(29 days)
The GelPort Blunt Tip Trocar System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
The GelPort Blunt Tip Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.
The provided text is a 510(k) summary for a medical device (GelPort Blunt Tip Trocar System) and related FDA correspondence. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) for demonstrating the device meets performance criteria.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on performance and functional testing. The key statement is:
"The performance and functional testing of the GelPort Blunt Tip Trocar System compared to its predicate device demonstrated that the GelPort Blunt Tip Trocar System is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed."
This implies that the device was tested to ensure it functions similarly to the predicate device, but the specific acceptance criteria and results of these tests are not detailed in this summary. The FDA's 510(k) clearance process often relies on demonstrating equivalence rather than establishing new performance benchmarks with clinical studies, especially for devices like trocars.
Therefore, I cannot provide the requested information from the given text.
To answer your prompt, I would need a document that specifically outlines the performance study, its methodology, and its results against predefined acceptance criteria.
§ 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.