(88 days)
The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR™-8 and DUR™-8E are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.
Both the DUR™-8 and DUR™-8E are non-sterile, reusable flexible fiberoptic endoscopes. They feature a lubricious polyurethane outer covering, a patented cable compensation system, a patented torque-stabilization shaft construction, duel light transmission, a rotating light post, luer lock irrigation and biopsy ports, and a detachable light guide. The optics, illumination carriers, working channel, manufacturing methods and specifications of both devices are identical.
The DUR™-8E is a modification of the DUR™-8 designed to provide the clinician with greater control over the distal tip of the endoscope. The DUR™-8 has a passive deflection section, while the DURTM-8 Elite has an actively controllable section proximal to the primary active deflection section. A secondary deflection control lever has been added to the head of the DURTM-8 Elite.
The provided text is a 510(k) summary for the ACMI USA Series™ DUR™-8 and DUR™-8 Elite Flexible Ureteropyeloscope and Choledochoscope. It does not contain information about acceptance criteria or a study proving the device meets said criteria as requested in the prompt.
The document primarily focuses on:
- Device Identification: Proprietary name, common name, classification name.
- Sponsor Information: Contact details, date prepared.
- Predicate Devices: A list of previously cleared devices to which this device claims equivalence.
- Device Description: Detailed physical and functional characteristics of the DUR™-8 and DUR™-8E, highlighting the differences between the two models (active vs. passive deflection).
- Intended Use: Specific medical procedures and anatomical areas for which the devices are indicated.
- Technological Characteristics and Substantial Equivalence: The basis for claiming equivalence to predicate devices (similarities in indications for use, design, materials, technological, and operational characteristics).
- FDA Clearance Letter: Official communication from the FDA granting 510(k) clearance, confirming substantial equivalence to predicate devices, and outlining regulatory responsibilities.
- Indications for Use Statement: A formal statement of the device's intended uses.
Therefore, I cannot extract the requested information from the provided text. The prompt asks for details related to acceptance criteria, device performance metrics, sample sizes, expert qualifications, and study methodologies which are not present in this 510(k) summary. These types of details are typically found in validation reports, design control documents, or specific performance studies, which are not part of this submission summary.
§ 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.