(29 days)
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.
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.
The provided text describes specific performance tests and their results for the ES2 Neuromonitoring Accessory Instruments, particularly focusing on the newly introduced LITe Y-Needles.
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit from "Passing Results") | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable biocompatibility profile commensurate with anticipated exposure (in line with FDA guidance June 16, 2016 "Use of International Standard ISO 10993-1" and ISO 10993-1:2009). | All samples passed, demonstrating an acceptable biocompatibility profile. |
| Sterility and Packaging | Packaging and sterilization appropriate for single-use, sterile-packaged devices (as per 2016 FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile", using "Established Category A" sterilization method, Gamma Radiation). This includes passing visual inspection, seal strength, bubble emission, and packaging aging tests. | All samples passed, demonstrating appropriate packaging and sterilization. |
| EMC and Safety | Device does not present a new worst case and meets all applicable UL Safety and EMC tests, as determined by EMC risk evaluation per IEC 60601-1. | Met all applicable UL Safety and EMC tests and did not present a new worst case. |
| Stationary Potential Generation Test | Generated stationary potential less than or equal to predefined acceptance criteria to prevent false positives during neuromonitoring. | Passing results demonstrated stationary potential less than or equal to predefined acceptance criteria. |
| Electrical Resistance | Resistance of conductive portion less than or equal to predefined acceptance criteria, and resistance of insulating portion greater than or equal to predefined acceptance criteria. | Passing results demonstrated resistance measurements met predefined acceptance criteria for conductivity and resistivity. |
| Current Variance | Current deviation less than or equal to predefined acceptance criteria along the axial length. | Passing results demonstrated current deviation less than or equal to predefined acceptance criteria. |
| Signal Conduction (amplitude change) | Signal loss less than or equal to predefined acceptance criteria along the axial length. | Passing results demonstrated signal loss less than or equal to predefined acceptance criteria. |
Additional Study Information:
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state numerical sample sizes for each test (e.g., number of LITe Y-Needles tested for biocompatibility, sterility, etc.). It refers to "All samples" passing for several tests ("All samples passed acceptance criteria testing on subject device").
- Data Provenance: The studies were conducted by Stryker Spine ("Stryker Spine conducted Safety and EMC testing"). While the exact location of the testing is not specified, it is implied to be within the company's testing facilities or contracted labs, likely in the US, given the FDA submission. The nature of these tests (bench testing, material testing) means they are prospective in the sense that they were designed and executed specifically for this submission.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. These are engineering performance tests of the device itself (biocompatibility, electrical properties, sterility) rather than clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" for these tests is defined by established engineering and medical device standards (e.g., ISO 10993, IEC 60601-1, FDA guidances).
-
Adjudication Method for the Test Set:
- Not applicable. As these are objective performance tests based on measurable physical and chemical properties and adherence to standards, an adjudication method for test results by multiple experts is not described or typically required. The results are binary (pass/fail) based on comparison to predefined numerical criteria.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is an accessory instrument that assists surgeons in locating spinal nerves by delivering electrical stimulation. It does not involve human readers interpreting diagnostic images, nor does the document describe any clinical trials comparing human performance with and without the device. The device's function is direct electrical stimulation and measurement, not interpretation.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the performance data presented is for the device itself ("algorithm only" in the sense of the device's inherent functionality without surgeon input during the testing phase) and its interaction with standard electrical and biological models. For example, the Stationary Potential Generation Test measured the device's electrical output when stimulated at clinical current levels in a biological simulant. These are standalone performance characteristics of the instrument.
-
Type of Ground Truth Used:
- The "ground truth" for these performance tests is based on established scientific principles, international standards (ISO, IEC), and regulatory guidances (FDA). For instance:
- Biocompatibility: Adherence to ISO 10993-1.
- Sterility: Adherence to FDA guidance and "Established Category A" sterilization methods.
- Electrical Performance (EMC, Stationary Potential, Resistance, Current Variance, Signal Conduction): Adherence to IEC 60601-1 and predefined engineering specifications based on the device's intended physiological interaction.
- The "ground truth" for these performance tests is based on established scientific principles, international standards (ISO, IEC), and regulatory guidances (FDA). For instance:
-
Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The device's function is based on direct electrical stimulation and measurement, not on learned patterns from a dataset.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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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 (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 andplacing 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 thespinal nerves by providing proximity information before, during or after bonepreparation and placement of bone screws in open and percutaneous minimally | |
| Summary of theTechnologicalCharacteristics | The Stryker Spine ES2 Neuromonitoring Accessory Instruments are substantiallyequivalent to the predicate devices in terms of design, function, principals ofoperation, technological characteristics, and indications and intended uses. Seetable below for comparisons to predicate ES2 Neuromonitoring AccessoryInstruments. | |
| Summary of thePerformance 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 validationactivities demonstrate the line extension does not impact the ES2Neuromonitoring Instrument's safety and effectiveness. Furthermore, the designverifications and validations performed as a result of the risk analysis andpresented herein demonstrate the proposed device does not raise new questionsof safety or effectiveness. Thus, the proposed modification and the predicatedevice are considered substantially equivalent. | |
| Summary of the Performance Data | ||
| Test | Test Method Summary | Results |
| Biocompatibility | A material biocompatibility evaluation wasperformed on the subject device in line with FDAguidance dated June 16, 2016 "Use ofInternational Standard ISO 10993-1" and inaccordance with ISO 10993-1:2009 and, Biologicalevaluation of medical devices – Part 1: Evaluationand Testing. The LITe Y-Needle is categorized as:Externally communicating patientcontacting with tissue/bone/dentincontact;limited exposure ≤24hrs | All samples passed acceptance criteriatesting on subject device. The devicedemonstrated it had an acceptablebiocompatibility profile commensuratewith anticipated exposure. |
| Sterility andPackaging | Testing appropriate for the sterile packaged LITEY-Needles device was performed as per the 2016FDA Guidance "Submission and Review of SterilityInformation in Premarket Notification (510(k))Submissions for Devices Labeled as Sterile", aresterilized using an "Established Category A"sterilization method, Gamma Radiation. Thistesting included but not limited to the following:Physical stressing | All samples passed acceptance criteriatesting on subject device anddemonstrated that packaging andsterilization was appropriate for singleuse, 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 testingto evaluate the electrical performance and safetyof the ES2 accessory instruments used forneuromonitoring applications. Safety tests wereconducted and/or evaluated per IEC 60601-1. | EMC risk evaluation per IEC 60601-1demonstrated that the subject devicedid not present a new worst case andmet all applicable UL Safety and EMCtests. |
| StationaryPotentialGeneration Test | The purpose of this test is to verify that a potentialstationary potential(s) produced when applyingelectrical current to the LITe Y-300 and Y-400needles are not sufficiently large so false positive isnot produced when used for neuromonitoring.The LITe® Y-Needle was placed in a biologicalsimulant and connected to the stimulation probe.Recording probes and thermocouples were placedin the simulant.The LITE® Y-Needle was stimulated at clinicalcurrent levels for 60 seconds. Using a fixed sweeptrace capture, the average stationary potential wasobtained for the full duration. | The passing results of the stationarypotential testing demonstrated that theLITe® Y-Needles generated a stationarypotential less than or equal to thepredefined acceptance criteria. |
| ElectricalResistance | The purpose of this test is to ensure the resistiveand conduction sections of the needles areappropriate to allow for current conduction andcurrent insulation during neuromonitoring.Probes were connected to the conductive andinsulating portions of the device. The resistance ofthe conductive portion was measured. Theresistance of the insulating portion was measured. | The passing results of the resistance testdemonstrated that the LITe® Y-Needlesexperienced a resistance measurementless than or equal to the predefinedacceptance criteria for conductivity andgreater than or equal to the predefinedacceptance criteria for the resistivity. |
| Current Variance | The purpose of this test is to verify the degree ofcurrent deviation along the axial length of theLITe® Y-Needle. This testing ensures the signal isconducted in a consistent manner as delivered bythe neuromonitoring device.The LITe® Y-Needles were connected tostimulation probes at the conductive locations ofthe device. Clinical current levels were applied tothe device for 10seconds, 100seconds, and 500seconds. The transmitted current was recordedand compared to the applied current. | The passing results of the currentdeviation test demonstrated that theLITe® Y-Needles experienced a currentdeviation less than or equal to thepredefined acceptance criteria. |
| Summary of the Performance Data | ||
| Test | Test Method Summary | Results |
| Signal Conduction(amplitudechange) | The purpose of this test is to verify the degree ofsignal loss the axial length of the LITe® Y-Needle.This testing ensures the signal is conducted in aconsistent manner as delivered by theneuromonitoring device.The LITe® Y-Needles were connected to astimulation probe at the conductive locations ofthe device. The device was stimulated using clinicalcurrent levels and the percentage difference of thepower input was compared to the transmittedsignal wave. | The passing results of the signal loss testdemonstrated that the LITe® Y-Needlesexperienced a signal loss less than orequal to the predefined acceptancecriteria. |
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| Summary of the Technological Characteristics | |||
|---|---|---|---|
| Primary Predicate | |||
| Characteristics | Subject device | ES2 Spinal SystemNeuromonitoring AccessoryInstruments | |
| 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) | |
| NeuromonitoringAccessoriesInstruments | Awl, Taps, Screwdriver and 200,300 and 400LITe Y-Needles | Awl, Taps, Screwdriver | |
| Materials | Stainless steel, ABS and Radel | Awl, Taps, and Screwdriver:Surgical Grade Stainless SteelDilators and Tap Sleeve- RADEL | |
| Indications for use | The ES2 Neuromonitoring instruments (Awls,Taps, Screwdriver and LITe Y-NEEDLE 200, 300and 400) can be used by the surgeon to assist inlocation of the spinal nerves by providingproximity information before, during or afterbone preparation and placement of bone screwsin open and percutaneous minimally invasiveposterior surgical approaches of the non-cervical spine. | Identical | |
| Summary of the Technological Characteristics | |||
| Primary Predicate | |||
| Characteristics | Subject device | ES2 Spinal SystemNeuromonitoring AccessoryInstruments | |
| 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 areprovided as single-use sterile packaged devices.Non-sterile devices are provided with validatedsterilization parameters to assure an SAL of 10-6. | Non-sterile devices are provided withvalidated sterilization parameters toassure an SAL of 10-6. | |
| Reusable or Singleuse? | 200,300,and 400 LITe Y-Needles-Single useAwls, Taps, and Screwdriver- Reusable | Awls, Taps, and Screwdriver-Reusable | |
| Use of Dilators | Dilators or Needle depth stop | Identical | |
| Compatible withCommonNeuromonitoringConsoles & Software | Compatible with FDA cleared neuromonitoringsystems. | Identical | |
| Connection toNeuromonitoring unit | Clip or Probe (based on NeuromonitoringSystem used) | Identical | |
| IEC 60601Compliant | Yes | Yes | |
| Min. exposed surfacearea during tissuestimulation | 0.53mm² | 0.53mm² |
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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.