(119 days)
The 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.
The Fujinon G5 Colonoscopes are medical endoscopes used for visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The G5 colonoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 Scopes do not have a lens wash port. The J-Port was repositioned. A G5 forceps inlet port was modified. The jet wash line check valve was removed. The suction and air/water cylinders and valves were upgraded. The G5 colonoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. Upgrade to CA-500 cleaning adaptor. The G5 colonoscopes are used with a processor (EPX-201 for EC-250HL5 and VP-402 for EC-450HL5), a colonoscopy unit, and a cart. Each colonoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, adapters, valves, and the Operation Manual. The Fujinon G5 colonoscopes are used in conjunction with other peripherals specified 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fujinon G5 Colonoscopes:
Overview:
The provided document is a 510(k) summary for the Fujinon G5 Colonoscopes. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a PMA (Premarket Approval) application.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicit acceptance criteria defined in a quantitative, measurable manner for the performance of the Fujinon G5 Colonoscopes as a standalone device. Instead, the entire submission hinges on demonstrating substantial equivalence to existing predicate devices.
The "performance" is implicitly defined by the device's technological characteristics and its similarity to the predicate.
| Feature / Characteristic | Predicate Device Specification (Implicit Acceptance Criteria) | Fujinon G5 Colonoscopes Reported Performance |
|---|---|---|
| Indications for Use | "visualization of the lower digestive tract, for observation, diagnosis, and endoscopic treatment of the rectum and large intestine." | "visualization of the lower digestive tract, for observation, diagnosis, and endoscopic treatment of the rectum and large intestine." |
| Composition of Patient Contact Materials | Identical to predicate device | "identical to the materials used in the predicate device." |
| Viewing Direction | Forward | Forward |
| Observation Range | K944620 (EC-400HL): Not explicitly stated, but assumed to be within acceptable clinical range | EC-450HL5: 3-100mm; EC-250HL5: 7-100mm (These range specifications may differ slightly but are considered "minor differences" and acceptable within the context of substantial equivalence). |
| Field of View | K944620 (EC-400HL): Not explicitly stated, but assumed to be 140 degrees for equivalence. | EC-450HL5: 140 degrees; EC-250HL5: 140 degrees |
| Image Size | Super Image | Super Image |
| Bending Capacity | K944620 (EC-400HL): Not explicitly stated, but assumed to be similar. | UP: 180 deg, DOWN: 180 deg, LEFT: 160 deg, RIGHT: 160 deg (for both models) |
| Reprocessing/Sterilization Method | Same method as predicate | Same method as predicate |
| Processors and Peripherals | Same as predicate devices | Same as predicate devices |
| Electromagnetic Compatibility (EMC) | Met EMC testing requirements (implicit) | "subject device has been subjected to and passed EMC testing requirements." |
2. Sample Size for Test Set and Data Provenance
The document does not describe a "test set" in the traditional sense of evaluating a new device's performance against ground truth data. Instead, it relies on demonstrating equivalence to predicate devices which have already been cleared.
- Sample Size: Not applicable in the context of this 510(k) submission for direct performance testing. The "sample" is the device itself and its technical specifications compared to the predicate.
- Data Provenance: Not applicable for performance data generation. The data provenance relevant here refers to the previous clearance of the predicate devices (K944620 and K944759), and the previous clearance of the G5 upgrade in K040048. These are regulatory clearances, not clinical study data provenance.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. Ground truth, in the context of clinical performance, was not established for this 510(k) submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess reader performance with and without an AI aid, or to compare different diagnostic methods. The Fujinon G5 Colonoscopes are endoscopes, primarily tools for visualization and intervention, not an AI-assisted diagnostic system.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone performance study was not done. This device is a physical endoscope with minor design changes, not a standalone algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for this 510(k) submission. The "ground truth" for the predicate devices' safety and effectiveness would have been established through their initial clearances (which might have involved clinical data, engineering analyses, etc.), but this document relies on similarity to those cleared devices. For the G5 colonoscopes themselves, the "truth" being established is their equivalence to the predicate via technical specifications and existing regulatory clearances.
8. Sample Size for Training Set
- Sample Size: Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 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.