(133 days)
Not Found
No
The description focuses on electrical stimulation and compatibility with existing neuromonitoring systems, with no mention of AI or ML.
No.
The device is used to assist in the location of spinal nerves by providing proximity information during surgical procedures, which is a diagnostic/guidance function, not a therapeutic one. It does not treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device "can be used to assist in location of the spinal nerves by providing proximity information," and the "Device Description" elaborates that it delivers "electrical stimulation to assist in location of the spinal nerves during intraoperative neurological monitoring." This information gathering for the purpose of guiding medical decisions (locating nerves for surgical approaches) defines it as a diagnostic device.
No
The device description explicitly states the devices are "manufactured from surgical grade stainless steel" and are "accessory devices" to be used with neuromonitoring systems, indicating they are physical instruments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ES2® Awl, ES2® Taps, and ES2® Screwdriver are surgical instruments used during surgery to assist in locating spinal nerves by delivering electrical stimulation. They are used in vivo (within the living body), not in vitro (outside the living body).
- Intended Use: The intended use clearly states their purpose is to assist in locating spinal nerves during surgical procedures. This is a surgical aid, not a diagnostic test performed on a specimen.
Therefore, the function and intended use of these devices fall outside the scope of In Vitro Diagnostics. They are surgical accessory devices used for intraoperative neuromonitoring.
N/A
Intended Use / Indications for Use
The ES2® Awl, ES2® Taps, and ES2® Screwdriver 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.
Product codes (comma separated list FDA assigned to the subject device)
ETN
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed to demonstrate that the subject devices are substantially equivalent to the identified predicate instruments in terms of design, performance and intended use. The ES2® Neuromonitoring Accessory Instruments were tested for electrical safety in accordance with IEC 60601-1-2 for EMC and Safety. The instruments were also evaluated as per IEC 60601-1. A porcine animal study was conducted to assess the performance, functionality, and safety of the ES2® Neuromonitoring Accessory Instruments and implants utilizing the powered screw insertion option, corded and cordless. Bench test data and assessment confirmed substantial equivalence to the NuVasive® NVM5® predicates, and the safety and efficacy of the devices.
Laboratory tests were conducted in compliance with applicable Good Laboratory Practices (GLP) requirements stipulated in 21 CFR Part 58.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
NuVasive® NVM5 System - K112718, NuVasive® NVM5 System - K123307, Stryker Spine ES2® Spinal System - K122845
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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. |
| Intended Use | The ES2® Awl, ES2® Taps, and ES2® Screwdriver are
intended to be used with the ES2® Dilators & ES2® Tap
Sleeve during neuromonitoring applications. The
neuromonitoring accessory instrument set-up is also intended
to be used for bone screw insertion under power. |
| Summary of the Technological
Characteristics | The Stryker Spine ES2® Neuromonitoring Accessory Instruments are
substantially equivalent to the predicate devices in terms of design,
function, principals of operation, technological characteristics, and
indications 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 during
percutaneous minimally invasive surgical approaches. The predicate
NuVasive® NVM5® instruments and the ES2® Neuromonitoring
Accessories are used with dilators and/or a tap sleeve to provide
insulation. 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 without
power for bone screw insertion. As FDA cleared in 510(k)
#K122845, the power supply can be corded or cordless. Bench
testing demonstrated that the ES2® Screwdriver can deliver safe and
effective neuromonitoring signals using the non-powered or
powered (corded and cordless) bone screw placement/insertion
options. |
Section 008: 510(k) Summary
1
Traditional 510(k) #K140400
,
Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
2
raditional 510(k) #K140400
Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
OMPARISON OF ES2® NEUROMONITORING ACCESSORY INSTRUMENT AND THE PREDICATE DEVICE FOR ISSOCIETY
| Characteristic | Subject Device:
ES2® Neuromonitoring
Accessory Instruments | Predicate Device:
NuVasive® NVM5® System | Substantial Equivalence |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Neuromonitoring Accessories
Instruments | Awl, Taps, and Screwdriver | Taps and Screwdriver | Yes - The ES2® and predicate
system use the same types of
accessory instruments for
neuromonitoring applications during
bone preparation/pilot hole starter
and bone screw placement. The
ES2® Neuromonitoring Accessory
Instruments are 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 or Tap Sleeve | Dilators | Yes |
| Compatible with Common
Neuromonitoring Consoles &
Software | Compatible with FDA cleared
neuromonitoring systems to
include the NuVasive® NVM5®
System | NuVasive® NVM5® System | Yes |
| Connection to Neuromonitoring
unit | Clip or Probe (based on
Neuromonitoring System used) | Clip | Yes - the use of a clip or probe is
dependent on the neuromonitoring
console and/or surgeon's
preference. The clip or probe are
attached to the accessory instrument
on the exposed instrument contact
area above the dilator or tap sleeve
for both the ES2® and predicate
devices |
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Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
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| Materials | Indication for Use | Unknown |
|---|---|---|
| Awl, Taps, & Screwdriver: | ||
| Surgical Grade Stainless Steel | ||
| Dilators & 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
.
| | | surgeon to assess moderate
degrees of neuromuscular block
in effect by evaluating muscle
contraction following a train of
four stimulation pulses.
● TCMEP – Transcranial
stimulation techniques for motor
evoked potentials are used to
assess for acute dysfunction in
axonal conduction of the
corticospinal tract. The TCMEP
function provides an adjunctive
method to allow the surgeon to
monitor spinal cord motor
pathway integrity during
procedures with a risk of
surgically induced motor injury.
● SSEP – The SSEP function
allows the surgeon to assess
sensory spinal cord function in
surgical procedures during which
the spinal cord is at risk.
● Remote Reader – The Remote
Reader function provides real
time remote access to the
NVM5® System for monitoring
physician outside of the operating
room.
● The Guidance function is
intended as an aid for use in either
open or percutaneous pedicle
cannulation producedure in the
lumbar spine of adult patients,
and when used in conjunction
with radiographic imaging
anatomy for the creation of a
cannulation trajectory for bone
screw placement. |
|---------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Instruments provided as reusable | Yes
As selected for individual accessories. |
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Fraditional 510(k) #K140400
Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
| | non-sterile devices with validated
sterilization parameters to assure a
SAL of 10-6 | and validated to assure a SAL of 10-6 | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Surgical Approach | Open or Percutaneous/Minimally
Invasive | Open or Percutaneous/Minimally
Invasive | Yes |
| Electromagnetic Compatibility &
Electrical Safety | IEC 60601-1
IEC 60601-1-2
IEC 61000-3-2
IEC 61000-3-3 | IEC 60601-1-2 | Yes |
| Min. exposed surface area during
tissue stimulation | 0.53mm² | unknown | Yes - The test data demonstrated
that the design of the subject device,
the exposed surface area during
tissue stimulation, and
neuromonitoring instrument set-
up/configurations do not impact or
interfere with the electrical
signaling and are comparable to the
predicate devices. |
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Stryker Spine ES2® Spinal System Neuromonitoring Accessory Instruments
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| Summary of the Performance Data | This 510(k) pre-market notification seeks expanded indications for
the ES2® Awl, ES2® Taps, and ES2® Screwdriver to be used as
accessory instruments during neuromonitoring applications. No
design modifications, or changes in the materials of construction
were made to the ES2® Awl, ES2® Taps, or ES2® Screwdriver, as
previously presented in 510(k) #K122845, to facilitate
neuromonitoring. All instruments are manufactured from surgical
grade stainless steel. The materials of construction have been
well characterized and shown to have stable chemical and
mechanical properties that are not affected by aging or storage
conditions.
Performance testing was performed to demonstrate that the subject
devices are substantially equivalent to the identified predicate
instruments in terms of design, performance and intended use. The
ES2® Neuromonitoring Accessory Instruments were tested for
electrical safety in accordance with IEC 60601-1-2 for EMC and
Safety. The instruments were also evaluated as per IEC 60601-1. A
porcine animal study was conducted to assess the performance,
functionality, and safety of the ES2® Neuromonitoring Accessory
Instruments and implants utilizing the powered screw insertion
option, corded and cordless. Bench test data and assessment
confirmed substantial equivalence to the NuVasive® NVM5®
predicates, and the safety and efficacy of the devices.
Laboratory tests were conducted in compliance with applicable
Good Laboratory Practices (GLP) requirements stipulated in 21 CFR
Part 58. |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on the information and comparison tables included in this
510(k), the ES2® Neuromonitoring Accessory Instruments are
substantially equivalent to the NuVasive® NVM5® predicates. The
instruments are employed in the same manner, have similar intended |
| | and indications for use, principles of operation, and technological
characteristics. The ES2® subject devices met all required
acceptance criteria and did not create new safety or efficacy
concerns. |
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Traditional 510(k) #K140400
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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
10
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
11
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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