(342 days)
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.
Fujinon Colonoscope EC-530HL2 and EC-530LS2 are modified versions of our previouslycleared Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5 as described in K041903. The modified models are intended for observation, diagnosis, and endoscopic treatment of the lower digestive tract, which includes rectum, sigmoid colon, and large intestine, which remains the same as K041903.
The endoscopes are comprised of three general sections: an operation section, a flexible portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The flexible insertion portion contains glass fiber bundles, several channels and a charged couple device (CCD). The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity thereby providing enough light to the CCD to capture an image and display the image on the monitor. The endoscope also contains several channels to deliver air/water, provide suction and a working channel. The forceps channel or working channel is used to introduce endoscope accessories such as biopsy forceps. The umbilicus contains electronic components needed to operate the endoscope when plugged to the video processor and the light source.
The modified models are used in combination with Fujinon's video processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices.
This 510(k) premarket notification describes the Fujinon Colonoscopes EC-530HL2 and EC-530LS2, which are modified versions of previously cleared devices (K041903). The submission asserts substantial equivalence to the predicate devices and does not describe a new AI/ML-based device or a clinical study that evaluates its performance against acceptance criteria.
Therefore, most of the requested information cannot be found in the provided document.
Here's what can be extracted based on the input:
This submission did not involve an AI/ML device. It is for a medical device (colonoscope) and thus the following information is not applicable in the context of an AI/ML study.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria for diagnostic performance in the context of an AI/ML algorithm. Instead, it refers to compliance with safety and performance requirements for the colonoscope.
| Acceptance Criteria (Safety and Performance Requirements) | Reported Device Performance |
|---|---|
| IEC 60601-1 (General requirements for safety) | Evaluated in accordance |
| IEC60601-1-1 (Safety requirements for medical electrical systems) | Evaluated in accordance |
| IEC60601-1-2 (Electromagnetic compatibility) | Evaluated in accordance |
| IEC60601-2-18 (Safety of endoscopic equipment) | Evaluated in accordance |
| ISO10993 (Biological evaluation of medical devices) | Evaluated in accordance |
| Reprocessing instructions updated and validated | Updated and validated using a third party lab |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test was conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test was conducted.
4. Adjudication method for the test set: Not applicable. No clinical test was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: Not applicable. No clinical test was conducted. The ground truth for device safety and performance here would be compliance with the cited international standards and successful third-party validation for reprocessing.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary from the provided document:
The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Fujinon G5 Colonoscopes, Model EC-450HL5 and EC-250HL5, K041903). The modifications are described as minor dimensional changes, material changes, and relocation of the water jet inlet, which are stated not to adversely affect safety and effectiveness.
The "studies" mentioned are primarily focused on compliance with recognized international safety and performance standards for medical electrical equipment and biocompatibility, along with validation of reprocessing instructions. No clinical tests were conducted for this 510(k) submission to evaluate diagnostic performance of a new feature or an AI algorithm, as this is a device modification submission.
§ 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.