(260 days)
This device is used for endoscopic cannulation of the ductal system. This device is indicated for adult use only.
The subject devices consist of a catheter with a T-fitting, a Y-body connector, a hub, or a female luer lock on the proximal handle and 3 MM markings at the distal radiopaque tip.
The device distal tip configurations include stainless steel metal, tapered, dome and/or angled tips. ERCP catheters are available in single, double, or triple lumen configurations. All devices have an injection port/wire guide port. Some catheters include a stylet wire to facilitate advancement of the catheter, which is removed prior to wire guide insertion or contrast injection. ERCP catheters are used by passing the device through an endoscope. The injection port/wire guide port is then used to allow fluoroscopic visualization by injecting contrast and/or wire guide access to the desired duct.
This document describes the Cook Medical ERCP Catheters (ERCP, GT, FS-GT, HRC, and SUC) and their substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore no information relevant to the acceptance criteria of such a device can be extracted.
No information available for the requested sections:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.