equivalence, comparative performance evaluation using clinically relevant MMG signal simulation to capture a statistically significant sample to demonstrate high agreement with respect to performance of the primary predicate, biocompatibility, shelf-life, sterilization, packaging integrity, and software validations.
#### J. Conclusion
The indications for use and intended use of the subject device are consistent with those of the predicate devices. Comparison of technological characteristics and results of performance testing demonstrate substantial equivalence with the predicate devices.
