83 FR 52972 - Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 203 (October 19, 2018)

Page Range		52972-52973
FR Document		2018-22842

The Food and Drug Administration (FDA or we) is classifying the thermal vestibular stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the thermal vestibular stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Federal Register, Volume 83 Issue 203 (Friday, October 19, 2018)

[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52972-52973]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22842]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2018-N-3690]


Medical Devices; Neurological Devices; Classification of the 
Thermal Vestibular Stimulator for Headache

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the thermal vestibular stimulator for headache into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the thermal vestibular stimulator for headache's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective October 19, 2018. The classification was 
applicable on March 26, 2018.

FOR FURTHER INFORMATION CONTACT: Stacie Gutowski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240-
402-6032, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the thermal vestibular stimulator 
for headache as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by reducing regulatory burdens by 
placing the device into a lower device class than the automatic class 
III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that 
does not require premarket approval. We determine whether a new device 
is substantially equivalent to a predicate by means of the procedures 
for premarket notification under section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) established the first procedure for De 
Novo classification. Section 607 of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo 
application process by adding a second procedure. A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket application to market a substantially equivalent device 
(see 21 U.S.C. 360c(i), defining ``substantial equivalence''). Instead, 
sponsors can use the less-burdensome 510(k) process, when necessary, to 
market their device.

II. De Novo Classification

    On April 18, 2017, Scion NeuroStim, LLC submitted a request for De 
Novo classification of the ThermoNeuroModulation Device. 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.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on March 26, 2018, FDA issued an order to the requester 
classifying the device into class II. FDA

[[Page 52973]]

is codifying the classification of the device by adding 21 CFR 
882.5893. We have named the generic type of device thermal vestibular 
stimulator for headache, and it is identified as a prescription device 
used to stimulate the vestibular system by applying thermal waveforms 
through earpieces placed in a patient's ear canal for the treatment of 
headache.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

                Table 1--Thermal Vestibular Stimulator for Headache Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
                         Identified risks                                       Mitigation measures
----------------------------------------------------------------------------------------------------------------
Adverse tissue reaction..........................................  Biocompatibility evaluation, Cleaning
                                                                    validation, and Labeling.
Thermal injury...................................................  Labeling, Non-clinical performance testing,
                                                                    Thermal safety testing, Technical
                                                                    specifications, and Software verification,
                                                                    validation, and hazard analysis.
Ear tenderness and/or pruritus...................................  Labeling, Non-clinical performance testing,
                                                                    and Thermal safety testing.
Nausea and/or dizziness..........................................  Labeling, Non-clinical performance testing,
                                                                    and Software verification, validation, and
                                                                    hazard analysis.
Tinnitus.........................................................  Labeling, Non-clinical performance testing,
                                                                    and Software verification, validation, and
                                                                    hazard analysis.
----------------------------------------------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. This device is subject to premarket notification 
requirements under section 510(k) of the FD&C Act.
    At the time of classification, thermal vestibular stimulators for 
headache are for prescription use only. Prescription devices are exempt 
from the requirement for adequate directions for use for the layperson 
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met 
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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 the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' have been 
approved under OMB control number 0910-0844; the collections of 
information in 21 CFR part 814, subparts A through E, regarding 
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 820, regarding 
quality system regulations, have been approved under OMB control number 
0910-0073; 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.

List of Subjects in 21 CFR Part 882

    Medical devices.

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

PART 882--NEUROLOGICAL DEVICES

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

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


0
2. Add Sec.  882.5893 to subpart F to read as follows:


Sec.  882.5893  Thermal vestibular stimulator for headache.

    (a) Identification. The thermal vestibular stimulator for headache 
is a prescription device used to stimulate the vestibular system by 
applying thermal waveforms through earpieces placed in a patient's ear 
canal for the treatment of headache.
    (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) Performance testing must validate electromagnetic compatibility 
and electrical, mechanical, and thermal safety.
    (3) The technical parameters of the device, including waveform 
outputs and temperature limits, must be identified.
    (4) Cleaning validation of earpieces must be conducted.
    (5) Software verification, validation, and hazard analysis must be 
performed.
    (6) Labeling must include the following:
    (i) Information on how the device operates and the typical 
sensations experienced during treatment;
    (ii) A detailed summary of the device's technical parameters; and
    (iii) Instructions for maintenance and cleaning of the device.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22842 Filed 10-18-18; 8:45 am]
 BILLING CODE 4164-01-P

52972 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations

impurities, physical characteristics, and I. Background Under the second procedure, rather
reactivity with fluids. than first submitting a 510(k) and then
Upon request, FDA has classified the a request for classification, if the person
(ii) Performance testing must
thermal vestibular stimulator for determines that there is no legally
demonstrate the mechanical integrity
headache as class II (special controls), marketed device upon which to base a
and functionality of the system used to
which we have determined will provide determination of substantial
deliver the device and demonstrate the
a reasonable assurance of safety and equivalence, that person requests a
device meets established specifications,
effectiveness. In addition, we believe classification under section 513(f)(2) of
including output pressure for
this action will enhance patients’ access the FD&C Act.
propellant-based systems.
to beneficial innovation, in part by Under either procedure for De Novo
(6) Labeling must include: reducing regulatory burdens by placing
(i) Information identifying and classification, FDA is required to
the device into a lower device class than classify the device by written order
explaining how to use the device and its the automatic class III assignment.
components; and within 120 days. The classification will
The automatic assignment of class III be according to the criteria under
(ii) A shelf life. occurs by operation of law and without section 513(a)(1) of the FD&C Act.
Dated: October 15, 2018. any action by FDA, regardless of the Although the device was automatically
Leslie Kux, level of risk posed by the new device. placed within class III, the De Novo
Associate Commissioner for Policy. Any device that was not in commercial classification is considered to be the
[FR Doc. 2018–22784 Filed 10–18–18; 8:45 am] distribution before May 28, 1976, is initial classification of the device.
BILLING CODE 4164–01–P automatically classified as, and remains We believe this De Novo classification
within, class III and requires premarket will enhance patients’ access to
approval unless and until FDA takes an beneficial innovation, in part by
DEPARTMENT OF HEALTH AND action to classify or reclassify the device reducing regulatory burdens. When FDA
HUMAN SERVICES (see 21 U.S.C. 360c(f)(1)). We refer to classifies a device into class I or II via
these devices as ‘‘postamendments the De Novo process, the device can
Food and Drug Administration devices’’ because they were not in serve as a predicate for future devices of
commercial distribution prior to the that type, including for 510(k)s (see 21
21 CFR Part 882 date of enactment of the Medical Device U.S.C. 360c(f)(2)(B)(i)). As a result, other
Amendments of 1976, which amended device sponsors do not have to submit
[Docket No. FDA–2018–N–3690] the Federal Food, Drug, and Cosmetic a De Novo request or premarket
Act (FD&C Act). application to market a substantially
Medical Devices; Neurological FDA may take a variety of actions in equivalent device (see 21 U.S.C. 360c(i),
Devices; Classification of the Thermal appropriate circumstances to classify or defining ‘‘substantial equivalence’’).
Vestibular Stimulator for Headache reclassify a device into class I or II. We Instead, sponsors can use the less-
may issue an order finding a new device burdensome 510(k) process, when
AGENCY: Food and Drug Administration, necessary, to market their device.
HHS. to be substantially equivalent under
section 513(i) of the FD&C Act (21 II. De Novo Classification
ACTION: Final order. U.S.C. 360c(i)) to a predicate device that
On April 18, 2017, Scion NeuroStim,
does not require premarket approval.
SUMMARY: The Food and Drug LLC submitted a request for De Novo
We determine whether a new device is
Administration (FDA or we) is classification of the
substantially equivalent to a predicate
classifying the thermal vestibular ThermoNeuroModulation Device. FDA
by means of the procedures for
stimulator for headache into class II reviewed the request in order to classify
premarket notification under section
(special controls). The special controls the device under the criteria for
510(k) of the FD&C Act (21 U.S.C.
that apply to the device type are classification set forth in section
360(k)) and part 807 (21 CFR part 807).
identified in this order and will be part 513(a)(1) of the FD&C Act.
of the codified language for the thermal FDA may also classify a device We classify devices into class II if
vestibular stimulator for headache’s through ‘‘De Novo’’ classification, a general controls by themselves are
classification. We are taking this action common name for the process insufficient to provide reasonable
because we have determined that authorized under section 513(f)(2) of the assurance of safety and effectiveness,
classifying the device into class II FD&C Act. Section 207 of the Food and but there is sufficient information to
(special controls) will provide a Drug Administration Modernization Act establish special controls that, in
reasonable assurance of safety and of 1997 (Pub. L. 105–115) established combination with the general controls,
effectiveness of the device. We believe the first procedure for De Novo provide reasonable assurance of the
this action will also enhance patients’ classification. Section 607 of the Food safety and effectiveness of the device for
access to beneficial innovative devices, and Drug Administration Safety and its intended use (see 21 U.S.C.
in part by reducing regulatory burdens. Innovation Act (Pub. L. 112–144) 360c(a)(1)(B)). After review of the
modified the De Novo application information submitted in the request,
DATES: This order is effective October
process by adding a second procedure. we determined that the device can be
19, 2018. The classification was A device sponsor may utilize either
applicable on March 26, 2018. classified into class II with the
procedure for De Novo classification. establishment of special controls. FDA
FOR FURTHER INFORMATION CONTACT: Under the first procedure, the person has determined that these special
Stacie Gutowski, Center for Devices and submits a 510(k) for a device that has controls, in addition to the general
amozie on DSK3GDR082PROD with RULES

Radiological Health, Food and Drug not previously been classified. After controls, will provide reasonable
Administration, 10903 New Hampshire receiving an order from FDA classifying assurance of the safety and effectiveness
Ave., Bldg. 66, Rm. 2656, Silver Spring, the device into class III under section of the device.
MD 20993–0002, 240–402–6032, 513(f)(1) of the FD&C Act, the person Therefore, on March 26, 2018, FDA
Stacie.Gutowski@fda.hhs.gov. then requests a classification under issued an order to the requester
SUPPLEMENTARY INFORMATION: section 513(f)(2). classifying the device into class II. FDA

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Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Rules and Regulations 52973

is codifying the classification of the prescription device used to stimulate FDA has identified the following risks
device by adding 21 CFR 882.5893. We the vestibular system by applying to health associated specifically with
have named the generic type of device thermal waveforms through earpieces this type of device and the measures
thermal vestibular stimulator for placed in a patient’s ear canal for the required to mitigate these risks in table
headache, and it is identified as a treatment of headache. 1.

TABLE 1—THERMAL VESTIBULAR STIMULATOR FOR HEADACHE RISKS AND MITIGATION MEASURES
Identified risks Mitigation measures

Adverse tissue reaction ............................. Biocompatibility evaluation, Cleaning validation, and Labeling.
Thermal injury ............................................ Labeling, Non-clinical performance testing, Thermal safety testing, Technical specifications, and
Software verification, validation, and hazard analysis.
Ear tenderness and/or pruritus .................. Labeling, Non-clinical performance testing, and Thermal safety testing.
Nausea and/or dizziness ........................... Labeling, Non-clinical performance testing, and Software verification, validation, and hazard anal-
ysis.
Tinnitus ...................................................... Labeling, Non-clinical performance testing, and Software verification, validation, and hazard anal-
ysis.

FDA has determined that special number 0910–0844; the collections of (1) The patient-contacting
controls, in combination with the information in 21 CFR part 814, components of the device must be
general controls, address these risks to subparts A through E, regarding demonstrated to be biocompatible.
health and provide reasonable assurance premarket approval, have been (2) Performance testing must validate
of safety and effectiveness. For a device approved under OMB control number electromagnetic compatibility and
to fall within this classification, and 0910–0231; the collections of electrical, mechanical, and thermal
thus avoid automatic classification in information in 21 CFR part 820, safety.
class III, it would have to comply with regarding quality system regulations, (3) The technical parameters of the
the special controls named in this final have been approved under OMB control device, including waveform outputs and
order. The necessary special controls number 0910–0073; the collections of temperature limits, must be identified.
appear in the regulation codified by this information in part 807, subpart E, (4) Cleaning validation of earpieces
order. This device is subject to regarding premarket notification must be conducted.
premarket notification requirements submissions, have been approved under (5) Software verification, validation,
under section 510(k) of the FD&C Act. OMB control number 0910–0120; and and hazard analysis must be performed.
At the time of classification, thermal the collections of information in 21 CFR (6) Labeling must include the
vestibular stimulators for headache are part 801, regarding labeling, have been following:
for prescription use only. Prescription approved under OMB control number (i) Information on how the device
devices are exempt from the 0910–0485. operates and the typical sensations
requirement for adequate directions for experienced during treatment;
use for the layperson under section List of Subjects in 21 CFR Part 882
(ii) A detailed summary of the
502(f)(1) of the FD&C Act (21 U.S.C. Medical devices. device’s technical parameters; and
352(f)(1)) and 21 CFR 801.5, as long as (iii) Instructions for maintenance and
the conditions of 21 CFR 801.109 are Therefore, under the Federal Food, cleaning of the device.
met (referring to 21 U.S.C. 352(f)(1)). Drug, and Cosmetic Act and under
authority delegated to the Commissioner Dated: October 16, 2018.
III. Analysis of Environmental Impact of Food and Drugs, part 882 is amended Leslie Kux,
We have determined under 21 CFR as follows: Associate Commissioner for Policy.
25.34(b) that this action is of a type that [FR Doc. 2018–22842 Filed 10–18–18; 8:45 am]
does not individually or cumulatively PART 882—NEUROLOGICAL DEVICES BILLING CODE 4164–01–P
have a significant effect on the human
environment. Therefore, neither an ■ 1. The authority citation for part 882
environmental assessment nor an continues to read as follows: DEPARTMENT OF HEALTH AND
environmental impact statement is Authority: 21 U.S.C. 351, 360, 360c, 360e, HUMAN SERVICES
required. 360j, 360l, 371.
Food and Drug Administration
IV. Paperwork Reduction Act of 1995 ■ 2. Add § 882.5893 to subpart F to read
This final order establishes special as follows: 21 CFR Part 886
controls that refer to previously
§ 882.5893 Thermal vestibular stimulator [Docket No. FDA–2018–N–3634]
approved collections of information for headache.
found in other FDA regulations and
(a) Identification. The thermal Medical Devices; Ophthalmic Devices;
guidance. These collections of
vestibular stimulator for headache is a Classification of the Intranasal
information are subject to review by the
prescription device used to stimulate Electrostimulation Device for Dry Eye
Office of Management and Budget
the vestibular system by applying Symptoms
(OMB) under the Paperwork Reduction
amozie on DSK3GDR082PROD with RULES

Act of 1995 (44 U.S.C. 3501–3520). The thermal waveforms through earpieces AGENCY: Food and Drug Administration,
collections of information in the placed in a patient’s ear canal for the HHS.
guidance document ‘‘De Novo treatment of headache.
ACTION: Final order.
Classification Process (Evaluation of (b) Classification. Class II (special
Automatic Class III Designation)’’ have controls). The special controls for this SUMMARY: The Food and Drug
been approved under OMB control device are: Administration (FDA or we) is

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Document Created: 2018-10-19 01:25:15
Document Modified: 2018-10-19 01:25:15

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective October 19, 2018. The classification was applicable on March 26, 2018.
Contact		Stacie Gutowski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 240- 402-6032, [email protected]
FR Citation		83 FR 52972

83 FR 52972 - Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 203 (October 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration