[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Notices]
[Pages 60712-60713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30443]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0450]


Advanced Technology Laboratories; Premarket Approval of 
Ultramark 9 High DefinitionTM Imaging (HDITM) 
Ultrasound System With L10-5 Scanhead

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Advanced Technology Laboratories, 
Bothell, WA, for premarket approval, under the Federal Food, Drug, and 
Cosmetic Act (the act), of Ultramark 9 HDITM Ultrasound 
System with L10-5 Scanhead. After reviewing the recommendation of the 
Radiological Devices Panel, FDA's Center for Devices and Radiological 
Health (CDRH) notified the applicant, by letter on April 11, 1996, of 
the approval of the application.

DATES: Petitions for administrative review by December 30, 1996.
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: Robert A. Phillips, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1212.

SUPPLEMENTARY INFORMATION: On February 17, 1994, Advanced Technology 
Laboratories, Bothell, WA 98041-3003, submitted to CDRH an application 
for premarket approval of the Ultramark 9 HDITM 
Ultrasound System with L10-5 Scanhead. The device is an Ultrasonic 
Pulse-Echo Imaging System. The Ultramark 9 HDITM 
Ultrasound System with L10-5 Scanhead is indicated as an adjunct to 
mammography and physical breast examination to provide a high degree of 
physician confidence in differentiating benign from malignant or 
suspicious breast lesions. This device provides the physician with 
additional information to guide a biopsy decision. Utility of this 
system has been demonstrated for lesions with an indeterminate level of 
suspicion (LOS 2-4) by conventional diagnostic modalities. Using the 
HDITM system in the evaluation of solid mass characteristics can 
reduce the number of biopsies performed on indeterminate lesions.
    On December 11, 1995, the Radiological Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended approval of the application. On April 11, 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 the 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 December 30, 1996, 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).


[[Page 60713]]


    Dated: October 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-30443 Filed 11-27-96; 8:45 am]
BILLING CODE 4160-01-F