(177 days)
The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediativ use. The device can be used with staple line or tissue buttressing material.
The Intuitive Surgical SureForm 60 Reloads and accessories are intended to be used with a compatible da Vinci System for resection, transection of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical SureForm 45 Stapler, SureForm 45 Reloads and other Stapler accessories are intended to be used with a compatible da Vinci Surgical System for resection, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
The Intuitive Surgical 8 mm SureForm 30 Curved-Tip and 8 mm SureForm 30 Reloads and accessories are intended to be used with a compatible da Vinci Surgical System for resection of vasculature and tissue, and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric Surgery.
The Intuitive Surgical EndoWrist Stapler 30 Staplers, EndoWrist Stapler 45 Staplers, SureForm 45 Staplers, SureForm 60 Stapler, and 8 mm SureForm Staplers are fully wristed, articulating, surgical staplers and are designed for use exclusively with the Intuitive Surgical da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200 Systems). The staplers are controlled by the surgeon using the Surgeon Console of the IS4000/IS4200 Systems. They are intended for resection, transection and/or creation of anastomoses in surgery. The staplers achieve their intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The Reloads consist of a single-use cartridge that contains multiple staggered rows of implantable titanium alloy (Ti3A12.5V) staples. The reloads are sterile, single use devices that are offered in various configurations by product family. Each color represents a different staple leg height and tissue gap for use with various tissue thicknesses.
This document describes a 510(k) submission for surgical stapling systems and their reloads, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study data for AI/ML performance, sample sizes for test/training sets, expert consensus, MRMC studies, and ground truth establishment for AI/ML models is not applicable to this submission.
The 510(k) submission [K222839] for the Intuitive Surgical Inc. EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, and 8 mm SureForm 30 System concerns a modification (addition of a contraindication) to already marketed surgical stapling devices. The review focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and usability testing, rather than performance evaluation of an AI algorithm.
The "Usability testing" mentioned in the document is for the human use of the device, confirming surgeons can correctly select and safely use the device with the revised labeling, not for the performance of an AI algorithm.
§ 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.