(71 days)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTberapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)."
The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.
The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.
There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.
A sterile, single-use Distal Cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182 and K202661.
This document K220587 is a 510(k) Premarket Notification from Olympus Medical Systems Corp. regarding the EVIS EXERA III Duodenovideoscope Olympus TJF-Q190V.
Based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC). This document primarily addresses the substantial equivalence of device modifications to an existing predicate device, focusing on bench testing, sterilization, biocompatibility, and human factors.
The document explicitly states: "No clinical data were collected."
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it does not exist within this document for this specific device clearance.
Here's a breakdown of why each requested point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document discusses "performance testing bench," "sterilization validation," "shelf-life testing," "biocompatibility evaluation," and "human factors evaluation" as verification activities, but it does not specify quantitative acceptance criteria or reported performance metrics (like sensitivity, specificity, etc.) for the duodenoscope's diagnostic or therapeutic function.
- Sample sizes used for the test set and the data provenance: Not applicable in the context of a clinical performance study. The tests mentioned are engineering and safety validations.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with "ground truth" (e.g., disease presence) was performed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This document pertains to a medical imaging device (endoscope), not an AI/ML-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was performed.
- The sample size for the training set: Not applicable, as no AI/ML component is discussed.
- How the ground truth for the training set was established: Not applicable.
Summary from the document:
The 510(k) submission for the Olympus TJF-Q190V Duodenovideoscope focuses on design modifications to a sterile, single-use Distal Cover (MAJ-2315) used with the duodenoscope and labeling updates. The core duodenoscope device itself (TJF-Q190V) and the distal cover were previously cleared under K193182 and K202661. This submission aims to demonstrate that these specific modifications do not adversely affect device performance and that the device remains substantially equivalent to its predicate.
The non-clinical performance data summarized includes:
- Performance Testing Bench
- Sterilization Validation and Shelf-Life Testing
- Biocompatibility Evaluation
- Human Factors Evaluation
The conclusion is that the modified Distal Cover MAJ-2315 raises no new issues of safety and effectiveness and the device is substantially equivalent to the predicate device.
§ 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.