Who is the manufacturer of Brainscope Ahead 200?

Brainscope Company, Inc. filed the 510(k) submission for Brainscope Ahead 200 (K143643).

What is the FDA product code for Brainscope Ahead 200?

PIW. It is classified under 21 CFR 882.1450 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Brainscope Ahead 200?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Brainscope Ahead 200?

BrainScope® Ahead® 100 (Models M-100 and CV-100) (DEN 140025).

Who can help prepare an FDA 510(k) submission like Brainscope Ahead 200?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Brainscope Ahead 200

K143643 · Brainscope Company, Inc. · PIW · May 15, 2015 · Neurology

Device Facts

Record ID	K143643
Device Name	Brainscope Ahead 200
Applicant	Brainscope Company, Inc.
Product Code	PIW · Neurology
Decision Date	May 15, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1450
Device Class	Class 2

Intended Use

The Ahead® 200, consisting of two models, i.e., the Ahead® CV-200, is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years. A negative BrainScope® Classification may correspond to brain electrical activity consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury. A positive BrainScope® Classification corresponds to brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT. The Ahead® 200 device is intended to record, measure, and display brain electrical activity utilizing the calculation of standard quantitative EEG (qEEG) parameters from frontal locations on a patient's forehead. The Ahead® 200 calculates and displays raw measures for the following standard qEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user. The Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including and displaying brain electrical activity, and the function of storing and displaying MACE information. The Ahead® 200 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the device. The Ahead® 200 is a prescription use device.

Device Story

Portable, non-invasive, point-of-care EEG device; assesses brain electrical activity associated with TBI. Inputs: frontal EEG signals via disposable electrode headset. Processing: Harmony algorithm calculates qEEG parameters (Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension) from frontal leads; detects 8 types of artifacts. Outputs: BrainScope Classification (positive/negative), raw qEEG measures, and EEG waveforms. M-200 model includes electronic MACE cognitive assessment. Used by physicians or trained personnel in clinical settings. Output aids clinicians in evaluating patients for head CT; does not replace CT scan. Benefits: provides objective assessment to assist in triage/clinical decision-making for mild TBI.

Clinical Evidence

Bench testing only. Verification testing included software/UI verification, hardware verification, system performance, algorithm performance, packaging, biocompatibility (ISO 10993-1), and electromagnetic compatibility (IEC 60601-1-2). All tests passed.

Technological Characteristics

Portable handheld unit with disposable Ag/AgCl electrode headset (solid gel). Sensing: 7-channel frontal EEG (Fp1, Fp2, Fpz, AFz, F7, F8, A1, A2). Connectivity: Android-based OS, micro-SD storage, AES-128 encryption. Power: Li-ion rechargeable battery. Standards: IEC 60601-1 (3rd ed), IEC 60601-2-26, ANSI/AAMI EC12. Algorithm: Harmony (same as predicate).

Indications for Use

Indicated for patients aged 18-80 years who sustained a closed head injury within 24 hours and present with a Glasgow Coma Scale (GCS) score of 13-15 (mild traumatic brain injury).

Regulatory Classification

Identification

A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

Special Controls

In combination with the general controls of the FD&C Act, the Ahead 100 is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information: (i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed. (ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed. (2) The device parts that contact the patient must be demonstrated to be biocompatible. (3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety. (4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs). (5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use. (6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output ( *e.g.,* use in appropriate patient population, or for appropriate clinical decision).(7) The labeling and training information must include: (i) A warning that the device is not to be used as a stand-alone diagnostic. (ii) A detailed summary of the clinical performance testing, including any adverse events and complications. (iii) The intended use population and the intended use environment. (iv) Any instructions technicians should convey to patients regarding the collection of EEG data. (v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway. (vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.

Predicate Devices

BrainScope® Ahead® 100 (Models M-100 and CV-100) (DEN 140025)

Related Devices

K181179 — BrainScope One · Brainscope Company, Inc. · May 18, 2018
K183241 — BrainScope TBI (Model: Ahead 400) · Brainscope Company, Inc. · Feb 19, 2019
K161068 — Ahead 300 · Brainscope Company, Inc. · Sep 22, 2016
K181785 — Modified BrainScope One · Brainscope Company, Inc. · Dec 19, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing to the right. The profiles are connected by a flowing line that forms the shape of a bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 15, 2015 BrainScope Company, Inc. Michael Singer President and CEO 4350 East-West Highway Suite 1050 Bethesda, MD 20814 Re: K143643 Trade/Device Name: BrainScope Ahead 200 (models M-200 and CV-200) Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW Dated: April 15, 2015 Received: April 15, 2015 Dear Dr. Singer: 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 {1}------------------------------------------------ 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 forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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. for Sincerely yours, Felipe Aquel -S Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K143643 Device Name BrainScope Ahead 200 (models M-200 and CV-200) #### Indications for Use (Describe) • The Ahead® 200, consisting of two models, i.e., the Ahead® CV-200, is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years. · A negative BrainScope® Classification may correspond to brain electrical activity consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury. · A positive BrainScope® Classification corresponds to brain electrical activity that may be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT. · The Ahead® 200 device is intended to record, measure, and display brain electrical activity utilizing the calculation of standard quantitative EEG (qEEG) parameters from frontal locations on a patient's forehead. The Ahead® 200 calculates and displays raw measures for the following standard qEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user. • The Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including and displaying brain electrical activity, and the function of storing and displaying MACE information. · The Ahead® 200 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the device. • The Ahead® 200 is a prescription use device. 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for BrainScope. The word "BRAINSCOPE" is written in large, bold, blue letters. There are two horizontal blue lines above and below the word. The "O" in "SCOPE" has a waveform in it, and there is a registered trademark symbol to the right of the word. 4350 East-West Highway.Suite 1050.Bethesda.Maryland.20814 www.brainscope.com phone 240.752.7680 # Premarket Notification 510(k) Summary [Ahead® 200] ## 510(k) Summary ## A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 | Submitter's Name and Address: | BrainScope Company, Inc. 4350 East West Highway Suite #1050 Bethesda, Maryland 20814 Telephone Number: (240) 752-7680 Fax Number: (240) 752-7679 | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact Person Phone: Fax: Email: | Michael E. Singer, Ph.D., President and CEO (240) 752-7680 (240) 752-7679 michael.singer@brainscope.com | | Submission Correspondent Phone: Fax: Email: | Michael E. Singer, Ph.D., President and CEO (240) 752-7680 (240) 752-7679 michael.singer@brainscope.com | | Device Name | BrainScope® Ahead® 200 (Models M-200 and CV-200) | | Regulation Name | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | | Regulation Number | 21 CFR 882.1450 | | Classification | Class II | | Product Code | PIW | | Predicate Device | BrainScope® Ahead® 100 (Models M-100 and CV- 100) (DEN 140025) | | Date of Submission | December 22, 2014 | {5}------------------------------------------------ ## 1. Description of the Device BrainScope® Ahead® 200 is a Brain Injury Adjunctive The Interpretive Electroencephalograph Assessment Aid, Class II device. It is a portable, non-sterile, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) device and is intended to provide an objective assessment of brain electrical activity associated with traumatic brain injury (TBI). This brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis. The BrainScope® Ahead® 200 is comprised of two hardware components: the Handheld Device and the disposable Electrode Headset with patient application supplies. The main software components of the Ahead 200 are the application software and the BrainScope Algorithm Library (BSAL). The Ahead® 200 has two models: (1) the Ahead® M-200, which is intended for use by the military, and (2) the Ahead® CV-200, which is intended for civilian use. The Ahead® M-200 and the Ahead® CV-200 have the same indications for use and intended uses with the exception that the Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) and user-entered responses to the MACE questions. There is no interaction between EEG-related functionality, including analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information. The Ahead® M-200 and the Ahead® CV-200 have identical technological characteristics except that the Ahead® M-200 contains the additional MACE feature, i.e., an electronic version of the paper and pencil based MACE. The Ahead® 200 has the following similarities to the cleared predicate device: - . Same intended use - Same operating principle ● - Same fundamental scientific technology . - Same algorithm software ## 2. Intended Use of the Device - . The Ahead® 200, with models M-200 and CV-200, is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a head CT, but should not be used as a substitute for a CT scan. This device is to be used for this purpose in patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-80 years. - A negative BrainScope® Classification may correspond to brain electrical activity ● consistent with no structural brain injury visible on head CT in patients presenting as a mild traumatic brain injury, within 24 hours of injury. {6}------------------------------------------------ - A positive BrainScope® Classification corresponds to brain electrical activity that may . be present in both patients with or without a structural brain injury visible on head CT. A positive BrainScope® Classification does not establish the presence of a structural brain injury visible on head CT. - The Ahead® 200 is intended to record, measure, analyze, and display brain electrical . activity utilizing the calculation of standard quantitative EEG (gEEG) parameters from frontal locations on a patient's forehead. The Ahead® 200 calculates and displays raw measures for the following standard qEEG measures: Absolute and Relative Power, Asymmetry, Coherence and Fractal Dimension. These raw measures are intended to be used for post hoc analysis of EEG signals for interpretation by a qualified user. - The Ahead® M-200 model additionally stores and displays an electronic version of ● the Military Acute Concussion Evaluation (MACE) cognitive assessment and userentered responses to the MACE questions. There is no interaction between EEGrelated functionality, including analyzing and displaying brain electrical activity, and the function of storing and displaying MACE information. - The Ahead® 200 is intended for use by physicians, or under the direction of a . physician, who have been trained in the use of the device. - The Ahead® 200 is a prescription use device. ● ## 3. Summary of Performance Data and Substantial Equivalence The Ahead® 200, models M-200 and CV-200, was designed and verified in accordance with the risk analysis and product requirements. All tests were conducted on the new model to establish substantial equivalence to the predicate (Ahead® 100, models M-100 and CV-100, DEN 140025). The Ahead® 200, models M-200 and CV-200, was tested and shown to be compliant with the following standards: - 1. ANSI/AAMI ES60601-1:2005/(R)2012 "Medical electrical equipment Part 1: General requirements for basic safety and essential performance" - 2. CAN/CSA C22.2 No 601.1-08(R2013), "Medical Electrical Equipment, Part 1: General Requirements for Safety" - 3. IEC/EN 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (including PEMS clause 14) - 4. IEC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs - 5. IEC/EN 60601-1-2:2007 Medical electrical equipment Section1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests - 6. ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process - 7. ANSI/AAMI EC12:2000 Disposable ECG Electrodes The following testing was conducted to demonstrate the safety and efficacy of the Ahead® 200, Models M-200 and CV-200, in its intended environment. {7}------------------------------------------------ #### Table 1.0 – Design Verification Test | Design Verification Test | Result | |-----------------------------------------------------------------------------------------------------------|--------| | Software (including User Interface) Verification Testing | Pass | | Hardware Verification | Pass | | System Performance and Functionality | Pass | | Algorithm Performance | Pass | | Packaging Testing | Pass | | Basic Safety and Essential Performance (IEC 60601-1, 3rd ed.) including PEMS clause 14 for Software | Pass | | Electromagnetic Compatibility | Pass | | Biocompatibility | Pass | | Reliability | Pass | This 510(k) submission represents the results of the testing and the detailed description to demonstrate that the Ahead® 200, models M-200 and CV-200, is substantially equivalent to the Ahead® 100, models M-100 and CV-100 (DEN 140025). The table 2.0 below provides a design comparison of the Ahead® 200 to the predicate Ahead® 100 (DEN 140025) {8}------------------------------------------------ | | Ahead® 200, models M- 200 and CV-200 | Ahead® 100, models M- 100 and CV-200 (Predicate Device, DEN100425) | Notes | |------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Major System Components | 1. Handheld computer and DAB 2. Disposable Electrode Headset 3. Software 4. Algorithm 5. Accessories | 1. Handheld Unit including patient interface cable 2. Disposable Electrode Headset 3. Software 4. Algorithm 5. Accessories | Same | | Components Physical Dimension | | | | | Device Size (mm) | Handheld Unit: 90x165x30 Data Acquisition Board (DAB): 130x110x50 | 114x200x51 | Ahead® 200 handheld is smaller and DAB is ergonomic | | Weight | Max 0.620kg (1.4 lbs.) | Max 1.4kg (2.5lbs) | Ahead® 200 is lighter | | Ingress Protection and Operational Environment | | | | | Ingress Protection | IP54 minimum as per IEC 60529 | IP4X as per IEC 60529 | Ahead® 200 is much better protected from solid and liquid ingress | | Operational Temperature | 0°C to 38°C (32°F to 100°F) | 0°C to 50°C (32°F to 122°F) | Ahead 100 has wider range but both devices meet product requirements | | Electrical Hardware | | | | | | Ahead® 200, models M- 200 and CV-200 | Ahead® 100, models M- 100 and CV-200 (Predicate Device, DEN100425) | Notes | | Location of Analog to Digital Conversion (ADC) | Immediately after Electrode Headset | After patient interface cable | Ahead® 200 signal chain is more immune to noise | | Common Mode Rejection Ratio (CMRR) | < -100 dB | < - 85 dB | Ahead® 200 better CMRR | | Low pass filtering prior to signal processing | 0.3 Hz to 43Hz | 0.3 Hz to 43Hz | Same | | System Noise Floor | < 0.4 µV in 0.3 Hz to 43Hz bandwidth | < 0.4 µV in 0.3 Hz to 43Hz bandwidth | Same | | ADC Resolution | 45 nV/bit | 31.2nV/bit | Both devices have better resolution than their noise floor | | ADC Sampling Rate | 1000 Hz, down sampled to 100 Hz for algorithm processing | 1000 Hz, down sampled to 100 Hz for algorithm processing | Processing bandwidth used by algorithm is same | | Data Channel | 7 | 7 | Same | | Storage Capacity | | | | | Total Capacity | 32 GB in micro-SD card | 4 GB in CF card | Ahead® 200 has significantly more storage memory space | | Battery | | | | | Battery Chemistry | Li-ion rechargeable battery pack | Li-ion rechargeable battery pack | Same | | Battery Run- Time | Minimum of 10 patient recordings sessions in one charge. Equivalent of 120 minutes of effective operation. | Minimum of 140 minutes of effective operation. | Ahead® 100 is better in raw numbers but both devices meet requirement. | | Battery Longevity | 1-2 years of service before replacement | 1-2 years of service before replacement | Same | | | Ahead® 200, models M- 200 and CV-200 | Ahead® 100, models M- 100 and CV-200 (Predicate Device, DEN100425) | Notes | | Battery Safety Considerations | IEC 60950-1:2005 compliant. Evaluated as part of IEC 60601-1 certification | The battery pack is equipped with a thermal protection device to prevent excess charge and discharge currents. Battery and battery pack safety evaluated as part of IEC 60601-1 certification. | Verification methodology was different as data on Ahead® 100 battery pack was limited. Ahead® 200 battery is fully certified and did not require additional testing. | | Battery Charging | Full recharge in less than 4 hours in device turned off mode | Full recharge in less than 3.5 hours in device turned off mode | Ahead® 200 battery takes 30 minutes more to charge. | | Accessories | Battery charger and charging cable | Battery charger and charging cable | Actual battery charger and cables are different as the interface connectors and battery packs are different. Accessories for both devices are fully compliant to IEC 60601-1. | | Electrode Headset | | | | | Electrode Placement System | The International 10-20 System is used as a basis for electrode placement. | The International 10-20 System is used as a basis for electrode placement. | Same | | Electrode Positions Utilized | Fp1, Fp2, Fpz, AFz, F7, F8, A1, A2 | Fp1, Fp2, Fpz, AFz, F7, F8, A1, A2 | Same | | | Ahead® 200, models M- 200 and CV-200 | Ahead® 100, models M- 100 and CV-200 (Predicate Device, DEN100425) | Notes | | Electrode Material | Single use Ag/AgCl electrode sensor array headset with solid gel | Single use Ag/AgCl electrode sensor array headset with wet gel | Difference in the electrolytic gel material. Despite difference both electrodes meet ANSI/AAMI EC12 standard for electrode electrical performance. | | Electrode Impedance Test | Yes, at start of recording and during recording | Yes, at start of recording | Ahead® 200 provides better usability and data quality by performing continuous out of (EEG) band impedance measurement. | | Headset Authentication | Yes. Ahead 200 utilizes hardware based headset authentication. | No such authentication is possible on the Ahead 100. | Ahead® 200 provides better usability and data quality by ensuring use of approved headsets. | | System Software and Algorithms | | | | | Operating System | Android | MontaVista Linux | Ahead® 200 utilizes a modern and updated mobile OS compared to the Ahead 100. | | | Ahead® 200, models M- 200 and CV-200 | Ahead® 100, models M- 100 and CV-200 (Predicate Device, DEN100425) | Notes | | Graphical User Interface - Screens | Patient Information Electrode Impedance Raw EEG Waveform Dashboard Screen GCS score and warning IFU warnings Classification Results Data Review screen MACE (military version) | Patient Information Electrode Impedance Raw EEG Waveform GCS score and warning IFU warnings Classification Results Data Review screen MACE (military version) | Ahead® 200 improves usability by including the Dashboard screen. The Dashboard screen gives the user real- time indication of the progress of on-going EEG recording. | | Encryption | AES-128 for intra-device communication | None for intra-device communication | Ahead® 200 has enhanced encryption | | Automatic Artifacting | 8 types of artifact detection | 8 types of artifact detection | Same | | Classification Algorithm | Harmony | Harmony | Same | | Real Time EEG Display | Yes | Yes | Same | | Data Analysis | ● Conversion from time domain to frequency domain Derivation of multiple ● features such as absolute power, relative power, coherence, etc. Calculation of a ● discriminant function for structural injury | Conversion from time ● domain to frequency domain Derivation of multiple ● features such as absolute power, relative power, coherence, etc. Calculation of a ● discriminant function for structural injury | Same | | | Ahead® 200, models M-200 and CV-200 | Ahead® 100, models M-100 and CV-200 (Predicate Device, DEN100425) | Notes | | Results Presentation | Positive and Negative BrainScope classification as described in IFU Display screens with information on specific raw measures EEG playback The Ahead® M-200 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment | Positive and Negative BrainScope classification as described in IFU Display screens with information on specific raw measures EEG playback The Ahead® M-100 model additionally stores and displays an electronic version of the Military Acute Concussion Evaluation (MACE) cognitive assessment | Same | | Compliance to Standards | | | | | ISO 14971: 2000 Risk Management | Yes | Yes | Same | | ISO 10993- 1:2009 - Biological evaluation of medical devices | Yes | Yes | Same | | ANSI/AAMI EC12:2000 | Yes | Yes | Same | | IEC60601-1 - General requirements for basic safety and essential performance | Yes, for 3rd edition | Yes, for 2nd edition | Ahead® devices were compliant to recognized consensus versions at the time of submission | | | Ahead® 200, models M- 200 and CV-200 | Ahead 100, models M- 100 and CV-200 (Predicate Device, DEN100425) | Notes | | IEC 60601-1- 2:2007 Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | Yes | Yes | Same | | IEC 60601-2-26: Particular Requirements for the Safety of Electro- encephalographs | Yes, compliant with 2012 version | Yes, compliant with 2002 version (for use with 2nd ed.) | Ahead® 200 compliant with updated version of standard | | ASTM D4169-09, performance of packaging | Yes, compliant to DC 13, AL 1 | Yes, compliant to DC 13, AL 2 | Ahead® 200 compliant to stricter limits on same tests. | ## Table 2.0 Comparison between Ahead® 200 & the predicate device Ahead® 100 {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ {14}------------------------------------------------ The table 3.0 below provides a comparison summary of the features of Ahead® 200 to the predicate device, the Ahead® 100. ### Table 3.0 Comparison Summary of Features | Functional Features | Same/Different | |---------------------|------------------------------------------------------------------------| | Indications | Same | | Technology | Same fundamental technology with current faster operating system | | Software Algorithm | Same Harmony algorithm | {15}------------------------------------------------ | Functional Features | Same/Different | |---------------------|--------------------------------------------------------------------------------------------------------------| | User Interface | Same features but Ahead® 200 has improved usability by including the Dashboard screen. | | | The Dashboard screen gives the user real-time indication of the progress of on-going EEG recording. | ### 4. Conclusion The information and data provided in this 510(k) notification establishes that the Ahead® 200, with models M-200 and CV-200, is substantially equivalent to the currently cleared device Ahead® 100, models M-100 and CV-100. The intended use is identical to the predicate device. The proposed device Ahead® 200 shares the basic design and fundamental operating principles to the currently cleared device (Ahead® 100, DEN 140025).