(83 days)
The Mauna Kea Technologies F-400 System is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.
The F-400 system is a confocal microscope with a fiber optic probe which allows in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure. The F-400 system has been designed to allow real-time observations of tissues. The device is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers and is thus composed of several elements: a Laser Scanning Unit, proprietary software running on a remote computer, a medical grade flat panel display and Miniaturized Fiber Optic Probes. The F-400 system can be used with any legally marketed endoscope with a working channel of 2.8 mm or greater.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for the Mauna Kea Technologies F-400 System, focusing on substantial equivalence to predicate devices, device description, and intended use.
The relevant section states:
"Accepted scientific methods were followed to conduct non-clinical testing, i.e., design verification and validation and testing to recognized standards. The purpose of this testing served to evaluate whether safety or effectiveness had been adversely affected by technological differences between the F-400 system and the predicate devices."
And further:
"In conclusion, the data from the non-clinical testing, i.e., design verification and validation and testing to FDA recognized standards demonstrated that the F-400 system is as safe and effective as all of the above mentioned predicate devices."
This indicates that non-clinical testing (design verification, validation, and testing to recognized standards in areas like electrical safety, electromagnetic compatibility, laser safety, biocompatibility, etc.) was performed to demonstrate that the F-400 system is "as safe and effective" as its predicate devices. However, specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) and the detailed results of a comparative study for these metrics are not provided in this summary.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or MRMC studies for a performance study. No clinical or comparative effectiveness study data is presented in 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.