(219 days)
No
The description of the RecogniZe algorithm details a rule-based approach involving filtering, fragmentation, feature extraction, and detection based on heightened regularity in EEG wave sequences. It does not mention training on data or using machine learning techniques.
No
The device is used to record, collect, and display EEG/aEEG data, and to assist in the assessment of HIE severity and seizure detection. It does not provide any therapy or treat any condition.
No
The "Intended Use / Indications for Use" section explicitly states: "The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition." While it aids in assessment and identifies sections that may correspond to seizures, it requires professional judgment for diagnosis.
No
The device description explicitly states that the system consists of hardware components including a Data Acquisition Box (DAB), Touchscreen Monitor, Roll Stand or optional Desktop Stand, and Neonatal Sensor set, in addition to the software.
Based on the provided information, the Olympic Brainz Monitor (OBM) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- OBM Function: The OBM is an electroencephalograph (EEG) system. It measures and records the electrical activity of the patient's brain by placing electrodes on the head. This is a non-invasive procedure that directly measures physiological signals from the body, not from a specimen taken from the body.
- Intended Use: The intended use clearly states that the device acquires signals from electrodes placed on the patient's head to display and analyze brain activity. It does not involve the analysis of biological specimens.
- Device Description: The device description reinforces that it passively records electroencephalographic activity from the patient through electrodes.
Therefore, the Olympic Brainz Monitor falls under the category of a medical device that directly interacts with the patient's body to acquire physiological data, rather than an IVD device that analyzes specimens taken from the body.
N/A
Intended Use / Indications for Use
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
- The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
- The signals acquired from P3-P4 channel is intended to assist in the assessment of Hypoxic-Ischemic Encephalopathy severity and long-term outcome, in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
- The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that may correspond to electrographic seizures in only the centro-parietal regions of full term neonates (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centro-parietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
Product codes
OMA, OMB, OMC
Device Description
The Olympic Brainz Monitor is a three-channel electroencephalograph (EEG) system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient's brain by placing two or more electrodes on the head. The device does not introduce, transfer or deliver any type of energy to the patient. As any other electroencephalograph the device passively record the electroencephalographic activity from the patient trough the hydrogel electrodes and then process the signal for display, analysis and archiving.
The Olympic Brainz Monitor system consists of the following:
- Data Acquisition Box (DAB)
- Touchscreen Monitor
- Roll Stand or optional Desktop Stand
- 9 Neonatal Sensor set (K033010)
- Software
These components have equivalent configuration and functions to those described in K093949 for the OBM Monitor. The Neonatal Sensor set (cleared on K033010) is an accessory to the device that is the only part that enters into contact with the patient. The sensor guarantees acquisition of the electroencephalographic signal and passively transfers it to the main unit. This is a set of five hydrogel skin electrodes that are attached to the patient's head at one extreme and to the Data Acquisition Box at the other extreme using standard touch-proof connectors.
The device allows practitioners to acquired, store, review and archive EEG activity from 4 centroparietal locations corresponding to C3, C4. P3 and P4 of the international 10-20 System. The device displays the recorded activity in form of the raw EEG and as amplitude integrated EEG (aEEG).
In addition the device now includes a seizure detection algorithm (i.e RecogniZe) to allow automated analysis of the recorded EEG. The RecogniZe Seizure Detection Algorithm identifies sections of the EEG trace where seizure activity is detected. The algorithm comprises filtering of the EEG signal, fragmentation of EEG signal into waves, wave-feature extraction, and elementary, preliminary and final detection. The main idea behind the algorithm is to detect heightened regularity in EEG wave sequences using wave intervals, amplitudes and shapes, as increased regularity is the major distinguishing feature of seizure discharges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Centroparietal locations corresponding to C3, C4, P3 and P4 of the international 10-20 System.
Indicated Patient Age Range
Neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks). Specifically, for Hypoxic-Ischemic Encephalopathy assessment and the RecogniZe algorithm, full term neonates (postconceptual age of 37 to 46 weeks).
Intended User / Care Setting
Qualified clinical practitioners; hospital environment (NICU, research).
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
Testing Dataset
All EEGs used for validation were collected from neonatal patients seen for routine clinical evaluation at the Neonatal Intensive Care Unit of St. Louis Children's Hospital, USA. An independent physician not taking part on the subsequent review/scoring of the data conducted database query and study inclusion from a patient database of consecutive recordings.
All studies consisted on EEGs recorded using the Stellate Harmonie for multichannel EEG recordings obtained from scalp locations according to the International 10-20 system, and Olympic Brains Monitor for limited channels) montage. All recordings meeting inclusion criteria were included independently of EEG patterns and technical quality.
Dataset Description:
Number of Events: 421
Total Number of Patients: 82
Number of Hours: 621
AGE (Mean ± SD) 38.3 (± 1.9) GENDER 44/38 (Female/Male)
All subjects involved in this study were neonates (defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks).
To avoid over-weighting recordings containing many events, a maximum of 13 events per limited-channel recording were permitted.
Analysis Method
EEG studies were de-identified, randomized and provided to board certified neurophysiologists that independently, blindly and manually marked seizures (no seizure detection algorithm was allowed) in the same manner they would normally do in clinical practice. Experts initially reviewed the full cohort of standard montage recordings (157) marking seizure onset and noting the topography of seizures. To annotate topography experts were asked to classify seizures as occurring in one of the following zones:
-
- Frontal (Left/Right)
-
- Centro-Parietal (Left/Right)
-
- Central Midline
-
- Temporal (Left/Right)
-
- Occipital (Left/Right)
After a 4 weeks wash-out period implemented to avoid any possible recognition of individual recordings, reviewers were provided with the limited-channel (C3-P3, C4-P4 and P3-P4) recordings for marking. Once EEGs were marked by the expert raters same limited channel studies were submitted for analysis using RecogniZe.
Detection Parameters
To conduct the analysis, the marked studies were played back and fed into the RecogniZe software, with detection settings at default values (detection threshold was 5μV). Measurements of event-based Positive Percent Agreement (PPA) and False Detection Rate (FDR) of the proposed detection system were assessed.
The event-based 'any-overlap' method' was used. An Event of Interest (EOI) detected by the algorithm was considered to match an EOI marked by the expert rater if there was any intersection between their two time periods. The any-overlap positive percent agreement was calculated by dividing the number of matched events by the total number of events.
All studies were annotated by the event detection algorithm. Notes were stored in time order in an annotation file for each study and were used for comparison against the annotated EEG files generated by the expert readers. PPA and FDR were calculated on the same dataset of recordings which combined seizure and non-seizure recordings.
Summary of Performance Studies
Non-Clinical: The OBM device is compliant with all currently accepted safety standards for medical devices of its class which was demonstrated through testing, verification of all components.
Clinical: Natus conducted an extensive clinical test to: 1) Evaluate the positive percent agreement (i.e., detection sensitivity) and false detection rate of RecogniZe, seizure detection algorithm, and to 2) Demonstrate equivalence of the seizure detection performance, in terms of positive percent agreement and false detection rates, of RecogniZe as compared to the gold standard, defined as seizures detected by a panel of 3 EEG board certified medical professionals.
Study Type: Clinical Validation Study
Sample Size: Total Number of Patients: 82, Number of Hours: 621, Number of Events: 421.
Key Results:
Electrographic Seizure Topography: Out of 635 seizures, 54% (340) were in the Centro-Parietal (Left+Right) zone, 17.1% (109) in Frontal, 19.6% (125) in Central Midline, 6.7% (43) in Temporal, and 2.8% (18) in Occipital.
Inter Rater Performance (Conventional EEGs): Inter-rater agreement for seizure detection varied between 78% and 81%. False detection per hour (FD/h) was 0.2 for all three raters.
Inter Rater Performance (Limited Channel EEG): Inter-rater PPA for scorer to scorer ranged between 58% and 66%. False detection per hour (FD/h) was 0.3 for all three raters.
Algorithm Performance:
With default settings (detection threshold at 5 µV), Recognized achieved 61% positive percent agreement and a false detection rate of 0.5/hr. When compared to the average rater PPA of 62% for 3-channel raw EEGs, Recognize's performance is substantially equivalent to that of medical experts.
Summary of Algorithm Performance at different thresholds:
| Threshold level (µV) | PPA (95% CI) | FDR (FP/h) (95% Cl) |
|---|---|---|
| 5 | 61% (52 - 68) | 0.5 (0.4-0.7) |
| 7.5 | 53% (39 - 55) | 0.2 (0.1 - 0.3) |
| 10 | 47% (33 - 49) | 0.1 (0.07 - 0.1) |
Key Metrics
- Positive Percent Agreement (PPA) / Detection sensitivity
- False Detection Rate (FDR) / False Positives per hour (FP/h)
Summary of Algorithm Performance at different thresholds:
| Threshold level (µV) | PPA (95% CI) | FDR (FP/h) (95% Cl) |
|---|---|---|
| 5 | 61% (52 - 68) | 0.5 (0.4-0.7) |
| 7.5 | 53% (39 - 55) | 0.2 (0.1 - 0.3) |
| 10 | 47% (33 - 49) | 0.1 (0.07 - 0.1) |
Predicate Device(s)
Olympic Brainz Monitor (K093949), IndenEvent (K092039), Persyst Reveal (K011397)
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
xltek
a division of natus
PAGE 1 of 17
510K Summary
Supplement 3
MAY 8 2013
Date: February 28, 2013
Submitted by: Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1
Contact Person: Daniel Ramirez Clinical Scientist Natus Medical Inc. Tel.: (905) 829-5300 ext 356 Fax .: (905) 829-5304 E-mail: Daniel.Ramirez-Rodriquez@natus.com
Propietary Name: Olympic Brainz Monitor (OBM)
Device Name: Olympic Brainz Monitor
Model: Olympic Brainz Monitor (OBM)
Common Name: Electroencephalograph
Classification Name: Amplitude Integrated electroencephalograph, Automatic Event Detection Software for Full-Montage Electroencephalograph, Reduced- Montage Standard Electroencephalograph
Product code: OMA, OMB, OMB, OMC
Device Class: II
Predicate Devices: Olympic Brainz Monitor (K093949) IndenEvent (K092039) Persyst Reveal (K011397)
The Olympic Brainz Monitor' is a three-channel electroencephalograph (EEG) system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient's brain by placing two or more electrodes on the head. The device does not introduce, transfer or deliver any type of energy to the patient. As any other electroencephalograph the device passively record the
1 Internal (Engineering) name of the Olympic Brainz Monitor is CFM7000.
1
Image /page/1/Picture/0 description: The image shows the logo for "xltek", which is described as a division of Natus. The logo features a stylized star-like symbol to the left of the text "xltek". Below the text is the phrase "a division of natus" in a smaller font size.
PAGE 2 of 17
electroencephalographic activity from the patient trough the hydrogel electrodes and then process the signal for display, analysis and archiving.
The Olympic Brainz Monitor system consists of the following:
- . Data Acquisition Box (DAB)
- Touchscreen Monitor .
- Roll Stand or optional Desktop Stand .
- 9 Neonatal Sensor set (K033010)
- Software .
These components have equivalent configuration and functions to those described in K093949 for the OBM Monitor. The Neonatal Sensor set (cleared on K033010) is an accessory to the device that is the only part that enters into contact with the patient. The sensor guarantees acquisition of the electroencephalographic signal and passively transfers it to the main unit. This is a set of five hydrogel skin electrodes that are attached to the patient's head at one extreme and to the Data Acquisition Box at the other extreme using standard touch-proof connectors.
An overview of hardware connectivity and system connectivity is illustrated below.
Image /page/1/Figure/12 description: The image shows a diagram of a panel PC with integrated touch screen, running Windows XP Embedded. It has VESA 100mm mounting and can be used as a desktop or roll-stand mounting. The diagram also shows a USB drive, USB connection, CDROM, server, printer, network, and 5-lead amplifier (DAB).
Olympic Brainz Monitor Connectivity
The device allows practitioners to acquired, store, review and archive EEG activity from 4 centroparietal locations corresponding to C3, C4. P3 and P4 of the international 10-20 System. The device displays the recorded activity in form of the raw EEG and as amplitude integrated EEG (aEEG).
2
Image /page/2/Figure/0 description: The image shows a screenshot of the "OLYMPIC BRAINZ MONITOR" software, specifically supplement 3, page 3 of 17. The display includes multiple graphs showing aEEG and EEG readings over time, with scales in microvolts. The time frame displayed ranges from 15:00 on 12/6/2012 to 14:00 on 12/11/2012, and the current time is 10:40:48 on 12/19/2012.
Real-time (EEG Waveform, aEEG) for the bilateral channels (C3-P3, C4-P4)
In addition the device now includes a seizure detection algorithm (i.e RecogniZe) to allow automated analysis of the recorded EEG. The RecogniZe Seizure Detection Algorithm identifies sections of the EEG trace where seizure activity is detected. The algorithm comprises filtering of the EEG signal, fragmentation of EEG signal into waves, wave-feature extraction, and elementary, preliminary and final detection. The main idea behind the algorithm is to detect heightened regularity in EEG wave sequences using wave intervals, amplitudes and shapes, as increased regularity is the major distinguishing feature of seizure discharges.
RecogniZe output display for seizure detections.
3
PAGE 4 of 17
Indications for Use
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
- The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with . neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
- . The signals acquired from P3-P4 channel is intended to assist in the assessment of Hypoxic-Ischemic Encephalopathy severity and long-term outcome, in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
- . The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that may correspond to electrographic seizures in only the centro-parietal regions of full term neonates (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centro-parietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the · Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
4
Image /page/4/Picture/0 description: The image shows the word "xltek" in a sans-serif font. Above the word is a logo that looks like a stylized person with their arms raised. Below the word is the phrase "a division of natus" in a smaller font.
PAGE 5 of 17
Predicate Comparison
| Device Feature | Subject Device:
OBM Brain Monitor | Predicate Device
OBM Brain Monitor
(K093949) |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use... | | |
| Purpose and function: | EEG monitoring | EEG monitoring |
| Patient population: | Neonatal | Neonatal |
| Environment of use: | Clinical environments
(NICU, research) | Clinical environments
(NICU, research) |
| Hardware Features... | | |
| Physical platform: | Mobile roll-pole | Mobile roll-pole |
| EEG system platform: | Pentium M, panel PC | Pentium M, panel PC |
| Display type: | 15" color LCD | 15" color LCD |
| Device control
method: | Touch-screen GUI | Touch-screen GUI |
| Mains power
transformer: | Internal to Monitor
(monitor houses a
medical grade power
supply) | Internal to Monitor
(monitor houses a
medical grade power
supply) |
| Skin Electrodes (K033010) | | |
| Electrode
configuration: | 4 signal electrodes +
reference | 4 signal electrodes +
reference |
| Shelf Life | 18 months | 18 months |
| Sterile | NO | NO |
| Leadwire
configuration: | Standard touch-proof
connections on OBM
DAB | Standard touch-proof
connections on OBM
DAB |
| DAB (Amplifier)
Performance... | | |
| Maximum number of
channels: | 3 | 3 |
| A-to-D converter: | 4-channel
multiplexed
successive-
approximation type | 4-channel multiplexed
successive-approximation
type |
| Sampling rate: | 2000 Hz | 2000 Hz |
| Sampling resolution: | 16 bits at 2000 Hz | 16 bits at 2000 Hz |
| Input impedance: | 50 MΩ@ 10Hz | 50 MΩ@ 10Hz |
| Device Feature | Subject Device:
OBM Brain Monitor | Predicate Device
OBM Brain Monitor
(K093949) |
| Noise in bandwidth: | 100 dB @ 60Hz | > 100 dB @ 60Hz |
| Sensitivity for max
DAB output: | ± 5 mVpK | ± 5 mVpK |
| Calibration: | One-time at factory
only | One-time at factory only |
| Bandwidth: | 0.5Hz ~ 450Hz | 0.5Hz ~ 450Hz |
| Impedance
monitoring: | Continuous on each
electrode | Continuous on each
electrode |
| Impedance check
signal: | 6 nArms at 353, 375,
400, 429Hz | 6 nArms at 353, 375, 400,
429Hz |
| Functional test
equipment: | none | none |
| Signal Quality... | | |
| Impedance alarm
limits | 15 kΩ Warning
messages and
troubleshooting
suggestions. Color
coded indications of
impedance levels. | 15 kΩ Warning messages
and troubleshooting
suggestions. Color coded
indications of impedance
levels |
| Signal quality
indication | Continuous
impedance check.
Continuous display of
impedance
values/trace. | Continuous impedance
check. Continuous display
of impedance
values/trace. |
| Notch filter | Yes 50/60 Hz | Yes 50/60 Hz |
| Displayed
Parameters... | | |
| Main parameters | EEG, aEEG
waveform | EEG, aEEG waveform |
| Secondary
parameters | None | None |
| | Subject Device: | Predicate Device |
| Device Feature | OBM Brain Monitor | OBM Brain Monitor
(K093949) |
| Signal reliability
parameters | Continuous
Impedance
values/trace | Continuous Impedance
values/trace |
| Monitor Features... | | |
| Patient identification
data | Shows patient name,
date of birth, time of
birth and ID | Shows patient name, date
of birth, time of birth and
ID |
| Event marking | Yes. User can mark
areas of interest. | Yes. User can mark areas
of interest. |
| Recorded file
reviewing. | Yes, on screen or
printed record. | Yes, on screen or printed
record. |
| External Interfaces... | | |
| Output to printer: | via Ethernet port | via Ethernet port |
| External data storage: | via USB port | via USB port |
| Software upgrades: | via USB port | via USB port |
| Standards
Compliance... | | |
| General & electrical
safety: | IEC 60601-1 | IEC 60601-1 |
| US national
deviations: | UL 60601-1 | UL 60601-1 |
| EEG particular
requirements: | IEC 60601-2-26 | IEC 60601-2-26 |
| Electromagnetic
compatibility: | IEC 60601-1-2 | IEC 60601-1-2 |
5
Image /page/5/Picture/0 description: The image shows the logo for "xltek, a division of natus". The logo features a stylized image to the left of the word "xltek". The words "a division of natus" are written in a smaller font size below the word "xltek".
Page 6 of 17
6
Image /page/6/Picture/0 description: The image shows the logo for Xltek, a division of Natus. The logo features a stylized "X" symbol to the left of the word "xltek". Below the word "xltek" is the text "a division of natus" in a smaller font size.
Page 7 of 17
Predicate Comparison for aEEG feature
| | Subject Device:
OBM Brain Monitor | Predicate Device
OBM Brain Monitor
(K093949) | |
|-----------------|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| a) Device Class | Class II | Class II | |
| b) Class Name | Electroencephalograp
h | Electroencephalograph | |
| c) User input | Touch-screen | Touch-screen | |
| | | Subject Device:
OBM Brain Monitor | Predicate Device
OBM Brain Monitor
(K093949) |
| d) | Have aEEG
tracing | Yes | Yes |
| e) | Have raw EEG
tracing | Yes | Yes |
| f) | Simultaneous
and
synchronized
aEEG an raw
EEG display | Yes | Yes |
| g) | Shows
Impedance
measurements | Continuous trace | Continuous trace |
| h) | aEEG signal
processing
algorithm | Filtered by aEEG filter,
rectified and semi
logarithmically
compressed | Filtered by aEEG filter,
rectified and semi
logarithmically
compressed |
| i) | aEEG filter
specification | Up to 2 Hz:
Rising by 60
dB/decade
2 Hz - 12 Hz:
Rising by 12
dB/decade
12 Hz - 16 Hz:
1 dB above 10 Hz
level
16 Hz - 30 Hz:
cut off slope 120
dB/decade
50 Hz and above
60 dB down on 10 Hz
response | Up to 2 Hz:
Rising by 60 dB/decade
2 Hz - 12 Hz:
Rising by 12 dB/decade
12 Hz - 16 Hz:
1 dB above 10 Hz level
16 Hz - 30 Hz:
cut off slope 120
dB/decade
50 Hz and above
60 dB down on 10 Hz
response |
| j) | aEEG display
scale | Semi logarithmic scale
from 0 to 100 micro
Volts. | Semi logarithmic scale
from 0 to 100 micro
Volts. |
| k) | Number of
electrodes | 4 active electrode + 1
reference | 4 active electrode + 1
reference |
| l) | Location of
electrodes | Centro-parietal
corresponding to C3,
C4, P3 and P4
locations of the 10/20
System | Centro-parietal
corresponding to C3,
C4, P3 and P4 locations
of the 10/20 System |
7
Image /page/7/Picture/4 description: The image shows the word "xltek" in a sans-serif font. Above the word is a small graphic of a person with outstretched arms. Below the word is the phrase "a division of natus" in a smaller font. The text is black and the background is white.
. '
K123079: OLYMPIC BRAINZ MONITOR SUPPLEMENT 3
:
. . . . . . . . . . . . . . . . . . . . .
.
Page 8 of 17
・
8
PAGE 9 of 17
| | Subject Device:
OBM Brain Monitor | Predicate Device
OBM Brain Monitor (K093949) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| m) CFM Display Controls | User can move through the aEEG trace data by touching the scroll bar or navigation buttons on the screen. User can scroll by page, or by Markers. | User can move through the aEEG trace data by touching the scroll bar or navigation buttons on the screen. User can scroll by page, or by Markers. |
| n) EEG display and positioning Controls | 1. Each EEG screen contains up to 15 seconds of EEG data. The default represents about 30 mm/sec or about 7 seconds of data.
2. EEG amplitude display ranges from 50 micro Volts (p-p) to 800 micro Volts (p-p).
3. User can move through the EEG forwards and backwards. | 1. Each EEG screen contains up to 15 seconds of EEG data. The default represents about 30 mm/sec or about 7 seconds of data.
2. EEG amplitude display ranges from 50 micro Volts (p-p) to 800 micro Volts (p-p).
3. User can move through the EEG forwards and backwards. |
| o) Additional controls | Record - user can press the Record button to start or stop recording | Record - user can press the Record button to start or stop recording |
No changes have been implemented to the OBM monitor since its clearance (K093949). The intended use, components, parts, materials and technological characteristics of the subject device, are the same as those described and cleared on K093949.The subject device is in all regards the same as the cleared OBM K093949.
The skin electrodes (also referred to as "sensors") provided for use with the OBM Brain Monitor is the Neonatal Sensor Set. This is a set of five hydrogel skin electrodes with standard touch-proof connectors that attach to the Data Acquisition Box. This sensor set was cleared under K033010.
The sole difference between the subject device and that cleared on K093949 is the addition of the RecogniZe, seizure detection module. A new intended use claim has been added to the subject OBM device IFU, to address the addition of this new component.
9
Page 10 of 17
Predicate Comparison for Seizure Detection
ど xitek
| | Subject Device:
OBM Monitor
(Recognize)
K123079 | Predicate Device:
IndentEvent
K092039 | Persyst Reveal
K011397 |
|-----------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| | OMA, OMC | OMB, OLT | GWS |
| | YES | YES | YES |
| Product Code
Identifies seizures
Intended Use | to mark sections of EEG
that may correspond to
electrographic seizures | to mark sections of EEG that
may correspond to
electrographic seizures | to mark sections of EEG
that may correspond to
electrographic seizures |
| Population | Neonatal | Adult | Adult |
| Number of Channels | 4 (C3,C4,P3 and P4) | 16 (standard 10/20 system) | Unknown |
| Type of recording
supported | Raw EEG (scalp only) | Raw EEG (scalp only) | Raw EEG (scalp only) |
| Type of analysis | Post-hoc | Post-hoc | Post-hoc |
| User Adjustable | YES | YES | YES |
| Output | Visible marks on
EEG/aEEG signal
display. | Visible marks on EEG signal
display. | Visible marks on EEG
signal display. |
| Positive Percent
Agreement (%) | 61% | 79.5% | 74% |
| False Detection Rate
(FP/h) | 0.6 | 0.08 | 0.3 |
10
| K123079: OLYMPIC BRAINZ MONITOR | |||
|---|---|---|---|
| xltek | |||
| a division of natus | SUPPLEMENT 3 | ||
| PAGE 11 of 17 |
RecogniZe is substantially equivalent to the cleared seizure detection algorithms IndentEvent (K092039) and Persyst Reveal (K011397).The subject devices as the predicates use raw EEG signal as the basis to carry their function i.e. analysis of the acquired EEG signal for seizure detection. As in the predicate devices, users of RecogniZe are provided with the possibility to adjust detection parameters that control the seizure detection capabilities. The output of the Recognize seizure detector, as that of the predicates, is marked EEG regions where the probable seizure activity is present, Similar to the predicates, the intended user of the subject device is a qualified medical practitioner who will review the marked EEG traces and use the information according to their professional judgment. As the predicates, RecogniZe is intended as a tool to aid in the assessment of long EEG recordings to help reduced the amount of time devoted to review. RecogniZe, as the predicates, does not provide any diagnostic conclusion.
Technological differences between RecogniZe and the predicates include the number and location of channels. Predicates use at least 16 channels while RecogniZe uses 3 channels located in C3, C4, P3 and P4 of the 10/20 System for Electrode Placement. We have shown in the clinical study that the majority of seizures in the neonate occur or are visible at centro-parietal electrodes. Risks associated with non-visible/detectable seizures have been mitigated trough detailed communication to the user and instructions for use of the device.
Predicate devices are intended for adult patients while the subject device is intended for neonates. Intrinsic differences on the EEG for both groups prevent us from comparing performance of predicates in neonates. However, substantially equivalence of RecogniZe is established through clinical testing proving that RecogniZe as the predicates is equivalent to performance of medical experts. Predicates have all been cleared based on their comparison to similar devices and to performance of expert encephalographers. In all cases performance of the predicates is comparable to that of the medical experts which has served as the basis for demonstration of safety, effectiveness and substantial equivalence. In this sense. RecogniZe performance is comparable to the predicates, i.e. RecogniZe performance is similar to that of the expert encephalographers confronted with a similar task. Therefore we claim Recognize is substantially equivalent to predicate devices.
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Brief Summary of Non-Clinical and Clinical Performance Tests
All functionalities and performance of the Olympic Brainz Monitor have been verify/validated through Bench and clinical performance tests according to the intended use- and user- of the device.
Non-Clinical: The OBM device is compliant with all currently accepted safety standards for medical devices of its class which was demonstrated through testing, verification of all components.
Clinical: Natus conducted an extensive clinical test to: 1) Evaluate the positive percent agreement (i.e., detection sensitivity) and false detection rate of RecogniZe, seizure detection algorithm, and to 2) Demonstrate equivalence of the seizure detection performance, in terms of positive percent agreement and false detection rates, of RecogniZe as compared to the gold standard, defined as seizures detected by a panel of 3 EEG board certified medical professionals.
RecogniZe Clinical Validation
Testing Dataset
All EEGs used for validation were collected from neonatal patients seen for routine clinical evaluation at the Neonatal Intensive Care Unit of St. Louis Children's Hospital, USA. An independent physician not taking part on the subsequent review/scoring of the data conducted database query and study inclusion from a patient database of consecutive recordings.
All studies consisted on EEGs recorded using the Stellate Harmonie for multichannel EEG recordings obtained from scalp locations according to the International 10-20 system, and Olympic Brains Monitor for limited channels) montage. All recordings meeting inclusion criteria were included independently of EEG patterns and technical quality.
Dataset Description:
Number of Events: 421
Total Number of Patients: 82
Number of Hours: 621
AGE (Mean ± SD) 38.3 (± 1.9) GENDER 44/38 (Female/Male)
All subjects involved in this study were neonates (defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks). The demographic characteristics of the population included for this study are shown below:
To avoid over-weighting recordings containing many events, a maximum of 13 events per limitedchannel recording were permitted.
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Image /page/12/Picture/0 description: The image shows the logo for "xltek, a division of natus". The logo consists of a stylized "X" symbol to the left of the word "xltek". Below the word "xltek" is the phrase "a division of natus" in a smaller font. The logo appears to be printed in black ink on a white background.
Analvsis Method
EEG studies were de-identified, randomized and provided to board certified neurophysiologists that independently, blindly and manually marked seizures (no seizure detection algorithm was allowed) in the same manner they would normally do in clinical practice. Experts initially reviewed the full cohort of standard montage recordings (157) marking seizure onset and noting the topography of seizures. To annotate topography experts were asked to classify seizures as occurring in one of the following zones:
-
- Frontal (Left/Right)
-
- Centro-Parietal (Left/Right)
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- Central Midline
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- Temporal (Left/Right)
-
- Occipital (Left/Right)
After a 4 weeks wash-out period implemented to avoid any possible recognition of individual recordings, reviewers were provided with the limited-channel (C3-P3, C4-P4 and P3-P4) recordings for marking. Once EEGs were marked by the expert raters same limited channel studies were submitted for analysis using RecogniZe.
Detection Parameters
To conduct the analysis, the marked studies were played back and fed into the RecogniZe software, with detection settings at default values (detection threshold was 5μV). Measurements of event-based Positive Percent Agreement (PPA) and False Detection Rate (FDR) of the proposed detection system were assessed.
The event-based 'any-overlap' method' was used. An Event of Interest (EOI) detected by the algorithm was considered to match an EOI marked by the expert rater if there was any intersection between their two time periods. The any-overlap positive percent agreement was calculated by dividing the number of matched events by the total number of events.
All studies were annotated by the event detection algorithm. Notes were stored in time order in an annotation file for each study and were used for comparison against the annotated EEG files generated by the expert readers. PPA and FDR were calculated on the same dataset of recordings which combined seizure and non-seizure recordings.
2 Wilson SB , Scheuer ML, Plumg B, Pacia S. Seizure detection: correlation of human experts. Clin Neurophysiol. 2003 Nov:114(11):2156-64.
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Results
Electrographic Seizure Topography.
The table below describes the topographical distribution of seizures detected with standard montage on conventional EEG recordings. According to majority rule, there were a total of 635 seizures in all recordings
| Zone | % visible seizures |
|---|---|
| Frontal (Left+Right) | 17.1% (109) |
| Central Midline | 19.6% (125) |
| Centro-Parietal (Left+Right) | 54% (340) |
| Temporal (Left+Right) | 6.7% (43) |
| Occipital (Left+Right) | 2.8% (18) |
| Total | 635 |
We have collapsed seizures from homologous zones (i.e temporal right, and so on). The most common location of seizures was the centro-parietal zones where 73% (465/635) of seizures occurred followed the frontal zones (17%, 109/635). Seizures visible in the occipital zones were the less frequent.
Inter Rater Performance
-
- Conventional EEGs (cEEG)
Inter-rater Positive Percent Agreement and False Detection / hour with cEGG
| EVENTS | ||||||
|---|---|---|---|---|---|---|
| Rater 1 | Rater 2 | Rater 3 | ||||
| PPA% | FD/h | PPA% | FD/h | PPA% | FD/h | |
| Rater 1 | 81 | 0.2 | 81 | 0.2 | ||
| Rater 2 | 78 | 0.2 | 57 | 0.2 | ||
| Rater 3 | 78 | 0.2 | 80 | 0.2 |
The inter-rater agreement reported in our study varies between 78 % and 81% for seizure detection : while FDR (false detection per hour (FD/h) was very close for all three raters (0.2 FD/h).
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| xitek
a division of natus | K123079: OLYMPIC BRAINZ MONITOR
SUPPLEMENT 3 | | |
|------------------------------|-------------------------------------------------|--|--|
| PAGE 15 of 17 | | | |
Limited Channel EEG 2.
Inter-rater PPA for scorer to scorer ranged between 58 and 66%, while FDR (false detection per hour (FD/h) was very close for all three raters (0.3 FD/h).
| Inter-rater Positive Percent Agreement and False Detection / hour with OBM | ||
|---|---|---|
| EVENTS | ||||||
|---|---|---|---|---|---|---|
| Rater 1 | Rater 2 | Rater 3 | ||||
| PPA% | FD/h | PPA% | FD/h | PPA% | FD/h | |
| Rater 1 | 62 | 0.3 | 66 | 0.3 | ||
| Rater 2 | 62 | 0.3 | 57 | 0.3 | ||
| Rater 3 | 66 | 0.2 | 58 | 0.2 |
The inter-rater agreement reported in our study varies between 58 % and 66% for seizure detection. Evaluating inter-rater agreement for seizure detection Walczak et al (1992) reported that seizure onset was correctly determined by 3 independent EEGers in 47% to 65% of extratemporal seizures like is the case for the study reported here where information available to EEGers was recorded at extratemporal (centro-parietal) sites.
Seizure recognition by expert reviewers is better when conventional EEG (cEEG) is used as compare to same task but with a Limited Channel Montage (LM-EEG). Expert reviewers detected a total of 635 seizures in cEEG versus 424 seizures in the LM-EEG. RecogniZe detected 258 seizures in the LM-EEG. With the limited number of channels, there are less visual cues available to perform the patterrecognition task necessary for seizure identification. This however, does not prevent seizure recognition, but somehow increases the difficulty of the task at hand.
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Image /page/15/Picture/0 description: The image shows the logo for "xltek", which is a division of Natus. The logo features a stylized human figure with outstretched arms above the text "xltek". A horizontal line separates the text from the phrase "a division of natus" written in a smaller font. The overall design is simple and corporate.
Algorithm Performance
The picture below presents RecogniZe performance using the full range of detection thresholds: 5uV, 7.5 µV and 10 µV.
Image /page/15/Figure/5 description: The image is a line graph titled "Recognize Performance". The x-axis is labeled "False Positive Rate (FP/h)" and ranges from 0.1 to 0.5. The y-axis is labeled "PPA (%)" and ranges from 0 to 70. There are three lines on the graph, each representing a different threshold level: 5 μV, 7.5 μV, and 10 μV.
The results revealed that as detection threshold increases the False Positive Rate improves (less False Positives per hour) at the expense of deterioration in the algorithm Positive Percent Agreement (PPA). With detection threshold set at 10 uV PPA drops to 47% and FDR decrease to 0.1 FP/h. With the default settings (detection threshold at 5 uV) Recognized achieved 61% positive percent agreement and a false detection rate of 0.5/hr, comparable to the range of inter-rater false detection rate of 0.3/hr and raters
| Threshold level
(μV) | PPA (95% CI)* | FDR (FP/h)
(95% Cl)* |
|-------------------------|---------------|-------------------------|
| 5 | 61% (52 - 68) | 0.5
(0.4-0.7) |
| 7.5 | 53% (39 - 55) | 0.2
(0.1 - 0.3) |
| 10 | 47% (33 - 49) | 0.1
(0.07 - 0.1) |
*Bootstrap 95% Cl
When confronted with 3 channels raw EEGs the average rater PPA was 62%. That is, any given expert EEGer positively agreed 62% on average with any of its peers for seizure identification in a limited channel montage. With a 61% PPA and an FDR of 0.5 FD/hr Recognize is substantially equivalent to the performance of medical experts confronted with similar task and amount of data
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Image /page/16/Picture/0 description: The image shows the logo for "xltek a division of natus". The logo consists of a stylized symbol to the left of the text "xltek". Below the text is the phrase "a division of natus" in a smaller font. The logo is in black and white.
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Conclusion:
.
Based on the results of the Clinical and non-clinical testing we conclude that the Olympic Brainz Monitor is safe, effective and substantially equivalent to predicates in intended use, and all other technological characteristics.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
May 08,2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Daniel Ramirez 2568 Bristol Circle Oakville, Ontario L6H 5S1 Canada
Re: K123079
Trade/Device Name: Olympic Brainz Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Amplitude-integrated electroencephalograph Regulatory Class: Class II Product Code: OMA, OMB, OMC Dated: April 9, 2013 Received: April 12, 2013
Dear Mr. Ramirez:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Ramirez
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address:
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
19
Indications for Use
510(k) Number: K123079
Device Name: XLTEK Olympic Brainz Monitor
Indications For Use:
The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.
- The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with . neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain.
- The signals acquired from P3-P4 channel is intended to assist in the assessment of Hypoxic-● Ischemic Encephalopathy severity and long-term outcome, in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event.
- The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that . may correspond to electrographic seizures in only the centro-parietal regions of full term neonates (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centroparietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information.
The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Victor Krauthamer -S 2013.05.09 14:53:25 -04'00'
(Division Sian Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123079
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