Ahead 300

K161068 · Brainscope Company, Inc. · PIW · Sep 22, 2016 · Neurology

Device Facts

• Record ID: K161068
• Device Name: Ahead 300
• Applicant: Brainscope Company, Inc.
• Product Code: PIW · Neurology
• Decision Date: Sep 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1450
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

The Ahead 300 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, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan. The Ahead 300 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 300 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. A negative Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT. A positive Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT. An equivocal Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation. The Ahead 300 provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram(EEG). The Ahead 300 also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone. The Ahead 300 also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

Device Story

Portable, non-invasive, point-of-care device for TBI assessment; records/analyzes frontal EEG signals; calculates QEEG parameters (Absolute/Relative Power, Asymmetry, Coherence, Fractal Dimension) and Brain Function Index (BFI); provides structural injury classification (Negative, Positive, Equivocal); includes cognitive performance tests and electronic clinical assessment tools. Operated by clinicians in clinical settings; provides objective data to aid CT decision-making; improves diagnostic accuracy over predecessor; benefits patients by potentially reducing unnecessary CT scans or identifying need for further observation.

Clinical Evidence

B-AHEAD III validation trial; N=720 adults (60.7% male, mean age 43.12, mean GCS 14.97, mean time since injury 13.9 hours). Co-primary endpoints (sensitivity/specificity for CT+ vs CT-) exceeded performance goals and showed significant improvement over Ahead 200. Secondary endpoints achieved for BFI and Equivocal zone functionality. High NPV and repeatability/reproducibility demonstrated.

Technological Characteristics

Portable device using Trimble T41 mobile platform (Android OS). Disposable Ag/AgCl electrode headset (International 10-20 system). 1kHz sampling (downsampled to 100Hz). CMRR < -100 dB; noise floor < 0.4 µV. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-26, ANSI/AAMI EC12, ISO 10993-1/5/10, MIL-STD-810G.

Indications for Use

Indicated for patients 18-85 years old with closed head injury within 72 hours and GCS 13-15, being considered for head CT. Adjunct to standard clinical practice; not a substitute for CT.

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 200 (K143643)
• ANAM Test System: Military Battery (K150154)
• Neurometric Analysis System (K974748)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2016

Brainscope Company Inc Michael Singer, PhD CEO 4350 East West Highway Suite 1050 Bethesda, Maryland 20814

Re: K161068

Trade/Device Name: Ahead 300 Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, PKQ, OLU Dated: August 24, 2016 Received: August 24, 2016

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR 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.

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Sincerely yours,

# Michael J. Hoffmann -A

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K161068

Device Name Ahead® 300

#### Indications for Use (Describe)

· The Ahead 300 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, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan.

· The Ahead 300 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 300 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.

· A negative Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.

· A positive Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.

· An equivocal Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.

· The Ahead 300 provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram(EEG).

· The Ahead 300 also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.

· The Ahead 300 also stores and displays electronic versions of standardized clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

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)

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Image /page/3/Picture/0 description: The image is a logo for BrainScope. The logo is in blue and features the word "BrainScope" in a bold, sans-serif font. The "C" in "Scope" is stylized with a waveform graphic. There are two horizontal lines underneath the word "BrainScope", and a registered trademark symbol is in the upper right corner of the logo.

4350 East-West Highway.Suite 1050.Bethesda.Maryland.20814

www.brainscope.com

# 510(k) SUMMARY1

| Submitter: | BrainScope® Company, Inc.<br>4350 East West Highway Suite #1050<br>Bethesda, MD 20814<br>Phone: [phone]<br>Fax: [phone]<br>www.brainscope.com |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael E. Singer, Ph.D.<br>Chief Executive Officer<br>BrainScope Company, Inc.<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 20, 2016 |
| Device Proprietary Name: | Ahead® 300 |
| Device Common Name: | Brain Injury Adjunctive Interpretive<br>Electroencephalograph Assessment Aid |
| Device Classification Name: | Brain Injury Adjunctive Interpretive<br>Electroencephalograph Assessment Aid |
| Classification Regulation: | 21 CFR § 882.1450 |
| Panel: | Neurology |
| Product Codes: | PIW, PKQ, OLU |
| Predicate Devices: | BrainScope Ahead 200 (K143643)<br>ANAM Test System: Military Battery (K150154)<br>Neurometric Analysis System (K974748) |

¹ Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c).

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Image /page/4/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. The "W" in scope is replaced with a brainwave symbol. There is a horizontal line above the word "BrainScope" and a registered trademark symbol to the right of the word.

### Device Description:

The Ahead 300 is a portable, non-invasive, non-radiation emitting, point of care device intended to provide results and measures to support clinical assessments and aid in the diagnosis of traumatic brain injury (TBI).

The Ahead 300 is a product of the continual technological evolution of the BrainScope Ahead 200 device. The device platform is essentially identical, and the core capability of the Ahead 300 remains the same as the Ahead 200. Both devices provide an algorithmbased structural injury classification of head injured patients using EEG features. The Ahead 300's accuracy is improved over the Ahead 200. The Ahead 300 also incorporates functions performed by additional legally marketed predicate devices, including an overall assessment of functional brain injury utilizing EEG, and two wellaccepted cognitive performance tests.

## Indications for Use:2

The Ahead 300's Indications for Use reflect the improved performance of the Ahead 300 as compared to the primary predicate, the Ahead 200. The Indications for Use also provide additional information to medical professionals and practitioners upon which they can make more informed decisions about the clinical diagnosis of patients that have sustained a closed head injury, by incorporating relevant portions of the Indications for Use associated with each leqally marketed secondary predicate, thereby improving the overall benefit/risk ratio compared to the predicate devices. As such, the Ahead 300 and the predicate devices are not identical, but the combined set of Indications for Use support the Intended Use of the Ahead 300. The Ahead 300's Indications for Use are as follows:

- The Ahead 300 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, who sustained a closed head injury within 72 hours, present with a Glasgow Coma Scale score (GCS) of 13-15, and are between the ages of 18-85 years. The Ahead 300 should not be used as a substitute for a CT scan.
- The Ahead 300 device is intended to record, measure, analyze, and display brain o electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The Ahead 300 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.

² The Ahead 300 is a combination device encompassing indications for use for 3 predicates devices. The Indications for Use statement for the Ahead 300 is a composite of the indications associated with the predicates. The differences do not alter the intended use of the device nor do they affectiveness of the device relative to the predicates. The subject and predicate devices have the same overall intended use.

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Image /page/5/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines above and below the word. The letter "O" in "Scope" is replaced with a brainwave graphic.

- A negative Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, likely corresponds to those with no structural brain injury visible on head CT.
- A positive Ahead 300 Structural Injury Classification using brain electrical activity ● in patients who sustained a closed head injury within 72 hours, likely corresponds to those with a structural brain injury visible on head CT.
- . An equivocal Ahead 300 Structural Injury Classification using brain electrical activity in patients who sustained a closed head injury within 72 hours, may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
- The Ahead 300 provides a measure of brain function (EEG Brain Function Index. . (BFI)) for the statistical evaluation of the human electroencephalogram (EEG).
- o The Ahead 300 also provides clinicians with quantitative measures of cognitive performance to aid in the assessment of an individual's level of cognitive function. These measures do not interact with any other device measures, and are stand alone.
- The Ahead 300 also stores and displays electronic versions of standardized ● clinical assessment tools that should be used in accordance with the assessment tools' general instructions. These tools do not interact with any other device measures, and are stand alone.

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Image /page/6/Picture/0 description: The image shows the logo for BrainScope. The logo is in blue and features the word "BRAINSCOPE" in a bold, sans-serif font. There are two horizontal lines above and below the word. The "W" in the middle of the word is replaced by a brainwave symbol.

| Table 1: Indications for Use Comparison to Predicate devices | |
|--------------------------------------------------------------|--|
| | |

| Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test<br>System -<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis System | Comments |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Ahead 300 is<br>indicated for use as<br>an adjunct to<br>standard clinical<br>practice to aid in<br>the evaluation of<br>patients who are<br>being considered<br>for a head CT,<br>sustained a closed<br>head injury within<br>72 hours, present<br>with a Glasgow<br>Coma Scale score<br>(GCS) of 13-15,<br>and are between<br>the ages of 18-85<br>years. The Ahead<br>300 should not be<br>used as a<br>substitute for a CT<br>scan. | The Ahead 200,<br>consisting of two<br>models, i.e., the<br>Ahead M-200<br>and the Ahead<br>CV-200, is<br>indicated for use<br>as an adjunct to<br>standard clinical<br>practice to aid in<br>the evaluation of<br>patients who are<br>being considered<br>for a head CT,<br>but should not be<br>used as a<br>substitute for a<br>CT scan. This<br>device is to be<br>used for this<br>purpose in<br>patients who<br>sustained a<br>closed head<br>injury within 24<br>hours, clinically<br>present as a mild<br>traumatic brain<br>injury with a<br>Glasgow Coma<br>Scale score<br>(GCS) of 13-15,<br>and are between<br>the ages of 18-<br>80 years. | N/A | N/A | Equivalent to primary<br>predicate, with<br>modifications<br>reflecting the Ahead<br>300 clinical trial<br>results, including:<br>· an expanded injury<br>time window (72<br>hours versus 24<br>hours for the Ahead<br>200),<br>· an expanded patient<br>age range (18-85<br>years versus 18-80<br>years for the Ahead<br>200). |
| The Ahead 300<br>device is intended<br>to record, measure,<br>analyze, and<br>display brain<br>electrical activity<br>utilizing the<br>calculation of<br>standard<br>quantitative EEG | The Ahead 200<br>device is<br>intended to<br>record, measure,<br>analyze, and<br>display brain<br>electrical activity<br>utilizing the<br>calculation of<br>standard | N/A | N/A | Same as primary<br>predicate. |
| Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test<br>System –<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis System | Comments |
| (QEEG)<br>parameters from<br>frontal locations on<br>a patient's<br>forehead. The<br>Ahead 300<br>calculates and<br>displays raw<br>measures for the<br>following standard<br>QEEG measures:<br>Absolute and<br>Relative Power,<br>Asymmetry,<br>Coherence and<br>Fractal Dimension.<br>These raw<br>measures are<br>intended to be<br>used for post hoc<br>analysis of EEG<br>signals for<br>interpretation by a<br>qualified user. | quantitative EEG<br>(QEEG)<br>parameters from<br>frontal locations<br>on a patient's<br>forehead. The<br>Ahead 200<br>calculates and<br>displays raw<br>measures for the<br>following<br>standard QEEG<br>measures:<br>Absolute and<br>Relative Power,<br>Asymmetry,<br>Coherence and<br>Fractal<br>Dimension.<br>These raw<br>measures are<br>intended to be<br>used for post hoc<br>analysis of EEG<br>signals for<br>interpretation by<br>a qualified user. | N/A | N/A | |
| A negative Ahead<br>300 Structural<br>Injury Classification<br>using brain<br>electrical activity in<br>patients who<br>sustained a closed<br>head injury within<br>72 hours, likely<br>corresponds to<br>those with no<br>structural brain<br>injury visible on<br>head CT. | A negative<br>BrainScope<br>Classification<br>may correspond<br>to brain electrical<br>activity<br>consistent with<br>no structural<br>brain injury<br>visible on head<br>CT in patients<br>presenting as a<br>mild traumatic<br>brain injury. | N/A | N/A | Equivalent to primary<br>predicate, with<br>proposed changes in<br>the Ahead 300<br>language reflecting<br>the significantly<br>improved accuracy<br>demonstrated by the<br>Ahead 300 trial<br>results. |
| A positive Ahead<br>300 Structural<br>Injury Classification<br>using brain | A positive<br>BrainScope<br>Classification<br>corresponds to | N/A | N/A | Equivalent to primary<br>predicate, with<br>proposed changes in<br>the Ahead 300 |
| Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test<br>System –<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis System | Comments |
| electrical activity in<br>patients who<br>sustained a closed<br>head injury within<br>72 hours, likely<br>corresponds to<br>those with a<br>structural brain<br>injury visible on<br>head CT. | brain electrical<br>activity that may<br>be present in<br>both patients<br>with or without a<br>structural brain<br>injury visible on<br>head CT. A<br>positive<br>BrainScope<br>Classification<br>does not<br>establish the<br>presence of a<br>structural brain<br>injury visible on<br>head CT. | | | language reflecting<br>the improved<br>accuracy<br>demonstrated by the<br>Ahead 300.<br>In addition, the<br>statement regarding<br>false positives in the<br>IFU of the predicate<br>is now expanded and<br>moved to the Safety<br>Summary section of<br>the User Manual. |
| An equivocal<br>Ahead 300<br>Structural Injury<br>Classification using<br>brain electrical<br>activity in patients<br>who sustained a<br>closed head injury<br>within 72 hours,<br>may correspond to<br>structural brain<br>injury visible on<br>head CT or may<br>indicate the need<br>for further<br>observation or<br>evaluation. | N/A | N/A | N/A | The Ahead 200 has<br>no equivocal zone.<br>This zone has been<br>added to provide<br>additional clinical<br>information to the<br>clinician for use in the<br>diagnostic process,<br>providing information<br>about patients who<br>are close to the<br>binary threshold for<br>classification. |
| The Ahead 300<br>provides a<br>measure of brain<br>function (EEG<br>Brain Function<br>Index, (BFI)) for the<br>statistical<br>evaluation of the<br>human<br>electroencephalogram (EEG). | N/A | N/A | The Neurometric<br>Analysis system<br>is to be used by<br>qualified medical<br>professionals for<br>the post-hoc<br>statistical<br>evaluation of the<br>human<br>electroencephalogram (EEG). | The Ahead 300 and<br>NAS both use<br>multivariate<br>composite features<br>as a measure of<br>abnormality of overall<br>brain function relative<br>to age expected<br>normal values, and<br>the functionality is<br>consistent with the<br>intended use of |
| Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test<br>System -<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis System | Comments |
| | | | | analyzing a patient's<br>electroencephalograp<br>h (EEG) to provide<br>an interpretation of<br>the patient's<br>neuropsychiatric<br>condition, as well as<br>to record, measure,<br>and display brain<br>electrical activity.<br>Removal of "post-<br>hoc" analysis reflects<br>the advances in<br>technology allowing<br>for real-time analysis<br>on the device, but<br>does not change<br>functionality. |
| The Ahead 300<br>also provides<br>clinicians with<br>quantitative<br>measures of<br>cognitive<br>performance to aid<br>in the assessment<br>of an individual's<br>level of cognitive<br>functioning. These<br>measures do not<br>interact with any<br>other device<br>measures, and are<br>stand alone. | N/A | The ANAM<br>Test System:<br>Military<br>Battery<br>provides<br>clinicians with<br>objective<br>measurement<br>s of cognitive<br>performance<br>in military<br>populations<br>ages 18 to 65<br>years, to aid<br>in the<br>assessment<br>of an<br>individual's<br>level of<br>cognitive<br>functioning.<br>The ANAM<br>Test System<br>should only<br>be used as an<br>adjunctive<br>tool for | N/A | Equivalent to<br>secondary predicate. |
| Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test<br>System –<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis System | Comments |
| | | evaluating<br>cognitive<br>function. | | |
| The Ahead 300<br>also stores and<br>displays electronic<br>versions of<br>standardized<br>clinical assessment<br>tools that should be<br>used in accordance<br>with the<br>assessment tools'<br>general<br>instructions. These<br>tools do not interact<br>with any other<br>device measures,<br>and are stand<br>alone. | The Ahead M-<br>200 model<br>additionally<br>stores and<br>displays an<br>electronic<br>version of the<br>Military Acute<br>Concussion<br>Evaluation<br>(MACE)<br>cognitive<br>assessment and<br>user-entered<br>responses to the<br>MACE questions.<br>There is no<br>interaction<br>between EEG-<br>related<br>functionality,<br>including<br>analyzing and<br>displaying brain<br>electrical activity,<br>and the function<br>of storing and<br>displaying MACE<br>information. | N/A | N/A | Equivalent to primary<br>predicate. IFU<br>language is<br>generalized to reflect<br>the fact that the<br>Ahead 300 stores<br>and displays multiple<br>assessment tools as<br>part of its library<br>function. Users will<br>know the full<br>capability of the<br>Ahead 300 from the<br>User Manual. |
| Topic / Area | Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test System:<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis<br>System |
| Platform | Trimble T41 mobile<br>device, Android OS | Trimble T41 mobile<br>device, Android OS | PC: Dell Latitude<br>E6440 Laptop<br>Computer, two button<br>USB connected<br>mouse, and Windows<br>7 Operating System | Stand-alone<br>post hoc<br>analysis<br>software that<br>may be run on<br>IBM-compatible<br>computer<br>systems. |
| Processed<br>EEG<br>Bandwidth | 1kHz sampled data<br>with DC to 300Hz<br>bandwidth and<br>100Hz sampled<br>data with 0.67Hz to<br>43Hz bandwidth | 1kHz sampled data<br>with DC to 300Hz<br>bandwidth and<br>100Hz sampled<br>data with 0.3Hz to<br>43Hz bandwidth | N/A | N/A |
| Common<br>Mode<br>Rejection<br>Ratio (CMRR) | < -100 dB (or<br>better) | < -100 dB (or<br>better) | N/A | N/A |
| System Noise<br>Floor | < 0.4 µV in 0.67 Hz<br>to 43Hz bandwidth | < 0.4 µV in 0.3 Hz<br>to 43Hz bandwidth | N/A | N/A |
| ADC<br>Resolution | 45 nV/bit | 45 nV/bit | N/A | N/A |
| ADC Sampling<br>Rate | 1000 Hz, down<br>sampled to 100 Hz<br>for algorithm<br>processing | 1000 Hz, down<br>sampled to 100 Hz<br>for algorithm<br>processing | N/A | N/A |
| Wireless data | No wireless<br>communication | No wireless<br>communication | N/A | N/A |
| Topic / Area | Proposed Device:<br>Ahead 300 | Primary<br>Predicate:<br>Ahead 200 | Secondary<br>Predicate:<br>ANAM Test System:<br>Military Battery | Secondary<br>Predicate:<br>Neurometric<br>Analysis<br>System |
| transmission | capability. | capability | | |
| Electrode<br>Placement<br>System | The International<br>10-20 System | The International<br>10-20 System | N/A | N/A |
| Electrode<br>Positions<br>Utilized | Fp1, Fp2, Fpz,<br>AFz, F7, F8, A1, A2 | Fp1, Fp2, Fpz,<br>AFz, F7, F8, A1, A2 | N/A | N/A |
| Electrode<br>Material | Single use Ag/AgCl<br>electrode sensor<br>array headset with<br>solid gel | Single use Ag/AgCl<br>electrode sensor<br>array headset with<br>solid gel…