(115 days)
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.
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 provided text describes the C2 NerveMonitor System, an intraoperative neurophysiological monitor. However, it does not contain specific acceptance criteria, a study that proves the device meets acceptance criteria, or details regarding the methodologies listed in your request (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth type, training set size, and ground truth establishment for the training set).
Instead, the document is a 510(k) Summary, which is a premarket notification to the FDA. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
The "NONCLINICAL AND CLINICAL TEST" section states:
"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."
This is a general statement of verification and claims similarity to predicate devices, but it does not present the detailed information you requested about acceptance criteria and performance studies.
Therefore, I cannot populate the table or answer the specific questions because the information is not present in the provided document.
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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 MotorNerve Monitor | K083242 |
| Magstim | Neurosign 400 Motor Nerve Monitor | K991583 |
| Medtronic Xomed | Xomed Ball-Tip MonopolarStimulation probe | K992869 |
| Magstim | Neurosign 800. 8 Channel MotorNerve Monitor with accessories | K980148 |
| Magstim | Neurosign 800 Motor Motor NerveMonitor 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
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COMPARISON OF TECHNICAL CHARACTERISTICS
807.92(a)(6)
| Device | Predicate DeviceNerve IntegrityMonitor 3.0 | Predicate DeviceNeurosign AvalancheThyroid/EMG MotorNerve Monitor | Predicate DeviceNeurosign 400Motor NerveMonitor | Subject DeviceC2 NerveMonitorSystem |
|---|---|---|---|---|
| Manufacturer | Medtronic Xomed | Magstim | Magstim | inomedMedizintechnikGmbH |
| 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-channelintraoperativeneurophysiologicalmonitor capable ofconnecting variousstyles of patientmonitoringelectrodes andsupplying electricalstimulus for evokedresponses. | Motor Nerve Monitor,based upon standardcomputercomponents, runningWindows XPembedded operatingsystem; information isprovided to thesurgeon via awaveform graph ofEMG activity, andaudio amplification ofthis signal so that thesurgeon hears this ashe/she is operating | Motor NerveMonitor, basedupon proprietaryhardware andsoftware;information isprovided to thesurgeon via awaveform graph ofEMG activity, andaudio amplificationof this signal sothat the surgeonhears this ashe/she is operating | C2 is a multi-channelintraoperativeneurophysiological monitorcapable ofconnectingvarious styles ofpatientmonitoringelectrodes andsupplyingelectrical stimulusfor evokedresponses. |
| Intended Use | The NIM 3.0 isintended forlocating andidentifying cranialand peripheralmotorand mixed motor-sensory nervesduring surgery,including spinalcord andspinalnerve roots.The APS electrodeis an accessoryintended forproviding automaticperiodic stimulationto nerves whenused with theMedtronic NerveMonitoringSystems. | Intra-operativemonitoring andstimulation of cranialand peripheral motornerves | Intra-operativemonitoring andstimulation ofcranial andperipheral motornerves | The C2 isintended for intra-operativemonitoring andstimulation forlocalization andidentification ofcranial andperipheral motorand mixed motorsensory nervesduring surgery,including spinalcord and spinalnerve roots. Thesystem canprovide anautomaticperiodicstimulation ofnerves. |
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| Device | Predicate DeviceNerve IntegrityMonitor 3.0 | Predicate DeviceNeurosignAvalancheThyroid/EMGMotor NerveMonitor | Predicate DeviceNeurosign 400Motor NerveMonitor | Subject DeviceC2 NerveMonitorSystem withaccessories |
|---|---|---|---|---|
| Hardware(main unit) | unknown | Standard PCcomponents | Proprietarymicroprocessordesign | Standard PCcomponents |
| HeadboxBandwidthSignal Gain | 4/8 Channel15Hz - 1,85kHz ±3dbunknown | 2/4 Channel8Hz - 8kHz ± 3dB500 | 4 Channel10Hz - 5kHz ± 3dB477 | 4/8 Channel0.5Hz - 5kHz ± 3dB,1-1000 |
| Software | unknown | Windows XPEmbedded | C++ proprietarycode | Windows XPEmbedded |
| Screen | Touch screen256Hx256W | 15" colour touchscreen | 6"electroluminescentdisplay | 8,4" LCD display |
| Method ofcontrol | Touch Screen | Touch screen - allcontrols viasoftware exceptpower ON/OFF | Controls viadedicated buttonsor via softwareusing menusselected usingfront-panel buttons | Front-panel dedicatedsoft keys, rotary knobs |
| Manner ofStimulation | Electricalstimulation via aprobe | Electricalstimulation via aprobe | Electricalstimulation via aprobe | Electrical stimulationvia a probe |
| StimulationRange | 0.01mA - 30mA | 0.05mA - 10mA | 0.05mA - 5mA | 0.01mA - 25mA |
| StimulationType | Monophasic,square pulse,duration 50-250μs | Square wave,negative edge,200μs pulse width,constant current | Square wave,negative edge,200μs pulse width,selectable from 100to 500μs, constantcurrent, constantvoltage | Monophasic, squarepulse, negative edge,duration 200μs,constant current |
| StimulationFrequency | 1Hz, 4Hz, 7Hz,10Hz | 3 or 30Hz | 3 or 30Hz | 1 - 30Hz |
| StimulationProbes | Monopolar, bipolar | Monopolar, bipolar,concentric | Monopolar, bipolar,concentric | Monopolar, bipolar,concentric |
| Electrodes | Cranial andperipheral motorand mixed-motor-sensory monitoring | Laryngealelectrode; needleelectrodes | Laryngealelectrode; needleelectrodes | Cranial and peripheralmotor and mixed-motor-sensorymonitoring |
| TrainingRequired forUse | Yes; both forsurgeon and ORstaff | Yes; both forsurgeon and ORstaff | Yes; both forsurgeon and ORstaff | Yes; both for surgeonand OR staff |
| Display andStorage | Waveform Signalsdisplayed onscreen, Storage onUSB StorageDevice | Waveform signalsdisplayed onscreen; stimulatedresponses may beoptionallyautomatically | Waveform signalsdisplayed onscreen; individualscreens may bestored in non-volatile memory | Waveform signalsdisplayed on screen;individual screens maybe stored in non-volatilememory; Storage onUSB Storage Device |
Section / Page 5-5
风 111647
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| recorded to disc | ||||
|---|---|---|---|---|
| PrintCapacity | Waveform data canbe printed to aexternal printer | Waveform data andpatient informationcan be printedusing the internalthermal printer orvia an externalLetter sized inkjetprinter for thegeneration ofreports usingstored data andannotatedcomments | Waveform data canbe printed to aproprietary externalthermal printer | Waveform data can beprinted on an externalprinter |
| Power | 100-240V 50/60Hz | 110/230V 50/60Hz | 110/230V 50/60Hz | 100-240V 50/60Hz |
| ElectricalSafety | EN 60601-1, TypeBF, Class I | EN60601-1; TypeBF, Class I | EN60601-1; TypeBF, Class I | EN 60601-1; Type BF,Class I |
| ComplianceStandards | CE-Mark | CE Mark; EN ISO13485 | CE Mark; BS EN9001; EN ISO13485 | CE Mark,EN ISO 13485 |
Accessories: Probes
…
| Device | Predicate DeviceNerve IntegrityMonitor 3.0 withaccessories | Predicate DeviceNeurosign AvalancheThyroid/EMG MotorNerve Monitor withaccessories | Predicate DeviceNeurosign 400/800Motor NerveMonitor withaccessories | Subject DeviceC2 NerveMonitorSystem withaccessories |
|---|---|---|---|---|
| Manufacturer | Medtronic Xomed | Magstim | Magstim | inomedMedizintechnikGmbH |
| 510(k) Number | K083124, K992869 | K083242 | K991583,K980148, K964869 | N/A |
| Device ClassProduct codeProbe | IIETN, GWF82-25401, 82-25100 | IIETN3600-00, 3602-00 | IIETN3600-00, 3602-00 | IIGWF, ETN522610, 522603,522605, 525603,525608 |
| Manner ofStimulation | Electrical stimulationvia a probe | Electrical stimulation via aprobe | Electrical stimulationvia a probe | Electrical stimulation |
| StimulationRange | 0.01mA - 30mA | 0.05mA - 10mA | 0.05mA - 5mA | 0.01mA - 25mA |
| StimulationType | Monophasic, squarepulse, duration 50-250μs | Square wave, negativeedge, 200μs pulse width,constant current | Square wave,negative edge, 200μspulse width,selectable from 100 to500μs, constantcurrent, constantvoltage | Monophasic,square pulse,negative edge,duration 200μs,constant current |
| StimulationFrequency | 1Hz, 4Hz, 7Hz, 10Hz | 3 or 30Hz | 3 or 30Hz | 1 - 30Hz |
| StimulationProbes | 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
)
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| Device | Predicate DeviceNerve IntegrityMonitor 3.0 withaccessories | Predicate DeviceNeurosign AvalancheThyroid/EMG MotorNerve Monitor withaccessories | Predicate DeviceNeurosign 400/800Motor NerveMonitor withaccessories | Subject DeviceC2 NerveMonitorSystem withaccessories |
|---|---|---|---|---|
| connectors- cable assembly | - cable assembly | connectors- cable assembly | connectors- cable assembly | |
| ProbeDimensions | - cable assembly- types: 1 / 64 mmelectrodelength | - 100 mm electrodelength | - 100 mm electrodelength | - cable assembly- types:1/45/85/130 mmelectrodelength |
| - types: 0.6/1.1 mmdiameter | - types: 0.4/0.6 mm tipdiameter | - types: 0.4/0.6 mmtip diameter | - types:0.4/0.5/0.65/1.4mm diameter-angled | |
| Tip Geometry | - fork electrode,round tip, angledbayonet 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 eyeelectrode, straight,blunt tip round tip,angled bayonettype, straight, blunttip |
| Patientcontactingmaterial | - stainless steel | - stainless steel | - stainless steel | - stainless steel |
| InsulationMaterial | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| ElectricalInsulation | Electrical insulationon all surfaces notintended to provideelectrical contact withthe patient | Electrical insulation on allsurfaces not intended toprovide electrical contactwith the patient | Electrical insulationon all surfaces notintended to provideelectrical contact withthe patient | Electricalinsulation on allsurfaces notintended to provideelectrical contactwith the patient |
| Accessories: Electrodes | ||||
| Device | Predicate DeviceNerve IntegrityMonitor 3.0 withaccessories | Predicate DeviceNeurosign AvalancheThyroid/EMG MotorNerve Monitor withaccessories | Predicate DeviceNeurosign 400/800Motor NerveMonitor withaccessories | Subject DeviceC2 NerveMonitorSystem withaccessories |
| Manufacturer | Medtronic Xomed | Magstim | Magstim | inomedMedizintechnikGmbH |
| 510(k) Number | - | K083242 | K991583,K980148, K964869 | N/A |
| Device Class | - | II | II | II |
| Product codeElectrodes | - | ETN1699-00, 1705-00 | ETN1699-00, 1705-00 | GWF, ETN530626, 530627,530666 |
| 510(k) Number | - | K083242 | K991583,K980148, K964869 | To be defined |
| Electrode type | - | needle electrodes | needle electrodes | needle electrodes |
| Electrodedesign | - | - tool holder-touch proof connectors- cable assembly | - tool holder-touch proof connectors- cable assembly | -PP tool holder-touch proof connectors- cable assembly |
| ProbeDimensions | - | - needle 20 mm- 0.45 mm diameter | - needle 20 mm- 0.45 mm diameter | - needle 15/20 mm- 0.45/5 mmdiameter |
| Geometry | - | - straight, needle tip | - straight, needle tip | - handle 20 mm- straight,45° angledelectrode, groundelectrode straight,needle tip |
| Patientcontactingmaterial | - | - stainless steel | - stainless steel | - stainless steel |
| InsulationMaterial | - | Polypropylene | Polypropylene | Polypropylene |
| Electricalinsulation | - | Electrical insulation on allsurfaces not intended toprovide electrical contactwith the patient | Electrical insulationon all surfaces notintended to provideelectrical contactwith the patient | Electrical insulationon all surfaces notintended to provideelectrical contactwith the patient |
. Section / Page 5-7
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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
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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
§ 882.1870 Evoked response electrical stimulator.
(a)
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.(b)
Classification. Class II (performance standards).