(82 days)
The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological, gynecologic and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber membrane. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shapememory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.
This submission, K030824, is for a medical device (LAP DISC Hand Access Device), not an AI/ML device. Therefore, the concepts of acceptance criteria, study data, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC, standalone algorithm) typically associated with AI/ML device evaluations are not applicable in this context.
The 510(k) summary provided indicates that this submission is for a device identical in technological characteristics to a previously cleared predicate device (K010870 and K020307), with the only differences being an expanded intended use statement and the addition of a measuring tape accessory.
The FDA's review for this type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and intended use. There is no mention of a study to prove acceptance criteria in the provided text because it is not relevant for this type of device submission.
§ 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.