(90 days)
Not Found
Yes
The "Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT." This classification system, based on analyzing complex biological signals (EEG) to predict a clinical outcome (presence of structural injury on CT), strongly suggests the use of a machine learning algorithm. While the terms AI/ML are not explicitly used, the description of the SIC function aligns with typical applications of ML in medical diagnostics.
No
The device is indicated for aid in evaluation and diagnosis of head injuries, not for treatment or therapy.
Yes
The device aids in the evaluation of patients with closed head injuries and helps determine the likelihood of structural brain injury visible on head CT, which is a diagnostic purpose. It explicitly states it is "intended to provide results and measures to support clinical assessments and aid in the diagnosis of mild traumatic brain injury (mTBI)."
No
The device description explicitly states it is a "portable, non-invasive, non-radiation emitting, point of care device" and records brain electrical activity utilizing electrodes on the forehead, indicating it includes hardware components for data acquisition.
Based on the provided text, the BrainScope TBI device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The BrainScope TBI device analyzes brain electrical activity (EEG) directly from the patient's forehead. It does not process blood, urine, tissue, or other biological samples.
- The intended use and device description focus on non-invasive measurement of brain activity and cognitive function. This is a direct measurement from the patient, not an analysis of a sample taken from the patient.
Therefore, the BrainScope TBI device falls under the category of a non-invasive diagnostic device rather than an In Vitro Diagnostic.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text - Not Found", which means the letter does not contain the required explicit approval or clearance language for a PCCP.
Intended Use / Indications for Use
· BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan.
• The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
· BrainScope TBI provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment.
· The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI 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.
· BrainScope TBI 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.
· BrainScope TBI also stores and displays electronic 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, PKO, OLU
Device Description
BrainScope TBI 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 mild traumatic brain injury (mTBI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI. BrainScope TBI provides healthcare professionals with a set of validated and clinically accepted library of concussion / mTBI assessments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead.
Indicated Patient Age Range
18-85 years
Intended User / Care Setting
Not Found
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)
Performance data was submitted to support the device modification made to the predicate. Normative data was collected from 707 healthy individuals with age range of 13-85 years to construct databases for the cognitive tests implemented on the BrainScope TBI. Test data demonstrated that the modifications made to the predicate namely – additional cognitive performance tests, additional standard clinical assessment (PECARN) and wireless connectivity are implemented as per specifications. These new modifications did not impact existing device functionality including core EEG based algorithms. The BrainScope TBI device conforms to all same basic safety and EMC standards as the predicate. The BrainScope TBI device was also tested to the most recent recognized consensus standard for EMC (IEC 60601-1-2 Ed. 4.0 2014) as shown below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BrainScope One (K181179), ANAM Test System: Military Battery (K150154)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 19, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
BrainScope Company Inc. Michael Singer CEO 4350 East West Hwy, Ste 1050 Bethesda. Maryland 20814
Re: K183241
Trade/Device Name: BrainScope TBI (Model: Ahead 400) Regulation Number: 21 CFR 882.1450 Regulation Name: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid Regulatory Class: Class II Product Code: PIW, PKO, OLU Dated: November 20, 2018 Received: November 21, 2018
Dear Michael 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For 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) K183241
Device Name BrainScope TBI (Model: Ahead 400)
Indications for Use (Describe)
· BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan.
• The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical activity to determine the likelihood of structural brain injury visible on head CT. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
· BrainScope TBI provides a measure of brain function Index, (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment.
· The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI 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.
· BrainScope TBI 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.
· BrainScope TBI also stores and displays electronic 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)
| ☑ 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 shows the logo for BrainScope. The logo is in blue and features the word "BrainScope" in a stylized font. There are two horizontal lines under the word. The registered trademark symbol is to the right of the word.
4330 East-West Highway.Suite 1000.Bethesda.Maryland.20814
phone 240.752.7680
510(k) SUMMARY1
| Submitter: | BrainScope® Company, Inc.
4330 East West Highway Suite #1000
Bethesda, MD 20814
Phone: (240) 752-7680
Fax: (240) 752-7679
www.brainscope.com |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael E. Singer, Ph.D.
Chief Executive Officer
BrainScope Company, Inc.
Phone: (240) 752-7677
Fax: (240) 752-7679
Email: michael.singer@brainscope.com |
| Prepared By: | Sabyasachi Roy, Ph.D.
Director Regulatory Affairs, Quality Assurance
&
Compliance |
| Device Proprietary Name: | BrainScope TBI (Model: Ahead 400) |
| Device Common Name: | Brain Injury Adjunctive Interpretive
Electroencephalograph Assessment Aid |
| Device Classification Name: | Brain Injury Adjunctive Interpretive
Electroencephalograph Assessment Aid |
| Classification Regulation: | 21 CFR § 882.1450 |
| Panel: | Neurology |
| Product Codes: | PIW, PKQ, OLU |
| Predicate Devices: | BrainScope One (K181179)
ANAM Test System: Military Battery (K150154) |
1 Prepared in accordance with 21 CFR § 807.87(h) and 21 CFR § 807.92(c). BrainScope TBI 510(k) Summary
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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. There are two horizontal lines, one above and one below the word. The "O" in scope has a brainwave graphic in the middle of it.
Device Description:
BrainScope TBI 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 mild traumatic brain injury (mTBI). It also contains configurable, selectable computerized cognitive performance tests and digitized standard clinical assessment intended to provide a multi-modal panel of measures to support the clinical assessment of concussion / mTBI. BrainScope TBI provides healthcare professionals with a set of validated and clinically accepted library of concussion / mTBI assessments.
Indications for Use:2
The BrainScope TBI's Indications for Use are as follows:
- . BrainScope TBI is a multi-modal, multi-parameter assessment indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who have sustained a closed head injury within the past 72 hours (3 days), are between the ages of 18-85 years, have a Glasgow Coma Scale (GCS) score of 13-15 (including patients with concussion / mild traumatic brain injury (mTBI)), and are being considered for a head CT. BrainScope TBI should not be used as a substitute for a CT scan.
- The BrainScope TBI Structural Injury Classification ("SIC") uses brain electrical . activity to determine the likelihood of structural brain injury visible on head CT. Negative likely corresponds to those with no structural brain injury visible on head CT. Positive likely corresponds to those with a structural brain injury visible on head CT. Equivocal may correspond to structural brain injury visible on head CT or may indicate the need for further observation or evaluation.
- BrainScope TBI provides a measure of brain function (EEG Brain Function Index, . (BFI)) for the statistical evaluation of the human electroencephalogram (EEG), aiding in the evaluation of head injury as part of a multi-modal, multi-parameter assessment.
- . The BrainScope TBI device is intended to record, measure, analyze, and display brain electrical activity utilizing the calculation of standard quantitative EEG (QEEG) parameters from frontal locations on a patient's forehead. The BrainScope TBI 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.
- BrainScope TBI also provides clinicians with quantitative measures of cognitive . performance to aid in the assessment of an individual's level of cognitive function.
2 The differences between the BrainScope TBI and its predicate (BrainScope One) do not alter the intended use of the device nor do they affect the safety and effectiveness of the predicate. The subject and predicate device have the same overall intended use.
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Image /page/5/Picture/0 description: The image shows the BrainScope logo in blue. The word "Brain" is written in a bold, sans-serif font with a horizontal line above and below it. The word "Scope" is written in a similar font, but with a wavy line in the middle of the "O" and a horizontal line below it. There is a registered trademark symbol to the right of the word "Scope".
These measures do not interact with any other device measures, and are stand alone.
- · BrainScope TBI 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.
| Proposed Device:
BrainScope TBI
(K183241) | Primary Predicate:
BrainScope One
(K181179) | Secondary
Predicate: ANAM
Test System -
Military Battery
(K150154) | Comments |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BrainScope TBI is a
multi-modal, multi-
parameter assessment
indicated for use as an
adjunct to standard
clinical practice to aid
in the evaluation of
patients who have
sustained a closed
head injury within the
past 72 hours (3 days),
are between the ages
of 18-85 years, have a
Glasgow Coma Scale
(GCS) score of 13-15
(including patients with
concussion / mild
traumatic brain injury
(mTBI)), and are being
considered for a head
CT. BrainScope TBI
should not be used as
a substitute for a CT
scan. | BrainScope One 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
(including concussion /
mild Traumatic Brain
Injury (mTBI)), and are
between the ages of
18-85 years.
BrainScope One
should not be used as
a substitute for a CT
scan. | N/A | Equivalent. As
cleared under
510(k) K181785. |
| The BrainScope TBI
device is intended to
record, measure,
analyze, and display
brain electrical activity
utilizing the calculation
of standard quantitative
EEG (QEEG)
parameters from frontal
locations on a patient's
forehead. The
BrainScope TBI | The BrainScope One
device is intended to
record, measure,
analyze, and display
brain electrical activity
utilizing the calculation
of standard quantitative
EEG (QEEG)
parameters from frontal
locations on a patient's
forehead. The
BrainScope One | N/A | Same as primary
predicate. |
| Proposed Device:
BrainScope TBI
(K183241) | Primary Predicate:
BrainScope One
(K181179) | Secondary
Predicate: ANAM
Test System –
Military Battery
(K150154) | Comments |
| 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. | 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 BrainScope TBI
Structural Injury
Classification (“SIC”)
uses brain electrical
activity to determine
the likelihood of
structural brain injury
visible on head CT.
Negative likely
corresponds to those
with no structural brain
injury visible on head
CT. Positive likely
corresponds to those
with a structural brain
injury visible on head
CT. Equivocal may
correspond to
structural brain injury
visible on head CT or
may indicate the need
for further observation
or evaluation. | A negative BrainScope
One 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. | N/A | Equivalent. As
cleared under
510(k) K181785. |
| | A positive BrainScope
One 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. | N/A | Equivalent. As
cleared under
510(k) K181785. |
| | An equivocal
BrainScope One
Structural Injury
Classification using
brain electrical activity
in patients who
sustained a closed
head injury within 72
hours, likely | N/A | Equivalent. As
cleared under
510(k) K181785. |
| Proposed Device:
BrainScope TBI
(K183241) | Primary Predicate:
BrainScope One
(K181179) | Secondary
Predicate: ANAM
Test System –
Military Battery
(K150154) | Comments |
| | hours, may correspond
to structural brain injury
visible on head CT or
may indicate the need
for further observation
or evaluation. | | |
| BrainScope TBI
provides a measure of
brain function (EEG
Brain Function Index,
(BFI)) for the statistical
evaluation of the
human
electroencephalogram
(EEG), aiding in the
evaluation of head
injury as part of a multi-
modal, multi-parameter
assessment. | The BrainScope One
provides a measure of
brain function (EEG
Brain Function Index,
(BFI)) for the statistical
evaluation of the
human
electroencephalogram
(EEG). | N/A | Equivalent. As
cleared under
510(k) K181785. |
| BrainScope TBI 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 BrainScope One
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 ANAM Test
System: Military
Battery provides
clinicians with
objective
measurements of
cognitive
performance in
military populations
ages 18 to 65 years,
to aid in the
assessment of an
individual's level of
cognitive
functioning. The
ANAM Test System
should only be used
as an adjunctive tool
for evaluating
cognitive function. | Same as primary
predicate
(BrainScope One)
and equivalent to
secondary
predicate (ANAM
Test System –
Military Battery).
BrainScope TBI
extends age range
from 18-85 years
in predicate
(BrainScope One)
to 13 – 85 years.
Additional
performance data
including norming
study supported
the extended age
range. |
| BrainScope TBI also
stores and displays
electronic versions of
standardized clinical
assessment tools that
should be used in | The BrainScope One
also stores and
displays electronic
versions of
standardized clinical
assessment tools that | N/A | Equivalent.
Expanding the
availability of
clinical
assessment tools
does not affect the |
| Proposed Device:
BrainScope TBI
(K183241) | Primary Predicate:
BrainScope One
(K181179) | Secondary
Predicate: ANAM
Test System –
Military Battery
(K150154) | Comments |
| accordance with the
assessment tools'
general instructions.
These tools do not
interact with any other
device measures, and
are stand alone. | 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. | | safety and
effectiveness of
the device.
Expanding
functionality
increases the
utility of the device
and better meets
user needs. |
Table 1: Indications for Use Comparison to Predicate devices
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Image /page/6/Picture/0 description: The image shows the BrainScope logo. The logo is in blue and features the word "BrainScope" in a stylized font. There are horizontal lines above and below the word "BrainScope". The "o" in "Scope" is stylized with a brainwave pattern. There is a registered trademark symbol to the right of the word "Scope".
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Image /page/7/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 lines above and below the word, and the "O" in "Scope" is replaced with a brainwave graphic. A registered trademark symbol is located to the right of the word.
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Image /page/8/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 lines above and below the word, and the "O" in "Scope" is replaced with a brainwave graphic. A registered trademark symbol is located to the right of the word.
Comparison of Technological Characteristics with the Predicate Device:
The BrainScope TBI has similar technological characteristics as the legally marketed predicate devices. The BrainScope TBI includes the following modifications when compared to the primary predicate (BrainScope One):
- . Three additional computerized Cognitive Performance tests for a total of five. All five computerized Coqnitive Performance tests are intended for use on patients 13 - 85 years of age.
- . The addition of PECARN – Pediatric Head Injury Predication Rule to the library of Standard Clinical Assessments already included in BrainScope One.
- Expanded device connectivity to include an Over the Air (OTA) software upgrade . capability made possible using a Wi-Fi or Cellular connection.
All EEG based algorithms in both devices are limited to the FDA authorized age range of 18 to 85 years (Adolescent subgroup and Adult age patients).
The minor technological differences between the BrainScope TBI and the predicates do not raise new questions of safety and effectiveness and performance data demonstrate that the BrainScope TBI is as safe and effective as the predicate.
The BrainScope TBI is substantially equivalent to the predicates the BrainScope One and ANAM Test System - Military Battery.
| Topic /
Area | Proposed
Device:
BrainScope TBI | Primary
Predicate:
BrainScope One
(K181179) | Secondary
Predicate: ANAM
Test System –
Military Battery
(K150154) | Comments |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hardware | | | | |
| Platform | Trimble T41
mobile device,
Android OS | Trimble T41
mobile device,
Android OS | PC: Dell Latitude
E6440 Laptop | Same as primary
predicate. |
| Topic /
Area | Proposed
Device:
BrainScope TBI | Primary
Predicate:
BrainScope One
(K181179) | Secondary
Predicate: ANAM
Test System -
Military Battery
(K150154) | Comments |
| Processed
EEG
Bandwidth | 1kHz sampled
data with DC to
300Hz bandwidth
and 100Hz
sampled data
with 0.67Hz to
43Hz bandwidth | 1kHz sampled
data with DC to
300Hz bandwidth
and 100Hz
sampled data with
0.67Hz to 43Hz
bandwidth | N/A | Same as primary
predicate. |
| Common
Mode
Rejection
Ratio
(CMRR) |