[Federal Register Volume 76, Number 139 (Wednesday, July 20, 2011)]
[Rules and Regulations]
[Pages 43119-43121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18278]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2011-N-0499]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Focused Ultrasound Stimulator System for 
Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
focused ultrasound stimulator system for aesthetic use into class II 
(special controls). The special control(s) that will apply to the 
device is the guidance document entitled ``Class II Special Controls 
Guidance Document: Focused Ultrasound Stimulator System for Aesthetic 
Use.'' 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 rule is effective August 19, 2011. The classification was 
effective on September 11, 2009.

FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1436, Silver Spring, MD 20993-0002, 301-796-6392.

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 of the regulations (21 CFR part 807).
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device into class III 
under section 513(f)(1) of the FD&C Act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the FD&C 
Act. FDA will, within 60 days of receiving this request, classify the 
device by written order. This classification will be the initial 
classification of the device. Within 30 days after the issuance of an 
order classifying the device, FDA must publish a notice in the Federal 
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on March 14, 2008 classifying the Ulthera\TM\ Focused Ultrasound 
Stimulator System for Aesthetic Use 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 April 11, 2008, Ulthera, Inc. submitted a 
petition requesting classification of the Ulthera\TM\ Focused 
Ultrasound Stimulator System for Aesthetic Use under section 513(f)(2) 
of the FD&C Act. The manufacturer recommended that the device be 
classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. 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 petition, FDA determined that the device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls will provide reasonable 
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name Focused Ultrasound 
Stimulator System for Aesthetic Use and it is identified as a device 
using focused ultrasound to produce localized, mechanical motion within 
tissues and cells for the purpose of producing either localized heating 
for tissue coagulation or for mechanical cellular membrane disruption 
intended for noninvasive aesthetic use.
    FDA has identified the following risks to health associated 
specifically with this type of device and the recommended measures to 
mitigate these risks.
     Thermal injury from focused ultrasound exposure (thermal 
damage), such as erythema, edema, pigmentary changes, and pain. These 
are commonly seen risks associated with any energy delivery system that 
creates tissue heating. This risk is addressed by recommended treatment 
parameters that have been shown to be safe with little or no adverse 
effects. In addition, the recommended labeling includes warnings 
related to patient reaction in terms of pain and information to user in 
terms of observable skin reactions that are known to be precursors to 
the potential thermal adverse effects.
     Mechanical injury from focused ultrasound exposure 
(mechanical damage) induced by either cavitation or noncavitation 
means. Notable effects are pain and petechial hemorrhage (red spots). 
Further, skin contour changes due to scar formation are possible. This 
risk is addressed by recommended treatment parameters that have been 
shown to be safe with little or no adverse effects.
     Ocular injury represents a potentially unique serious risk 
from inadvertent ultrasound exposure. The mitigation of this risk is 
addressed by labeling recommendations to warn the user not to expose 
the eye to ultrasound radiation, as well as specific directions 
intended to ensure complete handpiece skin contact, which further 
reduces the risk of scattered ultrasound energy reaching the eye.
     Electrical shock is addressed by recommended testing of 
the device according to recognized U.S. and International Standards 
specifically designed to determine and measure potential electrical 
safety. Again, the recommended device labeling also includes specific 
warnings for the user in terms of device placement, appropriate 
electrical wiring needs, reminders to periodically check device wiring 
and accessories for damage, and avoidance of use of the device in

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environments where electrical shock is possible.
     Inflammation/foreign body response relates to possible 
issues that can occur following any type of therapeutic process in 
which tissue injury could occur. This risk is typical for any surgical 
procedure and is addressed by the recommendations to follow routine 
standard of care for any surgical patient that could include 
posttreatment skin care including use of moisturizers, antibacterial 
creams, and avoidance of potential risks such as use of perfumes, 
facial creams, and sunlight.
     Use error represents those risks to the patient that can 
occur from improper use of the device. In order to address this 
potential risk, we recommend the manufacturer provide a detailed 
operator manual which contains information on possible risks and 
hazards and how these should be avoided and clear recommended safe 
treatment procedures that include information on device settings for 
treatment, clear information on how the device is to be used during 
treatment, and recommended posttreatment care.

            Table 1--Risks to Health and Mitigation Measures
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            Identified risk              Recommended mitigation measures
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Thermal Injury from Focused Ultrasound   Section 6. Bench Testing.
 Exposure (Thermal Damage).              Section 7: Software Validation.
                                         Section 8. Animal Testing.
                                         Section 9. Clinical Testing.
                                         Section 13. Labeling.
Mechanical Injury from Focused           Section 6. Bench Testing.
 Ultrasound Exposure (Cavitation or      Section 7. Software Validation.
 other Mechanical Damage).               Section 8. Animal Testing.
                                         Section 9. Clinical Testing.
                                         Section 13. Labeling.
Ocular Injury..........................  Section 13. Labeling.
Electrical Shock.......................  Section 12. Electrical and
                                          Mechanical Safety Performance
                                          Testing.
Inflammation/Foreign Body Response.....  Section 10. Biocompatibility.
Use Error (Eye Injury).................  Section 13. Labeling.
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    FDA believes that the special controls guidance document, ``Class 
II Special Controls Guidance Document: Focused Ultrasound Stimulator 
System for Aesthetic Use,'' in addition to general controls, addresses 
the risks to health and provides reasonable assurance of the safety and 
effectiveness of the device. Therefore, on September 11, 2009, FDA 
issued an order to the petitioner classifying the device into class II. 
FDA is codifying the classification of the device by adding Sec.  
878.4590.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for focused ultrasound 
stimulator system for aesthetic use will need to address the issues 
covered in the special controls guidance. However, the firm need only 
show that its device meets the recommendations of the guidance or in 
some other way provides equivalent assurance of safety and 
effectiveness.
    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 focused ultrasound stimulator 
system for aesthetic use they intend to market.
    Elsewhere in this issue of the Federal Register, FDA is issuing a 
notice announcing the availability of the guidance document entitled 
``Class II Special Controls Guidance Document: Focused Ultrasound 
Stimulator System for Aesthetic Use'' that will serve as the special 
control for this device.

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. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of this device from class 
III to class II will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements of section 515 of 
the FD&C Act (21 U.S.C. 360e), and may permit small potential 
competitors to enter the marketplace by lowering their costs, the 
Agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross

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Domestic Product. FDA does not expect this final rule to result in any 
1-year expenditure that would meet or exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain state requirements ``different from or in 
addition to'' certain federal requirements applicable to devices. 21 
U.S.C. 360k; See Medtronic Inc., v. Lohr, 518 U.S. 470 (1996); and 
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The special controls 
established by this final rule create ``requirements'' for specific 
medical devices under 21 U.S.C. 360k, even though product sponsors have 
some flexibility in how they meet those requirements. Cf. Papike v. 
Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1991).

V. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520) is not required. This final rule establishes as special 
controls a guidance document that refers to previously approved 
collections of information found in other FDA regulations. These 
collections of information are subject to review by OMB under the PRA.

VI. References

    The following reference has 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.
    1. Petition from Ulthera, Inc., April 11, 2008.

List of Subjects in 21 CFR Part 878

    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 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

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


0
2. Section 878.4590 is added to subpart E to read as follows:


Sec.  878.4590  Focused ultrasound stimulator system for aesthetic use.

    (a) Identification. A Focused Ultrasound Stimulator System for 
Aesthetic Use is a device using focused ultrasound to produce 
localized, mechanical motion within tissues and cells for the purpose 
of producing either localized heating for tissue coagulation or for 
mechanical cellular membrane disruption intended for noninvasive 
aesthetic use.
    (b) Classification. Class II (special controls). The special 
control for this device is FDA's ``Class II Special Controls Guidance 
Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' See 
Sec.  878.1(e) for the availability of this guidance document.

    Dated: July 15, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18278 Filed 7-19-11; 8:45 am]
BILLING CODE 4160-01-P