(112 days)
The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.
The Wexler Endoscope Accessories is a group of instruments used during endoscopic procedures such as thoracoscopy and laparoscopy. The instruments include clamps, forceps, needle holders, and scissors. The devices are made of stainless steel, and are supplied non-sterile.
The provided text describes a 510(k) submission for Wexler Endoscope Accessories. It does not contain information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert ground truthing, adjudication), or comparative effectiveness studies.
The submission focuses entirely on demonstrating substantial equivalence to a predicate device (Scanlan® thoracoscopic instruments, K945474) based on similar technological characteristics, intended use, and materials (stainless steel). The language used ("virtually identical," "no significant differences") suggests that formal performance studies with specific acceptance criteria were not required by the FDA for this particular submission, as the device is deemed sufficiently similar to an already cleared product.
Therefore, I cannot populate the requested tables and information. The document explicitly states:
- "There are no significant differences in either technology or performance specifications." This implies that performance testing beyond demonstrating substantial equivalence to the predicate was not performed or deemed necessary for this 510(k) clearance.
If this were a different type of submission (e.g., for a novel device or one with significant technological differences from predicates), such performance data would typically be included.
§ 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.