510(k)s jump as FDA works through backlog of submissions

October 3, 2001

FDA clearances rebounded sharply in August, tying the year-high number of 29 reached six months earlier. The sharp increase contrasted starkly with two months of very low numbers—20 in June and 21 in July. The reason for those poor showings may

FDA clearances rebounded sharply in August, tying the year-high number of 29 reached six months earlier. The sharp increase contrasted starkly with two months of very low numbers-20 in June and 21 in July. The reason for those poor showings may have become clear.

The August clearances include six products submitted in April or May. The submission dates indicate clearly that FDA reviewers took longer than the usual 90 days to examine these 510(k) submissions. If these reviews had been conducted in the prescribed time, the number of June and July clearances would have been in the mid 20s, typically the number reviewed and cleared by the FDA.

Three product types were affected by the delays. Two of the five clearances in radiation therapy were submitted in April. Two of the eight x-ray-related clearances were submitted in March. And two of the five ultrasound submissions were submitted in March, both involving Aloka products.

Cleared products represented five different types of radiologic equipment. X-ray systems had the largest number of clearances, barely edging out MR, eight products to seven. Ultrasound and radiation therapy each accounted for five clearances. CT and image management each had two.

MR clearances were composed of mostly minor offerings, namely coils or enhancements to existing systems. An exception was the Aug. 3 clearance of the GE Signa 1.5-tesla TwinSpeed scanner. TwinSpeed combines gradients from the Signa Horizon Cx and the Signa CVMR (cardiovascular) scanner. The product has the same basic technological characteristics as these two other devices and the same basic design, construction, and materials. The company has already begun installing these scanners at clinical sites (SCAN 9/5/01).

Another standout is GE’s PROSE (PRostate Spectroscopy and imaging Exam), an image-guided MR clinical assessment and spectroscopy package. PROSE, which cleared the FDA Aug. 22, acquires high-resolution anatomical images and volume-localized hydrogen spectra of the prostate. The option uses one or more sets of localizer images to determine the size and location of the spectroscopic volume. Data are acquired using an endorectal probe outfitted with phased-array coils. The relative concentrations of metabolites recorded using PROSE may indicate prostate disease. The new product is a version of the PRESS (Point RESolved Spectroscopy) double-spin-echo pulse sequence.

The two FDA-cleared CT products are noteworthy. GE’s HiSpeed X/i Smart Gantry Option CT scanner is built around a gantry mounted on a dolly. The gantry, rather than the patient table, moves during the examination. The system, which cleared the FDA Aug. 10, is not designed as a diagnostic scanner. Rather, the product is to be used in conjunction with a linear accelerator. GE did not ask the FDA to review any claims outside CT scanning, but the apparent purpose of the system is radiation therapy. The modified product uses the same solid-state detector and x-ray tube integrated with GE’s existing family of HiSpeed CT scanners.

GE also received clearance Aug. 7 for the CT Colonography/Navigator2 software package, which generates CT-based images of the inside, wall, and outside of the colon. The goal is to detect colonic lesions. CT Colonography works in concert with Navigator2, an advanced visualization software that provides endoluminal views. Navigator2 will be used to investigate polyps, tumors, and other structures within the anatomy.

The FDA cleared three new x-ray systems in August. The Easy Moving Mobile X-ray Unit, Model SM-HF, by Sedecal USA, passed Aug. 31. It is designed to examine all body parts, including the skull, spine, chest, and abdomen. The mobile unit, which can plug into the wall or run on batteries, is described by Sedecal as compact and quick to set up and operate. It is composed of a base unit housing the high-voltage generator, controls, and a turnable arm with rotating tube head. Adult and pediatric patients can be imaged standing, sitting, or lying down.

The ISI-2500 mobile C-arm from Imaging Services provides fluoroscopy during diagnostic and surgical procedures. The system, which cleared the FDA Aug. 23, may be used for gastrointestinal, urologic, orthopedic, neurologic, vascular, and emergency room procedures. The C-arm, which is made by Korean supplier Medison, has been sold into markets outside the U.S., including Asia and Latin America. The company describes the ISI-2500 as a high-end, low-cost C-arm equivalent mechanically and electrically to the GE OEC Medical Systems 9600 mobile C-arm. The key difference between the two products, according to Imaging Services, is the imaging chain.

Trex Enterprises of San Diego received FDA clearance to market its PDX-2000 portable digital x-ray system. The new product, which passed FDA review Aug. 16, consists of CXDI-22 retrofit, an amorphous silicon-based sensor generally available from Canon, a MinXray Portable Source Generator, and proprietary adaptations developed by Trex. The system supports general radiographic procedures.

Radiation therapy clearances were typical of past months, with four of the five clearances involving brachytherapy or enhancements to existing systems. The one exception was CyberKnife, an image-guided, stereotactic radiosurgery system from Accuray of Sunnyvale, CA, which passed the FDA Aug. 10. CyberKnife combines planning, imaging, and treatment subsystems. The treatment planning component can process CT and MR data sets into 3-D models. Diseased and surrounding healthy tissue is rendered in the context of reference markers known as fiducials that allow the patient to be properly oriented for treatment. This component also calculates dosage. The imaging system delivers real-time, orthogonal x-ray images of the patient to verify treatment position and alignment by tracking the skull and fiducials in 3-D space. These data are then compared with the 3-D model to ensure accurate pointing of the 6-Mv linear accelerator. The planning system can handle up to 300 CT slices and fuse these data with those from MR.

In diagnostic ultrasound, Aloka has been cleared to market two new products. The SSD-5000, cleared Aug. 29, is a variation of the company’s SSD-5500. The new system may be fitted with any of 23 different transducers. The SSD-1000, cleared Aug. 30, is similar to the SSD-1400. The new product can be configured with up to 18 transducers.

Following are FDA-provided data on the other August clearances.

Ultrasound

  • EUB ultrasound scanner/Sonoprobe (Hitachi Medical Corporation of America, Aug. 10). The product consists of two separate assemblies: the Hitachi EUB-525/EUB-2000 and Fujinon SP711 Sonoprobe system, an optional add-on that allows the two imaging systems to utilize Fujinon probes. The intended use is for endoscopic observation of the GI tract and biliary system.
  • GE Logiq 100 Pro (GE Medical Systems, Aug. 23). The new system is an enhanced version of the GE Logiq Alpha 100. The portable general-purpose system consists of a hand-carried console weighing about 22 pounds. The black-and-white system is capable of real-time B- and M-mode imaging with linear and curved-linear array transducers.
  • Basic 1, Basic 2, Basic 3 (Atys Medical, Aug.10). The vascular test system is based on the use of peripheral Doppler integrated with photo- and pneumoplethysmography. The system is designed to assist in detecting peripheral vascular disease, both arterial and venous.

Radiotherapy

  • Kodak Radiation Oncology Software (Eastman Kodak, Aug. 10). The software enables digitization of phosphor plates exposed during computed radiography as a means for acquiring portal images and simulation images.
  • HDR Tandem/Ring Applicator with Rectal Retractor (Mick Radio-Nuclear Instruments, Aug. 27). The remote-controlled retractor is designed for use in brachytherapy.
  • MBI Pd 103 Brachytherapy Seed (Mills Biopharmaceuticals, Aug. 31). The palladium-103 radioactive seeds are designed for permanent interstitial treatment of tumors that cannot be resected and for the treatment of residual tumor after primary resection.
  • iViewGT EPID (Elekta Oncology Systems, Aug 14). This enhanced version of the existing iView Electronic Portal Imaging Device supports solid-state detectors for image acquisition.

Image Management

  • ViewStation, Image Processing System (Impac Medical Systems, Aug. 29). Enhanced version of the ViewStation product cleared by the FDA in May 1995. The PACS allows user to import, view, annotate, manipulate, enhance, manage, and archive patient images.
  • EL-DRY 4000 (Elk, Aug. 29). The laser printer records images onto Kodak DryView laser film.

MRI

  • Intercept Urethral Microcoil (Surgi-Vision, Aug. 31). The single-use, disposable coil is designed to image the male and female urethras and surrounding tissue. Signals are received by the coil and conveyed for processing through a small coaxial cable interfacing with a standard surface-coil connector. The microcoil and cable are sealed. The Intercept-Urethral Microcoil is designed for use with a 1.5-tesla GE Signa system.
  • Multipurpose Flexible Receiving Coil (BioSound Esaote, Aug. 29). The coil is designed to improve operation of Esaote’s E-scan system and MR scanners optimized for imaging extremities.
  • MMI Muscle Imaging System (Millennium Magnetic Imaging, Aug.6). Using isotronic or isometric movement, the product serves as an external trigger for the MR scanner when performing dynamic studies of joints. It is intended for subjects evaluated for musculoskeletal diseases, and deformities, and sports injuries.
  • Neurovascular Array Coil (MRI Devices, Aug. 14). The coil provides data for imaging the head and neck.
  • Multi-Purpose Flex Array Coil, Model 235 Series (Medical Advances, Aug. 14). The coil, which is designed for conventional and angiographic imaging of the head, neck, and extremities, is compatible with GE Signa 1.5-tesla systems that can support phased-array imaging.

X-Ray

  • Digora PCT (Soredex Instrumentarium, Aug. 10). The phosphor-plate system records imaging data on reusable plates. Energy from the latent images is released using a scanning laser. Digora PCT is an enhanced version of the Digora, which cleared the FDA in February 1994.
  • LifeRay WL and KW Cassettes (Ferrania, Aug. 9). The cassettes hold radiographic film in close contact with an x-ray-intensifying screen.
  • In Space 3-D Software Option (Siemens Medical Solutions, Aug. 3). The software option reconstructs data obtained with standard angiographic C-arms into 3-D models.
  • Hip Morphometry Software (GE Lunar, Aug. 3). The software will be marketed as part of the Lunar’s Advanced Hip Assessment Software, which analyzes data obtained using dual-energy x-ray absorptiometry of the proximal femur with the Prodigy bone densitometer. Hip Morphometry Software measures the hip axis length (SCAN 9/19/01).
  • Revolution XR/d (GE Medical Systems, Aug. 10). The general-purpose digital radiography system consists of an elevating radiographic table, x-ray tube, x-ray tube hanger, collimator, system controller, generator, and tilting radiographic wall stand. The system can be configured with either or both the table and wall stand, each of which is integrated with amorphous silicon detectors. GE announced FDA clearance of the Revolution XR/d system with dual-energy subtraction, which allows two successive x-ray exposures of the chest in less than a second. The system then automatically generates a standard radiograph, an image of the soft tissue with the bones removed, and an image of the skeletal system. This set of images promises to improve the detection of small pathologies (SCAN 9/19/01).