(62 days)
To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures
The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.
The provided text is a 510(k) summary for the Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Clips. This document asserts substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria, device performance, or ground truth.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on similarity to already approved devices rather than new performance data.
§ 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.