NEURALMAS

K100992 · Innovative Surgical Solutions, LLC ("Iss") · ETN · Sep 24, 2010 · Ear, Nose, Throat

Device Facts

• Record ID: K100992
• Device Name: NEURALMAS
• Applicant: Innovative Surgical Solutions, LLC ("Iss")
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Sep 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

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. This device is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.

Device Story

NeuralMAS is a multichannel intraoperative monitor used by surgeons to locate and map motor nerves. The system inputs include electrical stimulus (1-15 mA, monophasic square pulse) applied via a monopolar probe and mechanomyographic (MMG) signals captured by skin-surface sensors from muscles innervated by the target nerve. The device transforms these inputs by detecting mechanical muscle contractions resulting from nerve stimulation. The system consists of a touchscreen PC control unit, a patient module, and various probes/sensors. It provides real-time feedback to the surgeon, alerting them when a nerve is activated, thereby assisting in nerve identification and trauma minimization during surgery. The device is intended for use in an operating room environment.

Clinical Evidence

No clinical data. Bench testing and animal study (sheep) performed. Animal study compared NeuralMAS to a predicate device during simulated surgery, demonstrating positive and overall percent agreement in ascertaining spinal nerve status and location.

Technological Characteristics

Multichannel (10-channel) intraoperative monitor. Uses skin-surface MMG sensors (electromechanical) vs. subdermal needle electrodes. Stimulator: constant electrical current (1-15 mA), monophasic square pulse, 100µs pulse duration, 2Hz rate. Control unit: touchscreen PC. Connectivity: disposable probes, stimulators, sensors, electrodes. Sterilization: not specified.

Indications for Use

Indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2 in patients undergoing surgical procedures where motor nerves are at risk.

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

• NIM-Spine, Medtronic Xomed (K031510)
• Rhythmlink (K072736)
• Axon Systems (KO62996)
• UniPlex Nanoline Cannula, Pajunk GMBH (K000722)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(K) SUMMARY

## 2 4 2010 SEP

Page .

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.

### Submitter's Identification: 1.

Christopher Wybo Director of Engineering and Regulatory Innovative Surgical Solutions, LLC 1002 Hoffman Ave. Royal Oak, MI 48067 Tel: [phone] Fax: [phone]

# Date Summary Prepared: September 24, 2010

### Name of the Device: 2.

| Trade or Proprietary Name: | NeuralMAS™ |
|----------------------------|-----------------------------------|
| Classification Name: | Surgical Nerve Stimulator/Locator |
| Device Class: | Class II |
| Classification: | 21 CFR §874.1820 |
| Product Code: | ETN |

### Common or Usual Name: 3.

(MMG) Mechanomyographic System, Intraoperative Avoidance Mapping and Nerve Monitor/Stimulator, Nerve Locator/Stimulator

#### Predicate Device Information: 4.

The subject device NeuralMAS™ is substantially equivalent to one or more of the following predicate devices:

- NIM-Spine, Medtronic Xomed, Jacksonville, Florida K031510
- Rhythmlink, Columbia, South Carolina K072736
- Axon Systems, Hauppauge, New York KO62996
- UniPlex Nanoline Cannula, Pajunk GMBH, Geisingen, Germany K000722

{1}------------------------------------------------

Page L

#### 5. Device Description:

The NeuralMAS™ system is a multichannel intraoperative monitor for use during surgeries in which a motor nerve is at risk. The NeuralMAS™ system records mechanomyographic (MMG) signals from muscles innervated by the affected nerve, which may originate from operator applied electrical stimulus or from direct or indirect 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 NeuralMAS™ system consists of a reusable Patient Module, a Control Unit comprised of a touch-screen PC and an assortment of disposable conductive probes, stimulators, sensors, electrodes and electrode leads.

#### Intended Use: 6.

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.

#### Comparison to Predicate Devices: 7.

The subject device has indications for use which are substantially equivalent to the predicate device, is composed of the same or equivalent materials as one or more commercially marketed devices, has the same or equivalent design features as the predicate device, is substantially equivalent in its method of use, and has functional characteristics which are the same or equivalent to those of one or more of the predicate devices. Due to the equivalency of indications for use, materials of composition, design features, method of use, and functional characteristics, the device raises no new safety or effectiveness issues.

NeuralMAS™ Nerve Mapping & Avoidance System

{2}------------------------------------------------

A

Page 3

# Table 1: Overview & Indications

| Subject Device: | Predicate Device: |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISS NeuralMAS | Medtronic NIM-Spine #K031510 |
| System Overview | System Overview |
| Uses low level electrical current to stimulate<br>nerves sufficient to produce a detectable<br>mechanical signal in contracting muscle using<br>skin-surface mounted mechanomyographic<br>(MMG) sensors. | Uses electrical current varying between<br>low and high levels to induce current flow<br>in stimulated nerves sufficient to produce a<br>detectable electrical signal in contracting<br>muscle using EMG needle electrodes<br>placed in the muscle. |

# Table 2: Physical Attributes

| Attribute | ISS NeuralMAS | Medtronic NIM-Spine<br>#K031510 |
|-----------------------------------------|--------------------------|---------------------------------------------------------------------------|
| Control Module: PC/Display | | |
| Type: | Touchscreen | Touchscreen |
| Number of Channels: | 10 | 8 |
| Channel<br>Enable/Disable<br>Controls: | Touchscreen controlled | Dedicated function touchpads for<br>independent channel<br>enable/disable |
| Event Threshold<br>Control and Display: | Touchscreen controlled | Adjustable graduated touchbar<br>with voltage threshold display |
| Stimulator | | |
| Type Constant: | Electrical Current (mA) | Electrical Current (mA) |
| Range: | 1-15 mA | 1-200 mA, max 540V compliant |
| Control: | Digitally controlled | Digitally controlled |
| Waveform: | Monophasic, square pulse | Monophasic, square pulse |
| Pulse Duration: | 100µs | 50, 100, 150, 200 or 250µs |

.

{3}------------------------------------------------

| Rate: | 2Hz | Switch selectable: 1, 5, or 10Hz |
|-------------------|-----------------------------|-----------------------------------------|
| Stimulus Probe: | Monopolar | Monopolar or bipolar |
| Activation: | Touch screen or hand switch | Two step touch screen or hand<br>switch |
| Monitoring Sensor | | |
| Function: | Mechanomyographic (MMG) | Electromyographic (EMG) |
| Type: | Electromechanical | Subdermal needle electrodes |
| Attachment Site: | Skin surface | Subdermal |

# Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as 8. follows:

A comparative performance evaluation was conducted in the sheep 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 NeuralMAS™ system are effective, such that spinal nerve status and location may be ascertained and monitored, and 2) the data acquired by the subject device during simulated surgical use in the animal model correlate well with those acquired simultaneously by a predicate device.

## Discussion of Clinical Tests Performed: ರು

Not Applicable

### 10. Conclusions:

The conclusions drawn from our non-clinical testing (to include our animal testing) of the subject device demonstrates that the subject device is as safe, as effective and performs as well as the legally marketed predicate device. The subject device is substantially equivalent in function to the legally marketed predicate device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized bird in flight, composed of three curved lines, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Innovative Surgical Solutions, LLC c/o Ms. Susan Goldstein-Falk MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 10021

Re: K100992

Trade/Device Name: NeuralMAS Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: August 27, 2010 Received: September 1, 2010

Dear Ms. Goldstein-Falk:

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. Iisting 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.

SEP 24 2010

{5}------------------------------------------------

Page 2 - Ms. Susan Goldstein-Falk

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robinm.k

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

K100992

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SEP 2 4 2010

Device Name: NeuralMAS

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

100992

Prescription Use
(Per 21 CFR 801.109)

510(k) Number