(137 days)
No
The summary describes a system for navigated brain therapy using rTMS and MRI-based localization, but there is no mention of AI or ML being used in the localization, stimulation control, or any other aspect of the device's operation. The software is described as controlling and interpreting, but not as using AI/ML algorithms.
Yes
The device is indicated for the treatment of Major Depressive Disorder in adult patients and delivers repetitive pulsed magnetic fields to treat the symptoms of major depressive disorder.
No
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosis. While it uses MRI-based localization and EMG measurements to map the brain for treatment, its primary purpose is therapeutic.
No
The device description explicitly states it is a "repetitive transcranial magnetic stimulation (rTMS) system" and includes components like coils and a head tracker, indicating it is a hardware system with controlling software, not software-only.
Based on the provided information, the Nexstim NBT® System 2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of Major Depressive Disorder. IVD devices are used to diagnose or monitor a disease or condition by examining specimens from the human body (like blood, urine, tissue).
- Device Description: The device delivers repetitive transcranial magnetic stimulation (rTMS) to induce neural action potentials for therapeutic purposes. It does not analyze biological samples.
- Mechanism of Action: The system uses magnetic fields to stimulate the brain, not to analyze biological markers in vitro.
The device is a therapeutic device that uses imaging and navigation for precise targeting of the treatment area.
N/A
Intended Use / 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.
Product codes
OBP, GWF, HAW, IKN
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging (MRI)
Anatomical Site
Brain, specifically Dorsolateral Prefrontal Cortex (DLPFC)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Trained medical professional. 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.
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
Not Found
Summary of Performance Studies
Study type: Bench Verification, Usability Validation, Sterilization and Shelf Life Verification, Biocompatibility Verification, Software Verification and Validation, Electrical Safety Verification, Electromagnetic Compatibility (EMC) Verification.
Key results:
- Shelf Life: NBT Head Tracker has a shelf life of 2 years. Nexstim Focal and Cooled Coils have a useful product life of 2 million pulses or 2 years from date of manufacture, whichever comes first.
- Biocompatibility: Patient contact materials comply with ISO 10993-1: 2009.
- Software Verification and Validation: Software complies with predetermined specifications and relevant standards/guidance (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).
- Electrical Safety: Complies with IEC 60601-1: 2005, Am1: 2012 and ANSI/AAMI ES 60601-1: 2005, Am2: 2010.
- Electromagnetic Compatibility: Complies with IEC 60601-1-2: 2007 and FCC 47 CFR §15.
- Bench Verification: Complies with predetermined specification and applicable standards/guidance (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; Study Comparing Nexstim's Navigated Coil Localization Method to Manually-Determined Method).
- Usability Validation: Complies with IEC 60601-1-6: 2010 and IEC 62366: 2007.
Summary: Verification and validation activities demonstrated that the Nexstim NBT System 2 is safe and effective when used in accordance with its intended use and labeling.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K112881, K162935, K133408, K150641
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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.