(49 days)
The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letters and "Indications for Use" document does not contain the specific information required to describe the acceptance criteria and the study proving the device meets those criteria.
The documents primarily focus on:
- Administrative corrections to trade names (Document 0).
- Substantial equivalence determination for the AquaShield System (Document 1).
- General regulatory information and compliance requirements for medical devices (Document 1 & 2).
- Indications for Use of the AquaShield System (Document 3), which states its purpose is to supply sterile water to endoscope procedures and its compatibility with US commercially available water bottles.
There is no mention of:
- A table of acceptance criteria or reported device performance.
- Sample sizes for test sets, data provenance, or details on training sets.
- Number or qualifications of experts, establishment of ground truth, or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical 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.