[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Notices]
[Pages 48718-48719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-1165]


Guidance for the Content of Premarket Notifications (510(k)s) for 
Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation 
of Kidney and Ureteral Calculi: Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for the Content of 
Premarket Notifications (510(k)s) for Extracorporeal Shock Wave 
Lithotripters Indicated for the Fragmentation of Kidney and Ureteral 
Calculi.'' This guidance describes the types of information that should 
be submitted in a premarket notification to support a decision of 
substantial equivalence for an extracorporeal shock wave lithotripter 
indicated for the fragmentation of kidney and ureteral calculi. 
Elsewhere in this issue of the Federal Register, FDA is reclassifying 
renal and ureteral extracorporeal shock wave lithotripters from class 
III (premarket approval) to class II (special controls).

DATES:  Submit written comments at anytime.

ADDRESSES:  Submit written requests for single copies on a 3.5" 
diskette of the guidance document entitled ``Guidance for the Content 
of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave 
Lithotripters Indicated for the Fragmentation of Kidney and Ureteral 
Calculi'' to the Division of Small Manufacturers Assistance (HFZ-220), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-
addressed adhesive labels to assist that office in processing your 
request, or fax your request to 301-443-8818.
    Submit written comments on ``Guidance for the Content of Premarket 
Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters 
Indicated for the Fragmentation of Kidney and Ureteral Calculi'' to the 
contact person listed below. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: John H. Baxley, Center for Devices and 
Radiological Health (CDRH) (HFZ-470), Food and Drug Administration, 
9200 Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1998, FDA initiated proceedings to reclassify the extracorporeal 
shock wave lithotripter for fragmentation of kidney and ureteral 
calculi from class III (premarket approval) to class II (special 
controls). To facilitate this reclassification, FDA prepared the 
document entitled ``Guidance for the Content of Premarket Notifications 
(510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the 
Fragmentation of Kidney and Ureteral Calculi.'' This document is the 
special control that has been established to support reclassification 
to class II, and also provides general guidance to industry on the 
content of premarket notifications for these devices.
    On July 30, 1998, a meeting of the Gastroenterology and Urology 
Devices Advisory Panel (the Panel) was held to seek its recommendations 
on this proposed reclassification, including advice on special controls 
and the content of premarket notifications. The Panel unanimously voted 
to reclassify the extracorporeal shock wave lithotripter for the 
fragmentation of kidney and ureteral stones into class II. Comments 
from the Panel have been incorporated into this guidance document.
    In the Federal Register of February 8, 1999 (64 FR 5987 to 5996), 
FDA published its proposal to reclassify the extracorporeal shock wave 
lithotripter for fragmentation of kidney and ureteral calculi to class 
II, as well as its announcement of the availability of the draft 
document entitled ``Guidance for the Content of Premarket Notifications 
(510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the 
Fragmentation of Kidney and Ureteral Calculi'' (64 FR 6100 to 6101). 
Both the proposed reclassification and the notice of availability 
provided an opportunity for public comment, which closed May 10, 1999.
    Based on the comments received on the draft guidance document, the 
following substantive changes have been incorporated into the revised 
version being made available at this time:
    1. Section 8.D (Clinical Performance Testing) was revised to more 
clearly state the recommended sample size. The guidance document now 
states that the study should enroll a total of 20 patients

[[Page 48719]]

with urinary stone disease at 2 investigational sites.
    2. Section 8.D (Clinical Performance Testing) was revised to state 
a post-procedure followup time range of 48 hours to 2 weeks (previously 
recommended as 1 week).
    3. Section 9 (Labeling) was revised to: (1) Correctly cite the 
agency's authority under the Federal Food, Drug, and Cosmetic Act, and 
(2) reword the precaution statement.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
the final regulation reclassifying the extracorporeal shock wave 
lithotripter for fragmentation of kidney and ureteral calculi to class 
II (special controls).

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
extracorporeal shock wave lithotripters indicated for the fragmentation 
of kidney and ureteral calculi. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
applicable statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance document is issued as Level 1 guidance consistent 
with GGP's.

III. Electronic Access

    In order to receive the document entitled ``Guidance for the 
Content of Premarket Notifications (510(k)s) for Extracorporeal Shock 
Wave Lithotripters Indicated for the Fragmentation of Kidney and 
Ureteral Calculi'' via your fax machine, call the CDRH Facts-on-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system and enter the document number 1226 followed 
by the pound sign (#). Follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with access to the Internet. 
Updated on a regular basis, the CDRH home page includes the document 
entitled ``Guidance for the Content of Premarket Notifications 
(510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the 
Fragmentation of Kidney and Ureteral Calculi,'' device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturers' assistance, information on video 
conferencing and electronic submissions, mammography matters, and other 
device-oriented information. The CDRH home page may be accessed at 
http://www.fda.gov/cdrh.

IV. Comments

    Interested persons may, at any time, submit to the contact person 
(address above) written comments regarding this guidance. Such comments 
will be considered when determining whether to amend the current 
guidance. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance document and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 12, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-20087 Filed 8-8-00; 8:45 am]
BILLING CODE 4160-01-F