Brain Anesthesia Response Monitor (Bar Monitor)

K213273 · Cortical Dynamics , Ltd. · OLW · Sep 1, 2023 · Neurology

Device Facts

• Record ID: K213273
• Device Name: Brain Anesthesia Response Monitor (Bar Monitor)
• Applicant: Cortical Dynamics , Ltd.
• Product Code: OLW · Neurology
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

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.

Device Story

The Brain Anaesthesia Response Monitor (BARM) non-invasively monitors brain function during anesthesia. It consists of a BAR Terminal (user interface), a Data Acquisition Module (DAM), and disposable Ag-AgCl cutaneous electrodes applied to the patient's forehead and behind the ear. The system acquires raw EEG signals, which the DAM processes to calculate the Composite Cortical State (CCS) index (0-100). The CCS is derived using a linearized Liley model of EEG genesis, with automated removal of diathermy or artifact-contaminated data. The output is displayed on the BAR Terminal for clinicians to assess anesthetic depth. The device is used in the OR and clinical research settings to assist in monitoring the effects of anesthetic/hypnotic agents, potentially aiding in the management of anesthesia administration.

Clinical Evidence

Clinical evidence includes three studies (n=20, n=21, n=42) evaluating CCS performance against OAA/S levels and BIS/M-Entropy indices. Studies demonstrated CCS is highly predictive of loss of response to verbal/painful stimuli (Pr ≥ 0.9) and emergence from anesthesia. CCS showed comparable performance to BIS and GE M-Entropy indices across various anesthetic agents (propofol, fentanyl, sevoflurane, xenon, remifentanil).

Technological Characteristics

Materials: Pre-gelled Ag-AgCl electrodes with biocompatible adhesives. Sensing: EEG signal acquisition via 3-electrode array. Connectivity: DAM interfaces with BAR Terminal. Software: Linearized Liley model of EEG genesis. Safety/Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 14971, ISO 10993-1. Dimensions: DAM 155x123x28mm. Power: 100-240VAC with >1 hour backup battery.

Indications for Use

Indicated for monitoring brain state in adult patients (22-65 years) in OR and clinical research labs during anesthesia/sedation with inhalation agents, propofol, and opioids.

Regulatory Classification

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.

Predicate Devices

• BIS EEG VISTA MONITOR SYSTEM (K072286)

Reference Devices

• GE M-Entropy (not specified)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

| <div> <span style="font-size: 10pt;"> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 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.<br>14 View Street<br>North Perth 6006<br>Western Australia<br>Tel: [phone] |
| Contact | Tim Marjenin<br>MCRA, LLC<br>803 7th Street NW, 3rd Floor<br>Washington, DC 20001 |
| Device | Trade Name: Brain Anaesthesia Response Monitor (BARM / BAR<br>Monitor)<br>Common Name: Index-Generating Electroencephalograph Software<br>Classification Name: Electroencephalograph<br>Regulation No: 21 CFR 882.1400<br>Product Code(s): OLW, OMC, GXY |
| Classification | Class II |
| Classification<br>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) .

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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<br>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,<br>OLT, OMC, ORT | OLW, OMC, GXY | Equivalent |
| Indications for Use | The BIS VISTA Monitoring<br>System is intended for use<br>under the direct supervision of<br>a licensed healthcare<br>practitioner or by personnel | The BAR Monitor is<br>intended to monitor the<br>state of the brain by real-<br>time data acquisition and<br>processing of EEG signals. | - |
| FEATURE | BIS EEG VISTA MONITOR<br>SYSTEM AND BISX | Subject Device | Comparison |
| | trained in its proper use. The<br>BIS VISTA Monitor is intended<br>for use on adult and pediatric<br>patients within a hospital or<br>medical facility providing<br>patient care to monitor the<br>state of the brain by data<br>acquisition of EEG signals.<br><br>The BIS™ may be used as an<br>aid in monitoring the effects of<br>certain anesthetic agents. Use<br>of BIS monitoring to help guide<br>anesthetic administration may<br>be associated with the<br>reduction of the incidence of<br>awareness with recall in adults<br>during general anesthesia and<br>sedation. | The system displays a<br>patient's EEG and<br>Composite Cortical State<br>(CCS), a proprietary<br>computed EEG index<br>related to the effect of<br>certain anesthetic or<br>hypnotic agents.<br>Anesthetic agents include<br>inhalation agents and<br>propofol in combination<br>with opioids.<br><br>The BAR Monitor is<br>intended to assist medical<br>professionals monitor adult<br>patients (22 to 65) in the<br>operating room (OR) and<br>clinical research laboratory | |
| EEG Waveforms<br>Amplitude (default) | 25 µV/ division | 25 µV/ division<br>(Default)<br>Additional sensitivity options<br>of 10 µV, 20 µV, 50 µV, 100<br>µV, 200 µV which displays<br>signals at 5, 10, 25, 50,<br>100 µV /division. | Equivalent |
| EEG Chart Speed<br>(default) | 30 mm/sec | 32mm/sec<br>(Default)<br>Additional options 8 & 16<br>mm/sec | Equivalent |
| Index calculated<br>related to effect of<br>anesthetic agents | BIS (0 to 100) | CCS (0 to 100) | Equivalent |
| Electromyograph<br>(EMG) Indicator | 30 – 55dB | Not Available | Different |
| Suppression Ratio<br>(SR) | 0 to 100% | SR is incorporated into the<br>Signal Quality measure<br>and not displayed | Different |
| Burst Count | 0 - 20/min | Parameter not calculated<br>nor displayed | Different |
| Signal Quality<br>Indicator (SQI) | 0-100 (20 points per bar) | 0 - 100%. Displayed on<br>trend chart when less than<br>100% | Different |
| Electrode<br>Impedance | Parameter displayed as Pass,<br>High, Noise, or Lead Off.<br>Unknown range. | Parameter not displayed | Different |
| Index calculated<br>related to effect of<br>anesthetic agents | 1 (BIS) | 1 (CCS) | Equivalent |
| Storage / recording | The duration of | BARM has data and trend<br>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<br>32°F to 104°F | 0°C to +40°C<br>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<br>14°F to 140°F | -20°C to +60°C<br>-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<br>Image: Four electrodes on a head | Three (green)<br>Image: Three electrodes on a head | Different |
| FEATURE | BIS EEG VISTA MONITOR<br>SYSTEM AND BISX | Subject Device | Comparison |
| Number of cables | Single Cable | Single Cable | Equivalent |
| Single Use or Re-<br>useable | Single-Use | Single-Use | Equivalent |
| Sterile or non-<br>sterile | Non-sterile | Non-sterile | Equivalent |
| Analog Noise | < 0.3 µV RMS<br>(2.0 µV peak-to-peak);<br>0.25 Hz to 50 Hz | < 0.4µV (RMS).<br>< 1.25 µV (peak to peak) | Equivalent |
| A/D | 16 bit | 16 bit | Equivalent |
| CMR | 110 dB | > 108 dB | Equivalent |
| Bandwidth | 0.16 - 450 Hz | 0.5 - 200 Hz | Equivalent |
| Sampling<br>Frequency | 256 Hz | 480 Hz | Different |
| Sampling Rate | 16,384 samples/second | 100,000 samples/second | Different |
| Unprocessed EEG<br>available | Yes | Yes | Equivalent |
| Display | 4" x %.25" Colour Touchscreen | 4" x 5.5" Colour<br>Touchscreen | Equivalent |
| Algorithm Output | The Bispectral Index<br>(BIS) is the output from a<br>multivariate discriminate<br>analysis that quantifies the<br>overall bispectral properties<br>(frequency, power, and<br>phase)throughout the entire<br>frequency range. | Composite Cortical State<br>(CCS) is derived from the<br>patients EEG using the<br>linearised Liley model of<br>EEG genesis. CCS is<br>derived every second from<br>the patients EEG after<br>automatic removal of data<br>materially contaminated by<br>diathermy or artifacts | Equivalent |
| Display of EEG<br>time series | Yes | Yes | Equivalent |
| Displays Depth of<br>Anesthesia index<br>value and trend<br>graph | BIS | CCS | Equivalent |
| Burst Suppression | Suppression is quantified as a<br>Suppression Ratio (SR). SR is<br>displayed and is not<br>incorporated into signal quality<br>measure | Burst suppression is<br>incorporated in signal<br>quality measure | Different |
| Medical device<br>safety and<br>EMC/EMI<br>certificates | UL 60601-1, IEC 60601-1, IEC<br>60601-2-26, CAN/CSA-<br>C22.2#601.1<br>IEC 60601-1-2:2001 | IEC60601-1:2005<br>IEC60601-<br>1:2005/AMD1:2012<br>IEC60601-1-6:2010<br>IEC60601-1-6:<br>2010/AMD1:2013<br>IEC60601-2-26:2016 | Equivalent |

#### Comparison Of Technological Characteristics With The Predicate Device

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## Non-clinical Performance Testing

The following non-clinical testing was conducted:

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- 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

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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 < 0.05 (Wilcoxon sign rank test)

#### Study 6001-004

The BARM algorithms have also been investigated by re-analysing previously recorded EEG data. In one randomized, multi-arm study in Belgium, anesthesia was induced by progressively

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increasing the effect-site concentration of propofol (0.75µg/ml starting dose, 0.25µg/ml increments every 4 minutes). Subjects were also co-administered either 0, 2 or 4ng/ml remifentanil (14 subjects per group, 42 total subjects). OAA/S assessments were performed before each increase in propofol dose. 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.

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.