(253 days)
The EP-6000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. BLI, LCI, and FICE are not intended for bronchoscopic examination.
FUJIFILM Video Processor EP-6000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor incorporates internal or external digital storage capacity. The processor employs fiber bundles to transmit light from three LED lamps, with a total power of 59.5W, to the body cavity. Brightness control is performed by the user. The processor provides for optional structural enhancement through user modes FICE, BLI, BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/2.0-1.1A. The processor is housed in a steel-polycarbonate case measuring 395x210x485mm.
This document describes the FUJIFILM Video Processor EP-6000, but it does not contain the requested information about acceptance criteria and a study proving the device meets those criteria.
The document primarily focuses on:
- Regulatory Clearance (510(k)): It's a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Specifies what the device is intended for, including endoscopic observation, diagnosis, and treatment using BLI, LCI, and FICE as adjunctive tools.
- Device Description: Explains the functionality, components, and physical characteristics.
- Comparison to Predicate Devices: Highlights differences such as the EP-6000 being a single unit for both video processing and light sourcing.
- Performance Data (General): Mentions that electrical, laser, photobiological safety, and software validation were evaluated against relevant standards. It also states that "Functional testing of the various image processing modes included Color Reproduction and Color Contrast Enhancement. All testing criteria were met, and the device functioned as intended in all instances."
However, this last point, "All testing criteria were met," is too high-level and does not provide:
- A specific table of acceptance criteria and reported device performance.
- Details about the study design: Sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or whether MRMC or standalone studies were conducted.
- No mention of training set size or ground truth for the training set.
Therefore, based solely on the provided text, I cannot fulfill your request for a detailed description of the acceptance criteria and the study that proves the device meets them. The document indicates that functional testing was performed and criteria were met, but it does not elaborate on what those criteria were or the specifics of the study.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.