(23 days)
The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is available in 5 mm short length, 5 mm regular length, 11 mm regular length, 12 mm regular length, and 12 mm long length sizes. The autosuture™ Modified VERSAPORT™ trocar with fixation sleeve has a sharp linear blade with a spring- loaded locking shield. Upon entry into a free space the shield advances to cover the blade, reducing the potential for injury to internal structures. The trocar sleeve contains an internal seal to prevent loss of pneumoperitoneum when instruments are inserted or withdrawn. The VERSASEAL™ self-adjusting seal accommodates instruments ranging from 5 mm to 12 mm and is designed to effectively reduce the seal diameter to allow insertion of smaller instruments. There is a stopcock valve for insufflation and rapid desufflation.
The provided text is a 510(k) summary for a medical device (autosuture™ Modified VERSAPORT™ trocar with fixation sleeve). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria, efficacy studies, or AI performance metrics as typically found in studies for AI-based medical devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or AI specific performance details (MRMC studies, standalone performance, etc.) because these details are not present in the provided document.
The "PERFORMANCE DATA" section states: "In-vitro and in-vivo tests were performed to verify that the autosuture™ Modified VERSAPORT™ trocar with fixation sleeve is substantially equivalent to the predicate devices in creation and maintaining a port of entry and to validate that the creation and maintaining a port of entry of a trocar with fixation sleeve will perform as intended."
This statement indicates that performance data exists to show substantial equivalence for mechanical/functional aspects (creating and maintaining a port of entry), but it does not provide the specific acceptance criteria or the results of these tests. It also does not mention any AI components or related performance metrics.
§ 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.