(178 days)
a. Processor EP-8000
- The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.
- This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.
- It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
- BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
b. Endoscope Model EG-860R
This product 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 Video Processor EP-8000 is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.
FUJIFILM Video Processor EP-8000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor employs fiber bundles to transmit light from four LED lamps (Violet, Blue, Green, and Amber), with a total power of 79.2W lamps, to the body cavity.
The EP-8000, like the VP-7000 and BL-7000, has additional image processing options called BLI, BLI-bright, and LCI that provide endoscopic assistance for white light imaging (WLI). There is also an additional image processing option called "ACI"(Amber-red Color Imaging).
ACI is an image processing function that simultaneously emphasizes the brightness and color difference of red information in endoscopic images and serves as an adjunct to white light imaging (WLI).
Compared to WLI mode, ACI relatively increases the ratio of amber red light and decreases the ratio of violet light.
Relatively high-saturation red information such as blood-like red in the image signal digitized by the camera unit is enhanced by signal processing.
The EP-8000 also has a Multi Observation option that allows endoscopic images to be displayed in the main screen area and sub-screen area by switching image processing options at every frame. This allows each image frame to be displayed in the main screen area and sub-screen area 1 with a different combination of image processing options applied [WLI+(LCI), LCI+(WLI), BLI+(WLI), WLI+(BLI)].
The device is AC operated at a power setting of 100-240V/50-60Hz/ 3.0-1.5A. The processor is housed in a steel-polycarbonate case measuring 395x210x515mm
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 and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.
The insertion portion 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, Instrument channel outlet, Objective lens, 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 Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The glass 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 and display the 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 and video processor, respectively.
The provided FDA 510(k) clearance letter and summary for FUJIFILM Processor EP-8000 and FUJIFILM Endoscope Model EG-860R focus on establishing substantial equivalence to predicate devices, primarily through engineering performance testing rather than clinical study data involving human readers or AI algorithms. The document explicitly states that the various imaging modes (BLI, LCI, ACI, FICE) are "adjunctive tools" and "not intended to replace histopathological sampling as a means of diagnosis." This indicates that the device operates as an image enhancement and visualization tool, not a diagnostic AI that makes independent claims.
Therefore, the study described in the document is a non-clinical engineering performance evaluation comparing the new device's image quality and functional parameters to those of existing predicate devices. It is not a clinical study involving an AI algorithm and human readers.
Here's an attempt to answer the questions based on the provided text, recognizing that many details typically requested for AI/human reader studies are not applicable or not provided in this type of 510(k) submission:
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format typical of standalone AI performance studies. Instead, it states that "the devices met the pre-defined acceptance criteria for the test" for the EG-860R, and for the EP-8000, "EP-8000 demonstrated substantial equivalence to VP-7000 and BL-7000 in Image performance and color reproduction." The acceptance criteria were "engineering requirements listed in this section" and "identical to those assessed for the predicate devices."
The "performance (of) Image and the performance of the WLI, FICE, BLI, BLI-bright, LCI and ACI imaging modes" was evaluated for the EP-8000. For the EG-860R, a range of performance characteristics was evaluated.
Table of Performance Evaluation (Based on provided text, not explicit acceptance criteria):
| Parameter Evaluated (EP-8000) | Description of Performance |
|---|---|
| Color Reproduction | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| Image Geometric Distortion | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| Image Resolution Performance | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| Depth of Field (DOF) Performance Test | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| ISO-SNR & Dynamic Range Performance | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| Image Intensity Uniformity | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| Field of View (FOV) | Demonstrated substantial equivalence to VP-7000 and BL-7000. |
| Parameter Evaluated (EG-860R) | Description of Performance |
|---|---|
| Image Geometric Distortion | Met pre-defined acceptance criteria. |
| Image Resolution Performance | Met pre-defined acceptance criteria. |
| Depth of Field (DOF) Performance Test | Met pre-defined acceptance criteria. |
| ISO-SNR & Dynamic Range Performance | Met pre-defined acceptance criteria. |
| Image Intensity Uniformity | Met pre-defined acceptance criteria. |
| Advanced Force Transmission | Met pre-defined acceptance criteria. |
| Adaptive Bending | Met pre-defined acceptance criteria. |
| Field of View | Met pre-defined acceptance criteria. |
| Bending Capability | Met pre-defined acceptance criteria. |
| Rate of Suction | Met pre-defined acceptance criteria. |
| Working Length | Met pre-defined acceptance criteria. |
| Diameter of Forceps Channel | Met pre-defined acceptance criteria. |
| Viewing Direction | Met pre-defined acceptance criteria. |
| Resolution | Met pre-defined acceptance criteria (same as reference devices). |
| LG Output | Met pre-defined acceptance criteria. |
| Uneven Illumination | Met pre-defined acceptance criteria. |
| Color Reproducibility | Met pre-defined acceptance criteria. |
| Air Volume | Met pre-defined acceptance criteria. |
| Water Volume | Met pre-defined acceptance criteria. |
Study Details:
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Sample size used for the test set and the data provenance:
This section describes engineering performance testing, not a clinical test set with patient data. The "test set" would refer to the physical devices and various test setups (e.g., optical phantoms, standardized targets) used to evaluate the specified engineering parameters. The document does not specify a "sample size" in terms of number of patient cases or images, as it is evaluating hardware and its image generation capabilities directly through engineering tests.- Provenance: Not applicable in the context of patient data. The tests were "conducted in combination with representative FUJIFILM gastroscopes."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context is established by the engineering specifications and calibrated measurement equipment, not clinical expert consensus. The device produces images; it does not make a diagnosis that would require expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical interpretation and consensus, which is not part of this engineering performance evaluation.
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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:
- No. An MRMC study was not performed. The submission describes engineering performance comparisons to predicate devices, not an evaluation of human reader performance with or without AI assistance. The new imaging modes (BLI, LCI, ACI, FICE) are explicitly stated as "adjunctive tools...not intended to replace histopathological sampling as a means of diagnosis."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm making independent diagnostic claims. The performance evaluated is that of the hardware (processor and endoscope) and its image enhancement capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and measurements. The "ground truth" for the performance tests (e.g., resolution, color reproduction, geometric distortion) would be derived from precisely known physical targets, measurement instruments, and established engineering standards. It is not clinical ground truth (e.g., pathology, clinical outcomes, or expert consensus) because the device's function is image generation and enhancement, not diagnostic interpretation.
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The sample size for the training set:
- Not applicable. This device is an endoscope and processor system, not a machine learning model that requires a training set in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this hardware device.
§ 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.