(157 days)
FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, and EC-760ZP-V/L have following indications for use.
FUJIFILM Endoscope Models EG-760R and EG-760Z are intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Models EC-760R-V/L and EC-760ZP-V/L are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM Water Tank Model WT-603 has following indications for use.
This product is intended for use in combination with FUJIFILM 700 system scopes 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 Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscopes. This portion also controls the flexibility of the distal end in the endoscopes. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide- semiconductor (CMOS) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. 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 umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source.
FUJIFILM Water Tank Model WT-603 consists of a container which holds the sterile water and a tank cover which provides delivery of water through the channel tube to the distal end of an Endoscope.
The subject devices are 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 K132210, K162622 and K163675.
This document describes the regulatory submission for several models of FUJIFILM Endoscopes (EG-760R, EG-760Z, EC-760R-V/L, EC-760ZP-V/L) and the FUJIFILM Water Tank Model WT-603. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily the Fujifilm 600 Series Endoscope Model EG-600WR and Water Tank Model WT-4 (K132210), and the Fujifilm Video Colonoscope Model EC-600WL v2 (K160196).
Based on the provided text, the acceptance criteria and study details are primarily focused on bench performance testing and compliance with established consensus standards, rather than clinical studies with human readers or specific statistical performance metrics (like sensitivity, specificity, AUC) against a ground truth.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed and states that the devices met pre-determined acceptance criteria and performance specifications. However, the document does not explicitly state the numerical acceptance criteria or specific quantitative performance values for each test. It broadly states that the devices met "pre-determined acceptance criteria" and demonstrated "substantially equivalent performance" to predicate devices.
| Acceptance Criterion Category | Reported Device Performance | Comments |
|---|---|---|
| Electrical Safety | Met pre-determined acceptance criteria; evaluated using ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009. | No specific numerical criteria or results provided. |
| Biocompatibility | Met pre-determined acceptance criteria; evaluated using ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. | No specific numerical criteria or results provided. |
| Endoscope Specific Testing | Met performance specifications for: Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, LG output, Flexibility adjustment mechanism. Evaluated using ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014. | No specific numerical criteria or results provided. |
| Cleaning, Disinfection, Sterilization | Met pre-determined acceptance criteria; evaluated according to AAMI TIR12:2010, AAMI TIR30:2011, and FDA's guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). | No specific numerical criteria or results provided. |
| Backflow Prevention (AW-603 valve) | Met pre-determined acceptance criteria; evaluated in compliance with FDA's Guidance "Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes" (January 20, 2015). | No specific numerical criteria or results provided. |
| Overall Equivalence | Bench testing data demonstrated substantially equivalent performance and safety to respective predicate devices. New functions (optical zoom, flexibility adjustment, Scope Connector) do not raise new safety/effectiveness concerns, supported by reference devices and prior clearances. | No specific numerical performance metrics are provided for this equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench performance testing of physical devices/components, not a test set of data (e.g., images for an AI algorithm).
- Sample Size: Not explicitly stated. The testing would have involved a number of manufactured devices/components rather than a "test set" in the context of data.
- Data Provenance: Not applicable in the context of data provenance for an AI algorithm. The tests were performed on the physical devices themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as the submission describes testing of endoscope hardware and reprocessing procedures, not an AI or diagnostic device that requires expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated above.
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:
No, an MRMC comparative effectiveness study was not done. This submission pertains to the hardware and reprocessing of endoscopes, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This submission is for endoscope hardware and related accessories, not an AI algorithm.
7. The Type of Ground Truth Used:
For the performance testing described, the "ground truth" would be established by the compliance with the specified international and national consensus standards (e.g., ISO, IEC, AAMI) and the device's own pre-determined engineering specifications. This is distinct from pathology, expert consensus on images, or outcomes data. The tests are designed to objectively measure physical characteristics and safety in comparison to these standards and the predicate device.
8. The Sample Size for the Training Set:
This information is not applicable as this submission is for endoscope hardware, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated above.
§ 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.