(235 days)
This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, and rectum.
FUJIFILM Double Balloon Endoscope EI-580BT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps and balloons. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion 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 in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K143556 and K172916.
The provided text describes the regulatory clearance of the FUJIFILM Double Balloon Endoscope EI-580BT and outlines the performance data submitted to demonstrate substantial equivalence to a predicate device. However, it does not contain information related to a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, AI assistance, or an algorithm's diagnostic accuracy.
The performance data mentioned in the document focuses on:
- Electrical safety: Compliance with standards like ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, etc.
- Biocompatibility: Compliance with ISO 10993 standards.
- Endoscope specific testing: Compliance with ISO 8600 standards.
- Cleaning, high-level disinfection, and sterilization: Compliance with AAMI TIR standards and FDA guidance.
- Usability testing: Compliance with IEC 62366-1:2015.
- Bench testing: Validation of features like "Advanced Force Transmission" and "Adaptive Bending," and performance specifications for field of view, bending capability, rates of air/water/suction, working length, channel diameter, viewing direction, resolution, and LG output.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study proving the device meets these criteria in the context of diagnostic accuracy, human-in-the-loop performance, AI assistance, or algorithm-only performance, as this information is not present in the provided text.
The document pertains to the clearance of an endoscope, which is a medical instrument for direct visualization, not an AI or image-analysis diagnostic device. The "performance data" discussed are engineering and safety specifications typical for such a device, not metrics like sensitivity, specificity, AUC, or reader performance improvement often associated with AI/diagnostic software.
§ 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.