[Federal Register Volume 70, Number 214 (Monday, November 7, 2005)]
[Rules and Regulations]
[Pages 67353-67355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 2005P-0366]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Low Energy Ultrasound Wound Cleaner

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the low 
energy ultrasound wound cleaner into class II (special controls). The 
special control that will apply to the device is the guidance document 
entitled ``Class II Special Controls Guidance Document: Low Energy 
Ultrasound Wound Cleaner.'' The agency is taking this action in 
response to a petition submitted under the Federal Food, Drug, and 
Cosmetic Act (the act) as amended by the Medical Device Amendments of 
1976, the Safe Medical Devices Act of 1990, and the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). The agency is 
classifying this device into class II (special controls) in order to 
provide a reasonable assurance of safety and effectiveness of the 
device. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of the guidance document that will serve as 
the special control for the class II device.

DATES: This rule is effective December 7, 2005. The reclassification 
was effective June 25, 2004.

FOR FURTHER INFORMATION CONTACT: David B. Berkowitz, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 152.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the 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 (the amendments), 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

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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 act, 
to a predicate device that does not require premarket approval. The 
agency determines whether new devices are substantially equivalent to 
previously marketed devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall 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 
such classification.
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on April 8, 2004, classifying the Celleration MIST Therapy 
System\TM\ in 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 that was subsequently reclassified into class I or class II. 
On April 29, 2004, Celleration, Inc., submitted a petition requesting 
classification of the Celleration MIST Therapy System\TM\ under section 
513(f)(2) of the act. The manufacturer recommended that the device be 
classified into class II.
    In accordance with 513(f)(2) of the act, FDA reviewed the petition 
in order to classify the device under the criteria for classification 
set forth in 513(a)(1) of the act. Devices are to be classified 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 has determined that the low energy ultrasound wound 
cleaner intended for the cleaning and maintenance debridement of wounds 
can be classified in class II with the establishment of special 
controls. FDA believes that class II special controls provide 
reasonable assurance of the safety and effectiveness of the device.
    The device is assigned the generic name ``Low energy ultrasound 
wound cleaner,'' and it is identified as a device that uses ultrasound 
energy to vaporize a solution and generate a mist that is used for the 
cleaning and maintenance debridement of wounds. Low levels of 
ultrasound energy may be carried to the wound by the saline mist.
    The potential risks to health associated with the device are: 
Delayed wound healing, thermal damage, inflammation/foreign body 
response, infection, and electrical shock. The special control guidance 
document entitled ``Class II Special Controls Guidance Document: Low 
Energy Ultrasound Wound Cleaner'' aids in mitigating the risk by 
recommending performance characteristics, safety testing, and 
appropriate labeling.
    Thus, in addition to the general controls of the act, a low energy 
ultrasound wound cleaner is subject to the special controls guidance 
document. FDA believes that following the class II special controls 
guidance document generally addresses the risks to health identified in 
the previous paragraph of this document. Therefore, on June 25, 2004, 
FDA issued an order to the petitioner classifying the device as 
described previously into class II and is codifying this device by 
adding Sec.  878.4410.
    Following the effective date of this final rule classifying the 
device, any firm submitting a 510(k) premarket notification for the 
device will need to address the issues covered in the special controls 
guidance. However, the firm would need to show only that its device 
meets the recommendations of the guidance, or in some other way 
provides equivalent assurances of safety and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements under section 
510(k) of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of this type of device and, therefore, the type of 
device is not exempt from premarket notification requirements. Thus, 
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 low energy ultrasound wound cleaner that 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. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs 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 under the 
Executive order.
    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 these devices 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 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 $115 million, using the most current (2003) Implicit 
Price Deflator for the Gross 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. FDA has

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determined that the rule does not contain policies that have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, the agency has concluded that the rule does not contain 
policies that have federalism implications as defined in the Executive 
order and, consequently, a federalism summary impact statement is not 
required.

V. Paperwork Reduction Act of 1995

    FDA concludes that this rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520) is not required.
    FDA also concludes that the special controls guidance document does 
not contain new information collection provisions that are subject to 
review and clearance by OMB under the PRA. Elsewhere in this issue of 
the Federal Register, FDA is publishing a notice announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.''

List of Subjects in 21 CFR Part 878

    Medical devices.

0
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 878.4410 is added to subpart E to read as follows:


Sec.  878.4410  Low energy ultrasound wound cleaner.

    (a) Identification. A low energy ultrasound wound cleaner is a 
device that uses ultrasound energy to vaporize a solution and generate 
a mist that is used for the cleaning and maintenance debridement of 
wounds. Low levels of ultrasound energy may be carried to the wound by 
the saline mist.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Low Energy Ultrasound Wound Cleaner.'' See Sec.  
878.1(e) for the availability of this guidance document.

    Dated: September 28, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22068 Filed 11-4-05; 8:45 am]
BILLING CODE 4160-01-S