(235 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the technology focuses on established techniques like TMS, EMG, and MRI-based localization. The performance study compares the device to direct cortical stimulation, not an AI/ML model.
No.
The device is used for non-invasive mapping and localization of brain areas for pre-procedural planning, not for treating any condition or disease.
Yes
The device is indicated for "non-invasive mapping of the primary motor cortex of the brain" and "noninvasive localization of cortical areas that do not contain essential speech function," providing information for "assessment" and "pre-procedural planning." These activities fall under the definition of diagnosis, as they involve identifying the location and function of specific brain areas.
No
The device description explicitly states that 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". This indicates the involvement of hardware components (TMS and EMG) in addition to software. NEXSPEECH is used in conjunction with this system, not as a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Nexstim NBS System and NEXSPEECH® work by applying magnetic stimulation to the brain and measuring the resulting muscle responses (electromyography) or observing speech function during stimulation. This is a non-invasive procedure performed directly on the patient's body, not on a specimen taken from the body.
- Intended Use: The intended use is for non-invasive mapping of the brain's motor and speech areas for pre-procedural planning. This is a diagnostic procedure performed on the patient, not a test performed on a sample.
Therefore, the Nexstim Navigated Brain Stimulation System and NEXSPEECH® fall under the category of in vivo diagnostic or therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
GWF, HAW, IKN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging
Anatomical Site
brain / primary motor cortex / cortical gyrus / essential language cortex / cortical areas of speech function
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study (NEXSPEECH® Clinical Study)
Sample size: 20 patients (age 25-70, 10 females)
Results: 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. Intraoperatively, the localization information provided by NEXSPEECH® should be verified by direct cortical stimulation.
Biocompatibility Testing:
Compliance with ISO 10993-1: 2009. Determined safe for patient use.
Software Verification and Validation:
Compliance with FDA guidance documents (The content of premarket submissions for software contained in medical devices, Off-the-shelf software use in medical devices, General principles of software validation) and standards (IEC 60601-1-4: 2000, IEC 62304: 2006). Results indicated compliance with predetermined specifications and standards.
Electrical Safety Testing:
Compliance with IEC 60601-1: 1988, Aml: 1991, Am2: 1995; IEC 60601-1-1: 2000; IEC 60950-1: 2005; and UL 2601-1: 1997. Results indicated compliance with standards.
Electromagnetic Compatibility (EMC) Testing:
Compliance with IEC 60601-1-2: 2007. Results indicated compliance with standards.
Performance Testing – Bench:
Compliance with 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. Results indicated compliance with predetermined specification and applicable standard.
Usability Testing:
Compliance with IEC 60601-1-6: 2010; and IEC 62366: 2007. Results indicated compliance with applicable standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: high sensitivity
Specificity: relatively low specificity
NPV: 0.84 (overall), 1.0 (in classical Broca)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
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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:
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_