[Federal Register Volume 79, Number 128 (Thursday, July 3, 2014)]
[Rules and Regulations]
[Pages 37946-37948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15625]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2014-M-0799]


Medical Devices; Neurological Devices; Classification of the 
Transcutaneous Electrical Nerve Stimulator to Treat Headache

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
transcutaneous electrical nerve stimulator to treat headache 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 transcutaneous electrical nerve stimulator to treat 
headache 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 August 4, 2014. The classification was 
applicable on March 11, 2014.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1434, Silver Spring, MD 20993-0002, 301-
796-6476, michael.hoffmann@fda.hhs.gov.

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 under section 513(f)(2). 
Under the

[[Page 37947]]

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.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on November 20, 2012, classifying the Cefaly Device, 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 13, 
2012, STX-Med SPRL, submitted a request for classification of the 
Cefaly Device 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 March 11, 2014, 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 882.5891.
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for a transcutaneous electrical nerve stimulator to treat 
headache will need to comply with the special controls named in the 
final administrative order.
    The device is assigned the generic name transcutaneous electrical 
nerve stimulator to treat headache, and it is identified as a device 
used to apply an electrical current to a patient's cranium through 
electrodes placed on the skin.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks 
in table 1:

  Table 1--Transcutaneous Electrical Nerve Stimulator To Treat Headache
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                    Mitigation measures
------------------------------------------------------------------------
Adverse reactions to skin-contacting      Biocompatibility testing.
 materials.                               Labeling.
Electrical, mechanical, or thermal        Electromagnetic compatibility
 hazards that may result in user           testing.
 discomfort or injury.                    Electrical, mechanical, and
                                           thermal safety testing.
                                          Technical parameters.
                                          Electrode performance testing.
                                          Software verification,
                                           validation, and hazard
                                           analysis.
                                          Labeling.
Ineffective treatment...................  Clinical performance data.
                                          Labeling.
Failure to identify the correct           Clinical performance data.
 population.                              Labeling.
Misuse that may result in user            Labeling.
 discomfort, injury, or delay treatment
 for headaches.
------------------------------------------------------------------------

    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:
     The patient-contacting components of the device must be 
demonstrated to be biocompatible.
     Appropriate analysis/testing must validate electromagnetic 
compatibility and electrical, mechanical, and thermal safety.
     The technical parameters of the device, including 
waveform, output modes, maximum output voltage and current (with 500, 
2,000, and 10,000 ohm loads), pulse duration, frequency, net charge 
([mu]C) per pulse, maximum phase charge at 500 ohms, maximum current 
density (mA/cm\2\, r.m.s.), maximum average current (mA), maximum 
average power density (W/cm\2\), and the type of impedance monitoring 
system must be fully characterized.
     Electrical performance, adhesive integrity, shelf life, 
reusability, and current distribution testing of the electrodes must be 
conducted.
     Appropriate software verification, validation, and hazard 
analysis must be performed.
     Clinical performance data must demonstrate that the device 
is safe and effective as a treatment for headache in the indicated 
patient population.
     Labeling must include the following:
    [cir] Appropriate contraindications such as not for use in subjects 
with an implanted metallic or electronic device in the head, a cardiac 
pacemaker, or an implanted or wearable defibrillator;
    [cir] appropriate warnings such as not to apply the device on the 
neck or chest, not to use the device in the presence of electronic 
monitoring equipment, not to use in the bath or shower, not to use 
while sleeping, not to use while driving, not to use while operating 
machinery;
    [cir] appropriate precautions such as the long-term effects of 
chronic use of the device are unknown;

[[Page 37948]]

    [cir] a summary of the expected risks and benefits of using the 
device;
    [cir] a summary of the clinical performance data, including 
information on the patient population for which the device has and has 
not been demonstrated to be effective, and any adverse events and 
complications;
    [cir] information on how the device operates and the typical 
sensations experienced during treatment;
    [cir] a detailed summary of the device technical parameters;
    [cir] an expiration date/shelf life for the electrodes and the 
number of times they can be reused; and
    [cir] disposal instructions.
    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 transcutaneous electrical nerve 
stimulator to treat headache device 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 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. K122566 De Novo Petition for the Cefaly Device From STX-Med SPRL, 
dated December 13, 2012.

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.  882.5891 to subpart F to read as follows:


Sec.  882.5891  Transcutaneous electrical nerve stimulator to treat 
headache.

    (a) Identification. A transcutaneous electrical nerve stimulator to 
treat headache is a device used to apply an electrical current to a 
patient's cranium through electrodes placed on the skin.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (2) Appropriate analysis/testing must validate electromagnetic 
compatibility and electrical, mechanical, and thermal safety.
    (3) The technical parameters of the device, including waveform, 
output modes, maximum output voltage and current (with 500, 2,000, and 
10,000 ohm loads), pulse duration, frequency, net charge ([mu]C) per 
pulse, maximum phase charge at 500 ohms, maximum current density (mA/
cm\2\, r.m.s.), maximum average current (mA), maximum average power 
density (W/cm\2\), and the type of impedance monitoring system must be 
fully characterized.
    (4) Electrical performance, adhesive integrity, shelf life, 
reusability, and current distribution testing of the electrodes must be 
conducted.
    (5) Appropriate software verification, validation, and hazard 
analysis must be performed.
    (6) Clinical performance data must demonstrate that the device is 
safe and effective as a treatment for headache in the indicated patient 
population.
    (7) Labeling must include the following:
    (i) Appropriate contraindications such as not for use in subjects 
with an implanted metallic or electronic device in the head, a cardiac 
pacemaker, or an implanted or wearable defibrillator.
    (ii) Appropriate warnings such as not to apply the device on the 
neck or chest, not to use the device in the presence of electronic 
monitoring equipment, not to use in the bath or shower, not to use 
while sleeping, not to use while driving, not to use while operating 
machinery.
    (iii) Appropriate precautions such as the long-term effects of 
chronic use of the device are unknown.
    (iv) A summary of the expected risks and benefits of using the 
device.
    (v) A summary of the clinical performance data, including 
information on the patient population for which the device has and has 
not been demonstrated to be effective, and any adverse events and 
complications.
    (vi) Information on how the device operates and the typical 
sensations experienced during treatment.
    (vii) A detailed summary of the device technical parameters.
    (viii) An expiration date/shelf life for the electrodes and the 
number of times they can be reused.
    (ix) Disposal instructions.

    Dated: June 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15625 Filed 7-2-14; 8:45 am]
BILLING CODE 4164-01-P