NEURO CHECK DEVICE WITH IO-FLEX WIRE

K110696 · Baxano, Inc. · ETN · Jul 7, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K110696
• Device Name: NEURO CHECK DEVICE WITH IO-FLEX WIRE
• Applicant: Baxano, Inc.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Jul 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.

Device Story

Neuro Check Device is a sterile, single-use nerve locator used in minimally invasive spinal surgery. It functions as a passive probe that connects to a commercial EMG neuromonitoring system. The surgeon inserts the device into the neural foramen, guided by an iO-Flex wire and radiopaque platinum-iridium marker bands. The device delivers an electrical stimulus signal from the EMG system to electrodes on the probe tip to elicit a motor response, helping the surgeon identify nerve roots and avoid injury during subsequent use of a Baxano cutting and biting device. The device features a molded ABS handle with integrated switching and a flexible distal segment. It is designed to operate with increased stimulation parameters (up to 50 mA and 500 µs) to accommodate patients with less responsive nerves. The output is an EMG response monitored by the surgical team, which informs the surgeon's navigation and instrument placement, thereby reducing the risk of nerve damage in anatomically restricted or poorly visualized surgical fields.

Clinical Evidence

Bench testing only. Mechanical performance, electrical safety, and compatibility testing were conducted to verify design specifications. Sterilization validation was performed to achieve a sterility assurance level (SAL) of 10^-6 per ISO 11137-1:2006 and ISO 11137-2:2006.

Technological Characteristics

Passive nerve stimulation probe. Materials: 304 stainless steel shaft, Pebax insulation, ABS handle, platinum-iridium marker bands. Dimensions: 0.06-inch tip diameter, 12 electrodes (6 per side). Connectivity: Wired connection to external EMG systems. Sterilization: E-beam irradiation. No internal software or active electronics.

Indications for Use

Indicated for use in minimally invasive spinal column procedures where visualization is compromised to assist in the location of motor nerves.

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

• Baxano Neuro Check™ Device (K092729)
• NuVasive NeuroVision JJB and M5 System and Probes (K062765)
• Medtronic NIM Eclipse and Probes (K061113)
• Cadwell Sierra Wave EMG/NCV/EP (K924723)

Reference Devices

• iO-Flex Wire (K100958)

Submission Summary (Full Text)

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Қ 110696

JUL – 7 2011

Image /page/0/Picture/2 description: The image shows the word "BAXANO" in a bold, sans-serif font. A thin, curved line runs diagonally across the letter "X", adding a unique visual element to the word. The letters are all capitalized and evenly spaced, creating a balanced and legible composition.

# 510(k) Summary

| Submitter Identification | Baxano, Inc.<br>655 River Oaks Parkway<br>San Jose, CA 95134<br>Tel: [phone]<br>Fax: [phone] |
|--------------------------|------------------------------------------------------------------------------------------------------------|
| Contact Person | Edward J. Sinclair, V.P. of CA/RA/QA<br>Tel: [phone] |
| Date Prepared | June 30, 2011 |

| Device Name | |
|---------------------|----------------------------------------|
| Proprietary Name | Neuro Check™ Device with iO-Flex™ Wire |
| Common Name | Nerve locator |
| Classification Name | Surgical nerve stimulator/locator |
| Classification | 21 CFR §874.1820 |
| Device Class | Class II |
| Product Code | ETN |

Predicate Device

The modified Neuro Check Device is substantially equivalent to one or
more of the following predicate devices listed in Table 1 below:

| | Predicate Device | Product Code | 510(k) Number | Clearance Date |
|--|--------------------------------------------------------------------------------|--------------|---------------|----------------|
| | Baxano Neuro Check™ Device | ETN | K092729 | 10/02/2009 |
| | NuVasive NeuroVision JJB and<br>M5 System and Probes | GWF | K062765 | 01/24/2007 |
| | Medtronic NIM Eclipse and<br>Probes (formerly Axon Systems<br>OrthoMon System) | GWF, IKN | K061113 | 05/23/2006 |
| | Cadwell Sierra Wave<br>EMG/NCV/EP | GWF | K924723 | 03/23/1993 |

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#### Neuro Check™ Device with iO-Flex™ Wire are provided sterile and Device Description disposable after single-patient use.

The Neuro Check Device is designed to be pulled into the neural foramen by the iO-Flex Wire to enable the surgeon to direct a stimulus signal from a commercial EMG system to electrodes on the device enabling nerve root location prior to using a Baxano cutting and biting device. The Neuro Check Device is manufactured from biocompatible Pebax® tubing and stainless steel with a handle molded from ABS. The proximal end of the device handle has a pair of wires that connect to commercially available EMG systems.

The iO-Flex Wire is manufactured from nickel-titanium wire and connects to the distal end of the Neuro Check Device for placement in the neural foramen. No changes were made to the previously cleared iO-Flex Wire design (K100958) other than packaging modifications to include it within the Neuro Check Device packaging for surgeon convenience.

Since the previous clearance of the Neuro Check Device (K092729; October 2, 2009) changes were made to the physician labeling (the Instructions For Use) intended to provide compatibility with enhanced output stimulus signals of commercially-available intra-operative electromyography (EMG) neuromonitoring systems for motor nerve localization. Specifically, the maximum allowable EMG stimulation current amplitude to the Neuro Check Device was increased from 30 milliamps to 50 milliamps and the maximum current pulse width from 300 microseconds to 500 microseconds to support the stimulation parameters of commercially available EMG systems. There were no design modifications of the Neuro Check Device necessary to conform to the new electrical stimulation specifications.

In addition, several design modifications were implemented since the last Neuro Check Device clearance. These modifications include integrating the separate Switch Box into the Neuro Check Device handle, eliminating the need for this external accessory. The handle itself is now molded from ABS plastic instead of being machined from the same material. Two radiopaque platinum-iridium marker bands were added to the distal flexible section to assist with fluoroscopic positioning of the device. A slight bend is made in the distal flexible segment to assist in orienting the Neuro Check

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Device as it is positioned with respect to the patient. Lastly, the iO-Flex Wire was added to the Neuro Check Device package for user convenience. The Baxano Neuro Check™ Device is intended for use with an iO-Flex™ Intended Use cutting and biting device for location of motor nerves in settings where visualization is compromised. The modified Neuro Check Device with iO-Flex Wire is substantially Technological equivalent to the predicate Neuro Check Device (K092729) and the iO-Flex Characteristics and Substantial Wire (K100958). No changes were made to the previously cleared iO-Flex Wire design other than packaging modifications to include it with the Equivalence Neuro Check Device for surgeon convenience. The Neuro Check Device with iO-Flex Wire has the same indications for use and fundamental scientific technology as its predicate. Modification of the Neuro Check Device labeling allows for an increase in maximum EMG stimulation current to 50 milliamps (from 30 milliamps) and maximum pulse width to 500 microseconds (from 300 microseconds). This change provides compatibility with the range of settings typically associated with EMG intraoperative neuromonitoring systems and enhances the surgeon's ability to elicit an EMG response in patients whose nerves are less responsive to electrical stimulus. The predicate NuVasive NeuroVision M5 System and Probes (K062765) and Cadwell Sierra Wave EMG System (K924723) are cleared for stimulation current of 0-100 milliamps. The Cadwell Sierra Wave EMG System (K924723) is cleared for a stimulation pulse width of up to 1000 microseconds. Based upon the indications for use, technological characteristics and performance test results, changes to the Neuro Check Device with iO-Flex Wire do not raise new questions of safety or effectiveness. A summary of the Neuro Check Device technological characteristics compared to the legally marketed predicate devices is provided in Table 2 and 3 below.

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| Attribute | Modified Neuro<br>Check Device<br>(K110696) | Predicate Neuro<br>Check Device<br>(K092729) | Change |
|---------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------|
| Shaft Length | 4.5 inches | 4.6 inches | Equivalent |
| Handle Length | 6 inches | 2 inches | Handle is longer to<br>accommodate<br>switching |
| Lead Length | 152 inches | Probe cable: 72 inches<br>Twisted Wire Cable:<br>80 Inches | No change in total<br>lead length |
| Tip Diameter/<br>Exposure | 0.06 inches | 0.06 inches | No change |
| Shaft Material | 304 Stainless Steel | 304 Stainless Steel | No change |
| Shaft Insulation | Pebax | Pebax | No change |
| Handle Material | ABS | ABS | No change |
| Lead Wire<br>Material | 28AWG Stranded<br>Copper | Probe cable: 28AWG<br>Tinned Copper<br>Twisted Wire Cable:<br>28AWG Stranded<br>Copper | No change (Probe<br>cable is obsolete) |
| Lead Wire<br>Insulation | PVC | Probe cable: FEP<br>medical grade<br>Twisted Wire Cable:<br>PVC | No change (Probe<br>cable is obsolete) |
| Active surface<br>area | 0.018 square inches | 0.018 square inches | No change |
| Dimensions of<br>electrodes | Rectangular<br>shaped: 0.022<br>inches width x<br>0.069 inches length | Rectangular shaped:<br>0.022 inches width x<br>0.069 inches length | No change |
| Number of<br>electrodes | 12 (6 on white side,<br>6 on black side) | 12 (6 on white side,<br>6 on black side) | No change |
| Distance<br>between<br>electrode pair | 0.040 inches | 0.042 inches | Equivalent |

## Table 2. Physical Attributes

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| Feature /<br>Technological<br>Characteristic | Modified Baxano<br>Neuro Check Device<br>(K110696) | Baxano Neuro Check<br>Device<br>(K092729) | NuVasive<br>NeuroVision JJB<br>and M5 Systems<br>(K062765) | Medtronic NIM-<br>Eclipse<br>(K061113) | Cadwell Sierra<br>Wave<br>EMG/NCV/EP<br>(K924723) |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Intended Use /<br>Indications for<br>Use | The Baxano Neuro Check<br>Device is intended for use<br>with an iO-Flex cutting and<br>biting device for location<br>of motor nerves in settings<br>where visualization is<br>compromised. | For use with Baxano iO-<br>Flex cutting and biting<br>devices for localization of<br>motor nerves in settings<br>where visualization is<br>compromised. | The NeuroVision JJB<br>System is used for<br>intraoperative monitoring<br>and neurological status<br>assessment by the<br>administration of brief<br>electrical stimulus pulses<br>to neural tissues and the<br>EMG monitoring of the<br>associated muscle<br>groups. The System is<br>used in conjunction with<br>other NuVasive devices<br>to assist in gaining<br>controlled access to, and<br>visualization of the spine. | The OrthoMon system<br>is intended for use to<br>record, monitor and<br>stimulate/record<br>biopotential signals<br>including<br>electromyograph<br>(EMG), evoked<br>response and<br>nerve/muscle potentials<br>and for the<br>intraoperativė diagnosis<br>of acute dysfunction in<br>corticospinal axonal<br>conduction.<br>The system provides<br>feedback to the surgeon<br>and OR team to assist in<br>the localization and<br>assessment of spinal<br>nerves and verification<br>of placement of spinal<br>instrumentation to avoid<br>injury to at risk nerve<br>roots. | Unable to locate; not<br>available on FDA's web<br>site. |
| Device Class | II | II | II | II | II |
| Product Code | ETN | HAE and ETN | GWF | GWF, IKN | GWF |
| Regulation<br>Number | 21 CFR 874.1820 | 21 CFR 882.4840<br>21 CFR 874.1820 | 21 CFR 882.1870 | 21 CFR 882.1870<br>21 CFR 890.1375 | 21 CFR 882.1870 |
| Feature /<br>Technological<br>Characteristic | Modified Baxano<br>Neuro Check Device<br>(K110696) | Baxano Neuro Check<br>Device<br>(K092729) | NuVasive<br>NeuroVision JJB<br>and M5 Systems<br>(K062765) | Medtronic NIM-<br>Eclipse<br>(K061113) | Cadwell Sierra<br>Wave<br>EMG/NCV/EP<br>(K924723) |
| Clearance Date | | 10/02/2009 | 01/24/2007 | 05/23/2006 | 03/23/1993 |
| Device<br>Classification<br>Name | Surgical Nerve Stimulator /<br>Locator (ETN) | Surgical Nerve Stimulator<br>/ Locator (ETN) | Stimulator, Electrical,<br>Evoked Response | Stimulator, Electrical,<br>Evoked Response | Stimulator, Electrical,<br>Evoked Response |
| Surgical<br>Procedure | Minimally invasive<br>procedures involving the<br>spinal column where<br>visualization is<br>compromised | Minimally invasive<br>procedures involving the<br>spinal column where<br>visualization is<br>compromised | Minimally invasive<br>procedures involving the<br>spinal column where<br>anatomical restrictions<br>safely permit use. | Procedures that involve<br>nerve location and<br>mapping; including<br>spinal surgery. | Procedures that involve<br>nerve location and<br>mapping. |
| Stimulation<br>Probes | Monopolar and Bipolar | Monopolar and Bipolar | Monopolar | Monopolar and Bipolar | Unknown |
| Stimulation<br>Current<br>Amplitude | 0 mA - 50 mA | 0 mA - 30 mA | 0 mA - 80 mA JJB<br>0 mA - 100 mA M5 | 0 mA - 50 mA | 0-100 mA |
| Stimulation<br>Current Pulse<br>Width | 150 - 500 µsec | 150 - 300 µsec | 200 µsec | 50- 300 µsec | 50 - 1000 µsec |
| Stimulation<br>Current<br>Frequency | 3.0 - 5.0 Hz | 3.0 - 5.0 Hz | 5.0 Hz (standard) | Supports Stimulation<br>Frequency 1- 10 Hz | Supports Stimulation<br>Frequency up to 50 Hz |
| Power | Passive: To be used in<br>conjunction with standard<br>EMG monitoring systems | Passive: To be used in<br>conjunction with standard<br>EMG monitoring systems | AC Power | AC Power | AC Power |

Table 3. Substantial Equivalence Comparison Table

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| Feature /<br>Technological<br>Characteristic | Modified Baxano<br>Neuro Check Device<br>(K110696) | Baxano Neuro Check<br>Device<br>(K092729) | NuVasive<br>NeuroVision JJB<br>and M5 Systems<br>(K062765) | Medtronic NIM-<br>Eclipse<br>(K061113) | Cadwell Sierra<br>Wave<br>EMG/NCV/EP<br>(K924723) |
|----------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------|
| Probe Patient<br>Contact<br>Materials | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-40 | UL 60601-1<br>IEC 60601-1-2<br>CAN/CSA C22.2#601.1<br>IEC 60601-2-40 | Information not<br>publically available | IEC 60601-1 protected<br>pin design<br>EN/IEC 60601-1-2 | UL2601-1, CSA601-1,<br>EN60601-1<br>EN60601-1-1<br>EN60601-2-40<br>EN60601-1-1-2 |
| Sterilization | E-beam | E-beam | EtO for reusable probes;<br>unknown for disposable | EtO for reusable probes;<br>unknown for disposable | Unknown |
| Software | None | None | Proprietary | Proprietary | Proprietary / Optional |

and the comments of the country

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| Non-Clinical<br>Tests | Mechanical performance tests were conducted to verify that the device<br>meets design specifications and performance characteristics, based upon the<br>intended use. The modified Neuro Check Device was subjected to<br>electrical safety and compatibility testing and was certified to following<br>standards, including all applicable normative reference standards: |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • IEC 60601-1: 1988 +A1:1991 +A2:1995 Medical Electrical<br>Equipment Part 1: General Requirements for Safety |
| | • IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40:<br>Particular requirements for the safety of electromyographs and<br>evoked response equipment |
| | • IEC 60601-1-2: 2001 + A1:2004 Medical Electrical Equipment Part<br>1-2: General Requirements for Safety Collateral Standard:<br>Electromagnetic Compatibility |
| Sterilization<br>Data | The Neuro Check Device with iO-Flex Wire is sterilized by electron beam<br>irradiation, identical to the method used by the predicate Neuro Check<br>Device and the iO-Flex Wire (K081742, K092729 and K100958). The<br>sterilization process has been validated by an approved contract facility to<br>provide a sterility assurance level (SAL) of 10-6 in accordance with ISO<br>11137-1:2006 and ISO 11137-2:2006. The device is not labeled as non-<br>pyrogenic. |
| Conclusions | Baxano has determined that the non-clinical and sterilization testing<br>demonstrate that the modified Neuro Check Device with iO-Flex Wire is as<br>safe, as effective, and performs as well as the legally marketed predicated<br>devices. |

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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing the wings and a stylized tail. The logo is black and white.

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

Baxano, Incorporated c/o Mr. Edward Sinclair Vice President, Clinical Regulatory & Quality Affairs 655 River Oaks Parkway San Jose, California 95134

JUL = 7 2011

Re: K110696

Trade/Device Name: Neuro Check Device with iO-Flex Wire Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 24, 2011 Received: May 25, 2011

Dear Mr. Sinclair:

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 (reporting of medical

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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,

Melvin R. Felder, MD

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

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## Indications for Use

#### K-11-6-696 510(k) Number (if known):

### Device Name: Baxano Neuro Check™ Device with iO-Flex™ Wire

Indications For Use:

The Baxano Neuro Check™ Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.

Prescription Use X (Part 21 CFR 801 Subpart D) * AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael J. Hyman

(Division Sigh-C Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K110646