[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Rules and Regulations]
[Pages 9083-9085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03388]



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Rules and Regulations
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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / 
Rules and Regulations

[[Page 9083]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2013-M-0042]


Medical Devices; Neurological Devices; Classification of the 
Neuropsychiatric Interpretive Electroencephalograph Assessment Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
neuropsychiatric interpretive electroencephalograph (EEG) assessment 
aid into class II (special controls). 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 20, 2014. The classification was 
applicable beginning July 15, 2013.

FOR FURTHER INFORMATION CONTACT: Peter Como, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2463, Silver Spring, MD 20993-0002, 301-796-6919.

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, July 9, 2012, 126 Statute 1054), provides two procedures by which 
a person may request that FDA 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 
under section 513(f)(2). Under the second procedure, rather than first 
submitting a premarket notification under section 510(k) 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. Within 
30 days after the issuance of an order classifying the device, FDA must 
publish a notice in the Federal Register announcing this 
classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on November 18, 2011, classifying the Neuropsychiatric EEG-Based 
Assessment Aid (NEBA) System for attention-deficit/hyperactivity 
disorder into class III, because it was not substantially equivalent to 
a device that was introduced or delivered for introduction into 
interstate commerce for commercial distribution before May 28, 1976, or 
a device which was subsequently reclassified into class I or class II. 
On December 8, 2011, Lexicor Medical Technology, LLC, submitted a 
request for classification of the NEBA System 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) of the FD&C Act. 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 de novo 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 July 15, 2013, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 882.1140 (Sec.  
882.1440).
    Following the effective date of this final classification 
administrative order, any firm submitting a 510(k) premarket 
notification for a neuropsychiatric interpretive EEG assessment aid 
will need to comply with the special controls named in the final 
administrative order.
    The device is assigned the generic name neuropsychiatric 
interpretive electroencephalograph assessment aid,

[[Page 9084]]

and it is identified as a prescription device that uses a patient's EEG 
to provide an interpretation of the patient's neuropsychiatric 
condition. The neuropsychiatric interpretive EEG assessment aid is used 
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 with 
this type of device and the measures required to mitigate these risks:

   Table 1--Neuropsychiatric Interpretive EEG Assessment Aid Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility.
Electromagnetic incompatibility........  Electromagnetic compatibility
                                          testing.
Equipment malfunction leading to injury  Electrical safety, thermal, and
 to user/patient (shock, burn, or         mechanical testing.
 mechanical failure).                    Labeling.
False result leading to delay in         Performance testing.
 treatment or unnecessary treatment due  Hardware and software
 to hardware failure.                     verification, validation, and
                                          hazard analysis.
                                         Technical parameters.
                                         Labeling.
False result due to incorrect artifact   Operator training.
 reduction.
                                         Software verification and
                                          validation.
                                         Labeling.
False result due to incorrect placement  Operator training.
 of electrodes.
                                         Clinical performance testing.
                                         Labeling.
False result when a neuropsychiatric     Clinical performance testing.
 interpretive EEG assessment aid is      Device design characteristics.
 used for confirmatory support or        Labeling.
 support for further testing.
Use error..............................  Clinical performance testing.
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
    1. The technical parameters of the device, hardware and software, 
must be fully characterized and must demonstrate a reasonable assurance 
of safety and effectiveness.
    a. Hardware specifications must be provided. Appropriate 
verification, validation, and hazard analysis must be performed.
    b. 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 and 
software design specification. 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, thermal, and mechanical safety.
    4. Clinical performance testing must demonstrate the accuracy, 
precision, 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, and negative predictive value 
per the device intended use. Repeatability of measurements must be 
demonstrated using interclass correlation coefficients and illustrated 
by qualitative scatter plot(s).
    6. The device design must include safeguards to prevent use of the 
device as a stand-alone diagnostic.
    7. The labeling must include the following information:
    a. A warning that the device is not to be used as a stand-alone 
diagnostic.
    b. A detailed summary of the clinical performance testing, 
including any adverse events and complications.
    c. The qualifications and training requirements for device users 
including technicians and clinicians.
    d. The intended use population and the intended use environment.
    e. Any instructions technicians should convey to patients regarding 
the collection of EEG data.
    f. Information allowing clinicians to gauge clinical risk 
associated with integrating the EEG interpretive assessment aid into 
their diagnostic pathway.
    g. Where appropriate, validated methods and instructions for 
reprocessing of any reusable components.
    Neuropsychiatric interpretive EEG assessment aids are prescription 
devices restricted to patient use only upon the authorization of a 
practitioner licensed by law to administer or use the device. (Proposed 
Sec.  882.1440(a); see section 520(e) of the FD&C Act (21 U.S.C. 
360j(e)) and Sec.  801.109 (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 neuropsychiatric interpretive EEG 
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,

[[Page 9085]]

neither an environmental assessment nor an environmental impact 
statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative 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 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. K112711--De Novo Request per 513(f) pursuant to the Agency's NSE 
Determination, dated November 18, 2011, From Lexicor Medical 
Technology, LLC, dated December 7, 2011.

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.  882.1440 to subpart B to read as follows:


Sec.  882.1440  Neuropsychiatric interpretive electroencephalograph 
assessment aid.

    (a) Identification. The neuropsychiatric interpretive 
electroencephalograph assessment aid is a prescription device that uses 
a patient's electroencephalograph (EEG) to provide an interpretation of 
the patient's neuropsychiatric condition. The neuropsychiatric 
interpretive EEG assessment aid is used 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 must demonstrate a reasonable assurance 
of safety and effectiveness.
    (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 and 
software design specification. 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, thermal, and mechanical safety.
    (4) Clinical performance testing must demonstrate the accuracy, 
precision, 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, and negative 
predictive value per the device intended use. Repeatability of 
measurements must be demonstrated using interclass correlation 
coefficients and illustrated by qualitative scatter plot(s).
    (6) The device design must include safeguards to prevent use of the 
device as a stand-alone diagnostic.
    (7) The labeling must include the following information:
    (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 qualifications and training requirements for device users 
including technicians and clinicians.
    (iv) The intended use population and the intended use environment.
    (v) Any instructions technicians should convey to patients 
regarding the collection of EEG data.
    (vi) Information allowing clinicians to gauge clinical risk 
associated with integrating the EEG interpretive assessment aid into 
their diagnostic pathway.
    (vii) Where appropriate, validated methods and instructions for 
reprocessing of any reusable components.

    Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03388 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P