Who can help prepare an FDA 510(k) submission like NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)?

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.

NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

Q: Who is the manufacturer of NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)?

Nexstim OY filed the 510(k) submission for NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) (K112881).

Q: What is the FDA product code for NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)?

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

Q: What is the regulatory pathway for NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)?

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

K112881 · Nexstim OY · GWF · May 22, 2012 · Neurology

Device Facts

Record ID	K112881
Device Name	NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
Applicant	Nexstim OY
Product Code	GWF · Neurology
Decision Date	May 22, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1870
Device Class	Class 2
Attributes	Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K112881 · May 22, 2012	NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)	Nexstim OY	Routine clinical intraoperative direct cortical stimulation (DCS) mapping data	The study compared non-invasive preoperative speech mapping results from the Nexstim NBS System with NEXSPEECH against intraoperative DCS mapping results obtained during routine awake surgery to establish clinical effectiveness.	Clinical study; Direct cortical stimulation; Routine clinical practice; Pre-surgical planning

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
NEXSPEECH Clinical Trial; Comparative study against intraoperative direct cortical stimulation (DCS)	20 patients (age 25-70, 10 females) with a lesion requiring surgical intervention in the vicinity of essential language areas; Sample Size: 20; Number of Sites: 2 university hospitals	Direct cortical stimulation (DCS) performed during awake surgery	Concordance of speech area localization between NBS NEXSPEECH and DCS

Indications for Use

The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH® provides information that may be used in presurgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NEXSPEECH® is intended to be verified by direct cortical stimulation. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals.

Device Story

NBS System 4 combines MRI-based 3D localization of cortical motor areas with noninvasive TMS and simultaneous EMG to identify brain regions evoking muscle responses. NEXSPEECH module adds speech function assessment via object naming tasks time-locked to rapid-rate TMS trains to create transient virtual lesions. Used in clinical settings by trained professionals for pre-procedural/pre-surgical planning. Output consists of mapped cortical areas visualized on patient MRI; helps clinicians identify essential language/motor cortex locations. Benefits include non-invasive pre-surgical mapping to guide surgical planning and minimize post-operative deficits. NEXSPEECH findings require intraoperative verification via direct cortical stimulation (DCS).

Clinical Evidence

Clinical study of 20 patients (age 25-70) compared NEXSPEECH mapping to intraoperative direct cortical stimulation (DCS) during awake surgery. Results showed high sensitivity and high negative predictive value (NPV=0.84 overall; NPV=1.0 in Broca's area). Study concluded NEXSPEECH is effective for identifying non-essential speech areas, with positive findings requiring intraoperative DCS verification. No adverse events reported.

Technological Characteristics

System integrates MRI-based 3D navigation with TMS and EMG. TMS uses figure-8 focal or cooled focal coils; biphasic waveform; max electric field ~172 V/m. EMG system: up to 6 channels, 10-500 Hz range, 3 kHz sampling. Complies with ISO 10993-1 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 62366 (usability).

Indications for Use

Indicated for non-invasive mapping of primary motor cortex to cortical gyrus for pre-procedural planning; NEXSPEECH indicated for non-invasive localization of cortical areas lacking essential speech function for pre-surgical planning in patients undergoing brain surgery. Not for use during surgery. For use by trained clinical professionals.

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

Nexstim Oy / eXimia Navigated Brain Stimulation System (K091457)
Radionics, Inc. / Ojemann Cortical Stimulator (K924226)

Submission Summary (Full Text)

{0}------------------------------------------------ K112881 MAY 2 2 2012 Submission Date: 29 September 2011 Submitter: Nexstim Oy Elimaenkatu 9b 00510 Helsinki, Finland Submitter and Official Contact: Mr. Rainer Harjunpää Director, Quality and Regulatory Affairs Nexstim Oy Elimaenkatu 9b 00510 Helsinki, Finland +011 358 (9) 2727 1710 rainer.harjunpaa(@nexstim.com Manufacturing Site: Nexstim Oy Elimaenkatu 9b 00510 Helsinki, Finland Trade Name: Nexstim Navigational Brain Stimulation (NBS) System 4, and Nexstim NBS System 4 with NEXSPEECH® Stimulator, electrical, evoked response Classification Name: 21 CFR §882.1870, 21 CFR §882.4560, 21 CFR §890.1375 Classification Regulation: GWF, HAW, IKN Product Code: | Substantially Equivalent Devices: | New Nexstim Model | Predicate 510(k) Number | Predicate Manufacturer / Model | |--------------------------------------|-------------------------------------------------------------|----------------------------|--------------------------------------------------------------| | | Nexstim Navigational Brain Stimulation (NBS) System 4 | K091457 | Nexstim Oy / eXimia Navigated Brain Stimulation System | | | Nexstim NBS System 4 with NEXSPEECH® | K924226 | Radionics, Inc. / Ojemann Cortical Stimulator | | | | K091457 | Nexstim Oy / eXimia NBS System | {1}------------------------------------------------ ### Device Description: The NBS System 4 combines magnetic resonance imaging-based, three dimensional localization of cortical motor areas of the brain with noninvasive TMS and simultaneous electromyography measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated. NEXSPEECH® is intended to be used in conjunction with the NBS System 4 for localization and assessment of cortical areas of speech function for pre-procedural planning purposes. Indications for Use: The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for preprocedural planning. Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH® provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NEXSPEECH® is intended to be verified by direct cortical stimulation. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals. Technology Comparison: The Nexstim NBS System and NBS System with NEXSPEECH® employ the same technological characteristics as the predicate devices. {2}------------------------------------------------ ## Summary of Performance Testing: #### Biocompatibility Patient contact materials which are part of the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® were designed to comply with the following standard: - ISO 10993-1: 2009, Biological evaluation of medical devices -. Part 1: Evaluation and testing within a risk management process, and were determined to be safe to use with patients. Software Verification and Validation Software for the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® was designed and developed according to a robust software development process, and were rigorously verified and validated. Software information is provided in accordance with internal documentation and the following Standards and guidance documents: - FDA guidance: The content of premarket submissions for software e contained in medical devices, 11 May 05; - FDA guidance: Off-the-shelf software use in medical devices, 09 . Sen 99: - FDA guidance: General principles of software validation; Final . guidance for industry and FDA staff, 11 Jan 02; - IEC 60601-1-4: 2000, Medical electrical equipment Medical . electrical equipment - Part 1-4: General requirements for safety -Collateral Standard: Programmable electrical medical systems; and - IEC 62304: 2006. Medical device software Software life cycle . processes. Test results indicate that the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® comply with its predetermined specifications, and the Standards and guidance documents. {3}------------------------------------------------ | Electrical Safety | The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® were tested for performance in accordance with the following Standards: IEC 60601-1: 1988, Aml: 1991, Am2: 1995, Medical electrical equipment - Part 1: General requirements for safety; IEC 60601-1-1: 2000, Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems; IEC 60950-1: 2005, Information technology equipment – Safety - Part 1: General requirements; and UL 2601-1: 1997, Medical electrical equipment - Part 1: General requirements for safety. Test results indicated that the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® comply with the Standards. | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electromagnetic Compatibility (EMC) Testing | The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® was tested for performance in accordance with the following Standard: IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. Test results indicated that the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® comply with the Standards. | | Performance Testing – Bench | The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® were tested for performance in accordance with internal documentation and the following FDA Guidance Documents and Standards: Guidance for Industry and Food and Drug Administration Staff Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems; and IEC 60601-2-40:1998, Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment. | Test results indicated that the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® comply with its predetermined specification and the applicable Standard. {4}------------------------------------------------ The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® Performance Testing were tested for usability in accordance with the following Standards: - Usability IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6: . General requirements for basic safety and essential performance -Collateral standard: Usability; and IEC 62366: 2007, Medical devices – Application of usability . engineering to medical devices. Test results indicated that the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® comply with the applicable Standards. The clinical performance of the Nexstim NBS System 4 and NBS Performance Testing System 4 with NEXSPEECH® was established by literature review and appropriate clinical study and validation testing. > The test results indicated that the Nexstim NBS System 4 is safe and effective for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. Furthermore, the test results indicated that the Nexstim NBS System 4 with NEXSPEECH® is safe and effective for noninvasive localization of cortical areas that do not contain essential speech function. ## NEXSPEECH® Clinical Study Description Nexstim has conducted a clinical trial to assess the safety and to establish the effectiveness of Nexstim Navigated Brain Stimulation (NBS) System with NEXSPEECH when used for preoperative mapping of essential language cortex that could be at risk during a surgical procedure. As the gold standard for intraoperative language mapping, direct cortical stimulation (DCS) performed during an awake surgery was selected as the reference method for the comparison (Tharin, Golby 2007). In the study, the mapping results obtained using Nexstim NBS System with NEXSPEECH module were compared to those obtained by invasive DCS performed during awake surgery. Preoperative speech mapping with NEXSPEECH was performed utilizing an object naming task time-locked to a rapid-rate transcranial magnetic stimulation train to non-invasively create a transient virtual lesion and thereby identify essential language areas (Lioumis 2012). Intraoperative language mapping was performed utilizing an object naming task and a simultaneous direct electrical stimulation of the exposed cortex to identify essential language areas (Picht 2006). The DCS was performed according to the normal clinical practice used at each study site. - Clinical *Performance Testing* - *Clinical* {5}------------------------------------------------ #### Subject Population Speech mapping with Nexstim NBS with NEXSPEECH and intraoperative cortical stimulation was performed in 20 patients (age 25-70, 10 females) with a lesion requiring surgical intervention in the vicinity of essential language areas recruited at departments of neurosurgery at 2 university hospitals. #### Comparison to Reference Method The locations of areas relevant to speech production were determined prior to surgery non-invasively with Nexstim NBS System and NEXSPEECH. The patients were subsequently operated by a neurosurgeon that performed a language mapping with DCS during an awake surgery procedure. Locations with positive or negative language response during direct cortical stimulation in the awake surgery were compared to those found in mapping with Nexstim NBS and NEXSPEECH module. A quantitative and qualitative analysis was carried out to evaluate the concordance of results obtained with both methods. #### Localization Assessment In order to evaluate the anatomical location of stimulation effects, each individual brain was divided into 37 individually named anatomical regions (Corina 2010). The NBS data and intraoperative DCS mapping data were both projected on the brain surface divided in this manner. See Figure 1 for schematic representation of the anatomical areas. Image /page/5/Figure/8 description: The image shows a diagram of the lateral surface of the human brain, with various regions labeled. The diagram includes labels such as PSFG, DPrG, MSFG, ASFG, PMFG, and MMFG in the frontal lobe. Other labeled regions include the parietal lobe (SPL, AnG), temporal lobe (MSTG, MMTG, MITG), and occipital lobe (DLOG, VLOG). Figure 1. Schematic representation of the anatomical areas used for assessing concordance of speech area localization by NBS NEXSPEECH and DCS. {6}------------------------------------------------ ## NexSpeech® Clinicial Study Conclusions #### Safety No adverse events related to NEXSPEECH use were reported in the patient population. #### Effectiveness The results of the present clinical trial demonstrate that NEXSPEECH has high sensitivity but relatively low specificity for localizing language areas. NEXSPEECH mapping has a very high overall negative predictive value everywhere in the brain (NPV=0.84), and particularly so in classical Broca (NPV = 1.0) Due to the high sensitivity of NEXSPEECH in obtaining speech responses. negative responses obtained with NEXSPEECH can be used to identify brain regions where DCS responses are unlikely to be obtained. This information on negative speech locations can be utilized for planning procedures. With this strategy, any positive NEXSPEECH responses should be verified by intraoperative DCS. Nexstim concludes that the clinical performance of NEXSPEECH speech mapping is sufficient for noninvasive localization of cortical areas that do not contain essential speech function. Intraoneratively, the localization information provided by NEXSPEECH® should be verified by direct cortical stimulation. ## References Corina DP, Loudermilk BC, Detwiler L, Martin RF, Brinkley JF, Ojemann G. Analysis of naming errors during cortical stimulation mapping: implications for models of language representation. Brain Lang. 2010 Nov;115(2):101-12. Lioumis P. Zhdanov A. Mäkelä N. Lehtinen H. Wilenius J. Neuvonen T, Hannula H, Deletis V, Picht T, Mäkelä JP. A novel approach for documenting naming errors induced by navigated transcranial magnetic stimulation. J Neurosci Methods. 2012 Mar 15;204(2):349-54. Picht, T., Kombos, T., Gramm, H.J., Brock, M., Suess, O., 2006. Multimodal protocol for awake craniotomy in language cortex tumour surgery, Acta Neurochir (Wien) 148, 127-137; discussion 137-128. Tharin S and Golby A. Functional brain mapping and its applications to neurosurgery. Neurosurgery 60:185-201, 2007 {7}------------------------------------------------ ## Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the Nexstim NBS System 4 and Nexstim NBS System 4 with NEXSPEECH®. The results of these activities demonstrate that the Nexstim NBS System 4 and Nexstim NBS System 4 with NEXSPEECH® is safe and effective when used in accordance with its intended use and labeling. Therefore, the Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are considered substantially equivalent to the predicate device. {8}------------------------------------------------ NDC C て | | Comparison of Device Specifications – NBS System 4 | | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Nexstim Oy eXimia NBS System (K091457) | Nexstim Oy NBS System 4 | | Intended use | The Nexstim eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals. | The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The Nexstim NBS System is not intended to be used during a surgical procedure. The Nexstim NBS System is intended to be used by trained clinical professionals. | | Tracking system accuracy | 1.6 mm (mean error in localization of the tool) | 1.6 mm (mean error in localization of the tool) | | Navigation principle | Based on anatomy (MRI picture) and calculated electric field | Based on anatomy (MRI picture) and calculated electric field | | TMS stimulus mode | Single pulse | Single pulse | | Coil configuration | Figure 8-shaped focal coil | Figure 8-shape focal and cooled focal coils | | Maximum applicator surface temperature | Focal coil: 41 °C | Focal coil: 41 °C Cooled focal coil: 43 °C | | Stimulation Output | Maximum electric field ~150 Volts/meter (V/m) measured 25 mm below the coil. | Maximum electric field ~172 V/m measured 25 mm below the coil. | | Maximum output in motor threshold (MT) units | ~2.2 times the motor threshold (MT) of a healthy adult hand muscle where 1 MT corresponds to 45% stimulation intensity. | ~2.5 times the MT of a healthy adult hand muscle where 1 MT corresponds to 40% stimulation intensity. | | Current waveform | Biphasic | Biphasic | | Pulse length | ~280 μs | ~230 μs | | Trigger input/output | 5V TTL input and output | 5V TTL output | | EMG assessment | Muscle response to stimulation measured with eXimia EMG | Muscle response to stimulation measured with eXimia EMG | | Number of EMG channels | Up to 6 channels | Up to 6 channels | | EMG measurement range | 10 - 500 Hz | 10 - 500 Hz | | Sampling rate | 3 kHz | 3 kHz | | Characteristic | Nexstim Oy eXimia NBS System (K091457) | Nexstim Oy NBS System 4 | | Common mode rejection ratio (CMRR) | > 90 dB at 10 - 250 Hz | > 90 dB at 10 - 250 Hz | | NBS system with TMS electrical rating | Voltage: 100-120 Vac 220-240 Vac Frequency: 50/60 Hz | Voltage: 100-120 Vac 220-240 Vac Frequency: 50/60 Hz | | EMG electrical rating | Voltage: 120-240 Vac Frequency: 50/60 Hz | Voltage: 120-240 Vac Frequency: 50/60 Hz | | Weight | eXimia weight: 300 kg TMS weight: 140kg Floor stand: 60kg | Total weight: 223 kg NBS System 4 has TMS II stimulator housed in the same cart with the whole NBS system. | | Dimensions | TMS cabinet: 72 cm (width) x 60 cm (depth) x 98 cm (height) NBS System cart: 80 cm (width) x 70 cm (depth) x 120 cm (height) | All housed in the NBS System 4 cart: 80 cm (width) x 70 cm (depth) x 209 cm (max. height) | Page 11 of 13 {9}------------------------------------------------ Page 12 of 13 {10}------------------------------------------------ 0(k) Summ Stocedure. The Nexstim NBS System with NEXSPEE ntended to be used by trained clinical professionals. exstim NBS System with NEXSPE ended to be used during a surgical Response to stimulation measured with CMT for for determination in in in in in in in in in in in in in in in in mana Response qualificanse by sponse of and the films for offexstim Oy NBS System 4 v NEXSPEECH® -10 Hz in 0,1 Hz st inguage are Yes mparison of Device Specifications - Nexstim NBS System 4 with NEXSPEE es requency selectable from 5、10、2 7 and 100Hz mapping: locate sensorime and descending montor protocorporations it the safest online the total to the same the safest some integral profile to the the sorimotor cortex and descen or pathways. egra Radionics Inc. Oje. ortical Stimulator (K924 ch mapping: identify esser hage sites to maximise thise thinks umour resection and minim anent language deficits. d for intraoperative con tion mapping to aid in ns in the vicinity of es le response measured w hal/3rd Party EMG. Resp tial language si ential cortex (es ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------exstim Oy eXimia Navigated Stimulation System (K09145 ally trigged single pulses (no r Iotor corte ട് IS mode support Stimulation respons detection Area of brain to be stimulated rTMS frequenc range haracteristic ntended use Page 13 of {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Nexstim Ov c/o Mr. Rainer Harjunpää Director of Ouality and Regulatory Affairs Elimäenkatu 9B. FI-00510 Helsinki. Finland MAY 2 2 2017 Re: K112881 Trade/Device Name: Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH (TM) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, HAW, IKN Dated: May 3, 2012 Received: May 10, 2012 Dear Mr. Harjunpää: 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. {12}------------------------------------------------ #### Page 2 - Mr. Rainer Harjunpää 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.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 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 Small Manufacturers, 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Erh. Rur, mo Malvina B. Eydelman, A Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {13}------------------------------------------------ Indications for Use 510(k) Number (if known): Device Name: Indications for Use: K112881 Nexstim Navigated Brain Stimulation (NBS) System 4 and NBS System 4 with NEXSPEECH® The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. Nexstim NEXSPEECH®, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH® provides information that may be used in presurgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by NEXSPEECH® is intended to be verified by direct cortical stimulation. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals. AND/OR . Over-The-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kristen Bowsher (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices K112881 510(k) Number_

NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

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NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

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Predicate Devices

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