(701 days)
K072286 - BIS EEG VISTA MONITOR SYSTEM
Not Found
No
The summary describes a proprietary computed index (CCS) derived from EEG signals, but there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with ML model development. The performance studies focus on comparing the CCS index to existing indices (BIS and M-Entropy) using traditional statistical metrics like prediction probability.
No
Explanation: The device is described as a monitor that acquires and processes EEG signals to display brain state and a computed EEG index. It is intended to assist medical professionals in monitoring patients and does not directly provide therapy or affect the body's structure or function for treatment.
Yes
The device is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals, display a patient's EEG and Composite Cortical State (CCS), and assist medical professionals in monitoring patients in the operating room. This involves providing information that medical professionals can use to understand and assess a patient's physiological state, which is a diagnostic function. The device also mentions that CCS is related to the effect of certain anesthetic or hypnotic agents, indicating it helps understand the patient's response to these agents.
No
The device description explicitly lists three components, two of which are hardware: the Data Acquisition Module (DAM) and the disposable cutaneous electrode sensor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BAR Monitor's Function: The BAR Monitor directly measures and processes electrical signals from the brain (EEG) through electrodes placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor the state of the brain during anesthesia, not to diagnose a disease or condition based on a biological sample.
The BAR Monitor is a device that monitors physiological signals (EEG) from the patient's body in real-time. This falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BAR Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system displays a patient's EEG and Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents include inhalation agents and propofol in combination with opioids.
The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65 years of age) in the operating room (OR) and clinical research laboratory.
Product codes (comma separated list FDA assigned to the subject device)
OLW, OMC, GXY
Device Description
The Brain Anaesthesia Response Monitor (BARM) is a device designed to non-invasively monitor brain function in response to anesthetic agents including inhalation agents in the operating room (OR) and clinical research laboratory. The system consists of the following three components:
- . Brain Anaesthesia Response (BAR) Terminal - Provides a user interface to control the DAM, set configuration parameters and display the DAM output for users.
- . Data Acquisition Module (DAM) - Collects and processes the signal sent by the electrodes and calculates the Composite Cortical State (CCS) index and outputs the information to the BAR Terminal.
- Disposable cutaneous electrode sensor- The electrodes collect Brain electrical activity (EEG) signals and transfers them to the DAM. The electrodes are made from pre-gelled Ag-AgCl. The electrodes are connected with patient leads which is plugged into the DAM. The electrodes are applied to the patients' forehead and behind the ear and is held in place via biocompatible adhesives.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead and behind the ear (for electrode placement)
Indicated Patient Age Range
22 to 65 years of age
Intended User / Care Setting
medical professionals monitor adult patients in the operating room (OR) and clinical research laboratory.
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)
- Study U111-1124-2523:
- Study type: double-blinded, randomized controlled design
- Sample size: 20 subjects
- Key results: "CCS was observed to decrease from OAA/S 4 (FLD: 73, FMD: 79) to OAAS/0 (FLD: 57, FMD: 58). CCS was found to be equivalently predictive of loss of response as the BIS™ index, based on prediction probability (Pr 0.9 for both devices)."
- Study ACTRN12618000916246:
- Study type: double-blinded, randomized controlled design
- Sample size: 21 patients (10 subjects for sevoflurane, 11 subjects for xenon)
- Key results: "CCS was observed to increase from the cessation of anesthetic and across the signs of emergence, with comparable values to the BIS™ index. CCS and BIS values were only significantly different at cease gas in the sevoflurane group, but without a ground truth assessment at cease gas, it is unclear whether CCS or BIS more accurately reflects actual patient state. BIS and CCS values were lower at emergence endpoints for xenon than for sevoflurane. This effect has been previously reported for the BIS. Prediction probabilities calculated across the emergence endpoints for CCS were equivalent to or better than that for the BIS for the sevoflurane group, the xenon group and both groups combined."
- Study 6001-004:
- Study type: re-analysing previously recorded EEG data from a randomized, multi-arm study
- Sample size: 42 total subjects (14 subjects per group)
- Key results: "CCS was observed to decrease with decreasing OAA/S level - OAA/S 5 (awake) median CCS: 86 (0ng/ml group), 80 (2ng/ml group), 78 (4ng/ml group); OAA/S 0 (unresponsive) median CCS: 38 (0ng/ml), 44 (2ng/ml), 53ng/ml (4ng/ml). These findings support a recommended range of CCS>80 corresponding to awake and CCS between 40-60 corresponding to unresponsive. CCS varies comparably to other depth of anesthesia indices. Prediction probabilities calculated across all OAA/S levels were 0.85, 0.84, 0.78, and 0.83 (0, 2, 4ng/ml and all combined respectively), equivalent to values obtained using GE M-Entropy™ state and response entropy measures. Prediction probabilities between OAA/S 5 and OAA/S 0 were ≥0.99 indicating near perfect discrimination, CCS is also highly predictive of response to vocal stimulus (P) 3 0.86). Across all OAA/S levels, CCS has comparable prediction probabilities to the State and Response Entropy indexes of the M-Entropy monitor."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Prediction probability (Pr): 0.9 for both BIS and CCS in Study U111-1124-2523.
- Prediction probabilities for CCS across all OAA/S levels in Study 6001-004: 0.85, 0.84, 0.78, and 0.83 (0, 2, 4ng/ml and all combined respectively).
- Prediction probabilities between OAA/S 5 and OAA/S 0 in Study 6001-004: ≥0.99.
- Prediction probability for CCS responsiveness to vocal stimulus in Study 6001-004: ≥ 0.86.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072286 - BIS EEG VISTA MONITOR SYSTEM
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 1, 2023
Cortical Dynamics Ltd % Tim Marjenin Vice-President Mcra, LLC. 803 7th Street NW, 3rd floor Washington, District of Columbia 20001
Re: K213273
Trade/Device Name: Brain Anesthesia Response Monitor (Bar Monitor) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLW, OMC, GXY Dated: August 4, 2023 Received: August 4, 2023
Dear Tim Marjenin:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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,
Ting Song -S
for
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213273
Device Name
Brain Anesthesia Response Monitor (BAR Monitor)
Indications for Use (Describe)
The BAR Monitor is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system displays a patient's EEG and Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents include inhalation agents and propofol in combination with opioids.
The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65 years of age) in the operating room (OR) and clinical research laboratory.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K213273
Image /page/3/Picture/2 description: The image shows the logo for Cortical Dynamics. The logo features a stylized letter C in gray and blue, followed by the words "CORTICAL DYNAMICS" in gray and blue. Below the logo is the text "ADVANCED BRAIN MONITORING" in black.
510(k) Summary
| Date | August 4, 2023 |
|---|---|
| Owner/Sponsor | CORTICAL DYNAMICS LTD. |
| 14 View Street | |
| North Perth 6006 | |
| Western Australia | |
| Tel: +61 3 8741 1130 | |
| Contact | Tim Marjenin |
| MCRA, LLC | |
| 803 7th Street NW, 3rd Floor | |
| Washington, DC 20001 | |
| Device | Trade Name: Brain Anaesthesia Response Monitor (BARM / BAR |
| Monitor) | |
| Common Name: Index-Generating Electroencephalograph Software | |
| Classification Name: Electroencephalograph | |
| Regulation No: 21 CFR 882.1400 | |
| Product Code(s): OLW, OMC, GXY | |
| Classification | Class II |
| Classification | |
| Panel | Neurology |
| Predicate Device | K072286 - BIS EEG VISTA MONITOR SYSTEM |
Device Description
The Brain Anaesthesia Response Monitor (BARM) is a device designed to non-invasively monitor brain function in response to anesthetic agents including inhalation agents in the operating room (OR) and clinical research laboratory. The system consists of the following three components:
- . Brain Anaesthesia Response (BAR) Terminal - Provides a user interface to control the DAM, set configuration parameters and display the DAM output for users.
- . Data Acquisition Module (DAM) - Collects and processes the signal sent by the electrodes and calculates the Composite Cortical State (CCS) index and outputs the information to the BAR Terminal.
- Disposable cutaneous electrode sensor- The electrodes collect Brain electrical activity (EEG) .
4
signals and transfers them to the DAM. The electrodes are made from pre-gelled Ag-AgCl. The electrodes are connected with patient leads which is plugged into the DAM. The electrodes are applied to the patients' forehead and behind the ear and is held in place via biocompatible adhesives.
Image /page/4/Figure/2 description: The image shows a medical device setup with three labeled components. The first component, labeled "1 BAR Terminal", is a device with a screen displaying a graph and the number 57. The second component, labeled "2 Data Acquisition Module (DAM)", is a white box connected by wires to both the BAR Terminal and the third component, labeled "3 Electrode", which is attached to a person's head.
Intended Use
The BAR Monitor is intended to monitor the state of the brain by real- time data acquisition and processing of EEG signals. The system displays a patient's EEG as well as Composite Cortical State (CCS), a proprietary computed EEG index related to the effect of certain anesthetic or hypnotic agents. Anesthetic agents include inhalation agents and propofol in combination with opioids.
The BAR Monitor is intended to assist medical professionals monitor adult patients (22 to 65) in the operating room (OR) and clinical research laboratory.
| FEATURE | BIS EEG VISTA MONITOR
SYSTEM AND BISX | Subject Device | Comparison |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K072286 | - | N/A |
| Company | Aspect Medical System Inc. | Cortical Dynamics Ltd. | N/A |
| Regulation | 21 CFR 882.1400 | 21 CFR 882.1400 | Identical |
| Class | II | II | Identical |
| Product Code | OLW,
OLT, OMC, ORT | OLW, OMC, GXY | Equivalent |
| Indications for Use | The BIS VISTA Monitoring
System is intended for use
under the direct supervision of
a licensed healthcare
practitioner or by personnel | The BAR Monitor is
intended to monitor the
state of the brain by real-
time data acquisition and
processing of EEG signals. | - |
| FEATURE | BIS EEG VISTA MONITOR
SYSTEM AND BISX | Subject Device | Comparison |
| | trained in its proper use. The
BIS VISTA Monitor is intended
for use on adult and pediatric
patients within a hospital or
medical facility providing
patient care to monitor the
state of the brain by data
acquisition of EEG signals.
The BIS™ may be used as an
aid in monitoring the effects of
certain anesthetic agents. Use
of BIS monitoring to help guide
anesthetic administration may
be associated with the
reduction of the incidence of
awareness with recall in adults
during general anesthesia and
sedation. | The system displays a
patient's EEG and
Composite Cortical State
(CCS), a proprietary
computed EEG index
related to the effect of
certain anesthetic or
hypnotic agents.
Anesthetic agents include
inhalation agents and
propofol in combination
with opioids.
The BAR Monitor is
intended to assist medical
professionals monitor adult
patients (22 to 65) in the
operating room (OR) and
clinical research laboratory | |
| EEG Waveforms
Amplitude (default) | 25 µV/ division | 25 µV/ division
(Default)
Additional sensitivity options
of 10 µV, 20 µV, 50 µV, 100
µV, 200 µV which displays
signals at 5, 10, 25, 50,
100 µV /division. | Equivalent |
| EEG Chart Speed
(default) | 30 mm/sec | 32mm/sec
(Default)
Additional options 8 & 16
mm/sec | Equivalent |
| Index calculated
related to effect of
anesthetic agents | BIS (0 to 100) | CCS (0 to 100) | Equivalent |
| Electromyograph
(EMG) Indicator | 30 – 55dB | Not Available | Different |
| Suppression Ratio
(SR) | 0 to 100% | SR is incorporated into the
Signal Quality measure
and not displayed | Different |
| Burst Count | 0 - 20/min | Parameter not calculated
nor displayed | Different |
| Signal Quality
Indicator (SQI) | 0-100 (20 points per bar) | 0 - 100%. Displayed on
trend chart when less than
100% | Different |
| Electrode
Impedance | Parameter displayed as Pass,
High, Noise, or Lead Off.
Unknown range. | Parameter not displayed | Different |
| Index calculated
related to effect of
anesthetic agents | 1 (BIS) | 1 (CCS) | Equivalent |
| Storage / recording | The duration of | BARM has data and trend
storage space for > 1000 | Equivalent |
| FEATURE | BIS EEG VISTA MONITOR SYSTEM AND BISX | Subject Device | Comparison |
| | trend data stored is approximately 72 hours. The duration of BISx data (processed EEG parameters, including the BIS value, with time and date of acquisition) stored is approximately 1200 hours. | hours | |
| AC Power | 100-240 VAC, 50-60 Hz 24 W | 100~240VAC, 50-60Hz, 30W | Equivalent |
| Rechargeable battery | A rechargeable lithium-ion battery inside the monitor provides approximately 45 minutes of back-up power when power cannot be supplied via the power cord. | BARM contains backup battery with > 1 hour runtime | Equivalent |
| Module Connection | BISX interfaces with BIS VISTA Monitoring system | DAM interfaces with BARM Terminal | Equivalent |
| Module: Dimensions | 2.6 in x 1.00 in x 4.25 in (6.6 cm x 2.5 cm x 10.8 cm) | DAM: 155x123x28mm (6.10x4.84x1.10 in) | Equivalent |
| Operating Temperature | 0°C to +40°C
32°F to 104°F | 0°C to +40°C
32°F to 104°F | Equivalent |
| Operating Humidity | 15% to 95% (non-condensing) | 10% to 95% @ +40°C non-condensing | Equivalent |
| Transport and Storage Environment | | | |
| Temperature | -10°C to +60°C
14°F to 140°F | -20°C to +60°C
-4°F to +140°F | Equivalent |
| Humidity | 15% to 95% (non-condensing) | 10% to 95% @ +40°C non-condensing | Equivalent |
| Pressure | 48 kPa to 106.7 kPa | 70kPa to 106 kPa | Equivalent |
| Cutaneous Electrode | | | |
| Product code | GXY | GXY | Equivalent |
| Where used | Head | Head | Equivalent |
| Material | Pre-gelled silver/silver chloride electrode array | Pre-gelled Ag-AgCl electrodes | Equivalent |
| Quantity | Four
Image: Four electrodes on a head | Three (green)
Image: Three electrodes on a head | Different |
| FEATURE | BIS EEG VISTA MONITOR
SYSTEM AND BISX | Subject Device | Comparison |
| Number of cables | Single Cable | Single Cable | Equivalent |
| Single Use or Re-
useable | Single-Use | Single-Use | Equivalent |
| Sterile or non-
sterile | Non-sterile | Non-sterile | Equivalent |
| Analog Noise | 108 dB | Equivalent |
| Bandwidth | 0.16 - 450 Hz | 0.5 - 200 Hz | Equivalent |
| Sampling
Frequency | 256 Hz | 480 Hz | Different |
| Sampling Rate | 16,384 samples/second | 100,000 samples/second | Different |
| Unprocessed EEG
available | Yes | Yes | Equivalent |
| Display | 4" x %.25" Colour Touchscreen | 4" x 5.5" Colour
Touchscreen | Equivalent |
| Algorithm Output | The Bispectral Index
(BIS) is the output from a
multivariate discriminate
analysis that quantifies the
overall bispectral properties
(frequency, power, and
phase)throughout the entire
frequency range. | Composite Cortical State
(CCS) is derived from the
patients EEG using the
linearised Liley model of
EEG genesis. CCS is
derived every second from
the patients EEG after
automatic removal of data
materially contaminated by
diathermy or artifacts | Equivalent |
| Display of EEG
time series | Yes | Yes | Equivalent |
| Displays Depth of
Anesthesia index
value and trend
graph | BIS | CCS | Equivalent |
| Burst Suppression | Suppression is quantified as a
Suppression Ratio (SR). SR is
displayed and is not
incorporated into signal quality
measure | Burst suppression is
incorporated in signal
quality measure | Different |
| Medical device
safety and
EMC/EMI
certificates | UL 60601-1, IEC 60601-1, IEC
60601-2-26, CAN/CSA-
C22.2#601.1
IEC 60601-1-2:2001 | IEC60601-1:2005
IEC60601-
1:2005/AMD1:2012
IEC60601-1-6:2010
IEC60601-1-6:
2010/AMD1:2013
IEC60601-2-26:2016 | Equivalent |
Comparison Of Technological Characteristics With The Predicate Device
5
6
7
Non-clinical Performance Testing
The following non-clinical testing was conducted:
8
- Battery Safety Testing per IEC 62133 .
- Electrical and Environmental Safety Testing per IEC 60601-1
- Electrical Safety and Essential Performance Testing per IEC 60601-2-26
- . EMC Testing per IEC 60601-1-2
- . Risk Assessment per ISO 14971
- Software Verification and Validation per FDA Software Guidance
- . Usability Evaluation per IEC 60601-1-6 and IEC 62366-1
- . Biocompatibility testing per ISO 10993-1
Per the completed testing the requirements and performance specifications for the subject device were met, including compliance with the requirements for electro-encephalographic medical devices and is as safe and effective for brain function monitoring in clinical settings.
Clinical Performance Data
Study U111-1124-2523
The U111-1124-2523 study was a double-blinded, randomized controlled design conducted in Melbourne, Australia with 20 subjects undergoing cardiac surgery. BARM was used to monitor anesthetic induction using propofol, fentanyl and benzodiazepines. Subjects were pre-sedated with lorazepam and midazolam to an Observer's Assessment of Alertness/Sedation (OAA/S) level 4 (lethargic response to name spoken). Subjects then received a 1mg/kg bolus of propofol followed by an infusion at 6mg/kg/hr until loss of response to verbal command and painful stimulus (OAA/S 0). Subjects then received either a low (FLD, 8μg/kg) or moderate dose (FMD, 16μg/kg) of fentanyl. CCS was observed to decrease from OAA/S 4 (FLD: 73, FMD: 79) to OAAS/0 (FLD: 57, FMD: 58). CCS was found to be equivalently predictive of loss of response as the BIS™ index, based on prediction probability (Pr 0.9 for both devices). Py has a value of 1 when the indicator variable (e.g., CCS, BIS) predicts observed anesthetic depth perfectly and a value of 0.5 when the indicator predicts no better than a 50:50 chance.
Study ACTRN12618000916246
The ACTRN12618000916246 study was a double-blinded, randomized controlled design in conducted in Melbourne, Australia with 21 patients. BARM was used to monitor emergence from sevoflurane (10 subjects) and xenon (11 subjects) anesthesia with remifentanil (0.1µg/kg/min). Anesthesia was maintained at 90% of the minimum alveolar concentration (MAC) equivalent of the respective agents while a lithotripsy procedure was performed. After the procedure was complete all anesthetic agents were ceased and the subject monitored every 30s for signs of emergence, including first response to name, first eyes open and spontaneously ventilating sufficient to remove the laryngeal mask. CCS was observed to increase from the cessation of anesthetic and across the signs of emergence, with comparable values to the BIS™ index. CCS and BIS values were only significantly different at cease gas in the sevoflurane group, but without a ground truth assessment at cease gas, it is unclear whether CCS or BIS more accurately reflects actual patient state. BIS and CCS values were lower at emergence endpoints for xenon than for
9
sevoflurane. This effect has been previously reported for the BIS. Prediction probabilities calculated across the emergence endpoints for CCS were equivalent to or better than that for the BIS for the sevoflurane group, the xenon group and both groups combined.
Image /page/9/Figure/2 description: The image contains two boxplot graphs comparing CCS and BIS values for two different groups: Sevoflurane and Xenon. Each graph plots the CCS and BIS values at four different time points: Cease Gas, First Response, Eyes Open, and Remove Mask. In the Sevoflurane group, there is a statistically significant difference (*) between the CCS and BIS values at the Cease Gas time point. The CCS and BIS values tend to increase over time in both groups.
CCS and BIS values at clinical endpoints and cessation of gas for sevoflurane and xenon groups. * p 80 corresponding to awake and CCS between 40-60 corresponding to unresponsive. CCS varies comparably to other depth of anesthesia indices. Prediction probabilities calculated across all OAA/S levels were 0.85, 0.84, 0.78, and 0.83 (0, 2, 4ng/ml and all combined respectively), equivalent to values obtained using GE M-Entropy™ state and response entropy measures. Prediction probabilities between OAA/S 5 and OAA/S 0 were ≥0.99 indicating near perfect discrimination, CCS is also highly predictive of response to vocal stimulus (P) 3 0.86). Across all OAA/S levels, CCS has comparable prediction probabilities to the State and Response Entropy indexes of the M-Entropy monitor.
Image /page/10/Figure/3 description: The image is a boxplot comparing CCS and OAA/S level at different concentrations of remifentanil. The x-axis is the OAA/S level, ranging from 0 to 5. The y-axis is the CCS, ranging from 0 to 100. There are three different concentrations of remifentanil: 0ng/ml, 2ng/ml, and 4ng/ml.
Box and whisker plots for CCS vs OAA/S level for each remifentanil group
Conclusion
Evaluation of the risks and performance data based on the differences between the subject and predicate devices does not raise any new issues or concerns related to safety or effectiveness. Cortical Dynamics has concluded that the BARM device is as safe and effective as the predicate device for its intended use and is substantially equivalent to the predicate device.