(11 days)
The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum.
The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum. The device is manufactured entirely from stainless steel is widely used in the medical field and biocompatibility is assured
The provided 510(k) summary for the "Maher Abdominal Wall Elevator" by Cook Urological, Incorporated and COOK OB/GYN® does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
This 510(k) summary is for a medical device (an abdominal wall elevator) that is likely a mechanical instrument. The typical "acceptance criteria" and "study" described in the input pertain to diagnostic algorithms or AI-driven devices, which require performance metrics like sensitivity, specificity, AUC, etc., and detailed clinical validation studies.
The information provided focuses on demonstrating substantial equivalence to a predicate device based on:
- Indications for use: Elevate/retract the abdominal wall for low-pressure laparoscopic procedures after pneumoperitoneum.
- Design and Construction: Entirely made from stainless steel.
- Materials equivalence: Stainless steel, which is widely used and biocompatible.
- Manufacturing quality: Manufactured according to specified process controls and a Quality Assurance Program.
Therefore, I cannot fill out the requested table or answer the questions because the document describes a traditional mechanical medical device, not an AI/diagnostic algorithm that would have such performance metrics and studies.
§ 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.