(178 days)
Fujifilm 600 Series Endoscope EC-600WL: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Fujifilm 600 Series Endoscope EG-600WR: 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 duodenum.
Fujifilm 600 Series (Water Tank, WT-4): This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL2 and EC-530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The proposed EG-600WR 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 is similar to K042043.
The endoscopes are comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels, and a complementary metal-oxide-semiconductor (CMOS) image sensor. 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 CMOS image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water, provide suction, and a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and light source.
The proposed models are used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscopic accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, cart).
The intended use, scientific fundamental technology and operating principle of the Water Tank WT-4 accessory, remains the same as the legally marketed Water Tank WT-2.
The minor modifications to the proposed devices were made for the purpose of overall product enhancement and general technological advancement.
The provided document describes the 510(k) premarket notification for Fujifilm 600 Series Endoscopes and the Water Tank WT-4, seeking substantial equivalence to previously cleared devices. It outlines the device description, indications for use, and the studies conducted to demonstrate safety and performance. However, this document does not contain information about a study that proves the device meets specific acceptance criteria related to a diagnostic algorithm or a specific performance metric like sensitivity or specificity. Instead, the studies presented are focused on demonstrating safety and compliance with recognized standards for medical devices.
Here's a breakdown of the requested information based on the provided text, with explanations where information is not present:
Acceptance Criteria and Device Performance Study for Fujifilm 600 Series Endoscopes and Water Tank WT-4
1. Table of acceptance criteria and the reported device performance
The document does not specify performance-based acceptance criteria (e.g., specific diagnostic accuracy thresholds, image quality metrics with acceptance levels) for the endoscopes or water tank. Instead, it lists safety and performance requirements (standards) to which the devices were evaluated and passed. The "reported device performance" is implicitly that the devices met these safety and performance standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Passed/Evaluated) |
|---|---|
| ANSI/AAMI ES60601-1 (General reqs. for basic safety & essential performance) | Passed evaluation |
| IEC60601-1-2 (Electromagnetic Compatibility) | Passed evaluation |
| IEC60601-2-18 (Safety of endoscopic equipment) | Passed evaluation |
| ISO10993-1 (Biological evaluation - general) | Passed evaluation (tested per ISO10993-5 and ISO10993-10) |
| ISO10993-5 (In vitro cytotoxicity) | Passed evaluation |
| ISO10993-10 (Irritation and skin sensitization) | Passed evaluation |
| ISO8600-1 (Optics & photonics - Medical endoscopes) | Passed evaluation (tested per ISO8600-3 and ISO8600-4) |
| ISO8600-3 (Field of view and direction of view) | Passed evaluation |
| ISO8600-4 (Maximum width of insertion portion) | Passed evaluation |
| Reprocessing instructions validated | Reprocessing instructions updated and validated |
2. Sample size used for the test set and the data provenance
The document clearly states: "No clinical testing was conducted." Therefore, there was no "test set" in the context of clinical or diagnostic performance evaluation with a sample size or data provenance. The evaluations were based on engineering, bench, and biocompatibility testing against recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical testing was conducted and no "test set" for diagnostic performance was used, there were no experts involved in establishing ground truth for such a purpose. The ground truth for the engineering and safety tests would have been the specifications of the standards themselves, verified by testing laboratories and engineers.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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. No MRMC study was mentioned, nor is this device an AI-assisted diagnostic tool. It is an endoscope and water tank.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or an AI system; it is a medical hardware device (endoscope and accessory).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the evaluations conducted (safety, biocompatibility, performance against technical specifications), the "ground truth" was defined by the requirements and methodologies outlined in the referenced international standards (e.g., IEC, ISO, ANSI/AAMI) that the device was tested against. For example, for biocompatibility testing, the ground truth would be the defined acceptable levels of cytotoxicity or irritation according to ISO 10993. For mechanical and electrical tests, it would be the published limits and methodologies in the respective IEC/ANSI/AAMI standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
Summary of the Study and Device Justification:
The studies performed for the Fujifilm 600 Series Endoscopes and Water Tank WT-4 were primarily bench testing, engineering verification, and biocompatibility evaluations to demonstrate compliance with recognized international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, ISO 8600 series).
The primary method for "proving the device meets acceptance criteria" in this context was demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon Colonoscopes EC-530HL2 and EC-530LS2, Fujinon G5 Gastroscope EG-450WR5, and Water Tank WT-2). The modifications were described as "minor modifications... for the purpose of overall product enhancement and general technological advancement." The lack of clinical testing further supports that the modifications were considered minor enough not to raise new questions of safety or effectiveness from a performance standpoint, allowing reliance on the predicate devices' established performance.
§ 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.