(29 days)
Not Found
No
The summary describes accessory instruments for neuromonitoring systems, focusing on electrical stimulation and signal conduction properties. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of these technologies. The performance studies are related to biocompatibility, sterility, electrical properties, and safety, not algorithmic performance.
No
The device is used to assist surgeons in locating spinal nerves and facilitating surgical procedures, not to treat a disease or condition. It is an accessory instrument for neuromonitoring systems.
Yes
The device assists in locating spinal nerves by providing proximity information through electrical stimulation, which is a diagnostic function.
No
The device description explicitly states that the device includes physical instruments made of surgical grade stainless steel and ABS, and describes testing related to the physical properties of these instruments (biocompatibility, sterility, electrical resistance, etc.).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used by a surgeon to assist in locating spinal nerves by providing proximity information during surgical procedures. This is an in-vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces that these are accessory instruments used with neuromonitoring systems to deliver electrical stimulation to assist in locating spinal nerves during intraoperative neurological monitoring. This is a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions based on tests performed on these types of samples.
The device is a surgical accessory used for intraoperative neuromonitoring, which is a procedure performed on a patient during surgery. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
PDQ
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 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.
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
Biocompatibility: A material biocompatibility evaluation was performed on the subject device in line with FDA guidance dated June 16, 2016 "Use of International Standard ISO 10993-1" and in accordance with ISO 10993-1:2009 and, Biological evaluation of medical devices – Part 1: Evaluation and Testing. The LITe Y-Needle is categorized as: Externally communicating patient contacting with tissue/bone/dentin contact;limited exposure
§ 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.
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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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| X 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: (201) 749-8176 | |
| Fax: (201) 831-3000 | ||
| Email:Nikin.Desai@stryker.com | ||
| 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 | ||
| 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- | |
| 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 |
| |
| 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. See
table below for comparisons to predicate ES2 Neuromonitoring Accessory
Instruments. | |
| Summary of the
Performance Data | See table below. | |
| Conclusion | The risk analysis performed on the proposed addition of 200, 300 and 400 LITE Y-
Needles to ES2 Neuromonitoring and subsequent verification and validation
activities demonstrate the line extension does not impact the ES2
Neuromonitoring Instrument's safety and effectiveness. Furthermore, the design
verifications and validations performed as a result of the risk analysis and
presented herein demonstrate the proposed device does not raise new questions
of safety or effectiveness. Thus, the proposed modification and the predicate
device are considered substantially equivalent. | |
| Summary of the Performance Data | | |
| Test | Test Method Summary | Results |
| Biocompatibility | A material biocompatibility evaluation was
performed on the subject device in line with FDA
guidance dated June 16, 2016 "Use of
International Standard ISO 10993-1" and in
accordance with ISO 10993-1:2009 and, Biological
evaluation of medical devices – Part 1: Evaluation
and Testing. The LITe Y-Needle is categorized as:
Externally communicating patient
contacting with tissue/bone/dentin
contact;limited exposure ≤24hrs | All samples passed acceptance criteria
testing on subject device. The device
demonstrated it had an acceptable
biocompatibility profile commensurate
with anticipated exposure. |
| Sterility and
Packaging | Testing appropriate for the sterile packaged LITE
Y-Needles device was performed as per the 2016
FDA Guidance "Submission and Review of Sterility
Information in Premarket Notification (510(k))
Submissions for Devices Labeled as Sterile", are
sterilized using an "Established Category A"
sterilization method, Gamma Radiation. This
testing included but not limited to the following:
Physical stressing | All samples passed acceptance criteria
testing on subject device and
demonstrated that packaging and
sterilization was appropriate for single
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
to evaluate the electrical performance and safety
of the ES2 accessory instruments used for
neuromonitoring applications. Safety tests were
conducted and/or evaluated per IEC 60601-1. | EMC risk evaluation per IEC 60601-1
demonstrated that the subject device
did not present a new worst case and
met all applicable UL Safety and EMC
tests. |
| Stationary
Potential
Generation Test | The purpose of this test is to verify that a potential
stationary potential(s) produced when applying
electrical current to the LITe Y-300 and Y-400
needles are not sufficiently large so false positive is
not produced when used for neuromonitoring.
The LITe® Y-Needle was placed in a biological
simulant and connected to the stimulation probe.
Recording probes and thermocouples were placed
in the simulant.
The LITE® Y-Needle was stimulated at clinical
current levels for 60 seconds. Using a fixed sweep
trace capture, the average stationary potential was
obtained for the full duration. | The passing results of the stationary
potential testing demonstrated that the
LITe® Y-Needles generated a stationary
potential less than or equal to the
predefined acceptance criteria. |
| Electrical
Resistance | The purpose of this test is to ensure the resistive
and conduction sections of the needles are
appropriate to allow for current conduction and
current insulation during neuromonitoring.
Probes were connected to the conductive and
insulating portions of the device. The resistance of
the conductive portion was measured. The
resistance of the insulating portion was measured. | The passing results of the resistance test
demonstrated that the LITe® Y-Needles
experienced a resistance measurement
less than or equal to the predefined
acceptance criteria for conductivity and
greater than or equal to the predefined
acceptance criteria for the resistivity. |
| Current Variance | The purpose of this test is to verify the degree of
current deviation along the axial length of the
LITe® Y-Needle. This testing ensures the signal is
conducted in a consistent manner as delivered by
the neuromonitoring device.
The LITe® Y-Needles were connected to
stimulation probes at the conductive locations of
the device. Clinical current levels were applied to
the device for 10seconds, 100seconds, and 500
seconds. The transmitted current was recorded
and compared to the applied current. | The passing results of the current
deviation test demonstrated that the
LITe® Y-Needles experienced a current
deviation less than or equal to the
predefined acceptance criteria. |
| Summary of the Performance Data | | |
| Test | Test Method Summary | Results |
| Signal Conduction
(amplitude
change) | The purpose of this test is to verify the degree of
signal loss the axial length of the LITe® Y-Needle.
This testing ensures the signal is conducted in a
consistent manner as delivered by the
neuromonitoring device.
The LITe® Y-Needles were connected to a
stimulation probe at the conductive locations of
the device. The device was stimulated using clinical
current levels and the percentage difference of the
power input was compared to the transmitted
signal wave. | The passing results of the signal loss test
demonstrated that the LITe® Y-Needles
experienced a signal loss less than or
equal to the predefined acceptance
criteria. |
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| Summary of the Technological Characteristics | |||
|---|---|---|---|
| Primary Predicate | |||
| Characteristics | Subject device | ES2 Spinal System | |
| Neuromonitoring Accessory | |||
| Instruments | |||
| Manufacturer/OEM | Stryker Spine | Stryker Spine | |
| 510(k) Number | K171807 | K140400 | |
| Product Code | |||
| (Regulation number) | PDQ (21 CFR 874.1820) | ETN (21 CFR 874.1820) | |
| Neuromonitoring | |||
| Accessories | |||
| Instruments | Awl, Taps, Screwdriver and 200,300 and 400 | ||
| LITe Y-Needles | Awl, Taps, Screwdriver | ||
| Materials | Stainless steel, ABS and Radel | Awl, Taps, and Screwdriver: | |
| Surgical Grade Stainless Steel | |||
| Dilators and Tap Sleeve- RADEL | |||
| Indications for 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. | Identical | ||
| Summary of the Technological Characteristics | |||
| Primary Predicate | |||
| Characteristics | Subject device | ES2 Spinal System | |
| Neuromonitoring Accessory | |||
| 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 | ||
| provided as single-use sterile packaged devices. | |||
| Non-sterile devices are provided with validated | |||
| sterilization parameters to assure an SAL of 10- |
-
| Non-sterile devices are provided with
validated sterilization parameters to
assure an SAL of 10-6. | |
| Reusable or Single
use? | 200,300,and 400 LITe Y-Needles-Single use
Awls, Taps, and Screwdriver- Reusable | Awls, Taps, and Screwdriver-
Reusable | |
| Use of Dilators | Dilators or Needle depth stop | Identical | |
| Compatible with
Common
Neuromonitoring
Consoles & Software | Compatible with FDA cleared neuromonitoring
systems. | Identical | |
| Connection to
Neuromonitoring unit | Clip or Probe (based on Neuromonitoring
System used) | Identical | |
| IEC 60601
Compliant | Yes | Yes | |
| Min. exposed surface
area during tissue
stimulation | 0.53mm² | 0.53mm² | |
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