(268 days)
FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. These products are intended to be used with a FUJIFILM ultrasonic processor. These products are not intended for use on children and infants.
FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a chargecoupled device (CCD) image sensor in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K181763.
The provided text is a 510(k) summary for the FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR. It describes the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument.
However, the document does NOT contain information about an AI-powered device or an AI performance study. Instead, it describes a medical device undergoing a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering performance, electrical safety, biocompatibility, and reprocessing validation.
Therefore, for the specific questions related to AI device acceptance criteria and performance study details (sample size for test set, data provenance, number of experts, adjudication, MRMC studies, standalone performance, ground truth, training set size), the provided text does not contain the information required to answer them.
The document primarily focuses on the physical and functional aspects of the endoscopes, such as control portion, insertion, umbilicus, and their compatibility with other FUJIFILM equipment. The performance data mentioned are related to:
- Electrical safety: evaluated using standards like ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, etc.
- Biocompatibility: evaluated using standards like ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
- Endoscope specific testing: evaluated using standards like ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
- Cleaning, high-level disinfection, and sterilization: evaluated according to AAMI TIR12:2010, AAMI TIR30:2011.
- Additional functional testing: including field of view, resolution, bending capability, working length, diameter of forceps channel, rates of suction, air supply, water supply, balloon water supply, balloon suction, viewing direction, LG output, axial resolution, lateral resolution, and penetration depth.
These are all standard tests for a physical medical device and do not involve AI or machine learning algorithms.
§ 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.