(176 days)
No
The summary does not mention AI, ML, or related terms, and the description of the technology focuses on established techniques like MRI-based localization and rTMS.
Yes
The device is indicated for the treatment of Major Depressive Disorder and delivers repetitive pulsed magnetic fields to treat symptoms, indicating a therapeutic purpose.
No
The device is indicated for the treatment of Major Depressive Disorder, not for diagnosing it. While it uses MRI to localize brain areas, this is for guiding the treatment, not for making a diagnosis.
No
The device description explicitly states that the system "consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation". It also mentions "non-invasive TMS and simultaneous electromyography (EMG) measurement". These components are hardware, not solely software. The performance studies also include hardware-related testing like Electrical Safety and EMC Verification.
Based on the provided information, the Nexstim Navigated Brain Therapy (NBT®) System 2 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 for diagnosis, monitoring, or screening.
- Nexstim NBT System 2 Function: The description clearly states that the Nexstim NBT System 2 is a non-invasive system that delivers repetitive transcranial magnetic stimulation (rTMS) to the brain for the treatment of Major Depressive Disorder. It uses MRI images for localization and delivers magnetic pulses externally.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
Therefore, the Nexstim NBT System 2 falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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 antidention in the current episode.
Product codes
OBP, GWF, HAW, IKN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Prefrontal cortex, cortical motor areas of the brain, DLPFC
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
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.
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, sample size, AUC, MRMC, standalone performance, key results)
The Nexstim NBT System 2 underwent performance testing for:
- Sterilization and Shelf Life Verification
- Biocompatibility Verification
- Software Verification and Validation
- Electrical Safety Verification
- Electromagnetic Compatibility (EMC) Verification
- Performance Testing – Bench Verification
- Performance Testing - Usability Validation
Test results indicated that the Nexstim NBT System 2 complies with its predetermined specifications and applicable Standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 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) |
|---|---|
| -------------------------------------------------------------------------------------- | ----------------------------------------------- |
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3
| Submission Date: | 19 November 2018 | |||
|---|---|---|---|---|
| 510(k) Number: | K182700 | |||
| Submitter: | Nexstim Plc | |||
| Elimaenkatu 9b | ||||
| 00510 Helsinki, Finland | ||||
| Submitter and | ||||
| Official Contact: | Ms. Anna Honkanen | |||
| Senior Manager, Quality and Regulatory Affairs | ||||
| Nexstim Plc | ||||
| Elimaenkatu 9b | ||||
| 00510 Helsinki, Finland | ||||
| +011 358 (9) 2727 170 | ||||
| anna.honkanen@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: | Proposed | |||
| Device | Predicate | |||
| 510(k) Number | Predicate | |||
| Manufacturer / Model | ||||
| Nexstim Navigated | ||||
| Brain Therapy | ||||
| (NBT®) System 2 | K173620 | Tonica Electronik A/S / Mag | ||
| Vita TMS Therapy System | ||||
| w/ 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 the
Submission | The purpose of this submission is to add the Intermittent Theta Burst
Protocol as another treatment option for the use of the Nexstim
Navigated Brain Therapy (NBT®) System for the treatment of Major
Depressive Disorder as stated in the indications for use statement. The
Tonica Electronik A/S / Mag Vita TMS Therapy System w/ Theta Burst
Stimulation (K173620) has been identified as the predicate device for the
addition. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | 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. |
| 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. |
6
Technology Comparison:
The Nexstim NBT System 2 employs the same technological characteristics as the predicate device.
| Characteristic | Tonica Electronik A/S
Mag Vita TMS
Therapy System w/
Theta Burst
Stimulation
(K173620) | NexstimNavigated
Brain Therapy
(NBT®) System 2
(K171902) | Nexstim NBT®
System 2
(Proposed Device) | Discussion of Major Differences |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended Use | The MagVita TMS
Therapy System w/
Theta Burst Stimulation
is indicated for the
treatment of Major
Depressive Disorder in
adult patients who have
failed to receive
satisfactory
improvement from prior
antidepressant
medication in the
current episode. | 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. | Same indication for
use statement as the
Mag Vita TMS
(K173620).
No change from the
indication for use
statement cleared in
K171902. | |
| Magnetic Field
Intensity | 120 % of MT | 120 % of MT | 120% of MT,
No change from the
one cleared in
K171902
Intensity is the same
as that used with the
Mag Vita TMS
(K173620). | |
7
| 10Hz Treatment
| parameters | ||||
|---|---|---|---|---|
| 10Hz Treatment | ||||
| parameters | Magnetic field | |||
| intensity: 120% of MT | ||||
| Frequency: 10Hz | ||||
| Train duration; 4 secs | ||||
| Inter-train interval 11- | ||||
| 26 secs | ||||
| Number of trains: 75 | ||||
| Maximum pulses per | ||||
| session: 3000 | Magnetic field | |||
| intensity: 120% of MT | ||||
| Frequency: 10Hz | ||||
| Train duration; 4 secs | ||||
| Inter-train interval 26 | ||||
| secs | ||||
| Number of trains: 75 | ||||
| Maximum pulses per | ||||
| session: 3000 | Magnetic field | |||
| intensity: 120% of MT | ||||
| Frequency: 10Hz | ||||
| Train duration; 4 secs | ||||
| Inter-train interval 11- | ||||
| 26 secs | ||||
| Number of trains: 75 | ||||
| Maximum pulses per | ||||
| session: 3000 | The minor protocol change to the inter-train interval | |||
| parameters was cleared by FDA in the MagVita TMS | ||||
| Therapy System 510(k) submission K171481 for | ||||
| Tonica Eleo A/S and the Neurostar TMS Therapy | ||||
| System (510(k) submission 160703 for Neuronetics, | ||||
| Inc. | ||||
| 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. | ||||
| Treatment session | ||||
| duration: 18.8-37.5 min | ||||
| Sessions/week: 5 | ||||
| Treatment schedule. 5 | ||||
| daily sessions for 6 | ||||
| weeks | Treatment session | |||
| duration: 37.5 min | ||||
| Sessions/week: 5 | ||||
| Treatment schedule. 5 | ||||
| daily sessions for 6 | ||||
| weeks | Treatment session | |||
| duration: 18.8-37.5 | ||||
| min | ||||
| Sessions/week: 5 | ||||
| Treatment schedule. 5 | ||||
| daily sessions for 6 | ||||
| weeks. |
8
| iTBS Treament
| parameters | NA | |||
|---|---|---|---|---|
| Magnetic field | ||||
| intensity: 120 % of MT | ||||
| Frequency: 50Hz (5 | ||||
| pulses (bursts) per sec) | ||||
| Train duration: 2 secs | ||||
| Inter-train interval: 8 | ||||
| secs | ||||
| Burst pulses: 3 | ||||
| Bursts: 200 | ||||
| Inter-pulse interval: 20 | ||||
| msec | ||||
| Number of trains: 20 | ||||
| Maximum pulses per | ||||
| session: 600 | ||||
| Treatment session | ||||
| duration: 3 min, 9 secs | The clinical | |||
| performance of TBS is | ||||
| dependent on the fact | ||||
| that the stimuli are of | ||||
| equal intensity. At the | ||||
| relevant TBS intensities | ||||
| required in the | ||||
| treatment setting, the | ||||
| individual intensity of | ||||
| the three stimuli is kept | ||||
| constant (i.e. at | ||||
| maximum a 1% drop | ||||
| referred to maximum | ||||
| machine output between | Magnetic field | |||
| intensity: 120 % of | ||||
| MT | ||||
| Frequency: 50Hz (5 | ||||
| pulses (bursts) per | ||||
| sec) | ||||
| Train duration: 2 secs | ||||
| Inter-train interval: 8 | ||||
| secs | ||||
| Burst pulses: 3 | ||||
| Bursts: 200 | ||||
| Inter-pulse interval: | ||||
| 20 msec | ||||
| Number of trains: 20 | ||||
| Maximum pulses per | ||||
| session: 600 | ||||
| Treatment session | ||||
| duration: 3 min, 9 | ||||
| secs | 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 | ||||
| The clinical | ||||
| performance of TBS | ||||
| is dependent on the | ||||
| fact that the stimuli | ||||
| are of equal intensity. | ||||
| At the relevant TBS | ||||
| intensities required in | ||||
| the treatment setting, | ||||
| the individual | ||||
| intensity of the three | ||||
| stimuli is kept | ||||
| constant (i.e. at | ||||
| maximum a 1% drop | ||||
| referred to maximum |
9
| | the first stimuli and the
third stimuli in a burst). | | machine output
between the first
stimuli and the third
stimuli in a burst). |
|-----------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Protocols | Standard and iTBS | Standard | Standard 10 Hz and
iTBS Same as
K173620. 10 Hz
cleared in K171902. |
| Area of Brain to
be Stimulated | DLPFC | DLPFC | DLPFC. |
| Coil Material | Copper winding with air
core | Copper winding with
air core | Copper winding with
air core.
No change from the
coil cleared in
K171902 |
| Coil Windings | 97 mm
11 windings | 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
Same coil as cleared
in K171902. |
| Amplitude Range | 1.7 SMT | 0 to 2.5 SMT | 0 to 2.5 SMT
No change from that
cleared in K171902 |
| Pulse Length | $280 \mu s$ | $230 \mu s \pm 5 \mu sec$ | $230 \mu s \pm 5 \mu sec$
No change from that
cleared in K171902 |
10
510(k) Summary
| Technology |
|---|
| Comparison |
| (continued): |
| Frequency Range | 0.1 - 100 Hz | 0.1 - 50 Hz | 0.1 - 50 Hz, no
change from range
cleared in K171902.
Includes iTBS
frequency of 50 Hz |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Tonica Electronik A/S
Mag Vita TMS
Therapy System w/
Theta Burst
Stimulation
(K173620) | NexstimNavigated
Brain Therapy
(NBT®) System 2
(K171902) | Nexstim NBT®
System 2
(Proposed Device) |
| Coil Positioning
Principle | Indirect targeting of
treatment target though
measured (5 cm)
distance and direction
from APB. Measure
derived from statistical
distance of DLPFC
from APB. | Individual patient
direct targeting of
anatomical treatment
location (DLPFC).
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.
No change from that
cleared in K171902. |
| 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.
No change from that
cleared in K171902 |
11
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. 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. 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. 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. Test results indicated that the Nexstim NBT System 2 complies with its
predetermined specification and the applicable Standard. |
| Performance Testing
- Usability
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. 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. |
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.