(15 days)
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Detector is combined with a Philips XD-S workstation (K063781) which consists of a computer, keyboard, display, mouse. The complete X-ray system would further include other Philips subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. The XD-S workstation and the complete X-ray systems are not changed other than by replacing an Xray receptor with the Wireless Portable Detector FD-W17.
The provided text describes a 510(k) submission for the "Wireless Portable Detector FD-W17." However, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test sets or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies.
The submission focuses on:
- Device Identification: Manufacturer, submitter, product names, classification.
- Compliance with Standards: Federal X-Ray performance standards (CFR 1020.30, .31), electrical safety (UL 60601-1, IEC 60601-1), radiation protection (IEC 60601-1-3), Electromagnetic Compatibility (IEC-60601-1-2), and risk management (ISO 14971).
- System Description: How the detector integrates into a larger X-ray system.
- Intended Use: Acquiring digital radiographic images for routine, intensive care, trauma, and pediatric exams, excluding fluoroscopy, angiography, and mammography.
- Equivalence Information: Demonstrating substantial equivalence to a predicate device (Pixium 4600) and other existing Philips components for the workstation and pre-processing.
- Safety Information: Mature technology, compliance with standards, wireless transmission evaluation, and risk management.
- Conclusion: Stating substantial equivalence based on similar indications for use, technological characteristics, and no new hazards.
- FDA Clearance Letter: Confirming substantial equivalence based on the provided indications for use.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.