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 Description

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 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.

AI/ML Overview

This 510(k) summary describes a device modification, so the study primarily focuses on demonstrating that the modified device remains as safe and effective as its predicate, rather than establishing efficacy for a new device. Therefore, acceptance criteria generally relate to ensuring the device meets relevant safety and performance standards after modification.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified table with corresponding performance. Instead, it describes general non-clinical tests conducted to confirm the modified device meets design specifications and performance characteristics based on its intended use and complies with relevant electrical and safety standards. The performance is indirectly "reported" as compliance with these standards and equivalency to the predicate device.

Acceptance Criteria (Implied)	Reported (Implied) Device Performance
Compliance with Mechanical Performance Specifications	"Mechanical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use." (Specific quantitative results are not provided in this summary).
Electrical Safety and Compatibility to Standards	"The modified Neuro Check Device was subjected to electrical safety and compatibility testing and was certified to following standards, including all applicable normative reference standards: IEC 60601-1: 1988 +A1:1991 +A2:1995 Medical Electrical Equipment Part 1: General Requirements for Safety; IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment; IEC 60601-1-2: 2001 + A1:2004 Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility."
Sterility Assurance Level (SAL) of 10^-6	"The sterilization process has been validated by an approved contract facility to provide a sterility assurance level (SAL) of 10^-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2006."
Maintenance of Intended Use and Fundamental Scientific Technology	The document states: "The Neuro Check Device with iO-Flex Wire has the same indications for use and fundamental scientific technology as its predicate." This is demonstrated through the comparative characteristic tables (Table 2 and 3) highlighting no significant changes to core functional attributes.
No new questions of safety or effectiveness	"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." This is a general conclusion based on all non-clinical testing and comparison to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document states "Mechanical performance tests were conducted" and "The modified Neuro Check Device was subjected to electrical safety and compatibility testing," implying that specific units of the device were tested. However, the exact number of devices or test repetitions is not provided in this summary.
Data Provenance: The tests are described as "non-clinical tests" conducted on the modified device itself. This indicates laboratory testing, not human or observational data. The provenance is internal to the manufacturer or an approved contract facility for sterilization validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Number of Experts: Not applicable/not specified. The "ground truth" for non-clinical performance and safety standards is the standard itself (e.g., IEC 60601-1). The validation of sterilization was done by an "approved contract facility." There's no mention of human expert adjudication for the non-clinical tests described.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. For non-clinical tests like mechanical, electrical, and sterilization, the "adjudication" is typically against pre-defined engineering specifications and regulatory standards. There is no multi-reader or human consensus method involved for these types of tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was it done?: No, an MRMC comparative effectiveness study was not done or described. This submission is for a device modification (510(k)), which typically focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicates, rather than extensive clinical efficacy studies comparing human reader performance with and without AI assistance. The device is a "Nerve locator" which assists a surgeon, but this filing does not involve any AI component or human interpretation of images requiring an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Was it done?: Not applicable/not described. This device is not an algorithm, but a physical medical device. Its "performance" is primarily assessed through its physical, electrical, and sterilization characteristics in non-clinical settings, not through an algorithm's standalone performance. The device is intended to be used with a commercial EMG system and a surgeon ("human-in-the-loop"), so "standalone algorithm performance" (without human interaction) does not apply.

7. Type of Ground Truth Used:

Ground Truth: For the non-clinical tests, the "ground truth" is adherence to established industry and regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ISO 11137-1:2006, ISO 11137-2:2006) and the device's own design specifications.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This document does not describe the development or testing of an AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

How Established: Not applicable, as there is no AI algorithm or training set discussed.

Summary

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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.655 River Oaks ParkwaySan Jose, CA 95134Tel: (408) 514-2200Fax: (408) 514-2221
Contact Person	Edward J. Sinclair, V.P. of CA/RA/QATel: 408-514-2220
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 andM5 System and Probes	GWF	K062765	01/24/2007
Medtronic NIM Eclipse andProbes (formerly Axon SystemsOrthoMon System)	GWF, IKN	K061113	05/23/2006
Cadwell Sierra WaveEMG/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.

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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 NeuroCheck Device(K110696)	Predicate NeuroCheck Device(K092729)	Change
Shaft Length	4.5 inches	4.6 inches	Equivalent
Handle Length	6 inches	2 inches	Handle is longer toaccommodateswitching
Lead Length	152 inches	Probe cable: 72 inchesTwisted Wire Cable:80 Inches	No change in totallead length
Tip Diameter/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 WireMaterial	28AWG StrandedCopper	Probe cable: 28AWGTinned CopperTwisted Wire Cable:28AWG StrandedCopper	No change (Probecable is obsolete)
Lead WireInsulation	PVC	Probe cable: FEPmedical gradeTwisted Wire Cable:PVC	No change (Probecable is obsolete)
Active surfacearea	0.018 square inches	0.018 square inches	No change
Dimensions ofelectrodes	Rectangularshaped: 0.022inches width x0.069 inches length	Rectangular shaped:0.022 inches width x0.069 inches length	No change
Number ofelectrodes	12 (6 on white side,6 on black side)	12 (6 on white side,6 on black side)	No change
Distancebetweenelectrode pair	0.040 inches	0.042 inches	Equivalent

Table 2. Physical Attributes

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Feature /TechnologicalCharacteristic	Modified BaxanoNeuro Check Device(K110696)	Baxano Neuro CheckDevice(K092729)	NuVasiveNeuroVision JJBand M5 Systems(K062765)	Medtronic NIM-Eclipse(K061113)	Cadwell SierraWaveEMG/NCV/EP(K924723)
Intended Use /Indications forUse	The Baxano Neuro CheckDevice is intended for usewith an iO-Flex cutting andbiting device for locationof motor nerves in settingswhere visualization iscompromised.	For use with Baxano iO-Flex cutting and bitingdevices for localization ofmotor nerves in settingswhere visualization iscompromised.	The NeuroVision JJBSystem is used forintraoperative monitoringand neurological statusassessment by theadministration of briefelectrical stimulus pulsesto neural tissues and theEMG monitoring of theassociated musclegroups. The System isused in conjunction withother NuVasive devicesto assist in gainingcontrolled access to, andvisualization of the spine.	The OrthoMon systemis intended for use torecord, monitor andstimulate/recordbiopotential signalsincludingelectromyograph(EMG), evokedresponse andnerve/muscle potentialsand for theintraoperativė diagnosisof acute dysfunction incorticospinal axonalconduction.The system providesfeedback to the surgeonand OR team to assist inthe localization andassessment of spinalnerves and verificationof placement of spinalinstrumentation to avoidinjury to at risk nerveroots.	Unable to locate; notavailable on FDA's website.
Device Class	II	II	II	II	II
Product Code	ETN	HAE and ETN	GWF	GWF, IKN	GWF
RegulationNumber	21 CFR 874.1820	21 CFR 882.484021 CFR 874.1820	21 CFR 882.1870	21 CFR 882.187021 CFR 890.1375	21 CFR 882.1870
Feature /TechnologicalCharacteristic	Modified BaxanoNeuro Check Device(K110696)	Baxano Neuro CheckDevice(K092729)	NuVasiveNeuroVision JJBand M5 Systems(K062765)	Medtronic NIM-Eclipse(K061113)	Cadwell SierraWaveEMG/NCV/EP(K924723)
Clearance Date		10/02/2009	01/24/2007	05/23/2006	03/23/1993
DeviceClassificationName	Surgical Nerve Stimulator /Locator (ETN)	Surgical Nerve Stimulator/ Locator (ETN)	Stimulator, Electrical,Evoked Response	Stimulator, Electrical,Evoked Response	Stimulator, Electrical,Evoked Response
SurgicalProcedure	Minimally invasiveprocedures involving thespinal column wherevisualization iscompromised	Minimally invasiveprocedures involving thespinal column wherevisualization iscompromised	Minimally invasiveprocedures involving thespinal column whereanatomical restrictionssafely permit use.	Procedures that involvenerve location andmapping; includingspinal surgery.	Procedures that involvenerve location andmapping.
StimulationProbes	Monopolar and Bipolar	Monopolar and Bipolar	Monopolar	Monopolar and Bipolar	Unknown
StimulationCurrentAmplitude	0 mA - 50 mA	0 mA - 30 mA	0 mA - 80 mA JJB0 mA - 100 mA M5	0 mA - 50 mA	0-100 mA
StimulationCurrent PulseWidth	150 - 500 µsec	150 - 300 µsec	200 µsec	50- 300 µsec	50 - 1000 µsec
StimulationCurrentFrequency	3.0 - 5.0 Hz	3.0 - 5.0 Hz	5.0 Hz (standard)	Supports StimulationFrequency 1- 10 Hz	Supports StimulationFrequency up to 50 Hz
Power	Passive: To be used inconjunction with standardEMG monitoring systems	Passive: To be used inconjunction with standardEMG monitoring systems	AC Power	AC Power	AC Power

Table 3. Substantial Equivalence Comparison Table

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Feature /TechnologicalCharacteristic	Modified BaxanoNeuro Check Device(K110696)	Baxano Neuro CheckDevice(K092729)	NuVasiveNeuroVision JJBand M5 Systems(K062765)	Medtronic NIM-Eclipse(K061113)	Cadwell SierraWaveEMG/NCV/EP(K924723)
Probe PatientContactMaterials	Stainless Steel	Stainless Steel	Stainless Steel	Stainless Steel	Stainless Steel
Safety	IEC 60601-1IEC 60601-1-2IEC 60601-2-40	UL 60601-1IEC 60601-1-2CAN/CSA C22.2#601.1IEC 60601-2-40	Information notpublically available	IEC 60601-1 protectedpin designEN/IEC 60601-1-2	UL2601-1, CSA601-1,EN60601-1EN60601-1-1EN60601-2-40EN60601-1-1-2
Sterilization	E-beam	E-beam	EtO for reusable probes;unknown for disposable	EtO for reusable probes;unknown for disposable	Unknown
Software	None	None	Proprietary	Proprietary	Proprietary / Optional

and the comments of the country

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Non-ClinicalTests	Mechanical performance tests were conducted to verify that the devicemeets design specifications and performance characteristics, based upon theintended use. The modified Neuro Check Device was subjected toelectrical safety and compatibility testing and was certified to followingstandards, including all applicable normative reference standards:
	• IEC 60601-1: 1988 +A1:1991 +A2:1995 Medical ElectricalEquipment Part 1: General Requirements for Safety
	• IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40:Particular requirements for the safety of electromyographs andevoked response equipment
	• IEC 60601-1-2: 2001 + A1:2004 Medical Electrical Equipment Part1-2: General Requirements for Safety Collateral Standard:Electromagnetic Compatibility
SterilizationData	The Neuro Check Device with iO-Flex Wire is sterilized by electron beamirradiation, identical to the method used by the predicate Neuro CheckDevice and the iO-Flex Wire (K081742, K092729 and K100958). Thesterilization process has been validated by an approved contract facility toprovide a sterility assurance level (SAL) of 10-6 in accordance with ISO11137-1:2006 and ISO 11137-2:2006. The device is not labeled as non-pyrogenic.
Conclusions	Baxano has determined that the non-clinical and sterilization testingdemonstrate that the modified Neuro Check Device with iO-Flex Wire is assafe, as effective, and performs as well as the legally marketed predicateddevices.

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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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

510(k) Number K110646

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.