(186 days)
The Olympus GF-UM30P Ultrasonic Endoscope is intended to be used in combination with the Ultrasound System, EU-M20, for endoccopic ultrasound inaging of the gastrointestinal tract wall, billiary and pancreatic duct, and surrounding organs. This instrument also provide for Endoscopic Ultrasound (EUS) guided fine needle aspiration (FNA) to acquire submucosal tissue.
In examining the GI tract, endoscopic ultrasound may be indicated. The conventional type ultrasound endoscope does not provide the capability for ultrasonic guidance of endoscopic accessories (i.e. biopsy forceps, aspiration biopsy needles, etc.) The mechanically radially scanning GF-UM30P ultrasound endoscope provides this capability since the direction of the sonographic scan coincides with the geometric plane in which the accessory enters.
The subject devices operates in B mode using the de-aerated water immersion or balloon contact method and offers a 250° scan. The outer diameter of the insertion tube is 11.7 mm and it's working length is 1265 mm.
Both subject and predicate devices have similar design, construction, intended use, and method of operation. The only difference between the two is that the subject device's scanning plane is parallel, rather than perpendicular, to the axis of the insertion tube. The Olynpus Endoscopic Ultrasound System. EU-M20, received marketing clearance in the 510(k) # K926514.
The MAJ-213 Balloon will be provided clean and should be EtO sterilized before use. The balloon is intended for single use only and should be discarded after use. All other components and related ancillary equipment of the subject device will be marketed non sterile and can be reprocessed as described in the Instruction Manuals.
This document, K963023, is a 510(k) summary for a medical device (Olympus GF-UM30P Ultrasonic Endoscope). It does NOT contain information about acceptance criteria, device performance studies, or AI/algorithm-related details.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on:
- Device Name and Classification: Identifies the device as an ultrasonic endoscope.
- Intended Use: Describes how the device is meant to be used, including endoscopic ultrasound imaging and fine needle aspiration.
- Device Description: Details its features, such as scanning type, outer diameter, working length, and comparison to a predicate device.
- Sterilization and Reprocessing: Instructions for use of accessories.
There is no mention of acceptance criteria, study results, sample sizes (for training or test sets), expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI or algorithmic performance evaluation.
To answer your questions, I would need a different type of document, such as a clinical study report, a performance evaluation section from a regulatory submission, or a scientific publication describing a study on an AI-powered 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.