[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16266-16269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07010]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2015-N-0802]


Medical Devices; Neurological Devices; Classification of the 
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment 
Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
brain injury adjunctive interpretive electroencephalograph assessment 
aid into class II (special controls). The special controls that will 
apply to the device are identified in this order and will be part of 
the codified language for the brain injury adjunctive interpretive 
electroencephalograph assessment aid's classification. The Agency is 
classifying the device into class II (special controls) in order to 
provide a reasonable assurance of safety and effectiveness of the 
device.

DATES: This order is effective March 27, 2015. The classification was 
applicable on November 17, 2014.

FOR FURTHER INFORMATION CONTACT: Jay Gupta, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G312, Silver Spring, MD 20993-0002, 301-796-2795, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification

[[Page 16267]]

under section 513(f)(2). Under the second procedure, rather than first 
submitting a premarket notification under section 510(k) of the FD&C 
Act and then a request for classification under the first procedure, 
the person determines that there is no legally marketed device upon 
which to base a determination of substantial equivalence and requests a 
classification under section 513(f)(2) of the FD&C Act. If the person 
submits a request to classify the device under this second procedure, 
FDA may decline to undertake the classification request if FDA 
identifies a legally marketed device that could provide a reasonable 
basis for review of substantial equivalence with the device or if FDA 
determines that the device submitted is not of ``low-moderate risk'' or 
that general controls would be inadequate to control the risks and 
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On August 20, 2014, BrainScope Company, Inc., submitted a request 
for classification of the BrainScope Ahead 100, Models CV-100 and M-100 
under section 513(f)(2) of the FD&C Act. The manufacturer recommended 
that the device be classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies devices 
into class II if general controls by themselves are insufficient to 
provide reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
request, FDA determined that the device can be classified into class II 
with the establishment of special controls. FDA believes these special 
controls, in addition to general controls, will provide reasonable 
assurance of the safety and effectiveness of the device.
    Therefore, on November 17, 2014, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  882.1450.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a brain 
injury adjunctive interpretive electroencephalograph assessment aid 
will need to comply with the special controls named in this final 
order. The device is assigned the generic name brain injury adjunctive 
interpretive electroencephalograph assessment aid, and it is identified 
as 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.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the mitigation 
measures required to mitigate these risks in table 1.

   Table 1--Brain Injury Adjunctive Interpretive Electroencephalograph
              Assessment Aid Risks and Mitigation Measures
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            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility.
                                         Labeling.
Equipment malfunction leading to injury  Electrical safety, thermal, and
 to user/patient (shock, burn, or         mechanical testing.
 mechanical failure).                    Electromagnetic compatibility
                                          testing.
                                         Labeling.
Delay in treatment or unnecessary        Performance testing.
 treatment due to hardware or software   Hardware and software
 failure.                                 verification, validation and
                                          hazard analysis.
                                         Electromagnetic compatibility
                                          testing.
                                         Technical parameters
                                         Labeling.
False result due to incorrect artifact   Software verification and
 reduction.                               validation.
                                         Labeling.
False result due to incorrect placement  Clinical performance testing.
 of electrodes.                          Labeling.
False result when a brain injury         Clinical performance testing.
 adjunctive interpretive EEG assessment  Device design characteristics.
 aid impacts the clinical decision.      Labeling.
Use error..............................  Clinical performance testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination 
with the general controls, address these risks to health and provide 
reasonable assurance of the safety and effectiveness:
     The technical parameters of the device, hardware and 
software, must be fully characterized and include the following 
information:
    [cir] Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    [cir] 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.
     The device parts that contact the patient must be 
demonstrated to be biocompatible.
     The device must be designed and tested for electrical 
safety, electromagnetic compatibility (EMC), thermal, and mechanical 
safety.
     Clinical performance testing must demonstrate the 
accuracy, precision-repeatability and reproducibility, of determining 
the EEG-based

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interpretation, including any specified equivocal zones (cut-offs).
     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.
     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).
     The labeling and training information must include:
    [cir] A warning that the device is not to be used as a stand-alone 
diagnostic.
    [cir] A detailed summary of the clinical performance testing, 
including any adverse events and complications.
    [cir] The intended use population and the intended use environment.
    [cir] Any instructions technicians should convey to patients 
regarding the collection of EEG data.
    [cir] Information allowing clinicians to gauge clinical risk 
associated with integrating the EEG interpretive assessment aid into 
their diagnostic pathway.
    [cir] 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.
    Brain injury adjunctive interpretive electroencephalograph 
assessment aid devices are prescription devices restricted to patient 
use only upon the authorization of a practitioner licensed by law to 
administer or use the device; see 21 CFR 801.109 (Prescription 
devices)). Prescription-use restrictions are a type of general controls 
as defined in section 513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the brain injury adjunctive 
interpretive electroencephalograph assessment aid they intend to 
market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 
CFR part 807, subpart E, regarding premarket notification submissions 
have been approved under OMB control number 0910-0120, and the 
collections of information in 21 CFR part 801, regarding labeling have 
been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

1. [DEN140025]: De Novo Request per 513(f)(2) from BrainScope 
Company, Inc., dated August 20, 2014.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Add Sec.  882.1450 to subpart B to read as follows:


Sec.  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.,

[[Page 16269]]

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.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07010 Filed 3-26-15; 8:45 am]
 BILLING CODE 4164-01-P