(105 days)
Aesculap's AdTec® is indicated for use in adult and pediatric (3.5mm instruments only) diagnostic and therapeutic general endoscopy and laparoscopy surgery.
AdTec® is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery. The system consists of single-use and reusable forceps, clamps, and scissors made of Stainless Steel with monopolar or bipolar capabilities. They facilitate in the grasping, cutting, and manipulation of soft tissue and blood vessels during laparoscopic procedures. The single-use instruments come completely assembled in one single piece, and are available in various lengths ranging from 220mm - 420mm. The reusable instruments are modular and consist of a jaw insert and an insulated outer tube with interchangeable ratcheting and non-ratcheting handles. They are also available in lengths ranging from 220mm - 420mm. The system also includes a single use trocar sleeve and a reusable trocar pin. The trocar sleeve is made of Grilon, and the trocar pin is made of Stainless Steel and PEEK. The trocar sleeve and trocar pin are available in a 3.5mm diameter and a 70mm length. They are accessories for the 3.5mm trocars cleared under K123102.
This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria (commonly seen for AI/ML devices). This is an FDA 510(k) clearance letter for the AdTec® surgical instruments, which are physical medical devices, not an AI/ML diagnostic or therapeutic device. As such, the types of performance studies and criteria you've asked about (e.g., sample size for test/training set, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission.
The document discusses substantial equivalence to predicate devices based on design, intended use, material composition, function, and range of sizes. It also briefly mentions a "failure mode and effects (FMEA) risk analysis" which identified no new risks, but this is not a study in the context of AI/ML device performance.
§ 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.