(387 days)
No
The summary describes a device that records and processes physiological signals (MMG) and electrical stimulus responses to assist in nerve localization. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The comparison is to a predicate device using similar signal processing techniques.
No
The device aids surgeons in locating and identifying nerves to minimize trauma during surgery, rather than directly treating a disease or condition.
Yes
The device is described as an "intraoperative monitor" that helps "locate and identify" motor nerves and "ascertain and monitor" spinal nerve status and location. This diagnostic function is explicitly stated in the "Intended Use / Indications for Use" and "Device Description" sections, and further supported by performance studies that evaluate its ability to determine nerve status and location.
No
The device description explicitly states that the system consists of a reusable Control Unit (touch-screen PC and Patient Module), a reusable Sensor Connector Module, and disposable probes, stimulators, sensors, electrodes, and electrode leads, indicating significant hardware components.
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 in vivo (within a living organism).
- Mechanism: The device works by recording mechanomyographic (MMG) signals from muscles and using electrical stimulus of nerves. These are physiological measurements taken directly from the patient during surgery.
- No mention of in vitro testing: There is no indication that the device analyzes samples (like blood, tissue, or urine) outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body in vitro (outside of the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient during surgery.
N/A
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. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
Product codes
PDQ
Device Description
The Sentio MMG® system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The Sentio MMG® system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated.
The Sentio MMG® system consists of a reusable Control Unit comprised of a touch-screen PC and Patient Module, a reusable Sensor Connector Module and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A comparative performance evaluation was conducted to assess statistical agreement between the subject device and the predicate. Results for positive, and overall percent agreement have established that 1) the principle functions of the Sentio MMG® system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) the data processed by the subject device following surgical use correlate well with those acquired by the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100992 NeuralMAS™, Innovative Surgical Solutions, LLC d/b/a Sentio, LLC, Wixom, Michigan
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
- · 1. Submitter's Identification:
Aashish Shah Vice President of Quality & Operations Sentio, LLC 50461 W Pontiac Trail Wixom, MI 48393 Tel: (248) 595-0420 Fax: (248) 956-8123
Date Summary Prepared: April 29th, 2014
2. Name of the Device:
Trade or Proprietary Name: Classification Name: Device Class: Classification: Product Code:
Sentio MMG® Neurosurgical Nerve Locator Class II 21 CFR §874.1820 PDQ
Common or Usual Name: 3.
Avoidance Intraoperative Mechanomyographic (MMG) Mapping and System, Nerve Monitor/Stimulator, Nerve Locator/Stimulator
Predicate Device Information: .4.
The subject device Sentio MMG® is substantially equivalent to the following predicate device:
K100992 NeuralMAS™, Innovative Surgical Solutions, LLC d/b/a Sentio, LLC, Wixom, Michigan
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Device Description: 5.
The Sentio MMG® system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The Sentio MMG® system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct mechanical stimulus occurring during the course of surgery. The monitor will assist early nerve identification by providing the surgeon with a tool to help locate and identify the particular nerve at risk to minimize trauma by alerting the surgeon when a particular nerve has been activated.
The Sentio MMG® system consists of a reusable Control Unit comprised of a touch-screen PC and Patient Module, a reusable Sensor Connector Module and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.
Intended Use: ર.
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. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
7. Comparison to Predicate Devices:
The subject device has indications for use which are the same as the predicate device, K100992, is composed of the same materials as the predicate commercially marketed device, has the same or equivalent design features as the predicate device, is substantially equivalent in its method of . use, incorporates the same fundamental scientific technology and has functional characteristics which are the same or equivalent to those of the predicate device. Due to the equivalency of indications for use, materials of composition, design features, method of use, scientific technology and functional characteristics, the device raises no new safety or effectiveness issues.
A comparison of the technological characteristics to the predicate device is provided below:
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Table 1: Overview & Indications
| Subject Device: | Predicate Device: |
|---|---|
| Sentio MMG® #K131304 | ISS NeuralMAS #K100992 |
| System Overview | |
| Uses low level electrical current to stimulate | |
| nerves sufficient to produce a detectable | |
| mechanical signal in contracting muscle using | |
| skin-surface mounted mechanomyographic | |
| (MMG) sensors. | System Overview |
| Uses low level electrical current to stimulate nerves sufficient to produce a | |
| detectable mechanical signal in contracting | |
| muscle using skin-surface mounted | |
| mechanomyographic (MMG) sensors. |
Table 2: Physical Attributes
| Attribute | Sentio MMG®
#K131304 | ISS NeuralMAS
#K100992 |
|-----------------------------------------|--------------------------|---------------------------|
| Control Module: PC/Display | | |
| Type: | Touchscreen | Touchscreen |
| Number of Channels: | 10 | 10 |
| Channel
Enable/Disable
Controls: | Touchscreen controlled | Touchscreen controlled |
| Event Threshold
Control and Display: | Touchscreen controlled | Touchscreen controlled |
| Stimulator | | |
| Type Constant: | Electrical Current (mA) | Electrical Current (mA) |
| Range: Control: | 1-15 mA | 1-15 mA |
| Waveform: | Digitally controlled | Digitally controlled |
| Pulse Duration: | Monophasic, square pulse | Monophasic, square pulse |
| | 100μς | 100μς |
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| Rate: | 2Hz | 2Hz |
|---|---|---|
| Stimulus Probe: | Monopolar | Monopolar |
| Activation: | Touch screen or hand switch | Touch screen or hand switch |
| Monitoring Sensor | ||
| Function: | Mechanomyographic (MMG) | Mechanomyographic (MMG) |
| Type: Attachment | Electromechanical | Electromechanical |
| Site: Attachment | Skin surface | Skin surface |
| Mode: | Adhesive | Adhesive |
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
A comparative performance evaluation was conducted to assess statistical agreement between the subject device and the predicate. Results for positive, and overall percent agreement have established that 1) the principle functions of the Sentio MMG® system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) the data processed by the subject device following surgical use correlate well with those acquired by the predicate device.
9. Discussion of Clinical Tests Performed:
Not Applicable
10. Conclusions:
The conclusions drawn from our non-clinical testing (to include our market data evaluation) of the subject device demonstrates that the subject device is as safe, as effective and performs better than the legally marketed predicate device. Any noted differences between the devices are minor and do not raise new issues of safety and effectiveness. The subject device is substantially equivalent to the legally marketed predicate device.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2014
Innovative Surgical Solutions, LLC Mr. Aashish Shah Vice President Quality & Operations 21520 Bridge Street Southfield, MI 48033
Re: K131304
Trade/Device Name: Sentio MMG Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ Dated: April 29, 2014 Received: April 30, 2014
Dear Mr. Shah:
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
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Page 2 - Mr. Aashish Shah
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Felipe Aquel - S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510{k} Number (if known) K131304
Device Name
Sentio MMG
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 (MMO) signals and electrical stimulus of nerves. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
ം Date: 2014.05.29
22:30:24 -04'00'
EF PSC Publishing Scriptocs (30)) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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