Who is the manufacturer of C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

Inomed Medizintechnik GmbH filed the 510(k) submission for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES (K111647).

What is the FDA product code for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

GWF. It is classified under 21 CFR 882.1870 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

510(k) clearance (submission type: Traditional).

What are the predicate devices for C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

Nerve Integrity Monitor 3.0 (K083124); Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor (K083242); Neurosign 400 Motor Nerve Monitor (K991583); Xomed Ball-Tip Monopolar Stimulation probe (K992869); Neurosign 800 8 Channel Motor Nerve Monitor with accessories (K980148); Neurosign 800 Motor Motor Nerve Monitor with accessories (K964869).

Who can help prepare an FDA 510(k) submission like C2 NERVEMONITOR SYSTEM WITH ACCESSORIES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

C2 NERVEMONITOR SYSTEM WITH ACCESSORIES

K111647 · Inomed Medizintechnik GmbH · GWF · Oct 6, 2011 · Neurology

Device Facts

Record ID	K111647
Device Name	C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
Applicant	Inomed Medizintechnik GmbH
Product Code	GWF · Neurology
Decision Date	Oct 6, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1870
Device Class	Class 2

Intended Use

The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device Indications for C2 NerveMonitor System Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities. Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death.

Device Story

C2 NerveMonitor System is a multi-channel intraoperative neurophysiological monitor; connects patient electrodes; supplies electrical stimulus for evoked responses. Inputs: electrical signals from nerves via probes/electrodes. Operation: system delivers electrical stimulus; monitors EMG activity; provides video/audio output of signals. Used in OR by surgeons/staff. Output: waveform graphs on LCD display; audio amplification of EMG signals; data storage on USB. Clinical utility: assists in nerve localization/identification during surgery; helps prevent nerve damage. Benefits: real-time feedback during complex procedures; aids surgical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Multi-channel neurophysiological monitor; 4/8 channels; bandwidth 0.5Hz-5kHz; signal gain 1-1000. Electrical stimulation: monophasic, square pulse, 200μs duration, constant current (0.01-25mA). Materials: stainless steel (patient contact), polypropylene (insulation). 8.4" LCD display. Connectivity: USB storage. Power: 100-240V. Safety: EN 60601-1, Type BF, Class I. Software: Windows XP Embedded.

Indications for Use

Indicated for intra-operative monitoring/stimulation to localize/identify cranial, peripheral motor, and mixed motor-sensory nerves during intracranial, extracranial, intratemporal, extratemporal, neck, thoracic, and extremity surgeries, including spinal procedures (e.g., degenerative treatments, pedicle screw, fusion, rhizotomy, orthopedic). Contraindicated for monitoring life-preserving functions or diagnosing brain death.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

Nerve Integrity Monitor 3.0 (K083124)
Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor (K083242)
Neurosign 400 Motor Nerve Monitor (K991583)
Xomed Ball-Tip Monopolar Stimulation probe (K992869)
Neurosign 800 8 Channel Motor Nerve Monitor with accessories (K980148)
Neurosign 800 Motor Motor Nerve Monitor with accessories (K964869)

Related Devices

K223254 — C2 Xplore · Inomed Medizintechnik GmbH · Jan 27, 2023
K152505 — C2 NerveMonitor System · Inomed Medizintechnik GmbH · Feb 1, 2016
K031510 — NIM-SPINE · Medtronic Xomed · Jun 18, 2003
K982595 — NIM4 · Xomed, Inc. · Sep 4, 1998
K964869 — NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR · The Magstim Company , Ltd. · May 14, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows handwritten text. The text at the top reads "K111647". Below that, the text reads "P. 1 of 8". The text appears to be written in black ink on a white background. OCT - 6 2011 # 510(k) Summary 807.92(c) # SPONSOR ### 807.92(a)(1) Company Name: inomed Medizintechnik GmbH Company Address Im Hausgruen 29 79312 Emmendingen, Germany Telephone: Fax: +49-7641-9414-0 +49-7641-9414-94 Contact Person: Telephone: Saschka Busch +49-7641-9414-87 Summary Preparation Date: August 24, 2011 ### DEVICE NAME Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: 807.92(a)(2) C2 NerveMonitor System Nerve Stimulator/Monitor Evoked Response Electrical Stimulator 21 CFR 882.1870 GWF, ETN Class II ### PREDICATE DEVICE 807.92(a)(3) | Company | Product | 510(k) # | |-----------------|------------------------------------------------------------------|----------| | Medtronic Xomed | Nerve Integrity Monitor 3.0 | K083124 | | Magstim | Nerve Avalanche Thyroid/EMG Motor Nerve Monitor | K083242 | | Magstim | Neurosign 400 Motor Nerve Monitor | K991583 | | Medtronic Xomed | Xomed Ball-Tip Monopolar Stimulation probe | K992869 | | Magstim | Neurosign 800. 8 Channel Motor Nerve Monitor with accessories | K980148 | | Magstim | Neurosign 800 Motor Motor Nerve Monitor with accessories | K964869 | {1}------------------------------------------------ ### DEVICE DESCRIPTION ### 807.92(a)(4) The C2 NerveMonitor System is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying stimulus for evoked responses. The EMG activity monitoring console uses both video and audio output. Responses monitored with the device may originate from operator applied stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery. The following probes and electrodes include a metal tip, an insulated elastic shaft and a profected electrical pin connector to attach them to the NerveMonitor: | Type | Description | |--------|----------------------------------------| | 522610 | Microfork probe | | 522603 | Bipolar concentric stimulation probe | | 522605 | Bipolar BCS stimulation probe, bayonet | | 525603 | Monopolar MS probe length 4.5cm angled | | 525608 | Monopolar MS probe flexible | | 530626 | 2 SDN electrodes | | 530627 | SDN electrode | | 530666 | Electrode 15 mm bipolar | ## DEVICE INTENDED USE ## 807.92(a)(5) The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device Indications for C2 NerveMonitor System Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities. Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death. Section / Page 5-3 K 111647 {2}------------------------------------------------ # COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) | Device | Predicate Device Nerve Integrity Monitor 3.0 | Predicate Device Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor | Predicate Device Neurosign 400 Motor Nerve Monitor | Subject Device C2 NerveMonitor System | |---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Medtronic Xomed | Magstim | Magstim | inomed Medizintechnik GmbH | | 510(k) Number | K083124 | K083242 | K991583 | N/A | | Device Class | II | II | II | II | | Product code | ETN, GWF | ETN | ETN | GWF, ETN | | Description | NIM 3.0 is a multi- channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. | Motor Nerve Monitor, based upon standard computer components, running Windows XP embedded operating system; information is provided to the surgeon via a waveform graph of EMG activity, and audio amplification of this signal so that the surgeon hears this as he/she is operating | Motor Nerve Monitor, based upon proprietary hardware and software; information is provided to the surgeon via a waveform graph of EMG activity, and audio amplification of this signal so that the surgeon hears this as he/she is operating | C2 is a multi- channel intraoperative neurophysiologic al monitor capable of connecting various styles of patient monitoring electrodes and supplying electrical stimulus for evoked responses. | | Intended Use | The NIM 3.0 is intended for locating and identifying cranial and peripheral motor and mixed motor- sensory nerves during surgery, including spinal cord and spinalnerve roots. The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems. | Intra-operative monitoring and stimulation of cranial and peripheral motor nerves | Intra-operative monitoring and stimulation of cranial and peripheral motor nerves | The C2 is intended for intra- operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The system can provide an automatic periodic stimulation of nerves. | {3}------------------------------------------------ | Device | Predicate Device Nerve Integrity Monitor 3.0 | Predicate Device Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor | Predicate Device Neurosign 400 Motor Nerve Monitor | Subject Device C2 NerveMonitor System with accessories | |-------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Hardware (main unit) | unknown | Standard PC components | Proprietary microprocessor design | Standard PC components | | Headbox Bandwidth Signal Gain | 4/8 Channel 15Hz - 1,85kHz ± 3db unknown | 2/4 Channel 8Hz - 8kHz ± 3dB 500 | 4 Channel 10Hz - 5kHz ± 3dB 477 | 4/8 Channel 0.5Hz - 5kHz ± 3dB, 1-1000 | | Software | unknown | Windows XP Embedded | C++ proprietary code | Windows XP Embedded | | Screen | Touch screen 256Hx256W | 15" colour touch screen | 6" electroluminescent display | 8,4" LCD display | | Method of control | Touch Screen | Touch screen - all controls via software except power ON/OFF | Controls via dedicated buttons or via software using menus selected using front-panel buttons | Front-panel dedicated soft keys, rotary knobs | | Manner of Stimulation | Electrical stimulation via a probe | Electrical stimulation via a probe | Electrical stimulation via a probe | Electrical stimulation via a probe | | Stimulation Range | 0.01mA - 30mA | 0.05mA - 10mA | 0.05mA - 5mA | 0.01mA - 25mA | | Stimulation Type | Monophasic, square pulse, duration 50-250μs | Square wave, negative edge, 200μs pulse width, constant current | Square wave, negative edge, 200μs pulse width, selectable from 100 to 500μs, constant current, constant voltage | Monophasic, square pulse, negative edge, duration 200μs, constant current | | Stimulation Frequency | 1Hz, 4Hz, 7Hz, 10Hz | 3 or 30Hz | 3 or 30Hz | 1 - 30Hz | | Stimulation Probes | Monopolar, bipolar | Monopolar, bipolar, concentric | Monopolar, bipolar, concentric | Monopolar, bipolar, concentric | | Electrodes | Cranial and peripheral motor and mixed-motor- sensory monitoring | Laryngeal electrode; needle electrodes | Laryngeal electrode; needle electrodes | Cranial and peripheral motor and mixed- motor-sensory monitoring | | Training Required for Use | Yes; both for surgeon and OR staff | Yes; both for surgeon and OR staff | Yes; both for surgeon and OR staff | Yes; both for surgeon and OR staff | | Display and Storage | Waveform Signals displayed on screen, Storage on USB Storage Device | Waveform signals displayed on screen; stimulated responses may be optionally automatically | Waveform signals displayed on screen; individual screens may be stored in non- volatile memory | Waveform signals displayed on screen; individual screens may be stored in non-volatile memory; Storage on USB Storage Device | Section / Page 5-5 风 111647 {4}------------------------------------------------ | | | recorded to disc | | | |-------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------| | Print Capacity | Waveform data can be printed to a external printer | Waveform data and patient information can be printed using the internal thermal printer or via an external Letter sized inkjet printer for the generation of reports using stored data and annotated comments | Waveform data can be printed to a proprietary external thermal printer | Waveform data can be printed on an external printer | | Power | 100-240V 50/60Hz | 110/230V 50/60Hz | 110/230V 50/60Hz | 100-240V 50/60Hz | | Electrical Safety | EN 60601-1, Type BF, Class I | EN60601-1; Type BF, Class I | EN60601-1; Type BF, Class I | EN 60601-1; Type BF, Class I | | Compliance Standards | CE-Mark | CE Mark; EN ISO 13485 | CE Mark; BS EN 9001; EN ISO 13485 | CE Mark, EN ISO 13485 | ## Accessories: Probes … | Device | Predicate Device Nerve Integrity Monitor 3.0 with accessories | Predicate Device Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor with accessories | Predicate Device Neurosign 400/800 Motor Nerve Monitor with accessories | Subject Device C2 NerveMonitor System with accessories | |---------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Manufacturer | Medtronic Xomed | Magstim | Magstim | inomed Medizintechnik GmbH | | 510(k) Number | K083124, K992869 | K083242 | K991583, K980148, K964869 | N/A | | Device Class Product code Probe | II ETN, GWF 82-25401, 82- 25100 | II ETN 3600-00, 3602-00 | II ETN 3600-00, 3602-00 | II GWF, ETN 522610, 522603, 522605, 525603, 525608 | | Manner of Stimulation | Electrical stimulation via a probe | Electrical stimulation via a probe | Electrical stimulation via a probe | Electrical stimulation | | Stimulation Range | 0.01mA - 30mA | 0.05mA - 10mA | 0.05mA - 5mA | 0.01mA - 25mA | | Stimulation Type | Monophasic, square pulse, duration 50- 250μs | Square wave, negative edge, 200μs pulse width, constant current | Square wave, negative edge, 200μs pulse width, selectable from 100 to 500μs, constant current, constant voltage | Monophasic, square pulse, negative edge, duration 200μs, constant current | | Stimulation Frequency | 1Hz, 4Hz, 7Hz, 10Hz | 3 or 30Hz | 3 or 30Hz | 1 - 30Hz | | Stimulation Probes | monopolar, bipolar | monopolar, bipolar, concentric | monopolar, bipolar, concentric | bipolar, concentric | | Probe design | - tool holder - touch proof | -tool holder -touch proof connectors | -tool holder - touch proof | - tool holder - touch proof | Section / Page 5-6 亿川b47 ) {5}------------------------------------------------ | Device | Predicate Device Nerve Integrity Monitor 3.0 with accessories | Predicate Device Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor with accessories | Predicate Device Neurosign 400/800 Motor Nerve Monitor with accessories | Subject Device C2 NerveMonitor System with accessories | |-----------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | | connectors - cable assembly | - cable assembly | connectors - cable assembly | connectors - cable assembly | | Probe Dimensions | - cable assembly - types: 1 / 64 mm electrode length | - 100 mm electrode length | - 100 mm electrode length | - cable assembly - types: 1/45/85/130 mm electrode length | | | - types: 0.6/1.1 mm diameter | - types: 0.4/0.6 mm tip diameter | - types: 0.4/0.6 mm tip diameter | - types: 0.4/0.5/0.65/1.4 mm diameter -angled | | Tip Geometry | - fork electrode, round tip, angled bayonet type | - hemispherical tip, bull's eye electrode, straight, blunt tip | - hemispherical tip, bull's eye electrode, straight, blunt tip | - fork electrode, hemispherical tip, bull's eye electrode, straight, blunt tip round tip, angled bayonet type, straight, blunt tip | | Patient contacting material | - stainless steel | - stainless steel | - stainless steel | - stainless steel | | Insulation Material | Polypropylene | Polypropylene | Polypropylene | Polypropylene | | Electrical Insulation | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | | Accessories: Electrodes | | | | | | Device | Predicate Device Nerve Integrity Monitor 3.0 with accessories | Predicate Device Neurosign Avalanche Thyroid/EMG Motor Nerve Monitor with accessories | Predicate Device Neurosign 400/800 Motor Nerve Monitor with accessories | Subject Device C2 NerveMonitor System with accessories | | Manufacturer | Medtronic Xomed | Magstim | Magstim | inomed Medizintechnik GmbH | | 510(k) Number | - | K083242 | K991583, K980148, K964869 | N/A | | Device Class | - | II | II | II | | Product code Electrodes | - | ETN 1699-00, 1705-00 | ETN 1699-00, 1705-00 | GWF, ETN 530626, 530627, 530666 | | 510(k) Number | - | K083242 | K991583, K980148, K964869 | To be defined | | Electrode type | - | needle electrodes | needle electrodes | needle electrodes | | Electrode design | - | - tool holder -touch proof connectors - cable assembly | - tool holder -touch proof connectors - cable assembly | -PP tool holder -touch proof connectors - cable assembly | | Probe Dimensions | - | - needle 20 mm - 0.45 mm diameter | - needle 20 mm - 0.45 mm diameter | - needle 15/20 mm - 0.45/5 mm diameter | | Geometry | - | - straight, needle tip | - straight, needle tip | - handle 20 mm - straight, 45° angled electrode, ground electrode straight, needle tip | | Patient contacting material | - | - stainless steel | - stainless steel | - stainless steel | | Insulation Material | - | Polypropylene | Polypropylene | Polypropylene | | Electrical insulation | - | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Electrical insulation on all surfaces not intended to provide electrical contact with the patient | . Section / Page 5-7 K111647 {6}------------------------------------------------ # Accessories: Electrodes Section / Page 5-8 从111647 {7}------------------------------------------------ # NONCLINICAL AND CLINICAL TEST 807.92(b) # SAFETY and EFFECTIVENESS Preclinical testing verified the design of this device and that all specified requirements were fulfilled. The C2 NerveMonitor and all corresponding accessories are similar in their risks and benefits, as well as their manner of performance, to the predicate devices listed. ### CONCLUSION ### 807.92(b)(3) The C2 NerveMonitor System with accessories are similar to the predicate devices in part or in whole in: - . intended use, . - materials and . - technological characteristics . The C2 NerveMonitor System introduces no new questions concerning safety and efficacy. Section / Page 5-9 {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved strokes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Inomed Medizintechnik GMBH c/o Mr. Saschka Busch IM Hausgruen 29 Emmendingen Germany 79312 - 6 2311 ೧೮೯ Re: K111647 Trade/Device Name: C2 NerveMonitor System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN Dated: August 30, 2011 Received: September 2, 2011 Dear Mr. Busch: 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 {9}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse overlis) (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (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 11 you desire specific davide to: your von vernices/CDRH/CDRHOffices/usm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part nove the regardions 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 Tou may obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Ru. Then. h Malvina B. Eydelman, Ma Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known): K | | | | 247 Device Name: C2 NerveMonitor System with accessories Indications for Use: The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device Indications for C2 NerveMonitor System Monitoring Procedures include: Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities. Indications for C2 NerveMonitor System monitoring of Spinal procedures include: Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Procedures and Thoracic Surgical Procedures. The system is not intended for monitoring life preserving functions. The system may not be used for diagnosing brain death. Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation **Prescription Use** **(Per 21 CFR 801.109)** *(Division Sign-Off)* Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K111647 Section / Page 4-2