(272 days)
The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor. The ED34-i10T is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, cannula/forceps elevator, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connected to the video processor via electrical contacts. The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel. The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned. The remote button is used to operate the function of video processor and external device from the control body, as necessary. The detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use. Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel. The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the body cavity is displayed on the monitor.
This document is a 510(k) summary for the PENTAX Medical ED34-i10T Video Duodenoscope, which is a medical device and not an AI or software-only product. Therefore, much of the requested information regarding AI-specific criteria (like training set size, ground truth for training data, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
However, I can extract and describe the acceptance criteria and performance data provided for the device as a whole.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria/Methodology | Reported Device Performance |
|---|---|---|
| Detachable Distal Cap | Durability, chemical resistance, autoclave, ultrasonic wave cleaning resistance, operating environment, thermal shock, and vibration resistance. | Results of all testing were within the acceptance criteria. |
| O-Ring Analysis | Design change to achieve a recommended minimum compression of 10% for sealing the Elevator Channel. | Design change created to achieve the recommended minimum compression of 10%. |
| Optical Testing | Measurement of signal-to-noise ratio, spatial resolution (MTF), distribution, and spectral F-distribution for the ED34-i10T in conjunction with the EPK-i5010 video processor. | All results show no differences between the subject device (ED34-i10T) and the predicate device (ED-3490TK). The ED34-i10T has more pixels for optical visualization, but overall optical properties are equivalent. |
| Reprocessing Validation | Simulated use testing, cleaning, high-level disinfection (HLD) validation studies conforming to FDA's 2015 Reprocessing Guidance. Acceptance criteria established per AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency. | Acceptance criteria were met after each phase of reprocessing. The effectiveness of reprocessing procedures was confirmed. A human factors study for reprocessing instructions was also conducted. |
| Biocompatibility | Assessment of cytotoxicity, sensitization, and intracutaneous reactivity of surface device materials (limited contact |
§ 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.