[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 Ultramark9 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