80 FR 15163 - Medical Devices; Neurological Devices; Classification of the Limited Output Transcutaneous Piezoelectric Stimulator for Skin Reactions Associated With Insect Bites

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 55 (March 23, 2015)

Page Range		15163-15165
FR Document		2015-06499

The Food and Drug Administration (FDA) is classifying the limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites 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 limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites' 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 80 Issue 55 (Monday, March 23, 2015)

[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Rules and Regulations]
[Pages 15163-15165]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06499]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2015-M-0619]


Medical Devices; Neurological Devices; Classification of the 
Limited Output Transcutaneous Piezoelectric Stimulator for Skin 
Reactions Associated With Insect Bites

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
limited output transcutaneous piezoelectric stimulator for skin 
reactions associated with insect bites 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 limited output transcutaneous piezoelectric stimulator for skin 
reactions associated with insect bites' 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 23, 2015. The classification was 
applicable on November 7, 2014.

FOR FURTHER INFORMATION CONTACT: Michael Hoffman, 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.hoffman@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

[[Page 15164]]

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 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 September 8, 2010, Ecobrands, Ltd., submitted a request for 
classification of the Zap-It! under section 513(f)(2) of the FD&C Act. 
Subsequently, on February 14, 2013, Tecnimed S.r.l., submitted a 
similar request for classification of the Zanza-Click, Mini-Click, and 
Disc-o-Click under section 513(f)(2) of the FD&C Act. Both 
manufacturers recommended that the devices be classified into class II 
(Refs. 1 and 2).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the requests in order to classify the devices 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 
requests, FDA determined that the devices 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 devices.
    Therefore, on November 7, 2014, FDA issued orders to both 
requestors classifying the devices into class II. FDA is codifying the 
classification of the devices by adding 21 CFR 882.5894.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a limited 
output transcutaneous piezoelectric stimulator for skin reactions 
associated with insect bites will need to comply with the special 
controls named in this final order. The device is assigned the generic 
name limited output transcutaneous piezoelectric stimulator for skin 
reactions associated with insect bites, and it is identified as a 
device intended to alleviate skin reactions associated with insect 
bites via cutaneous, piezoelectric stimulation at the local site of the 
bite.
    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--Limited Output Transcutaneous Piezoelectric Stimulator for Skin Reactions Associated With Insect Bites
                                          Risks and Mitigation Measures
----------------------------------------------------------------------------------------------------------------
            Identified risk                                         Mitigation measure
----------------------------------------------------------------------------------------------------------------
Cutaneous burns........................  Characterization of Electrical Output Labeling.
Adverse skin reactions.................  Biocompatibility Assessment.
Damage to sensitive tissue (e.g., eyes,  Labeling.
 lips, inside mouth, open wounds).
Infection..............................  Labeling.
Burns and other injuries due to          Labeling.
 ignition of flammable substances which
 may be used in the same intended use
 environment (e.g., insect repellent).
Interference with implanted devices and  Labeling.
 other patient care devices.
Failure to identify correct population   Labeling.
 and condition.
Device failure.........................  Non-clinical (Bench) 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:
     Appropriate testing to characterize the electrical output 
specifications of the device (i.e., total charge delivered, maximum 
instantaneous output current, maximum instantaneous output voltage, 
pulse duration, charge density) must be conducted.
     Mechanical bench testing must demonstrate that the device 
will withstand the labeled number duration of uses.
     All elements of the device that may contact the patient 
must be assessed to be biocompatible.
     Labeling must include:
    [cir] Validated instructions which addresses the following:
    [ssquf] Identification of areas of the body which are appropriate 
and not appropriate for contact with the device;
    [ssquf] whether use of the device in conjunction with flammable 
materials (e.g., insect repellent) is appropriate;
    [ssquf] use of the device on or near implanted devices; and
    [ssquf] how to identify the correct type of skin condition.
    [cir] Technical parameters of the device (maximum output voltage 
(instantaneous), maximum output current (instantaneous), and pulse 
duration).
    [cir] Language to direct end users to contact the device 
manufacturer and

[[Page 15165]]

MedWatch if they experience any adverse events with this device.
    [cir] The anticipated number of device uses prior to failure.
    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 not necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is exempt from premarket notification 
requirements. Persons who intend to market this type of device need not 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the limited output transcutaneous 
piezoelectric stimulator for skin reactions associated with insect 
bites 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 
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. References

    The following references have 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 are available electronically at http://www.regulations.gov.

1. DEN100024: De Novo Request per 513(f)(2) from Ecobrands, Ltd., 
dated September 8, 2010.
2. DEN130019: De Novo Request per 513(f)(2) from Tecnimed S.r.l., 
dated February 14, 2013.

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, 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.  882.5894 to subpart F to read as follows:


Sec.  882.5894  Limited output transcutaneous piezoelectric stimulator 
for skin reactions associated with insect bites.

    (a) Identification. A limited output transcutaneous piezoelectric 
stimulator for skin reactions associated with insect bites is a device 
intended to alleviate skin reactions associated with insect bites via 
cutaneous, piezoelectric stimulation at the local site of the bite.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Appropriate testing to characterize the electrical output 
specifications of the device (i.e., total charge delivered, maximum 
instantaneous output current, maximum instantaneous output voltage, 
pulse duration, charge density) must be conducted.
    (2) Mechanical bench testing must demonstrate that the device will 
withstand the labeled number duration of uses.
    (3) All elements of the device that may contact the patient must be 
assessed to be biocompatible.
    (4) Labeling must include:
    (i) Validated instructions which addresses the following:
    (A) Identification of areas of the body which are appropriate and 
not appropriate for contact with the device.
    (B) Whether use of the device in conjunction with flammable 
materials (e.g., insect repellent) is appropriate.
    (C) Use of the device on or near implanted devices.
    (D) How to identify the correct type of skin condition.
    (ii) Technical parameters of the device (maximum output voltage 
(instantaneous), maximum output current (instantaneous), and pulse 
duration).
    (iii) Language to direct end users to contact the device 
manufacturer and MedWatch if they experience any adverse events with 
this device.
    (iv) The anticipated number of device uses prior to failure.

    Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06499 Filed 3-20-15; 8:45 am]
 BILLING CODE 4164-01-P

15164 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations

whether new devices are substantially that could provide a reasonable basis for safety and effectiveness of the device for
equivalent to predicate devices by review of substantial equivalence with its intended use. After review of the
means of premarket notification the device or if FDA determines that the information submitted in the requests,
procedures in section 510(k) of the device submitted is not of ‘‘low- FDA determined that the devices can be
FD&C Act (21 U.S.C. 360(k)) and part moderate risk’’ or that general controls classified into class II with the
807 (21 CFR part 807) of the regulations. would be inadequate to control the risks establishment of special controls. FDA
Section 513(f)(2) of the FD&C Act, as and special controls to mitigate the risks believes these special controls, in
amended by section 607 of the Food and cannot be developed. addition to general controls, will
Drug Administration Safety and In response to a request to classify a provide reasonable assurance of the
Innovation Act (Pub. L. 112–144), device under either procedure provided safety and effectiveness of the devices.
provides two procedures by which a by section 513(f)(2) of the FD&C Act, Therefore, on November 7, 2014, FDA
person may request FDA to classify a FDA will classify the device by written issued orders to both requestors
device under the criteria set forth in order within 120 days. This classifying the devices into class II. FDA
section 513(a)(1). Under the first classification will be the initial is codifying the classification of the
procedure, the person submits a classification of the device. devices by adding 21 CFR 882.5894.
premarket notification under section On September 8, 2010, Ecobrands,
510(k) of the FD&C Act for a device that Ltd., submitted a request for Following the effective date of this
has not previously been classified and, classification of the Zap-It! under final classification order, any firm
within 30 days of receiving an order section 513(f)(2) of the FD&C Act. submitting a premarket notification
classifying the device into class III Subsequently, on February 14, 2013, (510(k)) for a limited output
under section 513(f)(1) of the FD&C Act, Tecnimed S.r.l., submitted a similar transcutaneous piezoelectric stimulator
the person requests a classification request for classification of the Zanza- for skin reactions associated with insect
under section 513(f)(2). Under the Click, Mini-Click, and Disc-o-Click bites will need to comply with the
second procedure, rather than first under section 513(f)(2) of the FD&C Act. special controls named in this final
submitting a premarket notification Both manufacturers recommended that order. The device is assigned the generic
under section 510(k) of the FD&C Act the devices be classified into class II name limited output transcutaneous
and then a request for classification (Refs. 1 and 2). piezoelectric stimulator for skin
under the first procedure, the person In accordance with section 513(f)(2) of reactions associated with insect bites,
determines that there is no legally the FD&C Act, FDA reviewed the and it is identified as a device intended
marketed device upon which to base a requests in order to classify the devices to alleviate skin reactions associated
determination of substantial under the criteria for classification set with insect bites via cutaneous,
equivalence and requests a classification forth in section 513(a)(1). FDA classifies piezoelectric stimulation at the local site
under section 513(f)(2) of the FD&C Act. devices into class II if general controls of the bite.
If the person submits a request to by themselves are insufficient to FDA has identified the following risks
classify the device under this second provide reasonable assurance of safety to health associated specifically with
procedure, FDA may decline to and effectiveness, but there is sufficient this type of device, as well as the
undertake the classification request if information to establish special controls mitigation measures required to mitigate
FDA identifies a legally marketed device to provide reasonable assurance of the these risks in table 1.

TABLE 1—LIMITED OUTPUT TRANSCUTANEOUS PIEZOELECTRIC STIMULATOR FOR SKIN REACTIONS ASSOCIATED WITH
INSECT BITES RISKS AND MITIGATION MEASURES
Identified risk Mitigation measure

Cutaneous burns ........................................................................................................................ Characterization of Electrical Output Labeling.
Adverse skin reactions ............................................................................................................... Biocompatibility Assessment.
Damage to sensitive tissue (e.g., eyes, lips, inside mouth, open wounds) ............................... Labeling.
Infection ...................................................................................................................................... Labeling.
Burns and other injuries due to ignition of flammable substances which may be used in the Labeling.
same intended use environment (e.g., insect repellent).
Interference with implanted devices and other patient care devices ......................................... Labeling.
Failure to identify correct population and condition ................................................................... Labeling.
Device failure .............................................................................................................................. Non-clinical (Bench) Testing Labeling.

FDA believes that the following • Mechanical bench testing must D whether use of the device in
special controls, in combination with demonstrate that the device will conjunction with flammable materials
the general controls, address these risks withstand the labeled number duration (e.g., insect repellent) is appropriate;
to health and provide reasonable of uses. D use of the device on or near
assurance of the safety and • All elements of the device that may implanted devices; and
effectiveness: contact the patient must be assessed to D how to identify the correct type of
• Appropriate testing to characterize be biocompatible. skin condition.
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the electrical output specifications of • Labeling must include: Æ Technical parameters of the device
the device (i.e., total charge delivered, (maximum output voltage
Æ Validated instructions which (instantaneous), maximum output
maximum instantaneous output current,
addresses the following: current (instantaneous), and pulse
maximum instantaneous output voltage,
pulse duration, charge density) must be D Identification of areas of the body duration).
conducted. which are appropriate and not Æ Language to direct end users to
appropriate for contact with the device; contact the device manufacturer and

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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 15165

MedWatch if they experience any 1. DEN100024: De Novo Request per 513(f)(2) (iii) Language to direct end users to
adverse events with this device. from Ecobrands, Ltd., dated September 8, contact the device manufacturer and
2010. MedWatch if they experience any
Æ The anticipated number of device 2. DEN130019: De Novo Request per 513(f)(2)
uses prior to failure. adverse events with this device.
from Tecnimed S.r.l., dated February 14,
2013.
(iv) The anticipated number of device
Section 510(m) of the FD&C Act uses prior to failure.
provides that FDA may exempt a class
II device from the premarket notification List of Subjects in 21 CFR Part 882 Dated: March 17, 2015.
requirements under section 510(k) of the Medical devices. Leslie Kux,
FD&C Act, if FDA determines that Therefore, under the Federal Food, Associate Commissioner for Policy.
premarket notification is not necessary Drug, and Cosmetic Act and under [FR Doc. 2015–06499 Filed 3–20–15; 8:45 am]
to provide reasonable assurance of the authority delegated to the Commissioner BILLING CODE 4164–01–P
safety and effectiveness of the device. of Food and Drugs, 21 CFR part 882 is
For this type of device, FDA has amended as follows:
determined that premarket notification DEPARTMENT OF DEFENSE
is not necessary to provide reasonable PART 882—NEUROLOGICAL DEVICES
assurance of the safety and effectiveness Department of the Navy
of the device. Therefore, this device ■ 1. The authority citation for 21 CFR
type is exempt from premarket part 882 continues to read as follows: 32 CFR Part 706
notification requirements. Persons who Authority: 21 U.S.C. 351, 360, 360c, 360e,
intend to market this type of device 360j, 371. Certifications and Exemptions Under
need not submit to FDA a premarket the International Regulations for
■ 2. Add § 882.5894 to subpart F to read Preventing Collisions at Sea, 1972
notification, prior to marketing the
as follows:
device, which contains information AGENCY: Department of the Navy, DoD.
about the limited output transcutaneous § 882.5894 Limited output transcutaneous ACTION: Final rule.
piezoelectric stimulator for skin piezoelectric stimulator for skin reactions
reactions associated with insect bites associated with insect bites. SUMMARY: The Department of the Navy
they intend to market. (a) Identification. A limited output (DoN) is amending its certifications and
II. Environmental Impact transcutaneous piezoelectric stimulator exemptions under the International
for skin reactions associated with insect Regulations for Preventing Collisions at
The Agency has determined under 21 bites is a device intended to alleviate Sea, 1972, as amended (72 COLREGS),
CFR 25.34(b) that this action is of a type skin reactions associated with insect to reflect that the Deputy Assistant
that does not individually or bites via cutaneous, piezoelectric Judge Advocate General
cumulatively have a significant effect on stimulation at the local site of the bite. (DAJAG)(Admiralty and Maritime Law)
the human environment. Therefore, (b) Classification. Class II (special has determined that USS JOHN
neither an environmental assessment controls). The special controls for this WARNER (SSN 785) is a vessel of the
nor an environmental impact statement device are: Navy which, due to its special
is required. (1) Appropriate testing to characterize construction and purpose, cannot fully
the electrical output specifications of comply with certain provisions of the 72
III. Paperwork Reduction Act of 1995 the device (i.e., total charge delivered, COLREGS without interfering with its
This final order establishes special maximum instantaneous output current, special function as a naval ship. The
controls that refer to previously maximum instantaneous output voltage, intended effect of this rule is to warn
approved collections of information pulse duration, charge density) must be mariners in waters where 72 COLREGS
found in other FDA regulations. These conducted. apply.
(2) Mechanical bench testing must DATES: This rule is effective March 23,
collections of information are subject to
demonstrate that the device will 2015 and is applicable beginning
review by the Office of Management and
withstand the labeled number duration January 28, 2015.
Budget (OMB) under the Paperwork
of uses.
Reduction Act of 1995 (44 U.S.C. 3501– FOR FURTHER INFORMATION CONTACT:
(3) All elements of the device that
3520). The collections of information in Commander Theron R. Korsak,
may contact the patient must be
part 807, subpart E, regarding premarket (Admiralty and Maritime Law), Office of
assessed to be biocompatible.
notification submissions have been (4) Labeling must include: the Judge Advocate General, Department
approved under OMB control number (i) Validated instructions which of the Navy, 1322 Patterson Ave. SE.,
0910–0120, and the collections of addresses the following: Suite 3000, Washington Navy Yard, DC
information in 21 CFR part 801, (A) Identification of areas of the body 20374–5066, telephone 202–685–5040.
regarding labeling have been approved which are appropriate and not SUPPLEMENTARY INFORMATION: Pursuant
under OMB control number 0910–0485. appropriate for contact with the device. to the authority granted in 33 U.S.C.
IV. References (B) Whether use of the device in 1605, the DoN amends 32 CFR part 706.
conjunction with flammable materials This amendment provides notice that
The following references have been (e.g., insect repellent) is appropriate. the DAJAG (Admiralty and Maritime
placed on display in the Division of (C) Use of the device on or near Law), under authority delegated by the
Dockets Management (HFA–305), Food implanted devices. Secretary of the Navy, has certified that
mstockstill on DSK4VPTVN1PROD with RULES

and Drug Administration, 5630 Fishers (D) How to identify the correct type of USS JOHN WARNER (SSN 785) is a
Lane, Rm. 1061, Rockville, MD 20852, skin condition. vessel of the Navy which, due to its
and may be seen by interested persons (ii) Technical parameters of the device special construction and purpose,
between 9 a.m. and 4 p.m., Monday (maximum output voltage cannot fully comply with the following
through Friday, and are available (instantaneous), maximum output specific provisions of 72 COLREGS
electronically at http:// current (instantaneous), and pulse without interfering with its special
www.regulations.gov. duration). function as a naval ship: Annex I,

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Document Created: 2018-02-21 09:47:32
Document Modified: 2018-02-21 09:47:32

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 23, 2015. The classification was applicable on November 7, 2014.
Contact		Michael Hoffman, 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, [email protected]
FR Citation		80 FR 15163

80 FR 15163 - Medical Devices; Neurological Devices; Classification of the Limited Output Transcutaneous Piezoelectric Stimulator for Skin Reactions Associated With Insect Bites

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 55 (March 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration