(83 days)
The hydrophilic guidewire is intended to facilitate the placement of devices through the urinary tract during endourologic procedures.
The Orchestra® Hydrophilic Guide Wire is a guidewire consisting of a metallic core wire with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. The guidewire is supplied sterile and non-pyrogenic.
The provided text describes the 510(k) summary for the Coloplast Orchestra® Hydrophilic Guidewire, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through an AI-based system.
Therefore, the information requested about acceptance criteria, device performance from an AI study, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text, as this device submission is for a physical medical product, not an AI/ML-driven solution.
The document states:
- Device Description: The Orchestra® Hydrophilic Guidewire is a metallic core wire with a polymer coating and a hydrophilic coating over a radiopaque polymer jacket, supplied sterile and non-pyrogenic.
- Intended Use: To facilitate the placement of devices through the urinary tract during endourological procedures.
- Predicate Device: Radifocus® Guidewire M from Terumo Medical Corp (K923607).
- Nonclinical Tests: Product performance testing compared the subject device to the predicate device and included: visual control, dimensional test, tensile test on guidewire, flexibility test for guidewire, X-rays opacity test, guidewire fracture test, guidewire flexibility damage resistance test, and oxidation test, and friction test.
Key takeaway regarding your request:
The document does not include information about AI/ML models, their acceptance criteria, performance metrics (like sensitivity, specificity), study designs for AI evaluation, sample sizes for AI testing or training, expert adjudication, or MRMC studies because the device in question is a physical guidewire, not an AI software. The "study" mentioned is a series of non-clinical, physical performance tests comparing the new device to a predicate device to establish substantial equivalence.
§ 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.