(321 days)
neoClose® PDS is indicated for the approximation of soft tissue or prosthetic material during open or laparoscopic surgical procedures.
The neoClose PDS device consists of absorbable PDS Anchors and neoClose Drivers. The PDS Anchor consists of an absorbable PDS suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose PDS Anchor x 2 (NCPDSX2-U) and the neoClose PDS Anchor x 4 (NCPDSX4-U). The neoClose PDS Anchors and Drivers are provided sterile (EtO). The neoClose PDS Anchors are pre-loaded on neoClose Drivers, which are passed through soft tissue for subsequent soft tissue or prosthetic material approximation.
I am sorry, but the provided text does not contain information about the acceptance criteria and the results of a study that proves a device meets these criteria. The document is a 510(k) summary for a medical device called "neoClose PDS Anchor", which mainly focuses on demonstrating its substantial equivalence to a predicate device for regulatory clearance. It discusses the device's description, indications for use, and comparison with predicate devices. However, it does not include details on specific performance acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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.