(50 days)
The EchoBrush™ is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
The EchoBrush™ consists of a cytology brush for sampling submucosal gastrointestinal lesions. There is a handle attached to the proximal end of the device. The handle can be attached and locked onto the ECHO-19 Ultrasound needle. A white piece of shrink tube can be seen for a length of 9mm from the handle along the nitinol shaft. This will indicate to the user that the brush is about exit the tip of the needle.
The provided text describes a 510(k) summary for the Cook Ireland EchoBrush™ Device. It does not contain information about specific acceptance criteria, device performance metrics, or a study design that proves the device meets such criteria in terms of clinical effectiveness or diagnostic accuracy.
The "Test Data" section only mentions:
- "Non-Clinical testing was performed on characteristics and operational functions of the EchoBrush™ deemed necessary to verify safety and performance."
- "Genotoxicity (Ames Test): The results of this test indicated that under the experimental conditions, the extracts of this test article were not mutagenic for any tester strain, with or without any S9 activation."
- "Mentor also performed chemical testing to support a 36 month shelf life for the SCHG." (Note: "SCHG" appears to be a typo, likely referring to the device itself or a component).
This information pertains to safety and shelf-life testing, not clinical performance or diagnostic accuracy. Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as such details are not present in the given text.
The document's purpose is a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, primarily through safety and functional characteristics, rather than extensive clinical performance studies.
§ 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.