(86 days)
The LQET Cannula/Trocar System provides access for instruments during laproscopic/endoscopic surgical procedures.
The LifeQuest Endoscopic Technologies, Inc., (LQET) CannulaTrocar System is composed of several components: cannula system, trocar/obturator, sealing caps, valve, and accessories. The cannulas are have working lengths of 40-110mm and internal diameters of 3-20mm. Single and Multi Port Caps are available. The trocars are available in pyramidal, blunt and conical shaped configurations with lengths and diameters to fir the cannulas. Both shielded and non-shielded trocar configurations are available. Cannula Accessories such as Hassan Suture Anchors, Stopcocks and Sealing Caps are available with the LQET Cannula/Trocar System. All devices that are provided sterile to the user are sterilized by ethylene oxide by the manufacturer. Reusable devices are recommended for sterilization by autoclave at the user facility.
The provided text does not contain acceptance criteria or a study that establishes device performance against such criteria.
The document is a 510(k) summary for the LQET Cannula/Trocar System, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific performance level of the device itself through a formal clinical study.
Here's what the document does mention regarding "performance data," and why it doesn't fit your request:
- "The LQET Cannula/Trocar System was subjected to performance bench testing in accordance with applicable industry and clinical standards." This is a general statement.
- "A study to determine the effectiveness of the recommended cleaning procedures was performed and found to be acceptable." This relates to cleaning protocols, not the primary function or safety of the device in a clinical setting.
- "The effectiveness of the recommended steam sterilization cycle for reusable components was performed and found to be acceptable." Again, this relates to sterilization, not the device's functional performance.
- "Several bench tests were performed to verify that the device performs as intended and that repeat sterilization of the components showed no effect to the device function." This is the closest statement to performance, but it lacks any specific metrics, acceptance criteria, or quantitative results. It's a high-level summary of verification testing.
Therefore, I cannot populate the table or answer the specific questions about the study, sample sizes, experts, or ground truth, as that information is not present in the provided text.
The document's purpose is to show that the LQET Cannula/Trocar System is "substantially equivalent" to existing, legally marketed devices. This means it has similar intended use, technological characteristics, and safety/effectiveness profiles, based on a comparison to predicate devices, rather than through a a de novo clinical performance study with 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.