[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
[Pages 59715-59717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 98P-0731]


Dental Devices; Classification of Sulfide Detection Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 59716]]

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
sulfide detection device into class II (special controls). The special 
controls that will apply to the sulfide detection device are 
restriction to prescription use, conformance with recognized standards 
relating to biocompatibility, electrical safety and sterility, 
submission of performance data from analytical and clinical studies 
demonstrating device effectiveness and adherence to specific labeling 
requirements. 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 Modernization Act of 
1997. The agency is classifying sulfide detection devices into class II 
(special controls) in order to provide a reasonable assurance of safety 
and effectiveness of the device.

EFFECTIVE DATE: December 7, 1998.

FOR FURTHER INFORMATION CONTACT: Robert S. Betz, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283.

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 the enactment of the Medical Device 
Amendments 1976, generally referred to as postamendments devices are 
classified automatically by statute into class III without any 
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 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 the FDA 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). FDA shall, within 60 days of 
receiving such as 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 May 15, 1998, classifying sulfide detection devices in class 
III. On May 18, 1998, Diamond General Development Corp. submitted a 
petition requesting classification into class II of the Diamond 
Probe/Perio 2000 System that is intended to measure 
periodontal pocket probing depths, evaluate the presence or absence of 
bleeding on probing, and to detect the presence of sulfides in 
periodontal pockets of adult patients. After reviewing the information 
submitted in the petition, its amendments, K980749, and medical 
literature, FDA concludes that this device, and substantially 
equivalent devices of this generic type, can be classified into class 
II with the establishment of special controls. 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 the safety and effectiveness of the device and there is 
sufficient information to develop special controls to provide such 
assurance. After reviewing the information submitted in the petition, 
FDA determined that sulfide detection devices can be classified into 
class II with the establishment of special controls. FDA believes that 
general controls and special controls will provide reasonable assurance 
of safety and effectiveness of the device.
    FDA has identified the following risks to health associated with 
this type of device: (1) Risks associated with the inability to develop 
adequate directions for use; (2) risks associated with 
biocompatibility, electrical safety, and sterility; (3) risks related 
to inaccurate device performance; and (4) risks associated with 
improper device use.
    FDA determined that the special controls described below address 
these risks and provide reasonable assurance of the safety and 
effectiveness of the device. Therefore on July 17, 1998, FDA issued an 
order to the petitioner classifying the sulfide detection device as 
described previously into class II subject to the special controls 
described below.
    Additionally, FDA is codifying the classification of this device by 
adding Sec. 872.1870 Sulfide detection device.
    In addition to the general controls of the act, the sulfide 
detection device is subject to the following special controls which, 
combined with general controls, provide reasonable assurance of the 
safety and effectiveness of the device: (1) Restriction of the sale, 
distribution, and use of this device to prescription use in accordance 
with 21 CFR 801.109; (2) conformance with recognized standards for 
biocompatibility, electrical safety, and sterility; (3) clinical and 
analytical testing sufficient to demonstrate that the device accurately 
measures probing depths, detects the presence or absence of bleeding on 
probing, and accurately detects the presence of sulfides in periodontal 
pockets in adult patients; (4) labeling that includes proper 
instructions for device storage, use, and maintenance.
    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 efficacy of 
the device. FDA has determined premarket notification is necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device, and therefore, the device is not exempt from the premarket 
notification requirements. Thus persons who intend to market this 
device must submit to FDA a premarket notification prior to marketing 
the 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 this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Flexibility Act 
(Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. 
L. 104-4). Executive Order 12866 directs agencies to assess all costs 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health

[[Page 59717]]

and safety, and other advantages; distributive impacts; and equity). 
The agency believes that this final rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In addition, the final rule is not a significant regulatory action as 
defined by the Executive Order, and so it is not subject to review 
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. Classification of these devices in 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 therefore, certifies 
that the final rule will not have a significant impact on a substantial 
number of small entities. In addition, this final rule will not impose 
costs of $100 million or more on either the private sector or State, 
local, and tribal governments in the aggregate, and, therefore a 
summary statement of analysis under section 202(a) of the Unfunded 
Mandates Act is not required.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget, under the Paperwork 
Reduction Act of 1995 is not required.

V. References

    The following references have been placed on display in the Dockets 
Management Branch (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 Diamond General Development Corp., dated May 
18, 1998.
    2. Solis-Gaffar, M. C., T. Fischer, and A. Gaffar, 
``Instrumental Evaluation of Odor Produced by Specific Oral 
Microorganisms,'' Journal of Cosmetic Chemistry, vol. 30, pp. 241 to 
247, 1979.
    3. Solis-Gaffar, M. C., K. N. Rustogi, and A. Gaffar, ``Hydrogen 
Sulfide Production from Gingival Crevicular Fluid,'' Journal of 
Periodontology, vol. 5 (10), pp. 603 to 606, 1980.

List of Subjects in 21 CFR Part 872

    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 
872 is amended as follows:

PART 872--DENTAL DEVICES

    1. The authority citation for 21 CFR part 872 continues to read as 
follows:

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

    2. Section 872.1870 is added to subpart B to read as follows:


Sec. 872.1870  Sulfide detection device.

    (a) Identification. A sulfide detection device is a device 
consisting of an AC-powered control unit, probe handle, probe tips, 
cables, and accessories. This device is intended to be used in vivo, to 
manually measure periodontal pocket probing depths, detect the presence 
or absence of bleeding on probing, and detect the presence of sulfides 
in periodontal pockets, as an adjunct in the diagnosis of periodontal 
diseases in adult patients.
    (b) Classification. Class II (special controls) prescription use in 
accordance with Sec. 801.109 of this chapter; conformance with 
recognized standards of biocompatibility, electrical safety, and 
sterility; clinical and analytical performance testing, and proper 
labeling.

    Dated: August 25, 1998.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 98-29569 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F