(143 days)
The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
The NovaGold Guidewire is constructed from a steerable, metallic core with a PTFE polymer coating over the shaft. A hydrophilic coating is applied over the distal portion of the device. The guidewire has a radiopaque, floppy tip.
The provided document describes a 510(k) premarket notification for a medical device called the NovaGold™ High Performance Guidewire. This document specifically states that the submission is for establishing substantial equivalence to a predicate device, rather than a study demonstrating clinical effectiveness with acceptance criteria.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The provided text focuses on:
- Predicate Device: K122816; Endscopic Wire Guide manufactured by Wilson-Cook Medical.
- Device Description: Steerable, metallic core with PTFE polymer coating, hydrophilic coating over the distal portion, radiopaque floppy tip.
- Intended Use: Selective cannulation of biliary ducts (common bile, pancreatic, cystic, right and left hepatic ducts) and aiding in placement of diagnostic/therapeutic devices during endoscopic procedures.
- Functional and Safety Testing: Bench testing according to applicable standards and guidances, providing assurance of safety and effectiveness, and demonstrating equivalence to the predicate.
- Comparative Technology Characteristics: Similarities to predicate in intended use, operating principle, packaging/sterilization, nominal diameter, similar lengths, Nitinol alloy core wires, distal radiopaque tip, and lubricious coatings.
- Non-Clinical Tests Submitted:
- Biocompatibility: Cytotoxicity (L-929 MEM Elution, Colony Microassay by Elution), Guinea Pig Maximization Sensitization, Irritation (Intracutaneous Reactivity), Chemical Characterization.
- Bench testing: Coating adherence, corrosion resistance, dimensional measurements, fracture resistance, tensile strength, torqueability.
- Shelf Life Testing: 13-month accelerated aging.
The conclusion is that the NovaGold guidewire is equivalent to the predicate device based on equivalent intended use and no differences raising new safety/effectiveness questions. This is a common approach for 510(k) clearances for devices that do not introduce novel technology or a new intended use.
§ 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.