Who is the manufacturer of Nexstim Navigated Brain Therapy (NBT) System 2?

Nexstim Plc filed the 510(k) submission for Nexstim Navigated Brain Therapy (NBT) System 2 (K171902).

What is the FDA product code for Nexstim Navigated Brain Therapy (NBT) System 2?

OBP. It is classified under 21 CFR 882.5805 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Nexstim Navigated Brain Therapy (NBT) System 2?

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

What are the predicate devices for Nexstim Navigated Brain Therapy (NBT) System 2?

Magstim Company Limited / Rapid² Therapy System (K143531).

Who can help prepare an FDA 510(k) submission like Nexstim Navigated Brain Therapy (NBT) System 2?

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 Therapy (NBT) System 2

K171902 · Nexstim Plc · OBP · Nov 10, 2017 · Neurology

Device Facts

Record ID	K171902
Device Name	Nexstim Navigated Brain Therapy (NBT) System 2
Applicant	Nexstim Plc
Product Code	OBP · Neurology
Decision Date	Nov 10, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5805
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Device Story

Repetitive transcranial magnetic stimulation (rTMS) system; delivers pulsed magnetic fields to prefrontal cortex to induce neural action potentials; treats MDD symptoms without inducing seizure. Inputs: patient MRI (DICOM), EMG signals. Operation: software imports MRI, generates 3D head model, localizes cortical motor areas, and guides TMS coil placement via navigation. Used in inpatient/outpatient settings (clinics, hospitals) by trained medical professionals. Output: targeted magnetic stimulation. Clinical decision-making: physician uses system to localize stimulation site and deliver therapy; benefits patient by providing non-invasive treatment for treatment-resistant depression.

Clinical Evidence

Bench testing only. Studies compared Nexstim's EMG-determined motor threshold (MT) method to manual methods (O'Reardon, 2007; Pridmore, 1998) and Nexstim's navigated coil localization to manual methods (Ahdab, 2010), demonstrating no significant statistical difference and substantially equivalent results.

Technological Characteristics

rTMS system; copper winding air-core coil; 10 Hz frequency; 120% MT intensity. 3D MRI-based navigation; EMG integration for MT detection. Complies with IEC 60601-1, IEC 60601-1-2, ISO 10993-1. Software-controlled; DICOM connectivity.

Indications for Use

Indicated for treatment of Major Depressive Disorder in adults who failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.

Regulatory Classification

Identification

A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.

Predicate Devices

Magstim Company Limited / Rapid² Therapy System (K143531)

Reference Devices

Nexstim Oy / Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System with NexSpeechTM (K112881)
Magstim Company Limited / Rapid² Therapy System (K162935)
Neuronetics, Inc. Neurostar TMS Therapy System (K133408)
Tonica Elektronik A/S / MagVita TMS Therapy System (K150641)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 10, 2017 Nexstim Plc Jarmo Laine Vice President, Medical Affairs Elimaenkatu 9b Helsinki, 00510 Finland Re: K171902 Trade/Device Name: Nexstim Navigated Brain Therapy (NBT) System 2 Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP, GWF, HAW, IKN Dated: October 11, 2017 Received: October 12, 2017 Dear Jarmo Laine: 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 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); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ### William J. Heetderks -S 2017.11.10 09:28:53 -05'00' Carlos L. Peña. PhD. MS for 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) K171902 Device Name Nexstim Navigated Brain Therapy (NBT) System 2 Indications for Use (Describe) Nexstim Navigated Brain Therapy (NBT) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ | Submission Date: | 01 October 2017 | | | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Nexstim Plc Elimaenkatu 9b 00510 Helsinki, Finland | | | | Submitter and Official Contact: | Mr. Jarmo Laine Vice President, Medical Affairs Nexstim Plc Elimaenkatu 9b 00510 Helsinki, Finland +011 358 50 374 2748 jarmo.laine@nexstim.com | | | | Manufacturing Site: | Nexstim Plc Elimaenkatu 9b 00510 Helsinki, Finland | | | | Trade Name: | Nexstim Navigated Brain Therapy (NBT®) System 2 | | | | Classification Name: | Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder | | | | Primary Classification Regulation and Product Code: | 21 CFR §882.5805 / OBP | | | | Secondary Classification Regulation and Product Code: | 21 CFR §882.1870 / GWF 21 CFR §882.4560 / HAW 21 CFR §890.1375 / IKN | | | | Substantially Equivalent Devices: | New Model | Predicate 510(k) Number | Predicate Manufacturer / Model | | | Nexstim Navigated Brain Therapy (NBT®) System 2 | K143531 | Magstim Company Limited / Rapid² Therapy System (Primary Predicate) | | | | K112881 | Nexstim Oy / Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System with NexSpeechTM (Reference Predicate) | | | | K162935 | Magstim Company Limited / Rapid² Therapy System (Reference Predicate) | | | | K133408 | Neuronetics, Inc. Neurostar TMS Therapy System (Reference Predicate) | | | | K150641 | Tonica Elektronik A/S / MagVita TMS Therapy System (Reference Predicate) | {4}------------------------------------------------ | Device Description: | The Nexstim NBT® System 2 is a repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder (MDD) without inducing seizure in patients who have failed one antidepressant medication. The Nexstim NBT System 2 is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units. The Nexstim NBT System 2 consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBT System 2 is provided by the software. The Nexstim NBT System 2 combines magnetic resonance imaging- based (MRI-based), three-dimensional (3-D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. The Nexstim NBT System 2 software is used to import a patient's MR image slices through standard DICOM communication protocols, and generates an accurate 3-D model of the patient's head which can be "peeled back" to reveal the anatomical structures of the brain. | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | {5}------------------------------------------------ #### Technology Comparison: The Nexstim NBT System 2 employs the same technological characteristics as the predicate devices. | Characteristic | Magstim Company Limited Rapid² Therapy System (K143531) (Primary Predicate) | Nexstim Oy NBS System 4 with NEXSPEECH™ (K112881) (Reference Predicate) | Nexstim Navigated Brain Therapy (NBT®) System 2 (Proposed Device) | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Magnetic Field Intensity | 120 % of motor threshold (MT) | Not applicable | 120 % of MT | | Frequency | 10 Hz | Not applicable | 10 Hz | | Train Duration | 4 seconds (sec) | Not applicable | 4 sec | | Inter-train Interval | 26 sec | Not applicable | 26 sec | | Number of trains | 75 | Not applicable | 75 | | Maximum pulses per session | 3,000 | Not applicable | 3,000 | | Treatment session duration | ~ 37.5 minutes | Not applicable | ~ 37.5 minutes | | Sessions/week | Five (5) | Not applicable | Five (5) | | Treatment schedule | Five (5) daily sessions for six (6) weeks | Not applicable | Five (5) daily sessions for six (6) weeks | | Area of brain to be stimulated | Dorsolateral Prefrontal cortex (DLPFC) | Language areas | DLPFC | | Coil Material | Copper winding with air core | Copper winding with air core | Copper winding with air core | | Coil Windings | 70 mm N = 3 x 19 turns /wing x 2 wings (1.75 mm x 6 mm) | 72 mm (coil wing distance 2 mm, coil wind center distance 74 mm) 10 turns/wing | 72 mm (coil wing distance 2 mm, coil wind center distance 74 mm) 10 turns/wing | | Average Inductance | 12 μH | 10.4 μH | 10.4 μH | | Characteristic (continued) | Magstim Company Limited Rapid² Therapy System (K143531) (Primary Predicate) | Nexstim Oy NBS System 4 with NEXSPEECH™ (K112881) (Reference Predicate) | Nexstim Navigated Brain Therapy (NBT®) System 2 (Proposed Device) | | Amplitude Range | 0.28 to 1.9 Standard MT (SMT) | 0 to 2.5 SMT | 0 to 2.5 SMT | | Pulse Length | 300 µsec | 230 µs ± 5 µsec | 230 µs ± 5 µsec | | Frequency Range | 0.1 - 30 Hz | 0.1 - 50 Hz | 0.1 - 50 Hz | | Coil Positioning Principle | Indirect targeting of treatment target though measured distance and direction (5cm) from Abductor Pollicis Brevis (APB). Measure derived from statistical distance of DLPFC from APB. | Individual patient direct targeting of anatomical treatment location (Language areas). Placing of E-field maximum location on 3D model built from patients individual MRI. | Individual patient direct targeting of anatomical treatment location (DLPFC). Placing of E-field maximum location on 3D model built from patients individual MRI. | | MT Response Detection | Visual qualitative monitoring for APB response. | EMG provides qualitative and quantitative data based on which user defines MT. | EMG provides qualitative and quantitative data based on which user defines MT. | {6}------------------------------------------------ ### Summary of Performance Testing: | Sterilization and Shelf Life Verification | The Nexstim NBT System 2 is not shipped sterile, and is not intended to be sterilized by the user. | |--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The NBT Head Tracker has a shelf life of 2 years. | | | The Nexstim Focal and Cooled Coils have a useful product life of two (2) million pulses or two (2) years from date of manufacture, whichever comes first. | | | No other Nexstim NBT System 2 component has a shelf life. | | Biocompatibility Verification | Patient contact materials which are part of the Nexstim NBT System 2 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 NBT System 2 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 contained in medical devices, 11 May 05; • FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; • FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; • FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14. • FDA guidance: Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) software, 14 Jan 05; and • IEC 62304: 2006, Medical device software – Software life cycle processes. Test results indicate that the Nexstim NBT System 2 software complies with its predetermined specifications, and the Standards and guidance documents. | | Electrical Safety Verification | The Nexstim NBT System 2 was tested for performance in accordance with the following Standards: • IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; and • ANSI/AAMI ES 60601-1: 2005, Am2: 2010, US National differences to IEC 60601-1: 2005. Test results indicated that the Nexstim NBT System 2 complies with the Standards. | | Electromagnetic Compatibility (EMC) Verification | The Nexstim NBT System 2 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; and | | | FCC 47 CFR §15, Telecommunication Chapter I--Federal ● Communications Commission Subchapter A-General- Radio Frequency Devices | | | Test results indicated that the Nexstim NBT System 2 complies with the Standards. | | Performance Testing – Bench Verification | The Nexstim NBT System 2 was 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 | | | Study Comparing Nexstim's Electromyography-Determined Motor ● Threshold (MT) Method to the Manually-Determined MT Method (O'Reardon, 2007; Pridmore, 1998) Demonstrating No Significant Statistical Difference Between Methods | | | Study Comparing Nexstim's Navigated Coil Localization Method to ● Manually-Determined Method (moving the coil 5.5 cm anteriorly from the motor cortex, Ahdab, 2010) Demonstrating Substantially Equivalent Results Between Methods | | | Test results indicated that the Nexstim NBT System 2 complies with its predetermined specification and the applicable Standard. | | Performance Testing – Usabilitv Validation | The Nexstim NBT System 2 was tested for usability in accordance with the following Standards: | | | 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 NBT System 2 complies with the applicable Standards. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the Nexstim NBT System 2. The results of these activities demonstrate that the Nexstim NBT System 2 is safe and effective when used in accordance with its intended use and labeling. > Therefore, the Nexstim NBT System 2 is considered substantially equivalent to the predicate devices.

Nexstim Navigated Brain Therapy (NBT) System 2

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Nexstim Navigated Brain Therapy (NBT) System 2

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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