(78 days)
The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.
Radius Medical Technologies, Inc. has developed a line of Endoscopic guidewires ranging in sizes of 0.025" to 0.035" diameter and lengths of 260 cm to 450 cm (in standard and stiff body types). The wires will be offered with a 5 cm radiopaque distal tip (angled and straight). The wires are constructed of a solid nitinol core wire, which tapers at its distal end. A shrink jacket surrounds the core over the entire length except the distal most 5 cm. A radiopaque tube covers the distal 5 cm. Single striped bands of ink are placed circumferentially onto the jacket and spaced in 1 cm intervals beginning at the 6 cm location and continuing to the 40 cm location from the distal tip. Multiple ink bands are used to delineate the 10, 15, and 20 cm locations. A coating is applied over the tip portion of the guidewire.
This document is a 510(k) premarket notification for the Radius Medical Technologies Next Generation Guidewire and does not contain information regarding an acceptance criteria table, device performance metrics, detailed study designs, or AI/ML components. Therefore, I cannot provide the requested information.
The document primarily focuses on:
- Regulatory information: Device classification, regulation numbers, product codes, and substantial equivalence determination.
- Device description: Physical characteristics, materials, and sizing of the guidewire.
- Intended use: To guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures.
- Predicate devices: Comparison to existing legally marketed guidewires.
- Performance testing (general statement): Mentions various tests performed (distal tip tensile, torqueability, tip flexibility, coating adherence/integrity, and electrical resistance) but does not provide specific acceptance criteria or detailed results.
There is no mention of an AI/ML component, expert ground truth, sample sizes for AI model training/testing, or MRMC studies in this document.
§ 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.