(176 days)
The 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.
The Nexstim Navigated Brain Therapy (NBT®) System is a non-invasive, 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 (1) 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 (3D) 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 to generate an accurate 3D model of the patient's head which can be electronically peeled back to reveal the anatomical structures of the brain.
The provided text is a 510(k) Premarket Notification from the FDA for the Nexstim Navigated Brain Therapy (NBT) System 2. This document is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed clinical study demonstrating the device's efficacy against specific, quantitative acceptance criteria in the manner one might see for a diagnostic AI.
The "acceptance criteria" discussed in this document are primarily related to technical specifications and regulatory compliance for a neurostimulation device, and the "study" proving it meets them refers to verification and validation activities against these technical standards, and a direct comparison to a predicate device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not explicitly detailed within this type of regulatory submission because the approval is based on demonstrating equivalence in technical characteristics and safety/performance, not on a novel clinical efficacy trial with specific, quantitatively defined "acceptance criteria" for a diagnostic algorithm's performance on a test set.
However, I can extract and present the information that is available and relevant to your request based on the provided document.
Acceptance Criteria and Device Performance (Based on Technical Equivalence)
The acceptance criteria here are implicitly met by demonstrating that the proposed device (Nexstim NBT® System 2 (Proposed Device)) is substantially equivalent to the predicate device (Tonica Electronik A/S Mag Vita TMS Therapy System w/ Theta Burst Stimulation ([K173620](https://510k.innolitics.com/search/K173620))) and the previously cleared version of its own device (Nexstim Navigated Brain Therapy (NBT®) System 2 ([K171902](https://510k.innolitics.com/search/K171902))), particularly for the new Intermittent Theta Burst (iTBS) Protocol. The "performance" is demonstrated by showing that the key technical characteristics are the same or comparable, and that compliance with relevant standards has been achieved.
Note: The performance here is primarily about technical specifications rather than statistical performance metrics (like sensitivity, specificity, AUC) for a diagnostic output, as this is a therapeutic rather than a diagnostic device, and the submission is focused on substantial equivalence.
| Acceptance Criteria Category (Derived from Equivalence Argument) | Reported Device Performance (Nexstim NBT System 2 - Proposed Device) | Discussion/Proof of Meeting Criteria |
|---|---|---|
| Magnetic Field Intensity | 120% of MT | Same as predicate (K173620) and previously cleared device (K171902). |
| 10Hz Treatment Parameters (Frequency, Train Duration, Inter-train Interval, Number of Trains, Max Pulses/Session, Session Duration, Sessions/Week, Treatment Schedule) | Aligned with predicate characteristics and FDA-cleared minor protocol changes for other equivalent devices. | "The Nexstim NBT System 2 is technologically equivalent to the MagVita TMS Therapy System as demonstrated in 510(k) submission K171902/S001, pages 4818-4822." |
| iTBS Treatment Parameters (Magnetic Field Intensity, Frequency, Train Duration, Inter-train Interval, Burst Pulses, Number of Trains, Max Pulses/Session, Session Duration) | Aligned with K173620, ensuring consistent stimulus intensity within bursts. | "The iTBS protocol was cleared by FDA in the Mag Vita TMS Therapy System w/ Theta Burst Stimulation 510(k) submission K173620 for Tonica Electrnik A/S. The Nexstim NBT System 2 is technologically equivalent to the MagVita TMS Therapy System as demonstrated in 510(k) submission K171902/S001, pages 4818-4822." |
| Protocols | Standard 10 Hz and iTBS | Same as K173620 for both protocols. 10 Hz was already cleared in K171902. |
| Area of Brain to be Stimulated | DLPFC (Dorsolateral Prefrontal Cortex) | Same as predicate and previously cleared device. |
| Coil Material | Copper winding with air core | Same as predicate and previously cleared device. No change from coil cleared in K171902. |
| Coil Windings | 72 mm, 10 turns/wing | Same as predicate and previously cleared device. Same coil as cleared in K171902. |
| Amplitude Range | 0 to 2.5 SMT | Same as previously cleared device. No change from that cleared in K171902. |
| Pulse Length | 230 µs ± 5 µsec | Same as previously cleared device. No change from that cleared in K171902. |
| Frequency Range | 0.1 - 50 Hz (includes iTBS frequency of 50 Hz) | No change from range cleared in K171902. |
| Coil Positioning Principle | Individual patient direct targeting of anatomical treatment location (DLPFC) using 3D MRI model | Same as previously cleared device. No change from that cleared in K171902. Differs from predicate which uses indirect targeting. However, this is already an established feature of the Nexstim NBT System (cleared in K171902). |
| MT Response Detection | EMG provides qualitative and quantitative data based on which user defines MT. | Same as previously cleared device. No change from that cleared in K171902. (Predicate uses visual qualitative monitoring). |
| Sterilization & Shelf Life | Not shipped sterile. NBT Head Tracker: 2 years. Focal/Cooled Coils: 2M pulses or 2 years. | Verified through testing. |
| Biocompatibility | Complies with ISO 10993-1:2009. | Determined safe for patient contact. |
| Software Verification & Validation | Rigorously verified and validated per internal process and FDA/IEC standards (e.g., FDA guidance for software, IEC 62304). | Test results indicate compliance with predetermined specifications and standards. |
| Electrical Safety | Complies with IEC 60601-1:2005, Am1:2012 and ANSI/AAMI ES 60601-1:2005, Am2:2010. | Test results indicate compliance with standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2007 and FCC 47 CFR §15. | Test results indicate compliance with standards. |
| Bench Verification (Performance Testing) | Complies with internal documentation and FDA Guidance for rTMS systems. | Test results indicate compliance with predetermined specification and applicable standard. |
| Usability Validation | Complies with IEC 60601-1-6:2010 and IEC 62366:2007. | Test results indicate compliance with applicable standards. |
Study Details:
-
Sample Size used for the Test Set and Data Provenance:
- This submission is a 510(k) premarket notification primarily demonstrating substantial equivalence for a therapeutic device (rTMS system for MDD), specifically adding a new treatment protocol (iTBS).
- The document does not describe a specific clinical "test set" or study in the sense of an independent data set used to evaluate a diagnostic algorithm's performance. Instead, it relies on:
- Bench testing and verification/validation activities against technical standards (listed in the table above).
- Comparison to a legally marketed predicate device (Tonica Electronik A/S / Mag Vita TMS Therapy System w/ Theta Burst Stimulation, K173620), which already had the iTBS protocol cleared.
- Comparison to its own previously cleared device version (K171902) to show that existing features remain unchanged or are consistent.
- Therefore, there's no "sample size" for patients/cases in a typical AI/diagnostic study sense within this document for a "test set." The document focuses on technical and safety equivalence.
-
Number of Experts used to establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable in the context of this 510(k) submission. This is not a study assessing the diagnostic performance of an AI against expert ground truth. The "ground truth" for this device's function is its ability to deliver the specified magnetic stimulation parameters accurately and safely, and for the clinical efficacy of this type of therapy for MDD, which is established by larger clinical trials for the class of devices and specific protocols (e.g., those reviewed for the predicate device).
-
Adjudication Method for the Test Set:
- Not applicable. No external "test set" requiring expert adjudication is described.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a therapeutic rTMS system, not a diagnostic AI system intended to assist human readers. Therefore, an MRMC study is not relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the traditional sense of a diagnostic algorithm. The device itself (the Nexstim NBT System 2) operates based on software control and delivered TMS pulses. Its "standalone performance" is implicitly demonstrated through the various verification and validation activities (software, electrical safety, EMC, bench testing), which confirm it functions according to its predetermined specifications, independently of a human operator, in terms of delivering the therapy. The clinical use always involves a trained medical professional.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is multi-faceted, aligning with the nature of a therapeutic device and a substantial equivalence review:
- Technical Specifications: The core "ground truth" for the device itself is its adherence to specified physical parameters (magnetic field intensity, frequency, pulse length, etc.) and compliance with recognized industry standards (IEC, ISO, FDA guidance) for safety and performance. This is verified through bench testing and engineering evaluations.
- Predicate Device Performance: The "ground truth" for clinical effectiveness of the iTBS protocol is based on the established performance of the predicate device (K173620) which already had clearance for this protocol. The submission argues that since the proposed device's technical characteristics for delivering iTBS are equivalent, its clinical effect would also be equivalent.
- Clinical Effectiveness of rTMS for MDD: The broader "ground truth" for the treatment of Major Depressive Disorder with rTMS is established by clinical outcomes data from pivotal studies that led to the approval of the predicate device and other similar rTMS systems for MDD. This document refers to the established indication for use for rTMS in MDD, rather than presenting new clinical trial data for this specific device's efficacy beyond the established equivalence.
- The "ground truth" for this submission is multi-faceted, aligning with the nature of a therapeutic device and a substantial equivalence review:
-
The sample size for the training set:
- Not applicable. This document describes a medical device seeking 510(k) clearance, not an AI/machine learning algorithm undergoing training with a specific dataset. The software is developed and verified via traditional software engineering processes, not "trained."
-
How the ground truth for the training set was established:
- Not applicable. As there is no "training set" for an AI/ML algorithm, no ground truth needed to be established in that context.
{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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 22, 2019
Nexstim Plc Anna Honkanen Senior Manager, Quality and Regulatory Affairs Elimaenkatu 9b 00510 Helsinki, Finland
Re: K182700
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 Dated: December 5, 2018 Received: December 10, 2018
Dear Anna Honkanen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.
Pamela D. Scott -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) K182700
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 antidention in the current episode.
Type of Use (Select one or both, as applicable)
| ☑ 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: | 19 November 2018 | |||
|---|---|---|---|---|
| 510(k) Number: | K182700 | |||
| Submitter: | Nexstim PlcElimaenkatu 9b00510 Helsinki, Finland | |||
| Submitter andOfficial Contact: | Ms. Anna HonkanenSenior Manager, Quality and Regulatory AffairsNexstim PlcElimaenkatu 9b00510 Helsinki, Finland+011 358 (9) 2727 170anna.honkanen@nexstim.com | |||
| Manufacturing Site: | Nexstim PlcElimaenkatu 9b00510 Helsinki, Finland | |||
| Trade Name: | Nexstim Navigated Brain Therapy (NBT®) System 2 | |||
| Classification Name: | Repetitive Transcranial Magnetic Stimulator For Treatment Of MajorDepressive Disorder | |||
| PrimaryClassificationRegulation andProduct Code: | 21 CFR §882.5805 / OBP | |||
| SecondaryClassificationRegulation andProduct Code: | 21 CFR §882.1870 / GWF21 CFR §882.4560 / HAW21 CFR §890.1375 / IKN | |||
| SubstantiallyEquivalent Devices: | ProposedDevice | Predicate510(k) Number | PredicateManufacturer / Model | |
| Nexstim NavigatedBrain Therapy(NBT®) System 2 | K173620 | Tonica Electronik A/S / MagVita TMS Therapy Systemw/ Theta Burst Stimulation |
{4}------------------------------------------------
Nexstim, Plc / Nexstim NBT® System 2
The Nexstim Navigated Brain Therapy (NBT®) System 2 was in K171902 determined to be equivalent to other legally marketed rTMS devices for use of the 10 Hz Standard Depression Treatment Protocol for treating patients with MDD as stated in the indication for use statement.
{5}------------------------------------------------
| Purpose of theSubmission | The purpose of this submission is to add the Intermittent Theta BurstProtocol as another treatment option for the use of the NexstimNavigated Brain Therapy (NBT®) System for the treatment of MajorDepressive Disorder as stated in the indications for use statement. TheTonica Electronik A/S / Mag Vita TMS Therapy System w/ Theta BurstStimulation (K173620) has been identified as the predicate device for theaddition. |
|---|---|
| Device Description: | The Nexstim Navigated Brain Therapy (NBT®) System is a non-invasive, repetitive transcranial magnetic stimulation (rTMS) system thatdelivers repetitive pulsed magnetic fields of sufficient magnitude toinduce neural action potentials in the prefrontal cortex to treat thesymptoms of major depressive disorder (MDD) without inducing seizurein patients who have failed one (1) antidepressant medication. |
| The Nexstim NBT System 2 is used for patient treatment by prescriptiononly and must be operated by a trained medical professional. It can beused in both inpatient and outpatient settings including physician'soffices and clinics, psychiatric hospitals, and general medical/surgicalhospitals with psychiatric units. | |
| The Nexstim NBT System 2 consists of a group of devices designed tolocalize the stimulation site in the brain and deliver rTMS stimulationusing controlling and interpretive software. Operational control of theNexstim NBT System 2 is provided by the software. | |
| The Nexstim NBT System 2 combines magnetic resonance imaging-based (MRI-based), three dimensional (3D) localization of cortical motorareas of the brain with non-invasive TMS and simultaneouselectromyography (EMG) measurement to locate areas of the brain thatare capable of evoking muscle responses when stimulated, and to locatethe target area for depression therapy. | |
| The Nexstim NBT System 2 software is used to import a patient's MRimage slices to generate an accurate 3D model of the patient's headwhich can be electronically peeled back to reveal the anatomicalstructures of the brain. | |
| Intended Use: | Nexstim Navigated Brain Therapy (NBT®) System 2 is indicated for thetreatment of Major Depressive Disorder in adult patients who have failedto achieve satisfactory improvement from prior antidepressantmedication in the current episode. |
{6}------------------------------------------------
Technology Comparison:
The Nexstim NBT System 2 employs the same technological characteristics as the predicate device.
| Characteristic | Tonica Electronik A/SMag Vita TMSTherapy System w/Theta BurstStimulation(K173620) | NexstimNavigatedBrain Therapy(NBT®) System 2(K171902) | Nexstim NBT®System 2(Proposed Device) | Discussion of Major Differences |
|---|---|---|---|---|
| Intended Use | The MagVita TMSTherapy System w/Theta Burst Stimulationis indicated for thetreatment of MajorDepressive Disorder inadult patients who havefailed to receivesatisfactoryimprovement from priorantidepressantmedication in thecurrent episode. | Nexstim NavigatedBrain Therapy(NBT®) System 2 isindicated for thetreatment of MajorDepressive Disorderin adult patients whohave failed to achievesatisfactoryimprovement fromprior antidepressantmedication in thecurrent episode. | Same indication foruse statement as theMag Vita TMS(K173620).No change from theindication for usestatement cleared inK171902. | |
| Magnetic FieldIntensity | 120 % of MT | 120 % of MT | 120% of MT,No change from theone cleared inK171902Intensity is the sameas that used with theMag Vita TMS(K173620). |
{7}------------------------------------------------
| 10Hz Treatmentparameters | ||||
|---|---|---|---|---|
| 10Hz Treatmentparameters | Magnetic fieldintensity: 120% of MTFrequency: 10HzTrain duration; 4 secsInter-train interval 11-26 secsNumber of trains: 75Maximum pulses persession: 3000 | Magnetic fieldintensity: 120% of MTFrequency: 10HzTrain duration; 4 secsInter-train interval 26secsNumber of trains: 75Maximum pulses persession: 3000 | Magnetic fieldintensity: 120% of MTFrequency: 10HzTrain duration; 4 secsInter-train interval 11-26 secsNumber of trains: 75Maximum pulses persession: 3000 | The minor protocol change to the inter-train intervalparameters was cleared by FDA in the MagVita TMSTherapy System 510(k) submission K171481 forTonica Eleo A/S and the Neurostar TMS TherapySystem (510(k) submission 160703 for Neuronetics,Inc.The Nexstim NBT System 2 is technologicallyequivalent to the MagVita TMS Therapy System asdemonstrated in 510(k) submission K171902/S001,pages 4818-4822. |
| Treatment sessionduration: 18.8-37.5 minSessions/week: 5Treatment schedule. 5daily sessions for 6weeks | Treatment sessionduration: 37.5 minSessions/week: 5Treatment schedule. 5daily sessions for 6weeks | Treatment sessionduration: 18.8-37.5minSessions/week: 5Treatment schedule. 5daily sessions for 6weeks. |
{8}------------------------------------------------
| iTBS Treamentparameters | NA | |||
|---|---|---|---|---|
| Magnetic fieldintensity: 120 % of MTFrequency: 50Hz (5pulses (bursts) per sec)Train duration: 2 secsInter-train interval: 8secsBurst pulses: 3Bursts: 200Inter-pulse interval: 20msecNumber of trains: 20Maximum pulses persession: 600Treatment sessionduration: 3 min, 9 secs | The clinicalperformance of TBS isdependent on the factthat the stimuli are ofequal intensity. At therelevant TBS intensitiesrequired in thetreatment setting, theindividual intensity ofthe three stimuli is keptconstant (i.e. atmaximum a 1% dropreferred to maximummachine output between | Magnetic fieldintensity: 120 % ofMTFrequency: 50Hz (5pulses (bursts) persec)Train duration: 2 secsInter-train interval: 8secsBurst pulses: 3Bursts: 200Inter-pulse interval:20 msecNumber of trains: 20Maximum pulses persession: 600Treatment sessionduration: 3 min, 9secs | The iTBS protocol was cleared by FDA in the MagVita TMS Therapy System w/ Theta BurstStimulation 510(k) submission K173620 for TonicaElectrnik A/S.The Nexstim NBT System 2 is technologicallyequivalent to the MagVita TMS Therapy System asdemonstrated in 510(k) submission K171902/S001,pages 4818-4822The clinicalperformance of TBSis dependent on thefact that the stimuliare of equal intensity.At the relevant TBSintensities required inthe treatment setting,the individualintensity of the threestimuli is keptconstant (i.e. atmaximum a 1% dropreferred to maximum |
{9}------------------------------------------------
| the first stimuli and thethird stimuli in a burst). | machine outputbetween the firststimuli and the thirdstimuli in a burst). | ||
|---|---|---|---|
| Protocols | Standard and iTBS | Standard | Standard 10 Hz andiTBS Same asK173620. 10 Hzcleared in K171902. |
| Area of Brain tobe Stimulated | DLPFC | DLPFC | DLPFC. |
| Coil Material | Copper winding with aircore | Copper winding withair core | Copper winding withair core.No change from thecoil cleared inK171902 |
| Coil Windings | 97 mm11 windings | 72 mm(coil wing distance 2mm, coil wind centerdistance 74 mm)10 turns/wing | 72 mm(coil wing distance 2mm, coil wind centerdistance 74 mm)10 turns/wingSame coil as clearedin K171902. |
| Amplitude Range | 1.7 SMT | 0 to 2.5 SMT | 0 to 2.5 SMTNo change from thatcleared in K171902 |
| Pulse Length | $280 \mu s$ | $230 \mu s \pm 5 \mu sec$ | $230 \mu s \pm 5 \mu sec$No change from thatcleared in K171902 |
{10}------------------------------------------------
510(k) Summary
| Technology |
|---|
| Comparison |
| (continued): |
| Frequency Range | 0.1 - 100 Hz | 0.1 - 50 Hz | 0.1 - 50 Hz, nochange from rangecleared in K171902.Includes iTBSfrequency of 50 Hz |
|---|---|---|---|
| Characteristic | Tonica Electronik A/SMag Vita TMSTherapy System w/Theta BurstStimulation(K173620) | NexstimNavigatedBrain Therapy(NBT®) System 2(K171902) | Nexstim NBT®System 2(Proposed Device) |
| Coil PositioningPrinciple | Indirect targeting oftreatment target thoughmeasured (5 cm)distance and directionfrom APB. Measurederived from statisticaldistance of DLPFCfrom APB. | Individual patientdirect targeting ofanatomical treatmentlocation (DLPFC).Placing of E-fieldmaximum location on3D model built frompatients individualMRI. | Individual patientdirect targeting ofanatomical treatmentlocation (DLPFC).Placing of E-fieldmaximum location on3D model built frompatients individualMRI.No change from thatcleared in K171902. |
| MT ResponseDetection | Visual qualitativemonitoring for APBresponse | EMG providesqualitative andquantitative databased on which userdefines MT. | EMG providesqualitative andquantitative databased on which userdefines MT.No change from thatcleared in K171902 |
{11}------------------------------------------------
Summary of Performance Testing:
| Sterilization andShelf LifeVerification | The Nexstim NBT System 2 is not shipped sterile, and is not intended tobe 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, whichevercomes first.No other Nexstim NBT System 2 component has a shelf life. |
|---|---|
| BiocompatibilityVerification | Patient contact materials which are part of the Nexstim NBT System 2were designed to comply with the following standard:ISO 10993-1: 2009, Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process. and were determined to be safe to use with patients. |
| Software Verificationand Validation | Software for the Nexstim NBT System 2 was designed and developedaccording to a robust software development process, and were rigorouslyverified and validated.Software information is provided in accordance with internaldocumentation and the following Standards and guidance documents: FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep99. FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02. FDA guidance: Content of premarket submissions for management ofcybersecurity in medical devices, 02 Oct 14. FDA guidance: Cybersecurity for Networked Medical DevicesContaining Off-The-Shelf (OTS) software, 14 Jan 05. IEC 62304: 2006, Medical device software – Software life cycleprocesses. Test results indicate that the Nexstim NBT System 2 software complieswith its predetermined specifications, and the Standards and guidancedocuments. |
| Electrical SafetyVerification | The Nexstim NBT System 2 was tested for performance in accordancewith the following Standards:IEC 60601-1: 2005, Am1: 2012, Medical electrical equipment - Part1: General requirements for basic safety and essential performance. ANSI/AAMI ES 60601-1: 2005, Am2: 2010, US National differencesto IEC 60601-1: 2005. Test results indicated that the Nexstim NBT System 2 complies with theStandards. |
| ElectromagneticCompatibility (EMC)Verification | The Nexstim NBT System 2 was tested for performance in accordancewith 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 – Requirementsand tests. FCC 47 CFR §15, Telecommunication Chapter I--FederalCommunications Commission Subchapter A-General- RadioFrequency Devices. Test results indicated that the Nexstim NBT System 2 complies with theStandards. |
| Performance Testing– Bench Verification | The Nexstim NBT System 2 was tested for performance in accordancewith internal documentation and the following FDA GuidanceDocuments and Standards:Guidance for Industry and Food and Drug Administration StaffClass II Special Controls Guidance Document: RepetitiveTranscranial Magnetic Stimulation (rTMS) Systems. Test results indicated that the Nexstim NBT System 2 complies with itspredetermined specification and the applicable Standard. |
| Performance Testing- UsabilityValidation | The Nexstim NBT System 2 was tested for usability in accordance withthe following Standards:IEC 60601-1-6: 2010, Medical electrical equipment – Part 1-6:General requirements for basic safety and essential performance -Collateral standard: Usability. IEC 62366: 2007, Medical devices – Application of usabilityengineering to medical devices. Test results indicated that the Nexstim NBT System 2 complies with theapplicable Standards. |
{12}------------------------------------------------
{13}------------------------------------------------
Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the Nexstim NBT System 2. The results of these activities demonstrate that the Nexstim NBT System 2 is as safe, as effective, and performs as well as or better than the predicate device.
Therefore, the Nexstim NBT System 2 is considered substantially equivalent to the predicate device.
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
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.(b)
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.