Cervello STIM

{0}------------------------------------------------ Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single abstract shape. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 27, 2016 Blackrock Neuromed % John Ziobro Principal Spectramedex 117 West South Street Oconomowo, Wisconsin 53066 Re: K151354 Trade/Device Name: Cervello Stim Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: December 22, 2015 Received: December 29, 2015 Dear Mr. Ziobro: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 yours, # William J. Heetderks -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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K151354 Device Name Cervello® STIM #### Indications for Use (Describe) The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Blackrock Neuromed. The logo features a stylized black penguin-like figure to the left of the text "BLACKROCK NEUROMED". The word "BLACKROCK" is in black, while "NEUROMED" is in blue. ## CERVELLO® STIM Traditional 510(k) Summary SECTION 3 ## Traditional 510(k) Summary - Blackrock NeuroMed, LLC 1. Applicant Name: 630 Komas DR, Suite 200 Salt Lake City, UT 84108 USA Establishment Registration Number: 3009161142 - Submission Correspondent: On behalf of Blackrock Neuromed, the following consultant is assigned the 2. responsibility of submission correspondence: John F. Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc. WI 53066 262.719.8922 - 3. Trade Name: CERVELLO® STIM - 4. Common Name: Cortical stimulator - న్. Description: Cortical Electrode (Per FDA Classification) - MICROMED S.P.A. 6. Manufacturing Site: (Hardware & Software) Via giotto 2 Mogliano veneto Treviso, ITALY 31021 Establishment Registration Number: 3005994236 - 7. Sterilization Site: N/A, The device is not provided sterile, nor does it need to be sterilized for its intended use - 8. Suggested Classification Regulation, Class & Product Code & Panel: 21 CFR 882.1310Neurology Class II Product Code: GYC Panel: Neurology - 9 Reason for Traditional 510(k): New submission - 10. Predicate Device(s): 510(k) Number: K072964 Manufacturer: Cardinal Health (Natus) Trade Name: Nicolet Cortical Stimulator Product Code: GYC (cortical electrodes) Classification: 21 CFR 882.1310 - Predicate Device(s): 510(k) Number: K924226 Manufacturer: Integra Life Sciences Trade Name: Ojemann Cortical Stimulator OCS2 Product Code: GYC (cortical electrodes) Classification: 21 CFR 882.1310 - Predicate Device(s): 510(k) Number: K110410 Manufacturer: Nihon Khoden CERVELLO® STIM Traditional 510(k) Submission {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Blackrock Neuromed. The logo consists of a stylized letter "B" that resembles a penguin, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "NEUROMED" in a lighter blue font. # CERVELLO® STIM Traditional 510(k) Summary VOLUME 2 SECTION 3 #### Trade Name: MS-120-BK Product Code: GYC (cortical electrodes), GWF (evoked response, electrical) Classification: 21 CFR 882.1310 | Predicate Device(s): | 510(k) Number: | K082629 | |----------------------|-----------------|-----------------------------| | | Manufacture: | Grass Telefactor (Astromed) | | | Trade Name: | S12X | | | Product Code: | GYC (cortical electrodes) | | | Classification: | 21 CFR 882.1310 | - 11. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared: | Harmonized standard | Title : | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2005 +<br>/A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and<br>essential performance | | IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral<br>standard: Safety requirements for medical electrical systems | | IEC 60601-1-4:1996<br>+A1:1999 | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral<br>Standard: Programmable electrical medical systems | | IEC 60601-2-26:2012 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety<br>and essential performance of electroencephalographs | | IEC 60601-2-40:1998 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of<br>electromyographs and evoked response equipment | | IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and<br>essential performance - Collateral standard: Electromagnetic compatibility -<br>Requirements and tests | | IEC 62304:2006 | Medical device software - Software life-cycle processes | #### 12. Summary Date: May 15, 2015 - 13. Indication for Use The Cervello® STIM cortical stimulator is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The Cervello® STIM itself is an accessory to the Cervello® Basic Biopotential Signal Acquisition System. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from it. The Cervello® STIM can operate only when so connected and with the Cervello software; it cannot serve as a stand-alone cortical stimulator. ## 14. Technological Characteristics The hardware and software is very similar to other products on the market and does not differ significantly in any respect. This system is combines the hardware and software platforms of the predicates and as such has it has identical technological characteristics. ## 15. Comparison to Predicates The main differences between the CERVELLO® STIM device under review and the predicate(s) (Namely the Nicolet Cortical Stimulator as the primary predicate) are as follows: - Physical size (the proposed device is smaller) | CERVELLO® STIM<br>Traditional 510(k) Submission | VOL_002/003_Traditional 510(k) Summary.docx<br>Confidential | Page 002/003-2 | |-------------------------------------------------|-------------------------------------------------------------|----------------| |-------------------------------------------------|-------------------------------------------------------------|----------------| {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Blackrock Neuromed. The logo consists of a stylized penguin-like figure on the left, followed by the word "BLACKROCK" in black, bold letters. Below "BLACKROCK" is the word "NEUROMED" in a lighter blue color. SECTION 3 - . Stand-alone versus component (The primary predicate is equivalent to the proposed device in terms that both are "accessories" to their parent systems) - . Required components (The proposed device MUST be used in concert with the CERVELLO® amplifier. The predicates may be used as stand-alone devices). - . User interface (The proposed device does not have any display – it's information is conveyed to the user via the software interface that is part of the EEG amplifier system. The predicate devices may include displayed information on the physical devices themselves). - Stimulation parameters. Some of the parameters of the proposed device are at the low end of the predicates (e.g. the train length of the proposed device = 1-15 seconds while predicates extend to 20 or 30 seconds), while some of the stimulation parameters exceed the range of the pulse width duration of the proposed device is 3 msec, while the predicate(s) do not exceed 2 msee). However, these differences do not impact the overall design intent of the device (it is still intended for the same intended user and intended use environment). A comparison of their stimulators and their parameters are shown in the following table: {6}------------------------------------------------ | | | | | | | VOLUME 2 | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | SECTION 3 | | Feature | Nicolet<br>Cortical Stimulator<br>(K072964) | Integra Life Sciences<br>Ojemann Cortical Stimulator<br>OCS2<br>(K924226) | Nihon Kohden<br>MS-120 BK<br>(K110410) | Grass-Telefactor<br>S12X<br>(K082629) | CERVELLO® STIM<br>SD LTM STIM<br>(New - Under Review) | Substantial<br>Equivalence<br>Comments | | Stimulation<br>Output<br>Method | Constant Current | Constant Current | Constant Current | Constant Current | Constant Current | Identical<br>specification.<br>Therefore,<br>Substantially<br>Equivalent | | Maximum<br>Stimulation<br>Charge | 15μC | 20μC | 4.5μC | 20μC | 20μC | Within the<br>range of the<br>predicates.<br>Therefore,<br>Substantially<br>Equivalent | | Current<br>Stimulation<br>Range | 0.1 to 15mA (peak) | 0 to 10 mA (peak) | 0 to 15 mA (peak) | 0.2 to 15 mA, except at 2ms when<br>current is limited to 10 mA | 0 to 15 mA (peak; up to 2KΩ<br>load) in steps of 0.1 mA | Within the<br>range of the<br>predicates.<br>Therefore,<br>Substantially<br>Equivalent | | Stimulation<br>Frequency | 1 to 100Hz<br>Single pulse or continuous | 5,10,20,50,75,100Hz | 0.1 to 50Hz | 2 to 100Hz except at pulse widths<br>of 1 or 2 ms when the frequency is<br>limited to 50Hz | Single pulse; continuous: from 0.1<br>Hz to 100 Hz in steps of 0.1 Hz | Within the<br>boundaries of<br>the predicates.<br>Therefore,<br>Substantially<br>Equivalent | | Stimulation<br>Pulse<br>Width<br>Duration | 0.1 to 1.0 msec per phase | 0.1 to 2.0 ms per phase | 0.05 to 0.3 msec per phase | 0.1 to 2.0 ms | 50 μs to 1000 μs in steps of 1 μs<br>(Equivalent to 0.1 to 1.0 msec) | Within the<br>boundaries of<br>the predicates,<br>Therefore,<br>Substantially<br>Equivalent | | Stimulation<br>Train<br>Length | User specified 0.1-30 seconds | Unknown | Unknown | 0.2 to 20 sec in 7 steps | User specified 1-15 seconds | Within the<br>range of the<br>predicates.<br>Therefore,<br>Substantially<br>Equivalent | | Output<br>Trigger | Trigger Out permits<br>synchronizing external<br>equipment | Unknown | Trigger input and output on the<br>connected acquisition system<br>ME1000-A | Unknown | Trigger on single pulse for<br>stimulation rate up to 20 Hz,<br>trigger on train start for higher | Trigger<br>capability<br>similar to | | | | CERVELLO®<br>STIM | | | | VOLUME 2 | | | | Traditional 510(k) Summary | | | | SECTION 3 | | | Nicolet<br>Cortical Stimulator | Integra Life Sciences<br>Ojemann Cortical Stimulator<br>OCS2 | Nihon Kohden<br>MS-120 BK | Grass-Telefactor<br>S12X | CERVELLO® STIM<br>SD LTM STIM | Substantial<br>Equivalence | | Feature | (K072964) | (K924226) | (K110410) | (K082629) | (New - Under Review) | Comments | | | | | | | stimulation rates | predicates.<br>Therefore,<br>Substantially<br>Equivalent | | Pulse shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Identical<br>specification.<br>Therefore,<br>Substantially<br>Equivalent | | Stimulation<br>Mode | Biphasic | Biphasic | Biphasic (high output mode; not<br>specified for the low output<br>mode) | Selectable positive, negative, or<br>alternating on successive pulses<br>Biphasic | Biphasic (with independently<br>controllable main & reverse<br>phases) | All devices are<br>biphasic<br>Therefore,<br>Substantially<br>Equivalent | | Stimulator<br>features<br>As per<br>advertising<br>materials | The Nicolet Cortical Stimulator<br>interfaces with the NicOne<br>· Stand alone unit or<br>seamlessly integrates with<br>NicOne EEG application<br>software | The Model OCS2 Ojemann<br>Cortical Stimulator is a portable,<br>battery-operated, bipolar stimulator<br>designed according to the<br>specifications of Dr. George<br>Ojemann of the University of<br>Washington, Seattle. It is especially<br>useful for cortical stimulation prior<br>to epilepsy surgery and for<br>intraoperative cortical mapping<br>before cortical incision or<br>placement of depth electrodes in<br>patients with seizure disorders. | The high and low setting.<br>stimulation current and<br>frequency of stimulation is<br>selected by the user. The Nihon<br>Kohden MS-120BK is<br>connected to the MEE 1000A<br>through the JB-116BK or JB-<br>132BK amplifier.<br>In the Low output setting the<br>Nihon Kohden MS-120BK<br>applies cortical stimulation<br>energy through the Nihon<br>Kohden stimulation pod (JS-<br>102B) which is connected to<br>commercially available cortical<br>electrodes (strip and grid<br>electrodes).<br>In the High output setting, the<br>MS-120BK outputs<br>electrostimulation pulse through<br>the Nihon Kohden extension<br>cord (BM-121B) which is<br>connected to commercially<br>available stimulation<br>electrode(s) | Stimulation can be via a traditional<br>hand-held electrode probe for<br>intraoperative stimulation, or via<br>intracranial electrodes using the<br>Grass ESAx Electrode Switching<br>Array option in conjunction with<br>Grass Technologies' Beehive<br>Video/EEG monitoring systems. | • It works in conjunction with<br>Micromed amplifier models SD<br>LTM 64 EXPRESS (i.e. Cervello<br>64)<br>· Direct connection to the<br>amplifier inputs, connection to the<br>patient through the standard<br>amplifier jackbox and<br>commercially available electrodes<br>(strip, grid or depth electrodes). | Equivalent<br>Features.<br>Differences are<br>for marketing<br>purposes and do<br>not impact the<br>design intent /<br>Intended use.<br>Therefore,<br>Substantially<br>Equivalent | | Image: BLACKROCK NEUROMED logo | | CERVELLO®<br>STIM | | | | VOLUME 2 | | | | Traditional 510(k) Summary | | | | SECTION 3 | | | Feature | Integra Life Sciences<br>Ojemann Cortical Stimulator<br>OCS2 | Nihon Kohden<br>MS-120 BK | Grass-Telefactor<br>S12X | CERVELLO® STIM<br>SD LTM STIM | Substantial<br>Equivalence<br>Comments | | | | (K924226) | (K110410) | (K082629) | (New - Under Review) | | | Number of<br>Channels<br>Capable of<br>Being<br>Selected | Nicolet<br>Cortical Stimulator<br>(K072964) | | | | | | | | • Two Stimulus Switching<br>Units may be used to<br>electronically select 128<br>electrodes, 64 electrode pairs<br>• Stimulates "user selectable"<br>electrode pairs or bipolar probe | | | • Direct Connect up to 128<br>channels for electrode selection and<br>EEG recording<br>• Two ESAx switching units can be<br>daisy chained for up to 128<br>channels<br>• ESAx connects any combination<br>of 64 electrodes to the plus and<br>minus stimulus output of the S12X | • Number of Stimulators: 1<br>electrical stimulators, positive and<br>negative electrode can be<br>switched to any of the 64<br>available output channels | Within the<br>range of the<br>predicates.<br>Therefore,<br>Substantially<br>Equivalent | CERVELLO® CERVELLO® STIM Traditional 510(k) Submission Confidential VOLUME 2 {7}------------------------------------------------ {8}------------------------------------------------ Confidential {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Blackrock Neuromed. The logo consists of a stylized penguin-like figure on the left, followed by the word "BLACKROCK" in black, bold letters. Below "BLACKROCK" is the word "NEUROMED" in a lighter blue color. The logo is clean and modern, with a focus on the company name and a simple, recognizable symbol. ## CERVELLO® STIM Traditional 510(k) Summary SECTION 3 ## 16. Conclusions Blackrock Neuromed, believes the proposed CERVELLO® STIM (Model SD LTM STIM) and its predicates, the Nicolet Cortical Stimulator, the Integra Ojemann Cortical Stimulator, The Nihon Kohden MS-120 BK Cortical Stimulator and the Grass-Telefactor Model S12X System, are substantially equivalent in their intended use, intended users, intended use environment and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics and safety standards. The differences that exist between the devices, relating to their physical size, the interconnectiveness with the other common components, their user interface, and minor differences in the stimulation parameters do not affect the relative safety and/or effectiveness.