(175 days)
The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.
The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.
This document is a 510(k) summary for a medical device (Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray), which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain the kind of information requested in your prompt (acceptance criteria, device performance metrics, study design, expert evaluation, etc.).
The information you are looking for is typically found in clinical studies, validation reports, or performance testing summaries, which are distinct from a 510(k) summary. A 510(k) summary primarily addresses the device's intended use, technological characteristics, and comparison to a predicate device to establish that it is as safe and effective.
Therefore, I cannot fulfill your request using the provided input because it does not contain the necessary details about acceptance criteria or a study proving device performance.
§ 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.