FDA clears advanced ultrasound systems for sale in U.S.

July 8, 2001

MRI and diagnostic ultrasound dominate the latest batch of imaging-related devices cleared by the FDA. These modalities accounted for half of the 26 products cleared for marketing in the U.S. Radiation therapy equipment came in third with five products,

MRI and diagnostic ultrasound dominate the latest batch of imaging-related devices cleared by the FDA. These modalities accounted for half of the 26 products cleared for marketing in the U.S. Radiation therapy equipment came in third with five products, and the remaining approvals were scattered among CT, x-ray, and image management.

The Logiq 9, a general-purpose diagnostic ultrasound product developed by GE Medical Systems, cleared May 18. The company cited its Logiq 700 as a substantially equivalent predicate. The specifications of the new product indicate a wide range of applications: fetal and obstetric, abdominal, pediatric, small parts, cardiac, peripheral vascular, and musculoskeletal. A battery of 13 transducers allows the device to do transesophageal, transrectal, transvaginal, and intraoperative imaging that includes abdominal, thoracic/cardiac, vascular, and neurological exams.

The system offers substantially improved ergonomics, operation, maneuvering, and ease of use. The mobile console measures 65 cm wide, 96 cm deep, and 144 cm high, and the user interface includes a computer keyboard and specialized controls in concert with a color video CRT. Data are digitally acquired, processed, and displayed.

Philips ATL was given the go-ahead May 4 to begin marketing the HDI 5000 with assisted border detection (ABD), XRES imaging, and panoramic measurement capability. The company cited Agilent’s Sonos 5500 digital acoustic quantification feature as basically equivalent to its ABD, which provides a semiautomated technique for calculating left ventricular volume and ejection fraction of the heart. Philips’ goal with ABD is to improve throughput by simplifying the steps required to outline the left ventricular cavity. The user has the option of accepting the automated trace and selected image frames or manually modifying the traces to allow proper alignment. The SieScape feature on Siemens’ Elegra system was cited as the predicate device for ATL’s panoramic measurement capability, which allows the user to perform distance or area measurements using tools already available on the HDI 5000. XRES imaging, which is similar to image processing filters already on the HDI 5000, enhances gray-scale image quality by reducing speckle and noise and clarifying tissue margins and boundaries. This feature will operate in real-time and after acquisitions, during review of the multiframe cineloop image onboard the HDI 5000.

MRI may be increasingly used in women’s healthcare with clearance of the Siemens MR breast biopsy device. The optional accessory, which is compatible with Siemens’ Magnetom MR scanners, is designed to provide images while allowing access to the breast for biopsy. The FDA agreed with Siemens’ assertion that the new device is substantially equivalent to the Philips stereotactic localization device. Prior to the FDA decision regarding the Siemens product, which was rendered May 30, Philips had the only commercially available MR biopsy device. In the November issue of Medica Mundi, a Philips-sponsored journal, physicians at the University of Bonn radiology department reported the use of Philips’ device to perform MR-guided wire localization on 202 lesions in 170 patients. Lesions were successfully removed in 194 of the 202 cases (97%).

Israel-based UltraGuide took a different tack on MRI guidance with the development of its MR-Guide 3000, which was cleared May 24, just two weeks after the 510(k) application was submitted. (The device was reviewed by a third party.) The frameless stereotactic device displays graphics that show the position and future path of a rigid interventional instrument, such as a biopsy or aspiration needle. Graphics appear on a computer monitor in the context of MR images of target organs. The system also allows the medical team to monitor patient respiration. Predicate devices cited were the Medtronics StealthStation and CT-Guide 1010. The MR-Guide 3000 uses an optical tracking system made up of an infrared light source that illuminates retroreflective targets so as to track the location and orientation of the interventional instrument. The tracking information is transmitted to a data processor, which merges the graphic overlay of the interventional instrument and the MR images.

MRI

  • BOLD option (Marconi Medical Systems; May 8). The blood oxygen level-dependent (BOLD) analysis package is designed to quantify small susceptibility changes in the human brain that occur when the subject performs specific tasks. The option uses echo-planar imaging sequences combined with postprocessing software. Analysis may include image coregistration, motion correction, statistical analysis of activation, division of data sets based on description of experiment paradigms, fusion of different types of image, and color coding. The device is designed for use on Marconi’s Infinion 1.5-tesla scanner and Eclipse MRI systems with software versions VIA 2.0E or higher.

  • Flow 7000 Peripheral Vascular Coil (USA Instruments; May 16). The 12-element, receive-only phased-array radio-frequency coil is dedicated to imaging vasculature and soft-tissue anatomy from the abdomen to the foot. The coil, designed specifically for use with the 1.5-tesla Intera scanner from Philips, consists of upper and lower sections, which are positioned above and below the patient’s lower torso and legs. The sections containing coil elements and accessory coil electronics are enclosed to prevent any exposure to the patient or environment.

  • Cardiac View 2001 (Cardiac MRI, a subsidiary of Magna Lab; May 21). The transesophageal probe, which was determined to be substantially equivalent to the SurgiVision Esophageal Stylet Coil, Medrad MRInnervu Endorectal Prostate Coil, and ATL Transesophageal Ultrasound Probe, is a receive-only coil (SCAN 6/6/01). The product is designed for placement within the esophagus to enhance visualization of the esophagus, including the aortic arch, descending aorta, and coronary vessels.

  • Mark 9000 Phased Array Shoulder Coil (USA Instruments; May 30). The receive-only RF coil is designed to image the shoulder and adjacent regions. Specifically engineered to work with the Signa 1.5-tesla MRI system from GE Medical Systems, the device consists of three volume RF coil elements in a phased-array design. Coil elements and associated circuitry are enclosed to prevent exposure to the patient or environment.

  • Model KFA-127 (MRI Devices; May 25). The coil is optimized for knee, foot, and ankle imaging.

Ultrasound

  • SP-711 Sonoprobe System (Hitachi Medical Corp. of America; May 30). The system, which works with the previously cleared EUB-6000, is intended for ultrasonic visualization of the gastrointestinal and biliary tracts using 15 endoscopic probes. Two types of probes are distinctive-one for use with a balloon/sheath, the other for use with a sheath alone. The SP-711 scans radially and does not have the linear scanning option offered by the predicate device, the SP-701. Other differences are in the probes: One series (PL26-7.5) operates at 7.5 MHz and has a distal diameter of 7.3 mm, and a second (PL2220) has a diameter of 2 mm and is designed for biliary inspection.

  • SSD-5500 with KI and A-SMA (Aloka; May 23). A-SMA (automated-segmental motional analysis) combines kinetic imaging (KI) and acoustic quantification. Together these capabilities allow differentiation of the cardiac chamber from surrounding muscle; division of the chamber into several regions; measurement of the area of each region; and computation of the rate of change for each region.

  • Olympus GF-UC140P-AL5 Ultrasonic Endoscope; (Olympus; May 15). The ultrasonic endoscope is designed to work in combination with the Aloka SSD-5500 for intraoperative applications, specifically neurological and transesophageal.

  • Artemis (Ultralink; May 22). The system is designed to produce high-resolution images of the anterior portion of the eye, such as the corneal epithelium and stroma, and to measure these tissues. Among the predicate devices named in its application was the Digital Ophthalmic Ultrasound Biomicroscope.

  • Tetrad TC-C3-ACP General Purpose Imaging Probe (Tetrad; May 4). The product, which was judged substantially equivalent to the Acuson C3 probe, is designed for use on the Acuson 128XP and Aspen. The probe is dedicated to fetal and abdominal imaging.

Radiotherapy

  • Eclipse 6.5 (Varian Medical Systems; May 2). Designed to support radiation therapy treatment planning, the device calculates and displays prospective treatment plans. Eclipse 6.5 plans the 3-D approaches for both photon and electron radiation therapy treatments, employing linear accelerators and similar devices with x-ray energies. It consists of a computer with graphics display, plotter output, film scanner, and backlit digitizer input. Specific purposes include diagnostic image analysis, contouring and segmentation, geometrical planning, photon and electron dose calculation, and plan review. System architecture has been designed to allow upgrading with dose calculation algorithms.

  • DCM (Dose Calculation Module) 1.0 (MDS Nordion; May 23). DCM calculates dose plans and communicates with a treatment planning system using DICOM. The module is essentially a 3-D radiotherapy dose engine for radiation dose planning, working with linear accelerators and cobalt-60 units. It can calculate dose for 3-D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields, total-body irradiation, multileaf collimators, motorized and dynamic wedges, and customized blocking.

  • Model 1131 IVD (Sun Nuclear; May 4). The in vivo dosimetry system measures the radiation output of a linear accelerator or radioactive substance such as cobalt-60 during treatment. It can be configured with four to 28 diode detectors. These diodes, when connected to the detector module, relay information about dose to a computer, which displays the dose value at the end of the treatment session.

  • Patient Dose Verification System (Thomason & Nielsen Electronics; May 8). Intended for use during radiation therapy, the device verifies the radiation dose given the patient. It consists of one reader and up to 20 dosimeters.

  • RadCalc (Lifeline Software; May 17). The PC-based software interfaces with the primary radiation therapy planning software to validate monitor units and doses administered by the primary radiation therapy planning system.

CT

  • SimpliCT (NeoRad AS; May 7). The optical guidance device is designed to facilitate CT-guided interventions using straight needles. Using an autocalibration system, SimpliCT assures that the desired point and angle of the needle are achieved. The stand-alone device is not connected physically to the CT or the needle. It consists of two lasers mounted on rails. One helps align the interventional device relative to the CT table; the other is used for needle guidance.

  • E-Z-EM PercuPump 2001 (E-Z-EM; May 16). The device is used to administer contrast agents used in CT. An accessory integrated into the PercuPump is used to detect extravasations of contrast media during powered contrast injections.

Image Management

  • Aquarius Workstation (TeraRecon; May 8). The workstation can be configured to allow basic functions associated with image review, communications, archiving, database maintenance, reporting, and simple 3-D. Alternatively, the device can be configured to allow sophisticated processing such as color volume rendering and calcium scoring. The computing engine is an off-the-shelf PC running MS Windows NT version 4.0 or Windows 2000. Software supports single or multiple processors of the Pentium III class. Minimum 512 MB memory and 18 GB hard drive space are required.

  • Goodnet (Goodman; May 25). The PACS is designed for use with MS Windows. It can be used for image archive and review in and outside of the radiology department, including cardiac catheterization suite, physician offices, and other remote locations.

X-Ray

  • CDMx Digital X-ray System (CamSight; May 21). The software allows assessment of digitally scanned dental radiographs. The device is specific to the examination of teeth, jaws, and oral structures.

  • Prognost ES (XMAR; May 30). The radiography system is used for routine exams of the skull, spinal column, chest, abdomen, extremities, and other body parts. It consists of a radiographic table containing a bucky and cassette tray, as well as an integrated tube mount with manual and automatic collimator.

  • MXD 100 (Modular X-Ray Devices; May 30). The radiography system is designed for use by primary-care physicians. The stand allows lateral exposure of a supine patient. Variable source-image distance and a fixed position of the film receptor minimize equipment adjustment.