(144 days)
DEN 140025
Not Found
No
The summary describes the device as calculating and displaying standard quantitative EEG (qEEG) parameters and utilizing a "BrainScope Algorithm Library (BSAL)". While algorithms are used, there is no mention of AI, ML, or any learning/adaptive capabilities. The performance studies focus on verification against a predicate device and compliance with standards, not on training or testing of an AI/ML model.
No.
The device is intended for diagnostic purposes (to aid in the evaluation of patients for a head CT) and is explicitly stated as an "assessment aid," not for treatment.
Yes
The device 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," and it provides "an objective assessment of brain electrical activity associated with traumatic brain injury (TBI)." This information helps in making a medical diagnosis, thus classifying it as a diagnostic device.
No
The device description explicitly states that the BrainScope® Ahead® 200 is comprised of two hardware components: the Handheld Device and the disposable Electrode Headset with patient application supplies.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states the device is a "portable, non-sterile, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) device". It records brain electrical activity from the patient's forehead, not from a sample taken from the patient (like blood, urine, or tissue).
- The intended use is to aid in the evaluation of patients, not to analyze a sample. The device is used as an "adjunct to standard clinical practice" and provides an "objective assessment of brain electrical activity". This is a direct measurement of a physiological process, not an analysis of a biological sample.
Therefore, the BrainScope® Ahead® 200 is a medical device that performs a direct physiological measurement (EEG) and provides an assessment based on that measurement, rather than analyzing a sample taken from the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PIW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal locations on a patient's forehead
Indicated Patient Age Range
18-80 years.
Intended User / Care Setting
Physicians, or under the direction of a physician, who have been trained in the use of the device.
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)
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:
- ANSI/AAMI ES60601-1:2005/(R)2012 "Medical electrical equipment Part 1: General requirements for basic safety and essential performance"
- CAN/CSA C22.2 No 601.1-08(R2013), "Medical Electrical Equipment, Part 1: General Requirements for Safety"
- IEC/EN 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (including PEMS clause 14)
- IEC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- IEC/EN 60601-1-2:2007 Medical electrical equipment Section1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
- ANSI/AAMI EC12:2000 Disposable ECG Electrodes
Design Verification Tests and Results:
- 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
Key Results for substantial equivalence:
- Same intended use
- Same operating principle
- Same fundamental scientific technology
- Same algorithm software
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
BrainScope® Ahead® 100 (Models M-100 and CV-100) (DEN 140025)
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
§ 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.
(a)
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.(b)
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.
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
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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:
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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:
-
- ANSI/AAMI ES60601-1:2005/(R)2012 "Medical electrical equipment Part 1: General requirements for basic safety and essential performance"
-
- CAN/CSA C22.2 No 601.1-08(R2013), "Medical Electrical Equipment, Part 1: General Requirements for Safety"
-
- IEC/EN 60601-1:2005+A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (including PEMS clause 14)
-
- IEC 60601-2-26:2012 Medical electrical equipment Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
-
- IEC/EN 60601-1-2:2007 Medical electrical equipment Section1.2 Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
-
- 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) |