(92 days)
The Kalera Vacuum Aspiration Catheter (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.
K-VAC is a sterile, single-use aspiration-irrigation catheter that is designed to assist in the removal of stone fragments during standard ureteroscopy. K-VAC is a dual-lumen catheter with two concentric lumens. The outer lumen is the irrigation lumen that accommodates delivery of irrigation/contrast solution. The larger, inner lumen is the aspiration lumen through which the stone fragments are removed. The inner diameter of the aspiration lumen is 2.5 mm. The distal 5 cm of the K-VAC tip is soft with a steering mechanism on the catheter handle and embedded wires to actuate the tip. In this way, stones and debris in the renal calyces can be fluidized with irrigation and aspirated.
An additional component to the device is a radiopaque introducer, which is 0.035" and 0.038" guidewire compatible. The tip of the introducer has a soft tapered tip.
The design of K-VAC allows the trained operator to maneuver and position K-VAC via a standard 12/14F ureteral access sheath under fluoroscopic guidance, followed by controlled irrigation and aspiration of stones and debris from the renal pelvis and calyces.
K-VAC is composed of well-characterized biocompatible materials commonly used in urinary catheters. The catheter is mechanical and contains no electrical components.
The provided text is a 510(k) summary for the Kalera Vacuum Aspiration Catheter (K-VAC), a medical device. It does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. Instead, it details the process for demonstrating substantial equivalence of a mechanical medical device to a predicate device, focusing on performance testing, biocompatibility, sterilization, and packaging/shelf life.
Therefore, I cannot extract the information required by your prompt, such as acceptance criteria for AI performance (like sensitivity, specificity), sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, because this document pertains to a physical, non-AI medical device.
The study described is a demonstration of equivalence to a predicate device (ClearPetra Suction-Evacuation Sheath, K161110) for a mechanical device, not the performance of an AI/ML algorithm.
Here's a breakdown of why this document doesn't fit your prompt's requirements for an AI/ML device:
- Device Type: The K-VAC is described as a "sterile, single-use aspiration-irrigation catheter" and "mechanical and contains no electrical components." This clearly indicates it's a physical medical device, not an AI/ML system.
- Performance Testing: The "Performance Testing" section outlines bench testing (dimensional conformance, flow, product cycling, tortuous path, actuation, torque, bond), animal studies (fluoroscopy, irrigation, aspiration in a porcine model), usability assessment, biocompatibility, sterilization, and packaging/shelf life. These are typical tests for mechanical medical devices, not AI/ML algorithms.
- "Acceptance Criteria" Context: The document refers to meeting "product specifications" and "design input requirements" related to the mechanical performance of the catheter. It does not mention any statistical thresholds for AI performance metrics (e.g., AUC, sensitivity, specificity).
- No AI/ML Specifics: There is no mention of algorithms, models, training data, test data, ground truth established by expert consensus for image interpretation, or any other elements common in AI/ML device validation.
In summary, the provided text is irrelevant to the prompt, as it concerns a mechanical medical device, not an AI/ML product.
§ 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.