(226 days)
Not Found
No
The summary describes a standard MEG/EEG system for signal acquisition, processing, and display, with no mention of AI or ML algorithms for interpretation or analysis. The performance studies focus on hardware and basic software functionality comparisons to a predicate device.
No
The device is described as a diagnostic tool used to measure brain signals and localize active areas or epileptic activity, aiding in neurosurgical planning. It does not perform any therapeutic function.
Yes
The device "measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals)...displayed, and may then be interpreted by trained physicians to help localize these active areas." This function falls under the definition of a diagnostic device, as it aims to identify and localize conditions or areas of interest within the brain. The text also states, "The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning." and "MEG is also used to non-invasively locate regions of epileptic activity within the brain."
No
The device description explicitly states it is a magnetoencephalograph (MEG) which records magnetic signals from the human brain and can optionally include an integrated SynAmps2 hardware system for EEG. It also mentions optional adult or child sized helmets. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Orion LifeSpan™ MEG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic purposes.
- Orion LifeSpan™ MEG Function: The Orion LifeSpan™ MEG non-invasively measures signals produced by the brain (MEG and optionally EEG). It does not examine specimens derived from the human body.
- Intended Use: The intended use describes the device as helping to localize active areas of the brain and identify locations of visual, auditory, and somatosensory responses, as well as epileptic activity. This is done by measuring the magnetic and electrical fields generated by the brain itself, not by analyzing biological samples.
Therefore, the Orion LifeSpan™ MEG falls under the category of a non-invasive medical device used for physiological measurement and localization within the body, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
• Hospital procedures
• Physiological monitoring of patients
• Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
Product codes
OLY, GWQ, OLX
Device Description
The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system.
The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets.
The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetoencephalography (MEG), Electroencephalography (EEG)
Anatomical Site
Brain
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Physicians or neurology laboratory technicians; The device is used in a magnetically shielded room (MSR); specifically excludes use as life support equipment.
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
Non-Clinical Performance Data
Empty-room noise performance comparison testing
- Test method summary: Compare the noise floor of the Orion LifeSpan™ MEG to that of the Elekta Neuromag using spectral analysis. The MEG system was activated in an empty magnetically shielded room (MSR), and noise spectra across clinically relevant frequencies (0.5-50 Hz, per the IEC 60601-2-26 standard) were recorded. The average noise level should not be greater than the (predicate).
- Results: The measured average noise performance was comparable to that of the Elekta Neuromag (Orion: 10.54 fTrms/√Hz; Elekta: 11.31fTrms/√Hz).
Phantom Comparison Test
- Test method summary: Compare the localization accuracy of the Orion LifeSpan™ MEG and Elekta Neuromag by taking an identical phantom signal and recording it with both systems. The average localization error and the maximum localization error needs to be less than one standard deviation away from that of the predicate (0.7mm, total error across all 3 dimensions).
- Results: The localization accuracy results were less than one standard deviation away from the Elekta Neuromag. The average localization error difference was 0.4mm (Orion: 2.3mm; Elekta: 1.9mm), and maximum localization error difference was 0.5mm (Orion: 4.22mm; Elekta: 3.72mm).
Device Compatibility Test
- Test method summary: The Orion LifeSpan™ MEG was tested upon integration of compatible devices (HPI Coils, EEG System, and evoked response stimulators, including Somatosensory, Visual and Auditory). Standard empty room recordings with each compatible device configuration were made. The average noise level (around 100Hz) of each device configuration was compared with the reference noise threshold (10fTrms/√Hz).
- Results: The empty room test results showed that the addition of each compatible device did not significantly increase the noise level of the Orion LifeSpan™ MEG when used without compatible devices, nor did integration of each device result in exceeding the noise threshold (at around 100Hz).
CURRY Software Verification and Validation tests
- Test method summary: All relevant CURRY Software specifications were verified and validated in accordance with IEC 62304:2006.
- Results: CURRY Software verification and validation tests show that the CURRY Software supports the Orion device functionalities in a manner comparable to the predicate, (i.e., processing, display, localization, MEG control functions).
Limited Channel Operation Test
- Test method summary: Phantom localization testing was performed to demonstrate device functionality and ability to meet source localization accuracy criteria while operating at three different degrees of channel operation (95%, 90%, and 80% of full channel capacity). The average localization error needs to be below 2mm, and the maximum localization error needs to be below 4mm.
- Results: The limited channel operation test demonstrates the device functionality and ability to meet source localization accuracy criteria (average localization error range: 0.05-0.09mm; maximum localization error range: 0.14-0.17mm) when operating without 20% of its channels (80% full channel capacity).
Clinical Performance Data
Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
February 14, 2020
Image /page/0/Picture/1 description: The image shows the logo for 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.
Compumedics Limited William Alam Quality Engineering Manager 30-40 Flockhart Street Abbotsford, 3067 Au
Re: K191785
Trade/Device Name: Orion LifeSpan™ MEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLY, GWQ, OLX Dated: January 10, 2020 Received: January 13, 2020
Dear William Alam:
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/cdrh/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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jay Gupta, M.S.E. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Orion LifeSpan MEG
Indications for Use (Describe)
The Orion LifeSpan MEG non-invasively measures the magnetoencephalographic (MEG) (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
• Hospital procedures
- · Physiological monitoring of patients
- · Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
| 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
510(k) Summary
The following 510(k) summary is being submitted in accordance with 21CFR807.92.
| Device Information:
| Submitter: | Compumedics Limited |
|---|---|
| Address: | 30-40 Flockhart Street, Abbotsford 3067, |
| Victoria, Australia | |
| Phone number: | +61 (0) 3 8420 7300 |
| Fax number: | +61 (0) 3 8420 7399 |
| Contact person: | William Alam |
| 30-40 Flockhart Street, Abbotsford 3067, | |
| Victoria, Australia | |
| Phone number: | +61 (0) 3 8420 7300 |
| Fax number: | +61 (0) 3 8420 7399 |
| Date prepared: | June 28, 2019 |
| Trade name: | Orion LifeSpan™ MEG |
| Common name: | Magnetoencephalograph (MEG) |
| Primary product code: | OLY |
| Secondary product code: | GWQ, OLX |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
Predicate Device Information:
| Trade Name: | Elekta Neuromag |
|---|---|
| Manufacturer: | Elekta Neuromag Oy |
| 510(k) number: | K041264 |
| Product code: | OLY, GWQ, OLX |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
4
Device Description
The Orion LifeSpan™ MEG is a magnetoencephalograph (MEG) which records magnetic signals from the human brain. The Orion LifeSpan™ MEG uses the CURRY software platform (K001781) to acquire, process and display these signals. Optionally EEG can be recorded simultaneously with the MEG using an integrated SynAmps2 (K023771) hardware system.
The Orion LifeSpan™ MEG can optionally be provided with adult, child or both sized helmets.
The Orion LifeSpan™ MEG is used by skilled operators or physicians trained in the acquisition and interpretation of such signals. It is used as an adjunct as part of a range of measurements performed, such as imaging and other studies, to form a more complete picture of the patient's pathology alongside a standard clinical workup.
Indications for Use
The Orion LifeSpan™ MEG non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.
It is assumed that the users of the Orion LifeSpan™ MEG are physicians or neurology laboratory technicians who have received training in the following areas:
*Hospital procedures
*Physiological monitoring of patients
*Training relevant to the specific discipline or disorder under investigation
Note: This indication for use specifically excludes use of the Orion LifeSpan™ MEG as life support equipment, for example vital signs monitoring in intensive care units.
5
Substantial Equivalence Discussion
The following technological differences exist between the Orion LifeSpan™ MEG and Elekta Neuromag.
| Orion
LifeSpan™ MEG (K191785) | Elekta Neuromag
(K041264) | Differences
(if any) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | | | |
| The Orion LifeSpan™ MEG non-invasively
measures the magnetoencephalographic
(MEG) signals (and, optionally,
electroencephalographic (EEG) signals)
produced by electrically active tissue of the
brain. These signals are recorded by a
computerized data acquisition system,
displayed, and may then be interpreted by
trained physicians to help localize these
active areas. The locations may then be
correlated with anatomical information of the
brain. MEG is routinely used to identify the
locations of visual, auditory, and
somatosensory in the brain when used in
conjunction with evoked response
stimulators. MEG is also used to non-
invasively locate regions of epileptic activity
within the brain. The localization information
provided by MEG may be used, in
conjunction with other diagnostic data, as an
aid in neurosurgical planning.
It is assumed that the users of the Orion
LifeSpan™ MEG are physicians or
neurology laboratory technicians who have
received training in the following areas:
*Hospital procedures
*Physiological monitoring of patients
*Training relevant to the specific discipline
or disorder under investigation
Note: This indication for use specifically
excludes use of the Orion LifeSpan™ MEG
as life support equipment, for example vital
signs monitoring in intensive care units. | The Elekta Neuromag non-invasively measures the
magnetoencephalographic (meg)
signals (and, optionally,
electroencephalographic eeg
signals) produced by electrically
active tissue of the brain. These
signals are recorded by a
computerized data acquisition
system, displayed, and may then
be interpreted by trained
physicians to help localize these
active areas. The locations may
then be correlated with
anatomical information of the
brain. Meg is routinely used to
identify the locations of visual,
auditory, somatosensory, and
motor cortex in the brain. Meg is
also used to non-invasively
locate regions of epileptic
activity within the brain. The
localization information
provided by meg may be used, in
conjunction with other
diagnostic data, in neurosurgical
planning. | No significant
difference, except
the Orion
LifeSpan™ MEG
is not
recommended for
use with motor
evoked response
stimulators.
Assumptions
regarding evoked
response
stimulators, the
types of users
permitted, and use
case exclusions are
made more
explicitly clear to
further ensure safe
usage. | |
| Features | Orion
LifeSpan™
MEG
(K191785) | Elekta
Neuromag
(K041264) | Differences (if any) |
| Technology | | | |
| Site of
patient | Head and Scalp | Head and Scalp | No difference. |
| Patient
Position | Supine | Supine and
upright | No significant difference.
Upright position is available
mostly for research purposes.
Supine position is common
for MEG study. |
| Underlying
Technology | Superconducting
magnetometry | Superconducting
magnetometry | No difference. |
| Overall
Sensitivity | 10fT/ $√$ Hz | 10fT/ $√$ Hz | No difference. See Non-
Clinical Performance Data. |
| MEG
Sensing
Locations | 186 (adult)
138 (pediatric) | 102 | No significant difference. |
| SQUID
Readout | Flux locked loop | Flux locked loop | No difference. |
| Features | Orion
LifeSpan™
MEG
(K191785) | Elekta
Neuromag
(K041264) | Differences (if any) |
| Pickup Coil
Design | Axial
gradiometer | Mix of planar
gradiometers
and
magnetometers | Despite difference in
orientation, each pickup coil
type measures components of
the magnetic field generated
from the same brain sources.
During source estimation
these signals are converted to
(for example) equivalent
current dipole locations,
orientations and strengths.
Therefore, there is no
significant difference arising
from the pickup coil designs. |
| Average
Coil-to-Coil
Spacing | 27.3 mm (Adult),
25 mm
(Pediatric)
average distance
b/w centers of
each sensing loc. | 34 mm average
distance
between centers
of each sensing
location. | No difference. See Non-
Clinical Performance Data
for discussion of
localization accuracy
testing. |
| Detector
Architecture | DROS SQUID | dc SQUID | No significant difference.
DROS SQUID is a type of dc
SQUID. |
| Interference
Elimination
(i.e., SSS,
SPS) | SSP, DSSP | SSP, tSSS (which
has superseded
SSS) | Note that DSSP is
conceptually equivalent to
tSSS in that it uses
temporal information to
separate interference from
signal.1 Therefore, no
significant difference. |
| Head
Position
Indicator
(Y/N) | Y | Y | No difference. |
| Features | Orion
LifeSpan™
MEG
(K191785) | Elekta
Neuromag
(K041264) | Differences (if any) |
| Offline
Average
Function to
Process
Raw Data | Y | Y | No difference. |
| Number of
SQUID
Sensor
Elements | 186 (adult) 138
(pediatric) Each
at a unique
location | 306 at 102
unique locations | Phantom dipole localization
accuracy has shown that
sampling density is sufficient
in the Orion. Therefore, no
functionally significant
difference is noted due to the
number of SQUID elements. |
| Number of
Auxiliary
Channels
for Other
Types of
Data (i.e.,
EEG) | Up to 256
unipolar and
16 bipolar
EEG channels
Up to 8 ADC
channels. | Up to 124
unipolar and
4 bipolar
EEG
channels.
Up to 8
ADC
channels. | No significant difference,
provided that 128 EEG
channels are included with
the Orion, instead of the
maximum (256). |
| Method of
Calculation
(i.e.,
idealized v.
individual
head model) | Spherical
conductor model
for idealized
head shapes.
Individual
realistic head
models using the
Boundary
Element Method
(BEM) | Spherical
conductor model
for idealized
head shapes.
Individual
realistic head
models using the
Boundary
Element Method
(BEM) | No difference. |
| Features | Orion
LifeSpan™
MEG
(K191785) | Elekta
Neuromag
(K041264) | Differences (if any) |
| Source
Estimate
Methods | ECD for clinical
analysis.
Single- and multi-
dipole time
varying source
estimates. | ECD for clinical
analysis.
Single- and multi-
dipole time
varying source
estimates. | Equivalent Current Dipole
(ECD) localization is the
primary method of source
calculation used in clinical
MEG. Various other methods
are available both from the
CURRY software and in the
software included with the
Elekta MEG, but these are not
generally used for clinical
applications. |
| Forward (or
inverse)
head models | See above two rows/No differences | | |
| Design | | | |
| Patient
Population | Adult and
pediatric | Adult | No significant difference. The
pediatric helmet is simply the
same as adult helmet except
the number of sensor and size. |
| Coverage | Whole cortex | Whole cortex | No difference. |
| Cryogen
Used | Liquid Helium | Liquid Helium | No difference. |
| Power
Source | Mains power | Mains power | No difference. |
| Software | CURRY
Multimodal
Neuroimaging
Software | Elekta Neuromag
Data Acquisition
Software | A clinical study that shows
Elekta Neuromag is
compatible with CURRY
software can be found on
document VOL_020_017. |
| Data
Acquisition | SynAmps2 | Inbuilt | A clinical study that shows
Elekta Neuromag is
compatible with SynAmps2
for data acquisition can be
found on document
VOL_020_017. |
| Features | Orion
LifeSpan™
MEG
(K191785) | Elekta
Neuromag
(K041264) | Differences (if any) |
| Minimum
Room Height | 2.1m | 2.3 m | No significant difference. |
| 60601-1
Classification | Type BF | Type BF | No difference. |
| Material | | | |
| Dewar
Helmet
Material | Fiberglass
composite | Fiberglass
composite | No difference. |
6
7
1 Sekihara, K., Kawabata, Y., Ushio, S., Sumiya, S., Kawabata, S., Adachi, Y. and Nagarajan, S.S., 2016. Dual signal subspace projection (DSSP): a novel algorithm for removing large interference in biomagnetic measurements. Journal of neural engineering, 13(3), p.036007.
8
9
10
11
Non-Clinical Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
| Test | Test method summary | Results |
|---|---|---|
| Empty-room | ||
| noise | ||
| performance | ||
| comparison | ||
| testing | Compare the noise floor of the | |
| Orion LifeSpan™ MEG to that of | ||
| the Elekta Neuromag using | ||
| spectral analysis.2 The MEG | ||
| system was activated in an empty | ||
| magnetically shielded room | ||
| (MSR), and noise spectra across | ||
| clinically relevant frequencies | ||
| (0.5-50 Hz, per the IEC | ||
| 60601-2-26 standard) were | ||
| recorded. The average noise level | ||
| should not be greater than the | ||
| (predicate). | The measured average noise | |
| performance was comparable to | ||
| that of the Elekta Neuromag | ||
| (Orion: 10.54 fTrms/√Hz; | ||
| Elekta: 11.31fTrms/√Hz) | ||
| Phantom | ||
| Comparison | ||
| Test | Compare the localization | |
| accuracy of the Orion LifeSpan™ | ||
| MEG and Elekta Neuromag by | ||
| taking an identical phantom signal | ||
| and recording it with both | ||
| systems. 2 The average | ||
| localization error and the | ||
| maximum localization error needs | ||
| to be less than one standard | ||
| deviation away from that of the | ||
| predicate (0.7mm, total error | ||
| across all 3 dimensions). | The localization accuracy results | |
| were less than one standard | ||
| deviation away from the Elekta | ||
| Neuromag. The average | ||
| localization error difference was | ||
| 0.4mm (Orion: 2.3mm; Elekta: | ||
| 1.9mm), and maximum | ||
| localization error difference was | ||
| 0.5mm (Orion: 4.22mm; Elekta: | ||
| 3.72mm). | ||
| Device | ||
| Compatibility | ||
| Test | The Orion LifeSpan™ MEG was | |
| tested upon integration of | ||
| compatible devices (HPI Coils, | ||
| EEG System, and evoked | ||
| response stimulators, including | ||
| Somatosensory, Visual and | ||
| Auditory). Standard empty room | ||
| recordings with each compatible | ||
| device configuration were made. | ||
| The average noise level (around | ||
| 100Hz) of each device | ||
| configuration was compared with | ||
| the reference noise threshold | ||
| (10fTrms/ $\sqrt$ Hz). | The empty room test results | |
| showed that the addition of each | ||
| compatible device did not | ||
| significantly increase the noise | ||
| level of the Orion LifeSpan™ | ||
| MEG when used without | ||
| compatible devices, nor did | ||
| integration of each device result | ||
| in exceeding the noise threshold | ||
| (at around 100Hz). | ||
| CURRY | ||
| Software | ||
| Verification | ||
| and | ||
| Validation | ||
| tests | All relevant CURRY Software | |
| specifications were verified and | ||
| validated in accordance with IEC | ||
| 62304:2006. | CURRY Software verification | |
| and validation tests show that the | ||
| CURRY Software supports the | ||
| Orion device functionalities in a | ||
| manner comparable to the | ||
| predicate, (i.e., processing, | ||
| display, localization, MEG | ||
| control functions). | ||
| Limited | ||
| Channel | ||
| Operation | ||
| Test | Phantom localization testing | |
| was performed to demonstrate | ||
| device functionality and ability | ||
| to meet source localization | ||
| accuracy criteria while | ||
| operating at three different | ||
| degrees of channel operation | ||
| (95%, 90%, and 80% of full | ||
| channel capacity). The average | ||
| localization error needs to be | ||
| below 2mm, and the maximum | ||
| localization error needs to be | ||
| below 4mm. | The limited channel operation test | |
| demonstrates the device | ||
| functionality and ability to meet | ||
| source localization accuracy | ||
| criteria ( average localization | ||
| error range: 0.05-0.09mm; | ||
| maximum localization error | ||
| range: 0.14-0.17mm) when | ||
| operating without 20% of its | ||
| channels (80% full channel | ||
| capacity). |
2 The Elekta Neuromag TRIUX MEG was measured at Swinburne University of Technology. Data dated: November 6th, 2019
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Additionally, evaluations were conducted in accordance with the following performance standards:
- · IEC 60601-1:2005+A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
- IEC 80601-2-26:2019 Medical electrical equipment Part 2-26: Particular . requirements for the basic safety and essential performance of electroencephalographs
- IEC 62304:2006 Medical device software Software lifecycle process .
- ISO 14971:2007 Medical devices Application of risk management to . medical devices
Clinical Performance Data
Clinical testing was not performed.
Conclusion
Based on the non-clinical performance, the Orion LifeSpan™ MEG was found to have a safety and effectiveness profile that is similar to the predicate device. The Orion LifeSpan™ MEG also demonstrates meeting the same minimum safety and performance requirements for medically acceptable, commercial MEGs.