(118 days)
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.
The Fujinon GS Gastroscopes are medical endoscopes used for visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The G5 Gastroscopes are offered in a 200 and 400 series. The EG-250WR5 represents the G5 Gastrooscope 200 series and the EG-450WR5 represents the G5 Gastroscope 400 series. The G5 Gastroscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Gastroscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Gastroscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Gastroscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Gastroscopes are used in conjunction with other perified in the Operation Manual such as: Light Source / Processor / Cart / Data Keyboard / Foot Switch / Monitor / Video Printer / Camera and Hard Copy Unit / VCR / Electrosurgical Instruments.
The provided text describes a 510(k) submission for Fujinon G5 Gastroscopes, focusing on minor design changes compared to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI performance or diagnostic accuracy.
The submission aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic system. The changes are described as "minor" and related to usability, ergonomics, and cleaning, not to the fundamental diagnostic or treatment capabilities that would typically require extensive performance studies with defined acceptance criteria.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted based on the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (due to nature of 510(k) for minor design changes) | The subject device has been subjected to and passed EMC testing requirements. The patient contact materials in the Gastroscopes are identical to the materials used in the predicate device. |
| The device is "as safe and effective as the predicate devices." (This is the overarching conclusion of the 510(k) process, not a specific performance criterion against a quantitative metric). | Substantially equivalent to predicate Fujinon EG-400HR (K944620) and Fujinon EG-200FP (K944759). Minor differences in observation range, field of view, diameter, bending capacity, and length. |
Missing Information:
- No specific, quantitative performance acceptance criteria are mentioned (e.g., sensitivity, specificity, accuracy for a detection task).
- No quantitative device performance metrics (e.g., specific accuracy rates) are provided.
2. Sample size used for the test set and the data provenance: Not applicable. This submission is about minor design changes to an existing device, not a performance study on a test set (clinical or imaging data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No such performance study was conducted or described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No such performance study was conducted or described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This submission is for a gastroscope, not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission is for a gastroscope, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established as part of a performance study described in this document. The "ground truth" for the clearance is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set or ground truth establishment for such a set.
§ 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.