(28 days)
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues: and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.
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.
These Video Duodenoscopes must be used with a PENTAX compatible Video Processor (software controlled device). The endoscopes have a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.
There is no information in the provided document about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
The document is a 510(k) premarket notification letter from the FDA to PENTAX of America, Inc., regarding PENTAX Medical ED3490TK Video Duodenoscope and PENTAX Medical ED34-i10T Video Duodenoscope.
The focus of the document is on establishing substantial equivalence to a predicate device (PENTAX ED-3490TK Video Duodenoscope, K161222), primarily based on intended use, technological characteristics, and safety/effectiveness considerations, rather than detailed performance study results of the type requested.
Specifically, the document states:
- Performance Data: "No performance standards or special controls applicable to these devices have been adopted under Section 513 or 514 of the Federal Food, Drug, and Cosmetic Act."
- Technological Characteristics: The differences between the subject devices and the predicate device are listed as "O-ring Thickness" and "Elevator Link Concentricity." The proposed design change to the O-ring was to demonstrate a "minimum of 10% Compression Ratio," and it is stated that "Through analysis, the modification has demonstrated a Compression Ratio that met the pre-determined acceptance criterion." This is the only mention of an acceptance criterion and its fulfillment by analysis, not by a detailed clinical or performance study with the metrics you've requested.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a regulatory clearance based on substantial equivalence, with a focus on design changes and their impact on safety and effectiveness, rather than a detailed performance study with clinical or AI-related metrics.
§ 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.