(29 days)
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, diagnostic fluoroscopy, conventional linear tomography, angiography and pediatric examinations.
The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, digital angiography and digital subtraction angiography (DSA).
The Platinum dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
The Platinum dRF is not indicated for use in interventional radiology.
The Apelem-DMS Platinum dRF Imaging System ("Platinum") is not a stand-alone device, but functions as a platform for FDA cleared or registered components (i.e. generator, panel detector, detector collimator, X-ray tube and software imaging packages), that are installed with a Apelem-DMS manufactured radiological examination table, control panel with system controller software, and electrical panel.
The Platinum dRF remote controlled table is a radiologic table equipped with a flat panel electronic detector. This table is used to perform general digital radiological, fluoroscopy and peripheral angiography. This device allows for treatment on the whole body, using all angles. It allows the user dynamic acquisition for the whole body, to target the zones to analyze, and to be able to track contrast media.
The subject of this Special 510(k) application is the additional offering of the Platinum with a different flat panel detector (RF4343 FL) that does not include some less regularly used options (of the FDA cleared Platinum with RF4343 flat panel detector), has lower frames/sec and does not include a lead shield for use with the RF4343 FL is manufactured and installed by DMS. This additional offering is less expensive and will fit the needs of most customers.
The provided document is a 510(k) premarket notification for a medical device (Platinum dRF Imaging System) seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that a new component (a different flat panel detector) does not alter the device's safety or effectiveness.
Therefore, this document does not contain the information requested regarding specific acceptance criteria for device performance, a study proving the device meets these criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.
The document states:
- The subject of this Special 510(k) application is the additional offering of the Platinum with a different flat panel detector (RF4343 FL) that does not include some less regularly used options (of the FDA cleared Platinum with RF4343 flat panel detector), has lower frames/sec and does not include a lead shield for use with the RF4343 FL is manufactured and installed by DMS.
- There is no change in the Indications for Use.
- The change in frame rate has no impact on image quality as the image specifications are not changes.
- The results of assessment under Design Controls supports that the Apelem-DMS Platinum dRF Imaging System with RF434FL flat panel detector is substantially equivalent to the predicate device. The differences between the RF4343 FL flat panel detector do not raise different issues of safety or effectiveness.
- The Platinum with RF4343 FL has no impact on the image quality or safety of the device, and does not raise different issues of safety or effectiveness.
This indicates that the submission relies on the previous clearance of the predicate device (K131766) and argues that the minor changes to the flat panel detector do not necessitate new performance studies or acceptance criteria beyond demonstrating continued compliance with general safety and performance standards for X-ray equipment.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.