82 FR 13553 - Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 48 (March 14, 2017)

Page Range		13553-13554
FR Document		2017-04939

The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device 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 vibratory counter-stimulation device'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.

Federal Register, Volume 82 Issue 48 (Tuesday, March 14, 2017)

[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)]
[Rules and Regulations]
[Pages 13553-13554]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04939]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2017-N-1123]


Medical Devices; Neurological Devices, Classification of the 
Vibratory Counter-Stimulation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
vibratory counter-stimulation device 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 vibratory 
counter-stimulation device'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 14, 2017. The classification was 
applicable on December 18, 2013.

FOR FURTHER INFORMATION CONTACT: Michael Hoffmann, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301-
796-6476, [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, also known as De Novo 
classification, 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 
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 shall 
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 June 14, 2011, classifying the Symphony 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 July 13, 2011, Sensory Medical, Inc. submitted a request for 
classification of the Symphony Device under section 513(f)(2) of the 
FD&C Act.
    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 December 18, 2013, FDA issued an order to the 
requestor classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 882.5895.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a vibratory 
counter-stimulation device will need to comply with the special 
controls named in this final order. A De Novo classification decreases 
regulatory burdens. When FDA classifies a device type as class I or II 
via the De Novo pathway, other manufacturers do not have to submit a De 
Novo request or PMA in order to market the same type of device, unless 
the device has a new intended use or technological characteristics that 
raise different questions of safety or effectiveness. Instead, 
manufacturers can use the less burdensome pathway of 510(k), when 
necessary, to market their device, and the device that was the subject 
of the original De Novo

[[Page 13554]]

classification can serve as a predicate device for additional 510(k)s 
from other manufacturers.
    The device is assigned the generic name vibratory counter-
stimulation device, and it is identified as a prescription device that 
provides electrically powered mechanical vibration to improve the 
quality of sleep in patients with primary Restless Legs Syndrome.
    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--Vibratory Counter-Stimulation Device Risks and Mitigation
                                Measures
------------------------------------------------------------------------
              Identified risks                    Mitigation measure
------------------------------------------------------------------------
Pain, discomfort, worsening of Restless      Non-clinical testing,
 Legs Syndrome symptoms.                      Software testing,
                                              Labeling.
Electrical shock...........................  Electrical safety testing,
                                              Labeling.
Burns......................................  Electrical and thermal
                                              safety testing, Labeling.
Adverse skin reactions.....................  Biocompatibility
                                              assessment, Labeling.
Interference with other medical devices....  Electromagnetic
                                              compatibility testing,
                                              Labeling.
------------------------------------------------------------------------

    FDA believes that special controls, in combination with the general 
controls, address these risks to health and provide reasonable 
assurance of the safety and effectiveness.
    Vibratory counter-stimulation devices are not safe for use except 
under the supervision of a practitioner licensed by law to direct the 
use of the device. As such, the device is a prescription device and 
must satisfy prescription labeling requirements (see 21 CFR 801.109, 
Prescription devices).
    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), 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 the device is 
not exempt from the premarket notification requirements of the FD&C 
Act. Persons who intend to market this type of device must submit a 
premarket notification (510(k)), prior to marketing the device, which 
contains information on the vibratory counter-stimulation device they 
intend to market.

II. Analysis of 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 
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, 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 part 882 continues to read as follows:

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

0
2. Add Sec.  882.5895 to subpart F to read as follows:


Sec.  882.5895   Vibratory counter-stimulation device.

    (a) Identification. A vibratory counter-stimulation device is a 
prescription device that provides electrically powered mechanical 
vibration to improve the quality of sleep in patients with primary 
Restless Legs Syndrome.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility (EMC), electrical safety, and thermal safety.
    (2) If the device contains software or firmware, appropriate 
verification, validation, and hazard analysis must be performed.
    (3) The elements of the device that contact the patient must be 
assessed to be biocompatible.
    (4) Non-clinical testing data (including vibration frequency, 
amplitude, and acceleration) must demonstrate that the device performs 
as intended under anticipated conditions of use.
    (5) Labeling must include:
    (i) Specific information pertinent to use of the device by the 
intended patient population and the treatment regimen;
    (ii) Warning to only use the device on normal, intact, clean, 
healthy skin;
    (iii) Warning to not use the device if the user has leg skin 
disorders, such as eczema, psoriasis, cellulitis, non-healing wounds;
    (iv) Warning to discontinue use if Restless Leg Syndrome symptoms 
worsen; and
    (v) Instructions for end users to contact the device manufacturer 
and MedWatch in case they experience any adverse events when using this 
device.

    Dated: March 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04939 Filed 3-13-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules and Regulations 13553

reference source shall have sequence I. Background In response to a request to classify a
generated independently of the In accordance with section 513(f)(1) of device under either procedure provided
manufacturer with respect to technology the Federal Food, Drug, and Cosmetic by section 513(f)(2) of the FD&C Act,
and analysis. Percent agreement and Act (the FD&C Act) (21 U.S.C. FDA shall classify the device by written
percent disagreement with the reference 360c(f)(1)), devices that were not in order within 120 days. This
sequences must be described for all commercial distribution before May 28, classification will be the initial
regions queried by the instrument. 1976 (the date of enactment of the classification of the device. In
(C) If applicable, data describing Medical Device Amendments of 1976), accordance with section 513(f)(1) of the
endogenous or exogenous substances generally referred to as postamendments FD&C Act, FDA issued an order on June
that may interfere with the instrument devices, are classified automatically by 14, 2011, classifying the Symphony
system. statute into class III without any FDA Device into class III, because it was not
(D) If applicable, data demonstrating rulemaking process. These devices substantially equivalent to a device that
the ability of the system to consistently remain in class III and require was introduced or delivered for
generate an accurate result for a given premarket approval unless and until the introduction into interstate commerce
sample across different indexing primer device is classified or reclassified into for commercial distribution before May
combinations. class I or II, or FDA issues an order 28, 1976, or a device which was
(ix) The upper and lower limit of subsequently reclassified into class I or
finding the device to be substantially
input nucleic acid that will achieve the class II.
equivalent, in accordance with section
claimed accuracy and reproducibility. On July 13, 2011, Sensory Medical,
513(i) of the FD&C Act, to a predicate
Data supporting such claims must also Inc. submitted a request for
device that does not require premarket classification of the Symphony Device
be summarized.
approval. The Agency determines under section 513(f)(2) of the FD&C Act.
Dated: March 8, 2017. whether new devices are substantially In accordance with section 513(f)(2) of
Leslie Kux, equivalent to predicate devices by the FD&C Act, FDA reviewed the
Associate Commissioner for Policy. means of premarket notification request in order to classify the device
[FR Doc. 2017–04941 Filed 3–13–17; 8:45 am] procedures in section 510(k) of the under the criteria for classification set
BILLING CODE 4164–01–P FD&C Act (21 U.S.C. 360(k)) and part forth in section 513(a)(1). FDA classifies
807 (21 CFR part 807) of the regulations. devices into class II if general controls
Section 513(f)(2) of the FD&C Act, by themselves are insufficient to
DEPARTMENT OF HEALTH AND also known as De Novo classification, as provide reasonable assurance of safety
HUMAN SERVICES amended by section 607 of the Food and and effectiveness, but there is sufficient
Drug Administration Safety and information to establish special controls
Food and Drug Administration Innovation Act (Pub. L. 112–144), to provide reasonable assurance of the
provides two procedures by which a safety and effectiveness of the device for
21 CFR Part 882 person may request FDA to classify a its intended use. After review of the
[Docket No. FDA–2017–N–1123] device under the criteria set forth in information submitted in the request,
section 513(a)(1). Under the first FDA determined that the device can be
Medical Devices; Neurological procedure, the person submits a classified into class II with the
Devices, Classification of the Vibratory premarket notification under section establishment of special controls. FDA
Counter-Stimulation Device 510(k) of the FD&C Act for a device that believes these special controls, in
has not previously been classified and, addition to general controls, will
AGENCY: Food and Drug Administration, within 30 days of receiving an order provide reasonable assurance of the
HHS. classifying the device into class III safety and effectiveness of the device.
ACTION: Final order. under section 513(f)(1) of the FD&C Act, Therefore, on December 18, 2013,
the person requests a classification FDA issued an order to the requestor
SUMMARY: The Food and Drug under section 513(f)(2). Under the
Administration (FDA) is classifying the classifying the device into class II. FDA
second procedure, rather than first is codifying the classification of the
vibratory counter-stimulation device submitting a premarket notification
into class II (special controls). The device by adding 21 CFR 882.5895.
under section 510(k) of the FD&C Act Following the effective date of this
special controls that will apply to the and then a request for classification final classification order, any firm
device are identified in this order and under the first procedure, the person submitting a premarket notification
will be part of the codified language for determines that there is no legally (510(k)) for a vibratory counter-
the vibratory counter-stimulation marketed device upon which to base a stimulation device will need to comply
device’s classification. The Agency is determination of substantial with the special controls named in this
classifying the device into class II equivalence and requests a classification final order. A De Novo classification
(special controls) in order to provide a under section 513(f)(2) of the FD&C Act. decreases regulatory burdens. When
reasonable assurance of safety and If the person submits a request to FDA classifies a device type as class I
effectiveness of the device. classify the device under this second or II via the De Novo pathway, other
DATES: This order is effective March 14, procedure, FDA may decline to manufacturers do not have to submit a
2017. The classification was applicable undertake the classification request if De Novo request or PMA in order to
on December 18, 2013. FDA identifies a legally marketed device market the same type of device, unless
FOR FURTHER INFORMATION CONTACT: that could provide a reasonable basis for the device has a new intended use or
Michael Hoffmann, Center for Devices review of substantial equivalence with technological characteristics that raise
rmajette on DSK30RV082PROD with RULES

and Radiological Health, Food and Drug the device or if FDA determines that the different questions of safety or
Administration, 10903 New Hampshire device submitted is not of ‘‘low- effectiveness. Instead, manufacturers
Ave., Bldg. 66, Rm. 2640, Silver Spring, moderate risk’’ or that general controls can use the less burdensome pathway of
MD 20993–0002, 301–796–6476, would be inadequate to control the risks 510(k), when necessary, to market their
michael.hoffmann@fda.hhs.gov. and special controls to mitigate the risks device, and the device that was the
SUPPLEMENTARY INFORMATION: cannot be developed. subject of the original De Novo

VerDate Sep<11>2014 15:10 Mar 13, 2017 Jkt 241001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1

13554 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Rules and Regulations

classification can serve as a predicate prescription device that provides FDA has identified the following risks
device for additional 510(k)s from other electrically powered mechanical to health associated specifically with
manufacturers. vibration to improve the quality of sleep this type of device and the measures
The device is assigned the generic in patients with primary Restless Legs required to mitigate these risks in table
name vibratory counter-stimulation Syndrome. 1.
device, and it is identified as a

TABLE 1—VIBRATORY COUNTER-STIMULATION DEVICE RISKS AND MITIGATION MEASURES
Identified risks Mitigation measure

Pain, discomfort, worsening of Restless Legs Syndrome symptoms ............................................. Non-clinical testing, Software testing, Labeling.
Electrical shock ................................................................................................................................ Electrical safety testing, Labeling.
Burns ............................................................................................................................................... Electrical and thermal safety testing, Labeling.
Adverse skin reactions .................................................................................................................... Biocompatibility assessment, Labeling.
Interference with other medical devices .......................................................................................... Electromagnetic compatibility testing, Labeling.

FDA believes that special controls, in part 807, subpart E, regarding premarket intended under anticipated conditions
combination with the general controls, notification submissions have been of use.
address these risks to health and approved under OMB control number (5) Labeling must include:
provide reasonable assurance of the 0910–0120, and the collections of (i) Specific information pertinent to
safety and effectiveness. information in 21 CFR part 801, use of the device by the intended
Vibratory counter-stimulation devices regarding labeling have been approved patient population and the treatment
are not safe for use except under the under OMB control number 0910–0485. regimen;
supervision of a practitioner licensed by (ii) Warning to only use the device on
List of Subjects in 21 CFR Part 882 normal, intact, clean, healthy skin;
law to direct the use of the device. As
such, the device is a prescription device Medical devices, Neurological (iii) Warning to not use the device if
and must satisfy prescription labeling devices. the user has leg skin disorders, such as
requirements (see 21 CFR 801.109, Therefore, under the Federal Food, eczema, psoriasis, cellulitis, non-healing
Prescription devices). Drug, and Cosmetic Act and under wounds;
Section 510(m) of the FD&C Act authority delegated to the Commissioner (iv) Warning to discontinue use if
provides that FDA may exempt a class of Food and Drugs, 21 CFR part 882 is Restless Leg Syndrome symptoms
II device from the premarket notification amended as follows: worsen; and
requirements under section 510(k), if (v) Instructions for end users to
FDA determines that premarket PART 882—NEUROLOGICAL DEVICES contact the device manufacturer and
notification is not necessary to provide MedWatch in case they experience any
■ 1. The authority citation for part 882 adverse events when using this device.
reasonable assurance of the safety and continues to read as follows:
effectiveness of the device. For this type Dated: March 8, 2017.
of device, FDA has determined that the Authority: 21 U.S.C. 351, 360, 360c, 360e, Leslie Kux,
360j, 360l, 371.
device is not exempt from the premarket Associate Commissioner for Policy.
notification requirements of the FD&C ■ 2. Add § 882.5895 to subpart F to read
[FR Doc. 2017–04939 Filed 3–13–17; 8:45 am]
Act. Persons who intend to market this as follows:
BILLING CODE 4164–01–P
type of device must submit a premarket § 882.5895 Vibratory counter-stimulation
notification (510(k)), prior to marketing device.
the device, which contains information (a) Identification. A vibratory counter- COURT SERVICES AND OFFENDER
on the vibratory counter-stimulation stimulation device is a prescription SUPERVISION AGENCY FOR THE
device they intend to market. device that provides electrically DISTRICT OF COLUMBIA
II. Analysis of Environmental Impact powered mechanical vibration to
improve the quality of sleep in patients 28 CFR Part 802
The Agency has determined under 21 with primary Restless Legs Syndrome.
CFR 25.34(b) that this action is of a type RIN 3225–AA12
(b) Classification. Class II (special
that does not individually or controls). The special controls for this Revision of Regulations Governing
cumulatively have a significant effect on device are: Freedom of Information Act Requests
the human environment. Therefore, (1) Appropriate analysis/testing must
neither an environmental assessment demonstrate electromagnetic AGENCY: Court Services and Offender
nor an environmental impact statement compatibility (EMC), electrical safety, Supervision Agency for the District of
is required. and thermal safety. Columbia.
III. Paperwork Reduction Act of 1995 (2) If the device contains software or ACTION: Interim final rule.
firmware, appropriate verification,
This final order establishes special validation, and hazard analysis must be SUMMARY: This interim final rule
controls that refer to previously performed. updates and clarifies the procedures for
approved collections of information (3) The elements of the device that submitting Freedom of Information Act
rmajette on DSK30RV082PROD with RULES

found in other FDA regulations. These contact the patient must be assessed to (FOIA) requests as required under the
collections of information are subject to be biocompatible. FOIA Improvement Act of 2016 (the
review by the Office of Management and (4) Non-clinical testing data 2016 Act) which was signed into law by
Budget (OMB) under the Paperwork (including vibration frequency, the President on June 30, 2016. This
Reduction Act of 1995 (44 U.S.C. 3501– amplitude, and acceleration) must rule makes the procedural changes
3520). The collections of information in demonstrate that the device performs as necessitated by the 2016 Act, including

VerDate Sep<11>2014 15:10 Mar 13, 2017 Jkt 241001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\14MRR1.SGM 14MRR1

Document Created: 2017-03-14 02:51:34
Document Modified: 2017-03-14 02:51:34

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 March 14, 2017. The classification was applicable on December 18, 2013.
Contact		Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD 20993-0002, 301- 796-6476, [email protected]
FR Citation		82 FR 13553
CFR Associated		Medical Devices and Neurological Devices

82 FR 13553 - Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 48 (March 14, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration