(230 days)
FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, and duodenum.
FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.
The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion with a knob which controls the bending portion. The forceps channel which runs through the the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.
The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.
This is a 510(k) summary for medical devices (endoscopes), and it refers to "bench testing data" and "performance specifications" being met, rather than clinical study results against acceptance criteria in the manner of an AI/algorithm-driven device.
From the provided text, there is no information about acceptance criteria or a study proving that an AI-driven device meets those criteria for the following reasons:
- Device Type: The devices described (FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP) are physical endoscopes for visualization, diagnosis, and treatment. They are not described as AI or software-as-a-medical-device (SaMD) products designed to process or interpret images/data using algorithms.
- Study Types Mentioned: The document refers to:
- Electrical safety evaluations (standards: ANSI/AAMI ES 60601-1-2012, IEC 60601-1-6:2020, IEC 60601-2-18:2009)
- Biocompatibility testing (standards: ISO 10993-5:2009, ISO 10993-10:2010, FDA guidance)
- Endoscope-specific testing (standards: ISO 8600-3:1997, ISO 8600-4:2014)
- Software-specific testing (standard: IEC 62304:2015, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) - This refers to software within the device, not a standalone AI algorithm for medical image analysis.
- Cleaning and disinfection validation (FDA guidance)
- Additional testing for physical parameters like Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Resolution, LG output, Uneven illumination, Viewing direction, Color reproducibility.
The phrase "Resolution" is listed twice, implying a focus on the optical performance of the endoscope itself.
Therefore, the information required for your request (acceptance criteria, study details for an AI-driven device) cannot be extracted from this document because it pertains to the clearance of a traditional medical device (an endoscope) and not an AI/algorithm-based diagnostic or treatment tool.
If this were an AI device, the document would typically contain sections explicitly detailing:
- The AI algorithm's intended use and function (e.g., detecting polyps, classifying lesions).
- Specific performance metrics (e.g., sensitivity, specificity, AUC) for the AI.
- The clinical study design, comparator (e.g., human experts), and statistical analysis.
- Details about the dataset used (test set, training set, ground truth derivation).
§ 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.