(133 days)
The ES2® Awl, ES2® Taps, and ES2® Screwdriver can be used 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 perculaneous minimally invasive posterior surgical approaches of the non-cervical spine.
The ES2® Neuromonitoring instruments (Awl, Taps, and Screwdriver) are accessory devices 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 are provided non-sterile.
The neuromonitoring application is a surgical option that allows the surgeon to locate the spinal nerves by providing proximity information during bone preparation and placement/insertion of bone screws. The ES2® Awl and ES2® Taps facilitate bone preparation, and the ES2® 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 neuromonitoring accessory instrument can be used with or without a
The Stryker Spine ES2® Neuromonitoring Accessory Instruments are intended to assist in locating spinal nerves by providing proximity information during bone preparation and placement of bone screws in posterior spinal surgical approaches.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (ES2® Neuromonitoring Accessory Instruments) |
|---|---|---|
| Neuromonitoring Accessories | Taps and Screwdriver (NuVasive® NVM5® System) | Awl, Taps, and Screwdriver. Used the same types of accessory instruments for neuromonitoring applications during bone preparation/pilot hole starter and bone screw placement. Employed and assembled in a similar manner with comparable set-up configurations to deliver electrical signals. Testing confirmed that the powered ES2® Screwdriver configuration does not interfere with the neuromonitoring signals and is safe and effective. |
| Use of Dilators | Dilators (NuVasive® NVM5® System) | Dilators or Tap Sleeve. |
| Compatibility with Neuromonitoring Consoles & Software | Compatible with NuVasive® NVM5® System | Compatible with FDA cleared neuromonitoring systems, including the NuVasive® NVM5® System. |
| Connection to Neuromonitoring Unit | Clip (NuVasive® NVM5® System) | Clip or Probe (based on Neuromonitoring System used). The clip or probe are attached to the accessory instrument on the exposed instrument contact area above the dilator or tap sleeve. |
| Materials | Unknown for NVM5® System. Assumed to be well-characterized and accepted biocompatible materials. | Awl, Taps, & Screwdriver: Surgical Grade Stainless Steel. Dilators & Tap Sleeve: RADEL®. Instruments composed of well-characterized and accepted biocompatible materials. Stable chemical and mechanical properties not affected by aging or storage conditions. |
| Indication for Use | Intraoperative neurophysiologic monitoring during spinal surgery; locating and evaluating spinal nerves (XLIF Detection, Screw Test); identifying spontaneous EMG activity (Free Run EMG); assessing neuromuscular block (Twitch Test); assessing acute dysfunction in corticospinal tract (TCMEP); assessing sensory spinal cord function (SSEP); remote access (Remote Reader); aid for pedicle cannulation (Guidance function). | The ES2® Awl, ES2® Taps, and ES2® Screwdriver can be used 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 posterior surgical approaches of the non-cervical spine. This is a subset of the predicate's indications, not resulting in a new or different intended use. |
| Sterilization | Validated to assure a SAL of 10-6 | Instruments provided as reusable non-sterile devices with validated sterilization parameters to assure a SAL of 10-6. |
| Surgical Approach | Open or Percutaneous/Minimally Invasive | Open or Percutaneous/Minimally Invasive. |
| Electromagnetic Compatibility & Electrical Safety | IEC 60601-1-2 (NuVasive® NVM5® System) | IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, IEC 61000-3-3. |
| Min. exposed surface area during tissue stimulation | Unknown (NuVasive® NVM5® System) | 0.53mm². Test data demonstrated that the design, exposed surface area, and neuromonitoring instrument set-up/configurations do not impact or interfere with electrical signaling and are comparable to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: A "porcine animal study" was conducted. The document does not specify the exact number of animals or the number of data points collected during this study.
- Data Provenance: The study was an animal study (porcine), which is a prospective, controlled experimental setting. The country of origin is not explicitly stated, but given Stryker's location (Allendale, NJ, USA) and the US FDA submission, it's highly probable the study was conducted in the US or under US regulatory guidelines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their qualifications used to establish ground truth in the porcine study. However, for a study assessing neuromonitoring performance, it is implied that experienced veterinary surgeons or neurophysiologists would be involved in conducting the procedures and evaluating the nerve proximity information.
4. Adjudication method for the test set:
- The document does not specify an adjudication method like 2+1 or 3+1. The assessment of performance, functionality, and safety was likely based on the observations and data collected by the surgical team and neuromonitoring specialists during the animal study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument (neuromonitoring accessory instruments) that directly assists in nerve location during surgery, not an AI-powered diagnostic imaging tool that would involve "human readers" or AI assistance in interpreting data in the traditional sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of this device. The ES2® Neuromonitoring Accessory Instruments are physical surgical tools. Their function is directly integrated with a human surgeon and a neuromonitoring system. There is no "algorithm only" or "standalone" performance to measure without human-in-the-loop, as the device's purpose is to provide real-time feedback to a human surgeon.
7. The type of ground truth used:
- The ground truth in the porcine animal study would have been established through direct observation during surgery and potentially histological examination or direct nerve stimulation protocols used to confirm nerve location and proximity. It relates to the physiological response to electrical stimulation for nerve localization.
8. The sample size for the training set:
- The document does not describe a "training set" in the context of machine learning. This device is a physical medical instrument, not a software algorithm that requires a training set. The performance evaluation was based on bench testing and an animal study.
9. How the ground truth for the training set was established:
- Not applicable, as there was no training set in the machine learning sense. The ground truth for the performance evaluation was established through the methodologies of the porcine animal study and bench testing, as described above.
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Traditional 510(k) #K140400
Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
| Proprietary Name: | ES2® Neuromonitoring Accessory Instruments |
|---|---|
| Common Name: | Surgical Nerve Stimulator/Locator |
| Classification Name and Reference: | 21 CFR §874.1820: Surgical Nerve Stimulator/Locator |
| Device Product Code: | ETN |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Soraya King |
| Regulatory Affairs Specialist | |
| 2 Pearl Court | |
| Allendale, NJ 07401 | |
| Telephone: (201) 760-8296 | |
| Fax: (201) 962-4296 | |
| Email: Soraya.King@Stryker.com | |
| Date Summary Prepared: | June 17, 2014 |
| Predicate Devices | NuVasive® NVM5 System - K112718 NuVasive® NVM5 System - K123307 Stryker Spine ES2® Spinal System - K122845 |
| Device Description | The ES2® Neuromonitoring instruments (Awl, Taps, and Screwdriver) are accessory devices 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 are provided non-sterile.The neuromonitoring application is a surgical option that allows the surgeon to locate the spinal nerves by providing proximity information during bone preparation and placement/insertion of bone screws. The ES2® Awl and ES2® Taps facilitate bone preparation, and the ES2® 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 neuromonitoring accessory instrument can be used with or without a |
| Indication for Use | The ES2® Awl, ES2® Taps, and ES2® Screwdriver can beused by the surgeon to assist in location of the spinal nerves byproviding proximity information before, during or after bonepreparation and placement of bone screws. |
| Intended Use | The ES2® Awl, ES2® Taps, and ES2® Screwdriver areintended to be used with the ES2® Dilators & ES2® TapSleeve during neuromonitoring applications. Theneuromonitoring accessory instrument set-up is also intendedto be used for bone screw insertion under power. |
| Summary of the TechnologicalCharacteristics | The Stryker Spine ES2® Neuromonitoring Accessory Instruments aresubstantially equivalent to the predicate devices in terms of design,function, principals of operation, technological characteristics, andindications and intended uses. As compared to the NuVasive®NVM5® predicates, the ES2® Awl, ES2®Taps, and ES2®Screwdriver are cannulated to allow for K-Wire placement duringpercutaneous minimally invasive surgical approaches. The predicateNuVasive® NVM5® instruments and the ES2® NeuromonitoringAccessories are used with dilators and/or a tap sleeve to provideinsulation. The electrical signal for both the NuVasive® NVM5®and ES2® instruments are supplied via electrodes (clip or probe)that are attached to the neuromonitoring contact zone of the awls,taps, or screwdrivers.In addition, the ES2® Screwdriver can be used with or withoutpower for bone screw insertion. As FDA cleared in 510(k)#K122845, the power supply can be corded or cordless. Benchtesting demonstrated that the ES2® Screwdriver can deliver safe andeffective neuromonitoring signals using the non-powered orpowered (corded and cordless) bone screw placement/insertionoptions. |
Section 008: 510(k) Summary
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Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
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Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
OMPARISON OF ES2® NEUROMONITORING ACCESSORY INSTRUMENT AND THE PREDICATE DEVICE FOR ISSOCIETY
| Characteristic | Subject Device:ES2® NeuromonitoringAccessory Instruments | Predicate Device:NuVasive® NVM5® System | Substantial Equivalence |
|---|---|---|---|
| Neuromonitoring AccessoriesInstruments | Awl, Taps, and Screwdriver | Taps and Screwdriver | Yes - The ES2® and predicatesystem use the same types ofaccessory instruments forneuromonitoring applications duringbone preparation/pilot hole starterand bone screw placement. TheES2® Neuromonitoring AccessoryInstruments are employed andassembled in a similar manner withcomparable set-up configurations todeliver electrical signals. Testingconfirmed that the powered ES2®Screwdriver configuration does notinterfere with the neuromonitoringsignals and is safe and effective. |
| Use of Dilators | Dilators or Tap Sleeve | Dilators | Yes |
| Compatible with CommonNeuromonitoring Consoles &Software | Compatible with FDA clearedneuromonitoring systems toinclude the NuVasive® NVM5®System | NuVasive® NVM5® System | Yes |
| Connection to Neuromonitoringunit | Clip or Probe (based onNeuromonitoring System used) | Clip | Yes - the use of a clip or probe isdependent on the neuromonitoringconsole and/or surgeon'spreference. The clip or probe areattached to the accessory instrumenton the exposed instrument contactarea above the dilator or tap sleevefor both the ES2® and predicatedevices |
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| Materials | Indication for Use | Unknown |
|---|---|---|
| Awl, Taps, & Screwdriver:Surgical Grade Stainless SteelDilators & Tap Sleeve: RADEL®The ES2® Awls, ES2® Taps, and ES2® Screwdriver can be used 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 posterior surgical approaches of the non-cervical spine. | The NVM5® System is a medical device that is intended for intraoperative neurophysiologic monitoring during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurophysiologic status. NVM5® provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), transcranial motor evoked potential (TceMEP) or somatosensory evoked potential (SSEP) responses of nerves. XLIF (Detection) - The XLIF (Detection) function allows the surgeon to locate and evaluate spinal nerves, and is used as a nerve avoidance tool. Basic & Dynamic Screw Test – The Screw Test functions allow the surgeon to locate and evaluate the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws. Free Run EMG – The Free Run EMG function identifies spontaneous EMG activity of spinal nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions. Twitch Test (Train of Four) – The Twitch Test Function allows the | Yes – Instruments composed of well-characterized materials and accepted biocompatible materials.Yes – the indications of the ES2® Neuromonitoring Accessory Instruments are a subset of the indications of the predicate device. This does not result in a new or different intended use as compared to the predicate. The subject and predicate instruments are employed in the same manner when used as a tool to assist the surgeon in locating spinal nerves before, during, or after bone preparation and bone screw placement for open and percutaneous surgical approaches. |
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raditional 510(k) #K140400
Stryker Spinc ES2® Spinal System Neuromonitoring Accessory Instruments
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| surgeon to assess moderatedegrees of neuromuscular blockin effect by evaluating musclecontraction following a train offour stimulation pulses.● TCMEP – Transcranialstimulation techniques for motorevoked potentials are used toassess for acute dysfunction inaxonal conduction of thecorticospinal tract. The TCMEPfunction provides an adjunctivemethod to allow the surgeon tomonitor spinal cord motorpathway integrity duringprocedures with a risk ofsurgically induced motor injury.● SSEP – The SSEP functionallows the surgeon to assesssensory spinal cord function insurgical procedures during whichthe spinal cord is at risk.● Remote Reader – The RemoteReader function provides realtime remote access to theNVM5® System for monitoringphysician outside of the operatingroom.● The Guidance function isintended as an aid for use in eitheropen or percutaneous pediclecannulation producedure in thelumbar spine of adult patients,and when used in conjunctionwith radiographic imaginganatomy for the creation of acannulation trajectory for bonescrew placement. | ||
|---|---|---|
| Sterilization | Instruments provided as reusable | YesAs selected for individual accessories. |
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Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
| non-sterile devices with validatedsterilization parameters to assure aSAL of 10-6 | and validated to assure a SAL of 10-6 | ||
|---|---|---|---|
| Surgical Approach | Open or Percutaneous/MinimallyInvasive | Open or Percutaneous/MinimallyInvasive | Yes |
| Electromagnetic Compatibility &Electrical Safety | IEC 60601-1IEC 60601-1-2IEC 61000-3-2IEC 61000-3-3 | IEC 60601-1-2 | Yes |
| Min. exposed surface area duringtissue stimulation | 0.53mm² | unknown | Yes - The test data demonstratedthat the design of the subject device,the exposed surface area duringtissue stimulation, andneuromonitoring instrument set-up/configurations do not impact orinterfere with the electricalsignaling and are comparable to thepredicate devices. |
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| Summary of the Performance Data | This 510(k) pre-market notification seeks expanded indications forthe ES2® Awl, ES2® Taps, and ES2® Screwdriver to be used asaccessory instruments during neuromonitoring applications. Nodesign modifications, or changes in the materials of constructionwere made to the ES2® Awl, ES2® Taps, or ES2® Screwdriver, aspreviously presented in 510(k) #K122845, to facilitateneuromonitoring. All instruments are manufactured from surgicalgrade stainless steel. The materials of construction have beenwell characterized and shown to have stable chemical andmechanical properties that are not affected by aging or storageconditions.Performance testing was performed to demonstrate that the subjectdevices are substantially equivalent to the identified predicateinstruments in terms of design, performance and intended use. TheES2® Neuromonitoring Accessory Instruments were tested forelectrical safety in accordance with IEC 60601-1-2 for EMC andSafety. The instruments were also evaluated as per IEC 60601-1. Aporcine animal study was conducted to assess the performance,functionality, and safety of the ES2® Neuromonitoring AccessoryInstruments and implants utilizing the powered screw insertionoption, corded and cordless. Bench test data and assessmentconfirmed substantial equivalence to the NuVasive® NVM5®predicates, and the safety and efficacy of the devices.Laboratory tests were conducted in compliance with applicableGood Laboratory Practices (GLP) requirements stipulated in 21 CFRPart 58. |
|---|---|
| Conclusion | Based on the information and comparison tables included in this510(k), the ES2® Neuromonitoring Accessory Instruments aresubstantially equivalent to the NuVasive® NVM5® predicates. Theinstruments are employed in the same manner, have similar intended |
| and indications for use, principles of operation, and technologicalcharacteristics. The ES2® subject devices met all requiredacceptance criteria and did not create new safety or efficacyconcerns. |
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Image /page/9/Picture/0 description: The image contains a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
July 1, 2014
Stryker Spine Sorava King Regulatory Affairs Specialist 2 Pearl Court Allendale. NJ 07401
Re: K140400
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: ETN Dated: April 1. 2014 Received: April 2. 2014
Dear Ms. King:
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 vour 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 I'DA '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
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Page 2 - Ms. Soraya King
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 (800) 638-2041 or (301) 796-7100 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" (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 Aguel -S
Carlos L. Peña, Ph.D., M.S. for
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) KI40400
Device Name
ES2® Neuromonitoring Accessory Instruments: ES20 Awl, ES20 Taps, and ES2® Screwdriver
Indications for Use (Describe)
The ES2® Awl, ES2® Taps, and ES2® Screwdriver can be used 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 perculaneous minimally invasive posterior surgical approaches of the non-cervical spine,
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)
Felipe Aquel -S
Date: 2014.07.01 14:20:03 -04'00'
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§ 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.