Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that measures and alerts based on MMG signals and electrical stimulus. There is no mention of AI, ML, or any learning or adaptive algorithms in the description or performance studies. The device appears to rely on direct signal processing and threshold-based alerting.

Therapeutic

No
The device assists in locating and mapping nerves and assessing their status during surgery; it does not provide treatment for a disease or condition.

Diagnostic

Yes

The device assists in assessing a patient's neurophysiologic status by measuring and comparing MMG signals and alerts the surgeon when monitored nerves are activated, which are diagnostic functions in a surgical context.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of "capital equipment and disposable devices, both sterile and non-sterile," indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states the device is for use in surgical procedures to assist in locating and mapping motor nerves by measuring in vivo (within the living body) signals (MMG and electrical stimulus response).
Device Description: The description reinforces that the device is used during surgical procedures to monitor nerve activity and assess neurophysiologic status in real-time within the patient.
IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.

This device operates directly on the patient's body during surgery, not on specimens outside the body. Therefore, it falls under the category of an in vivo diagnostic or monitoring device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

PDQ, ETN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

surgeon

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

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.

Key Metrics

Not Found

Predicate Device(s)

K131304, K162313, K102084

Reference Device(s)

K031510

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.

Summary

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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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY K173526

A. Submitter Information

| Manufacturer: | Medos International SARL
Chemin-Blanc 38
2400 Le Locle, Switzerland |
|-------------------|---------------------------------------------------------------------------|
| Submitter: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 |
| Contact Person: | Anna D'Lima
325 Paramount Drive
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
and Regulation:	Class II per 21 CFR §874.1820
Product Code and Description:	PDQ; Neurosurgical Nerve Locator
ETN; Stimulator, Nerve

D. Predicate Device Name

Primary:	SENTIO MMG (K131304)
Other:	NuVasive Next Generation NVM5 System (K162313), STIMPOD
NMS450 Nerve Stimulator (K102084)
Reference
Device:	NIM-Spine (K031510), predicate to original SENTIO MMG
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
(Monopolar) | Bipolar | Train of Four |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|
| Current Ranges | 0-20 mA | 0-2 mA | 20-80 mA |
| Current
Adjustment | 1 mA | 0.1 mA | 5 mA |
| Stimulation
Voltages | 115 V | 27 V | 350 V |
| Waveform | Monophasic
square pulse | Monophasic
square pulse | Monophasic
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
Probe | Single-use, sterile accessory used to provide electrical
stimulation to the surgical site | | |
| MMG Sensor | Single-use, non-sterile three-dimensional accelerometer
designed to provide feedback for locating and mapping motor
nerves | | |
| AC Power Supply | Delta MDS-060AAS12 B | | |
| Weight | Tablet: 0.68 Kg
Control Unit: 0.72 Kg | | |
| Dimensions | Tablet: 291 mm (D) x 193 mm (W) x 8 mm (H)
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
for Use	Substantially equivalent - The indications for use statement for the
SENTIO MMG Gen 2 is a combination of the primary and secondary
predicate devices. The differences do not change the intended use as
a surgical nerve stimulator / locator, nor raise new questions of safety
or effectiveness as demonstrated by results of the risk-based
verification and validation testing.
Capital
Equipment:
Control Unit
and
PC/Display
Capital
Equipment:
Control Unit
and
PC/Display
(continued)	Number of Channels - Enhanced signal acquisition in comparison to
primary predicate - Substantially equivalent to secondary predicates
for same purpose of detecting a muscle event as evidenced by
comparative performance evaluation.
User interface - Touchscreen Tablet PC - Same as the primary
predicate, substantially equivalent to secondary predicates with the
same functional specification (system operation).
Display Size - Substantially equivalent - Subject device meets the
same acceptance criteria and conforms to the same consensus
standards as the primary predicate device.
Weight - Substantially equivalent - Subject device meets the same
acceptance criteria and conforms to the same consensus standards
as the primary predicate device.
Audio - Same as primary predicate and substantially equivalent to
secondary predicates.
System
Stimulation	Type Constant - Constant Current (mA) - Same as primary predicate.
Stimulus Range - Standard (monopolar), Bipolar Mode, Train of Four

Substantially equivalent - Ranges are the same, or within, the
ranges of the primary predicate device, secondary predicates, or
reference device and have the same intended function.
Control - Digitally controlled, incremental adjustment - Standard
(monopolar), Bipolar Mode, Train of Four, or selectable range via
touchscreen - Same as primary predicate.
Maximum Stimulation Voltage - Substantially equivalent - Maximums
are within the limit settings of the primary predicate device, secondary
predicates, or reference device and have the same intended function.
Waveform - Monophasic square pulse - Same as primary predicate.
Pulse Width - Standard (monopolar), Bipolar Mode, Train of Four -
Same as primary predicate - Substantially equivalent - Ranges are
the same, or within, the ranges of the primary predicate device,
secondary predicates, or reference device and have the same
intended function.
Stimulation Rate - Same as the primary predicate and the same or
less than the secondary predicates and reference device. |
| Attribute | Substantial Equivalence Evaluation |
| Activation - Touchscreen or hand switch - Same as the primary
predicate. | |
| Sensors | Signal (electromechanical) - Same as primary predicate.
Attachment Site - Skin surface - Same as primary predicate.
Size - Reduced size for smaller site attachment - Same performance
criteria with reduced site attachment.
Connector type - 3.5mm Stereo plug - Substantially Equivalent -
3.5mm plug is independent of orientation. Same performance
requirements.
Technology - Digital - Substantially Equivalent as evidenced by
comparative performance evaluation.
Operating Voltage - 1.8V compared to 3.3V - Substantially Equivalent
lower power consumes less energy for operation yet meets the
same performance. |
| Stimulator
Probe | Same as primary predicate. |
| Ground
Patch | Attachment Site - Skin surface - Same as primary predicate.
Size - Same as primary predicate.
Connector Type - 1.5mm touch proof - Industry standard DIN 42-802. |
| Materials | Capital equipment is comprised of materials evidenced to be suited
for their specified purpose.
Stimulator Probe is biocompatible and the same as the primary
predicate.
Sensors are biocompatible and comprised of the same, or proven
equivalent materials.
Ground Patch is biocompatibility and comprised of the same, or
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.