ES2 Neuromonitoring Accessory Instruments

K171807 · Stryker Corporation · PDQ · Jul 18, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K171807
• Device Name: ES2 Neuromonitoring Accessory Instruments
• Applicant: Stryker Corporation
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Jul 18, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y-NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non-cervical spine.

Device Story

ES2 Neuromonitoring Accessory Instruments are surgical tools (awls, taps, screwdrivers, and LITe Y-Needles) used in non-cervical spine surgery. The devices connect to external, FDA-cleared neuromonitoring consoles via clips or probes to deliver electrical stimulation to surrounding tissue. By measuring the electrical response, the surgeon receives proximity information regarding the location of spinal nerves. This helps guide pedicle targeting, guidewire placement, bone preparation, and bone screw insertion. The instruments are used in OR settings by surgeons. The LITe Y-Needles are single-use and sterile-packed, while other instruments are reusable. The device provides real-time feedback to the surgeon, allowing for safer navigation near neural structures during spinal procedures.

Clinical Evidence

Bench testing only. Performance data included biocompatibility (ISO 10993-1), sterility/packaging validation (Gamma radiation), and electrical safety (IEC 60601-1). Functional testing verified stationary potential, electrical resistance, current variance, and signal conduction (amplitude change) against predefined acceptance criteria. No clinical data was required.

Technological Characteristics

Instruments manufactured from surgical grade stainless steel, ABS, and Radel. Sensing/actuation principle: electrical stimulation via conductive electrodes. Dimensions/form factor: manual surgical instruments (awls, taps, screwdrivers) and needles (200, 300, 400). Connectivity: wired connection to external neuromonitoring consoles. Sterilization: Gamma radiation for single-use needles; reusable instruments provided non-sterile with validated parameters. Compliant with IEC 60601-1.

Indications for Use

Indicated for use by surgeons to assist in locating spinal nerves by providing proximity information during bone preparation and bone screw placement in open and percutaneous minimally invasive posterior surgical approaches of the non-cervical spine.

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

• ES2 Spinal System Neuromonitoring Accessory Instruments (K140400)

Submission Summary (Full Text)

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Public Health Service

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

July 18, 2017

Stryker Corporation Mr. Nikin Desai Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401

Re: K171807

Trade/Device Name: ES2 Neuromonitoring Accessory Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ Dated: June 14, 2017 Received: June 19, 2017

Dear Mr. Desai:

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 device

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Michael J. Hoffmann -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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## Indications for Use

510(k) Number (if known) K171807

Device Name

ES2 Neuromonitoring Accessory Instruments

Indications for Use (Describe)

The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y-NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non-cervical spine.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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| 510(k) Summary: ES2® Neuromonitoring Accessory Instruments | | |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Stryker Spine | |
| Manufacturer/Submitter: | 2 Pearl Ct. | |
| | Allendale, NJ 07401 | |
| | Name: Nikin Desai | |
| Contact Person : | Phone: [phone] | |
| | Fax: [phone] | |
| | Email:[e-mail] | |
| Date Prepared: | 07/18/2017 | |
| Trade Name: | ES2 Neuromonitoring Accessory Instruments | |
| Common Name: | Surgical Nerve Stimulator/Locator | |
| Proposed Class: | Class II | |
| Classification Name: | Surgical Nerve Stimulator/Locator (21 CFR §874.1820) | |
| Product Code: | PDQ | |
| Predicate Devices: | Primary Predicate: | |
| | ES2 Spinal System Neuromonitoring Accessory Instruments | |
| | (K140400) | |
| | | |
| Device Description: | The purpose of this submission is to introduce a line extension to the ES2 | |
| | Neuromonitoring system to include the LITe Y-Needles. | |
| | | |
| | The ES2 Neuromonitoring instruments (Awl, Taps, Screwdriver and LITe® Y- | |
| | NEEDLE 200, 300 and 400) are accessory instruments to be used with FDA | |
| | cleared neuromonitoring systems to deliver electrical stimulation to assist in | |
| | location of the spinal nerves during intraoperative neurological monitoring of the | |
| | non-cervical spine in open and percutaneous minimally invasive posterior surgical | |
| | approaches. The instruments are manufactured from surgical grade stainless steel | |
| | and Acrylonitrile Butadiene Styrene (ABS). The Awls, taps and screwdriver are | |
| | provided non-sterile. The LITe Y-Needles are sterile packed and single use devices | |
| | that must be discarded after use. | |
| | | |
| | The neuromonitoring application is a surgical option that allows the surgeon to | |
| | locate the spinal nerves by providing proximity information during targeting, bone | |
| | preparation, and placement/insertion of bone screws. In addition to the | |
| | neuromonitoring function: The LITe Y-Needles assist in targeting the pedicle and<br>placing guidewires, the awl and taps facilitate bone preparation, and the | |
| | screwdriver facilitates bone screw placement/insertion. The surgical accessories | |
| | are compatible with commercially available FDA cleared neuromonitoring | |
| | consoles/systems and associated electrodes. The nerves are stimulated using | |
| | electrodes attached to the subject accessory devices. The screwdriver can be used | |
| | with or without a powered option for bone screw placement. | |
| | | |
| 510(k) Summary: ES2® Neuromonitoring Accessory Instruments | | |
| Indications for Use: | The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITE Y-<br>NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the<br>spinal nerves by providing proximity information before, during or after bone<br>preparation and placement of bone screws in open and percutaneous minimally<br> | |
| Summary of the<br>Technological<br>Characteristics | The Stryker Spine ES2 Neuromonitoring Accessory Instruments are substantially<br>equivalent to the predicate devices in terms of design, function, principals of<br>operation, technological characteristics, and indications and intended uses. See<br>table below for comparisons to predicate ES2 Neuromonitoring Accessory<br>Instruments. | |
| Summary of the<br>Performance Data | See table below. | |
| Conclusion | The risk analysis performed on the proposed addition of 200, 300 and 400 LITE Y-<br>Needles to ES2 Neuromonitoring and subsequent verification and validation<br>activities demonstrate the line extension does not impact the ES2<br>Neuromonitoring Instrument's safety and effectiveness. Furthermore, the design<br>verifications and validations performed as a result of the risk analysis and<br>presented herein demonstrate the proposed device does not raise new questions<br>of safety or effectiveness. Thus, the proposed modification and the predicate<br>device are considered substantially equivalent. | |
| Summary of the Performance Data | | |
| Test | Test Method Summary | Results |
| Biocompatibility | A material biocompatibility evaluation was<br>performed on the subject device in line with FDA<br>guidance dated June 16, 2016 "Use of<br>International Standard ISO 10993-1" and in<br>accordance with ISO 10993-1:2009 and, Biological<br>evaluation of medical devices – Part 1: Evaluation<br>and Testing. The LITe Y-Needle is categorized as:<br>Externally communicating patient<br>contacting with tissue/bone/dentin<br>contact;limited exposure ≤24hrs | All samples passed acceptance criteria<br>testing on subject device. The device<br>demonstrated it had an acceptable<br>biocompatibility profile commensurate<br>with anticipated exposure. |
| Sterility and<br>Packaging | Testing appropriate for the sterile packaged LITE<br>Y-Needles device was performed as per the 2016<br>FDA Guidance "Submission and Review of Sterility<br>Information in Premarket Notification (510(k))<br>Submissions for Devices Labeled as Sterile", are<br>sterilized using an "Established Category A"<br>sterilization method, Gamma Radiation. This<br>testing included but not limited to the following:<br>Physical stressing | All samples passed acceptance criteria<br>testing on subject device and<br>demonstrated that packaging and<br>sterilization was appropriate for single<br>use, sterile packaged devices. |
| Summary of the Performance Data | | |
| Test | Test Method Summary | Results |
| | Visual inspection Seal strength Bubble emission Packaging aging | |
| EMC and Safety | Stryker Spine conducted Safety and EMC testing<br>to evaluate the electrical performance and safety<br>of the ES2 accessory instruments used for<br>neuromonitoring applications. Safety tests were<br>conducted and/or evaluated per IEC 60601-1. | EMC risk evaluation per IEC 60601-1<br>demonstrated that the subject device<br>did not present a new worst case and<br>met all applicable UL Safety and EMC<br>tests. |
| Stationary<br>Potential<br>Generation Test | The purpose of this test is to verify that a potential<br>stationary potential(s) produced when applying<br>electrical current to the LITe Y-300 and Y-400<br>needles are not sufficiently large so false positive is<br>not produced when used for neuromonitoring.<br><br>The LITe® Y-Needle was placed in a biological<br>simulant and connected to the stimulation probe.<br>Recording probes and thermocouples were placed<br>in the simulant.<br><br>The LITE® Y-Needle was stimulated at clinical<br>current levels for 60 seconds. Using a fixed sweep<br>trace capture, the average stationary potential was<br>obtained for the full duration. | The passing results of the stationary<br>potential testing demonstrated that the<br>LITe® Y-Needles generated a stationary<br>potential less than or equal to the<br>predefined acceptance criteria. |
| Electrical<br>Resistance | The purpose of this test is to ensure the resistive<br>and conduction sections of the needles are<br>appropriate to allow for current conduction and<br>current insulation during neuromonitoring.<br><br>Probes were connected to the conductive and<br>insulating portions of the device. The resistance of<br>the conductive portion was measured. The<br>resistance of the insulating portion was measured. | The passing results of the resistance test<br>demonstrated that the LITe® Y-Needles<br>experienced a resistance measurement<br>less than or equal to the predefined<br>acceptance criteria for conductivity and<br>greater than or equal to the predefined<br>acceptance criteria for the resistivity. |
| Current Variance | The purpose of this test is to verify the degree of<br>current deviation along the axial length of the<br>LITe® Y-Needle. This testing ensures the signal is<br>conducted in a consistent manner as delivered by<br>the neuromonitoring device.<br><br>The LITe® Y-Needles were connected to<br>stimulation probes at the conductive locations of<br>the device. Clinical current levels were applied to<br>the device for 10seconds, 100seconds, and 500<br>seconds. The transmitted current was recorded<br>and compared to the applied current. | The passing results of the current<br>deviation test demonstrated that the<br>LITe® Y-Needles experienced a current<br>deviation less than or equal to the<br>predefined acceptance criteria. |
| Summary of the Performance Data | | |
| Test | Test Method Summary | Results |
| Signal Conduction<br>(amplitude<br>change) | The purpose of this test is to verify the degree of<br>signal loss the axial length of the LITe® Y-Needle.<br>This testing ensures the signal is conducted in a<br>consistent manner as delivered by the<br>neuromonitoring device.<br><br>The LITe® Y-Needles were connected to a<br>stimulation probe at the conductive locations of<br>the device. The device was stimulated using clinical<br>current levels and the percentage difference of the<br>power input was compared to the transmitted<br>signal wave. | The passing results of the signal loss test<br>demonstrated that the LITe® Y-Needles<br>experienced a signal loss less than or<br>equal to the predefined acceptance<br>criteria. |

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| Summary of the Technological Characteristics | | | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--|
| | | Primary Predicate | |
| Characteristics | Subject device | ES2 Spinal System<br>Neuromonitoring Accessory<br>Instruments | |
| Manufacturer/OEM | Stryker Spine | Stryker Spine | |
| 510(k) Number | K171807 | K140400 | |
| Product Code<br>(Regulation number) | PDQ (21 CFR 874.1820) | ETN (21 CFR 874.1820) | |
| Neuromonitoring<br>Accessories<br>Instruments | Awl, Taps, Screwdriver and 200,300 and 400<br>LITe Y-Needles | Awl, Taps, Screwdriver | |
| Materials | Stainless steel, ABS and Radel | Awl, Taps, and Screwdriver:<br>Surgical Grade Stainless Steel<br>Dilators and Tap Sleeve- RADEL | |
| Indications for use | The ES2 Neuromonitoring instruments (Awls,<br>Taps, Screwdriver and LITe Y-NEEDLE 200, 300<br>and 400) can be used by the surgeon to assist in<br>location of the spinal nerves by providing<br>proximity information before, during or after<br>bone preparation and placement of bone screws<br>in open and percutaneous minimally invasive<br>posterior surgical approaches of the non-<br>cervical spine. | Identical | |
| Summary of the Technological Characteristics | | | |
| | | Primary Predicate | |
| Characteristics | Subject device | ES2 Spinal System<br>Neuromonitoring Accessory<br>Instruments | |
| Surgical Approach | Open or Percutaneous/Minimally Invasive | Identical | |
| How supplied | 200,300 and 400 LITe Y-Needles- Sterile | Awls, Taps, and Screwdriver- Non- | |
| (Sterile/Non-sterile) | Awls, Taps, and Screwdriver- Non-Sterile | Sterile | |
| Sterilization | The 200,300 and 400 LITe Y-Needles are<br>provided as single-use sterile packaged devices.<br>Non-sterile devices are provided with validated<br>sterilization parameters to assure an SAL of 10-<br>6. | Non-sterile devices are provided with<br>validated sterilization parameters to<br>assure an SAL of 10-6. | |
| Reusable or Single<br>use? | 200,300,and 400 LITe Y-Needles-Single use<br>Awls, Taps, and Screwdriver- Reusable | Awls, Taps, and Screwdriver-<br>Reusable | |
| Use of Dilators | Dilators or Needle depth stop | Identical | |
| Compatible with<br>Common<br>Neuromonitoring<br>Consoles & Software | Compatible with FDA cleared neuromonitoring<br>systems. | Identical | |
| Connection to<br>Neuromonitoring unit | Clip or Probe (based on Neuromonitoring<br>System used)…