(649 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 ED-3490TK Video Duodenoscope must be used with a PENTAX compatible Video Processor (software controlled device). The endoscope has 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 device contains lightcarrying bundles to illuminate the body cavity and a charge couple device (CCD) to collectimage data. The instrumentcontains a working channel through which biopsy devices or other devices may be introduced. The Video Processor contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
This document is a 510(k) premarket notification for the PENTAX Medical ED-3490TK, Video Duodenoscope. The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic performance claim.
Therefore, many of the requested sections regarding AI/algorithm performance studies, such as specific acceptance criteria for diagnostic metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this submission. This is a medical device clearance for an endoscope, not an AI-powered diagnostic tool.
The document highlights changes to the device (distal end design, reprocessing procedures) and discusses non-clinical tests conducted to support safety and effectiveness.
Here's a breakdown based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI-driven diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and showing that design changes do not raise new questions of safety or effectiveness.
- Reported Device Performance:
- Safety and Performance Data (Non-clinical tests): "PENTAX Medical has conducted performance testing and design analysis to demonstrate the safety and effectiveness of the elevator wire channel seal, as well as the distal end cap seal strength and integrity."
- Biocompatibility: "Biocompatibility of the ED-3490TK was evaluated in accordance with ISO 10993-1."
- Software: "Software changes were made to enhance functionality and do not raise new or different questions of safety and effectiveness. Changes were validated in accordance with FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
- Reprocessing Validation: "Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. The following Technical Information Reports (TIRs) were referenced: AAMI TIR 12:2010, AAMI TIR30:2011."
- EMC and Electrical Safety: "No changes have been made to the EMC or electrical safety as compared to prior submission (K092710)."
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable for diagnostic performance. The document mentions "performance testing and design analysis" for mechanical and reprocessing aspects, but does not specify sample sizes in the context of a "test set" for a diagnostic algorithm because one is not being evaluated.
- The studies conducted are internal engineering and validation tests, not clinical studies with patient data for diagnostic evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This information is relevant for AI/diagnostic performance studies where ground truth is established by medical experts for image interpretation. This document pertains to an endoscope's mechanical and sterilization properties.
4. Adjudication Method for the Test Set:
- Not applicable. This applies to clinical diagnostic studies, not device engineering or reprocessing validation.
5. 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:
- No, an MRMC study was NOT done. This device is an endoscope, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was NOT done. This device is an endoscope, not an AI algorithm.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" would be established through engineering specifications, direct measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility, AAMI TIRs for reprocessing). It's not clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set:
- Not applicable. There is no AI algorithm being trained for this device notification.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no AI algorithm being trained for this device notification.
In summary, this 510(k) submission for the PENTAX Medical ED-3490TK Video Duodenoscope focuses on non-clinical testing (biocompatibility, reprocessing, mechanical integrity, software validation for functionality, EMC/electrical safety) to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic performance studies, and therefore, most of the requested fields regarding acceptance criteria and studies for AI performance are not relevant to this document.
§ 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.