(23 days)
The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
The OEC mobile workstation, which supports image display monitors, image processing and recording devices, is combined with a miniature C-arm to create the MINI 6800 Digital Mobile C-arm.
Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for North American markets, CCIR format for international markets, and DICOM 3.0.
The MINI 6800 has the following physical characteristics:
- . All components are contained in one mobile workstation.
- . An articulating arm is attached to the workstation and extends out from the main cabinet to position the x-ray imaging components.
- . All mechanical positioning of the workstation and articulating arm is manual (nonmotorized).
- . The system is powered by a non-detachable power cord.
- Power ratings between 100-240 VAC, 4-6 Amps at 50/60 Hz. .
- . Internal system power is insulated from input power by an isolation transformer.
- Fluoroscopic operation: .
- -- 40 to 80 kVp
- -- 20 to 160 µA (0.020 to 0.160 mA)
- Automatic Exposure Rate Control
Major components of the system include:
- Dual video monitors .
- Input isolation transformer .
- Digital image processing and x-ray control .
- Monoblock X-ray tube and high-voltage power supply .
- lmage intensifier ●
The provided text does not contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, or adjudication methods for the MINI 6800 Digital Mobile C-arm.
The document is a 510(k) Summary and a Substantial Equivalence Letter for the device. It focuses on:
- Device Description and Intended Use: General fluoroscopic visualization, surgical orthopedic, and extremity imaging, not for whole-body pediatric imaging.
- Substantial Equivalence: Comparing the MINI 6800 to other marketed mobile C-arms, stating they share similar functions and components (x-ray generator, image intensifier, video display, digital image processing).
- User Characteristics: Healthcare professionals trained in medical x-ray equipment.
- Technical Specifications: kVp, µA ranges, automatic exposure rate control, major system components (monitors, image intensifier, etc.), and physical characteristics.
- Standards Compliance: A list of product safety and electrical standards the device is designed in accordance with (e.g., 21 CFR 1020.30-32, ANSI/NFPA 70 & 99, UL 2601, various IEC standards).
Therefore, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study design, or performance metrics as this information is not present in the provided text. The document asserts conformity to various safety and performance standards ("designed in accordance with product safety requirements"), but it does not detail specific acceptance criteria for image quality, diagnostic accuracy, or any other functional performance and then report study results against those criteria. It is a regulatory submission for substantial equivalence, not a scientific publication detailing a performance study.
§ 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.