
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35842-35843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2015-N-1297]


Medical Devices; Gastroenterology-Urology Devices; Classification 
of the Vibrator for Climax Control of Premature Ejaculation; 
Republication

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order; republication.

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SUMMARY: The Food and Drug Administration (FDA) is republishing in its 
entirety a final order entitled ``Medical Devices; Gastroenterology-
Urology Devices; Classification of the Vibrator for Climax Control of 
Premature Ejaculation'' that published in the Federal Register on May 
28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent 
omission of information. FDA is classifying the vibrator for climax 
control of premature ejaculation 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 classification 
of the vibrator for climax control of premature ejaculation. 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 June 23, 2015. The classification was 
applicable on March 20, 2015.

FOR FURTHER INFORMATION CONTACT: Tuan Nguyen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G118, Silver Spring, MD 20993-0002, 301-796-5174, 
tuan.nguyen@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to 
classify a device under the criteria set forth in section 513(a)(1). 
Under the first procedure, the person submits a premarket notification 
under section 510(k) of the FD&C Act for a device that has not 
previously been classified and, within 30 days of receiving an order 
classifying the device into class III under section 513(f)(1) of the 
FD&C Act, the person requests a classification under section 513(f)(2). 
Under the 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 
November 21, 2013, Auris Medtech Europe, Ltd., submitted a request for 
classification of the ProlongTM under section 513(f)(2) of 
the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1). On June 17, 2014, the request for 
classification of ProlongTM was transferred from Auris 
Medtech Europe, Ltd., to Ergon Medical, Ltd., through an amendment to 
the request (Ref. 2).
    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 March 20, 2015, 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 876.5025.
    Following the effective date of this final classification order, 
any firm submitting a premarket notification (510(k)) for a vibrator 
for climax control of premature ejaculation will need to comply with 
the special controls named in this final order. The device is assigned 
the generic name vibrator for climax control of premature ejaculation, 
and it is identified as a device used for males who suffer from 
premature ejaculation. It is designed to increase the time between 
arousal and ejaculation using the stimulating vibratory effects of the 
device on the penis.
    FDA has identified the following risks to health associated 
specifically with this type of device, as well as the measures required 
to mitigate these risks in table 1.

[[Page 35843]]



 Table 1--Vibrator for Climax Control of Premature Ejaculation Risks and
                           Mitigation Measures
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            Identified risk                    Mitigation measures
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Pain or Discomfort due to Misuse of      Labeling.
 Device.
Burns..................................  Electrical and Thermal Safety
                                          Testing Labeling.
Electrical Shock.......................  Electrical Safety Testing
                                          Labeling.
Adverse Skin Reactions.................  Biocompatibility Testing.
Patient Injury due to Device Breakage    Mechanical Safety Testing
 or Failure.                              Labeling.
Interference With Other Devices/         Electromagnetic Compatibility
 Electrical Equipment.                    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:
     The labeling must include specific instructions regarding 
the proper placement and use of the device.
     The portions of the device that contact the patient must 
be demonstrated to be biocompatible.
     Appropriate analysis/testing must demonstrate 
electromagnetic compatibility safety, electrical safety, and thermal 
safety of the device.
     Mechanical safety testing must demonstrate that the device 
will withstand forces encountered during use.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act, if FDA determines that premarket notification 
is not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the vibrator for climax control of 
premature ejaculation 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. DEN130047: De Novo Request per 513(f)(2) from Auris Medtech 
Europe Ltd., dated November 21, 2013.
    2. Amendment to De Novo Request from Auris Medtech Europe Ltd., 
dated June 17, 2014.

List of Subjects in 21 CFR Part 876

    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 
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR part 876 continues to read as 
follows:

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

0
2. Republish Sec.  876.5025 to read as follows:


Sec.  876.5025  Vibrator for climax control of premature ejaculation.

    (a) Identification. A vibrator for climax control of premature 
ejaculation is used for males who suffer from premature ejaculation. It 
is designed to increase the time between arousal and ejaculation using 
the stimulating vibratory effects of the device on the penis.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The labeling must include specific instructions regarding the 
proper placement and use of the device.
    (2) The portions of the device that contact the patient must be 
demonstrated to be biocompatible.
    (3) Appropriate analysis/testing must demonstrate electromagnetic 
compatibility safety, electrical safety, and thermal safety of the 
device.
    (4) Mechanical safety testing must demonstrate that the device will 
withstand forces encountered during use.

    Dated: June 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15328 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P


