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[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Rules and Regulations]
[Pages 15163-15165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, [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

[[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
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            Identified risk                                         Mitigation measure
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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
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