(64 days)
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS DUODENOSCOPE with an instrument channel with a minimum diameter of @4.2mm.
The XCHF-B180Y1, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct. The XCHF-B180Y1 is basically identical to the predicate device, Olympus XCHF-BP Type 160F Choledochoscope, hereinaffer referred to as XCHF-BP160F in intended use, specifications, performance. The optical system of the XCHF-B180Y1 is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.
The provided document is a 510(k) premarket notification for a medical device, the OLYMPUS XCHF-B180Y1 Choledochoscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical study to establish acceptance criteria and performance against those criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them.
Here's a breakdown of why the requested information is absent based on the document:
- No acceptance criteria or device performance table: The document's closest equivalent to a performance table is the "Comparison of Specifications" (Table 13-2) which compares the subject device's technical specifications (e.g., Field of View, Depth of Field, Outer Diameter) to a predicate device. This is not a comparison of clinical performance or a statement of acceptance criteria for clinical outcomes.
- No mention of a test set, data provenance, experts, or adjudication method: These elements are characteristic of a clinical study designed to evaluate device performance against specific endpoints, which is not what a 510(k) submission typically requires for substantial equivalence. The document is comparing technical specifications and intended use.
- No MRMC comparative effectiveness study: The document does not describe any human reader study or any comparison of human readers with or without AI assistance. The device is an endoscope, not an AI-powered diagnostic tool.
- No standalone algorithm performance: As stated, this is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
- No type of ground truth mentioned: Ground truth is established for clinical endpoints, which are not being assessed in this 510(k) comparing technical specifications for substantial equivalence.
- No sample size for the training set or how ground truth was established for it: Again, these are concepts relevant to algorithm development and validation, not the submission for a physical endoscope demonstrating substantial equivalence.
In summary, the provided 510(k) document is for a traditional medical device (a choledochoscope) and demonstrates substantial equivalence by comparing its technical specifications and intended use to a legally marketed predicate device. It does not include information about clinical acceptance criteria or a study designed to prove the device meets such criteria.
The core of this 510(k) is found in "Table 13-2. Comparison of Specifications" and the accompanying text: "The XCHF-B180Y1 is similar to the predicate device XCHF-BP160F in specifications except for the material and optical system." and "When compared to the predicate device, the XCHF-B180Y1 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This is the "proof" the device meets the criteria for substantial equivalence, which is the regulatory hurdle for a 510(k), not a direct clinical performance study.
§ 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.