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###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 878
          - [Docket No. 2005P-0366]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Final rule.

# 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                           ( print page 67354)                        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 SystemTM                     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 SystemTM                     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 § 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                           ( print page 67355)                        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

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

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.

2. Section 878.4410 is added to subpart E to read as follows: 

§ 878.4410

                        (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 § 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