(146 days)
WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
WiScope® OM Endoscope System is also intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
WiScope® OM Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney, and the pancreaticobiliary system including the hepatic ducts and the common bile duct. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
This system includes a single-use digital ureteroscope/choledochoscope and an image system.
WiScope® Single-Use Digital Flexible Ureteroscope/Choledochoscope is a modified version of the currently marketed WiScope Single-Use Digital Flexible Ureteroscope device that widen its application area from urinary system to bile ducts. Other than that, nothing has changed. The image system stays the same.
The provided FDA 510(k) summary for the "WiScope OM Endoscope System" focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than on performance against specific acceptance criteria derived from clinical study results of an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria, study details for proving device performance (such as sample size, expert ground truth establishment, MRMC studies, standalone performance, and training set information) is not present in the provided document.
The document states:
- "No clinical study is included in this submission." (Page 7, Section 10. Clinical Test Conclusion)
- The comparison focuses on "intended use, technological characteristics, and performance characteristics" relative to predicate devices, and claims the device is "as safe and effective as the predicate devices." (Page 4, Section 8. Comparison of Technological Characteristics)
- "Non-Clinical Test Conclusion" (Page 7, Section 9) refers to previous 510(k) submission K181977 and explicitly states: "There is no change on product design, materials and packaging. The no-clinical performance test stays the same as K181977." This implies that the current submission relies on previously established non-clinical performance, not new studies proving performance against acceptance criteria for an AI/ML component.
This 510(k) submission is for an endoscope system (a medical device), not an AI/ML algorithm that identifies or performs automated tasks. Hence, the questions related to AI/ML specific performance metrics (like sensitivity, specificity, clinical outcome improvement via AI, ground truth establishment for AI, etc.) are not applicable to the content provided.
§ 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.