(104 days)
The CoralWell™ Single-use Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Not Found
This FDA 510(k) clearance letter for the CoralWell™ Single-use Ureteral Access Sheath does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.
The letter is a regulatory document confirming that the FDA has reviewed MacroLux Medical Technology Co., Ltd.'s premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines various regulatory requirements the manufacturer must adhere to (e.g., Quality System regulation, UDI Rule, adverse event reporting), but it does not detail performance testing or clinical studies.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
- Sample sized used for the test set and the data provenance: Not available. The document is about regulatory clearance, not performance testing details.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available, as no performance study is described.
- Adjudication method: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical medical instrument (ureteral access sheath), not an AI/software device. Therefore, an MRMC study with AI assistance is not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as it's not an algorithm.
- The type of ground truth used: Not available.
- The sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
To obtain information about performance criteria and testing for such a device, one would typically need to review the actual 510(k) submission summary or a separate technical document from the manufacturer, which would contain details of bench testing, biocompatibility studies, and potentially animal or clinical performance data if submitted. The clearance letter itself is a summary of the FDA's regulatory decision, not a detailed technical report.
§ 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.