(216 days)
THIS DEVICE IS INDICATED for USE IN ENDOSCOPIC SURGERY PROCEDURES for URETHROPEXY, INCLUDING FIXATION OF PROSTATIC MATERIAL, APPROXIMATION of TISSUES IN VARIOUS SURGICAL SPECIALTIES, SUCH AS REPAIR OF HERNIAS AND BLADDER NECK SUSPENSION
The Tacker is a device that consists of one disposable component and two permanently implantable components. The disposable component is a 45cm long stainless steel tube. The first permanently implantable component is a helical fastener. The second permanently implantable component is a PROLENE nonabsorbable "O" suture. The instrument is designed for introduction and use through an appropriately sized trocar sleeve or larger with the use of an appropriate seal.
The provided text is a 510(k) summary for a medical device called "Tacker." It describes the device, its intended use, and claims substantial equivalence to another marketed device. However, it does not include a study that details acceptance criteria and device performance in a way that allows for filling out the requested information.
Specifically, the text is a regulatory submission for premarket notification, focused on demonstrating substantial equivalence to a predicate device based on design and intended use, rather than presenting a detailed clinical study with performance metrics against acceptance criteria.
Therefore, I cannot provide the requested information from the given input.
Reasoning for inability to answer:
The document focuses on:
- Regulatory notification: It's a 510(k) submission to the FDA.
- Substantial equivalence: It claims the device is "substantially equivalent" to a predicate device, which is a regulatory pathway, not a performance study result.
- Device description and intended use: It provides details about the Tacker and its indications for use.
- Absence of study details: There is no mention of specific studies, acceptance criteria, results, sample sizes, expert qualifications, ground truth, or MRMC studies that would allow for the detailed table and answers requested.
§ 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.