(22 days)
Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Trans-esoph. (non-Card.), Other (spec.)
Mode of Operation: B, M, Combined (Spec.) B+M, Other (Spec.) Note 1
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, and imaging for guidance of biopsy.
Note 2: Specification for "Other" (1) the airways and tracheobronchial tree.
Not Found
This document is a 510(k) summary for the OLYMPUS BF type UC160F-OL8 EVS EXERA Ultrasonic Bronchofibervideoscope.
The provided document describes the intended use and clinical applications of the device, which are limited to Diagnostic Ultrasound Indications for Use.
However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory submission outlining the device's classification and intended uses for substantial equivalence to a predicate device, not a performance study report.
§ 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.