[Federal Register Volume 62, Number 62 (Tuesday, April 1, 1997)]
[Notices]
[Page 15528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8170]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0122]


Xillix Technologies Corp.; Premarket Approval of Xillix LIFE-Lung 
Fluoresence Endoscopy System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application submitted by Hogan and Hartson, Washington, 
DC, U.S. representative for Xillix Technologies Corp., Richmond, B.C., 
Canada, for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of Xillix LIFE-Lung Fluoresence Endoscopy 
System. After reviewing the recommendation of the Ear, Nose, and Throat 
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of September 19, 1996, of the 
approval of the application.

DATES: Petitions for administrative review by May 1, 1997.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kirby J. Cooper, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION: On December 21, 1995, Hogan and Hartson, 
Washington, DC, U.S. representative for Xillix Technologies Corp., 
Richmond, B.C. Canada, submitted to CDRH an application for premarket 
approval of Xillix LIFE-Lung Fluorescence Endoscopy System. The device 
is a fluorescence endoscopy system and is indicated for use as an 
adjunct to white light bronchoscopy, using an Olympus BF-20D 
bronchoscope, to enhance the physician's ability to identify and locate 
bronchial tissue, suspicious for moderate/severe dysplasia or worse, 
for biopsy and histologic evaluation in the following patient 
populations:
    1. Patients with known or previously diagnosed lung cancer; and
    2. Patients with suspected lung cancer including: (a) Patients with 
Stage I completely resected lung cancer, with no evidence of metastatic 
disease, who are at risk for secondary disease; and (b) patients 
suspected of having lung cancer because of clinical symptoms such as 
positive sputum cytology, hemoptysis, unresolved pneumonia, persistent 
cough, or positive x-ray.
    On June 11, 1996, the Ear, Nose, and Throat Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. On September 19, 1996, 
CDRH approved the application by a letter to the applicant from the 
Director of the Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under 21 CFR part 12 of 
FDA's administrative practices and procedures regulations or a review 
of the application and CDRH's action by an independent advisory 
committee of experts. A petition is to be in the form of a petition for 
reconsideration under 21 CFR 10.33(b). A petitioner shall identify the 
form of review requested (hearing or independent advisory committee) 
and shall submit with the petition supporting data and information 
showing that there is a genuine and substantial issue of material fact 
for resolution through administrative review. After reviewing the 
petition, FDA will decide whether to grant or deny the petition and 
will publish a notice of its decision in the Federal Register. If FDA 
grants the petition, the notice will state the issue to be reviewed, 
the form of review to be used, the persons who may participate in the 
review, the time and place where the review will occur, and other 
details.
    Petitioners may, at any time on or before May 1, 1997, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: March 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health
[FR Doc. 97-8170 Filed 3-31-97; 8:45 am]
BILLING CODE 4160-01-F