(38 days)
The Standard Trocar is a sterile, single-use device consisting of an obturator, a cannula, a 5mm adapter and introducer sheath. This system is indicated for use in general and abdominal minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
The Standard Trocar is a single-patient-use disposable trocar manufactured from biocompatible medical plastics. The device is comprised of a trocar cannula, obturator, 5 mm adaptor, and introducer sheath. The Standard Trocar is a sterile, single patient use surgical instrument intended to establish a port of entry for 19mm outer diameter instruments to be used during minimally invasive procedures. The 5 mm adaptor provides the means for the trocar to also be used with 5 mm diameter instruments. The trocar is compatible with commercially available laparoscopic instruments. In addition, as Standard Bariatrics develops additional laparoscopic instruments, the Standard Trocar will accommodate those devices. The Standard Trocar is sterilized using gamma irradiation and provided to the user in a Tyvek tray with peel lid.
The provided text describes the 510(k) premarket notification for the "Standard Trocar" and compares it to a predicate device, the "Applied Medical Modular Trocar." This document is a regulatory submission to the FDA, not a study report on an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and study details for an AI-powered device.
The document discusses performance testing for a medical device (trocar) in terms of its physical and mechanical properties, biocompatibility, and usability, demonstrating substantial equivalence to a predicate device. It does not involve any AI components, ground truth, expert consensus for AI model evaluation, or MRMC studies.
Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML device evaluation.
§ 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.