Predicate Devices

Reference Devices

BrainScope Ahead 200 (K143643), ANAM Test System: Military Battery (K150154), Neurometric Analysis System (K974748)

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly states that the Ahead 300 provides an "algorithmbased structural injury classification of head injured patients using EEG features." While it doesn't use the terms AI or ML directly, the use of an algorithm to classify structural injury based on complex EEG features strongly suggests the application of machine learning or a similar advanced algorithmic approach, especially given the context of improving accuracy over a previous version. The performance study also focuses on metrics like sensitivity, specificity, and NPV, which are common in evaluating the performance of classification algorithms, including those based on ML.

Therapeutic

No

The device is indicated for aid in evaluation and diagnosis of traumatic brain injury (TBI) and does not provide therapy or treatment.

Diagnostic

Yes

The device is intended to "aid in the diagnosis of traumatic brain injury (TBI)" and provides "Structural Injury Classification" that "likely corresponds to those with no structural brain injury visible on head CT" or "likely corresponds to those with a structural brain injury visible on head CT." This clearly indicates its role in supporting the diagnostic process.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable, non-invasive, non-radiation emitting, point of care device" and mentions utilizing "brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead." This indicates the device includes hardware components for acquiring EEG signals, not just software processing.

IVD (In Vitro Diagnostic)

Based on the provided information, the Ahead 300 is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic purposes.
Ahead 300's Function: The Ahead 300 is a non-invasive device that records and analyzes brain electrical activity (EEG) from the patient's forehead. It does not involve the collection or analysis of specimens taken from the body.
Intended Use: The intended use describes the device as an adjunct to clinical practice to aid in the evaluation of patients with closed head injuries. While it provides information to support diagnosis, it does so by analyzing electrical signals directly from the body, not from a specimen.

Therefore, the Ahead 300 falls under the category of a medical device that performs analysis in vivo (within the living body), rather than in vitro (in glass or outside the living body).

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for 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.

Product codes

PIW, PKQ, OLU

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 algorithm-based 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 well-accepted cognitive performance tests.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Forehead

Indicated Patient Age Range

18-85 years

Intended User / Care Setting

Clinicians, medical professionals and practitioners. Point of care.

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

The target population of the B-AHEAD III validation trial was aligned with that of the B-AHEAD II validation trial for the predicate device Ahead 200, and consisted of 720 adults; 60.7% males, mean age of 43.12 years, mean GCS of 14.97 and an average time since injury of 13.9 hours.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Performance Data:
The target population of the B-AHEAD III validation trial was aligned with that of the B-AHEAD II validation trial for the predicate device Ahead 200, and consisted of 720 adults; 60.7% males, mean age of 43.12 years, mean GCS of 14.97 and an average time since injury of 13.9 hours.

The co-primary endpoints, as defined by sensitivity and specificity of the study device classification distinguishing CT+ from CT-, successfully exceeded the performance goals, and demonstrated significantly improved performance over Ahead 200. A high negative predictive value (NPV), and repeatability and reproducibility of the device result were also successfully demonstrated.

The secondary endpoints reflect the evolution of the Ahead system, providing additional quantitative information about brain function using the EEG Brain Function Index which scales with severity of functional impairment, and reducing the risk of false negatives through the addition of the Equivocal Zone for classification of structural TBI. The Ahead 300 validation trial achieved secondary endpoints related to these two functionalities.

The Ahead 300 clinical validation trial successfully achieved its target performance, and demonstrating enhanced performance compared to the Ahead 200.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity, specificity, negative predictive value (NPV).

Predicate Device(s)

BrainScope Ahead 200 (K143643), ANAM Test System: Military Battery (K150154), Neurometric Analysis System (K974748)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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 (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" (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.

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.

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)