(82 days)
The Zutron Medical ZUTR-1003 Endoscope Leak Tester is designed to detect interior and exterior leaks in endoscopes.
The Zutron Medical Endoscope Leak Tester is a leak testing device that detects damage to the interior or exterior of an endoscope.
The provided text is a 510(k) premarket notification letter from the FDA regarding the Zutron Medical ZUTR-10003 Endoscope Leak Tester. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed performance studies.
The document states that "The device has passed internal testing and electrical safety testing requirements," and concludes that it is "substantially equivalent to the predicate device." However, no specific details about the methodology, sample sizes, or results of these tests are provided.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document only generally states that the device passed "internal testing."
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable/provided. This device is an endoscope leak tester, not an AI-assisted diagnostic tool that would typically involve human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/provided in the context of an endoscope leak tester. Its function is to autonomously detect leaks.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not applicable/provided. This device is not an AI/ML product where "training set" would apply in the usual sense.
- How the ground truth for the training set was established: Not applicable/provided.
In summary, the provided FDA letter confirms the regulatory clearance for the Zutron Medical ZUTR-10003 Endoscope Leak Tester based on substantial equivalence, but it does not detail the specific performance studies, acceptance criteria, or experimental methodologies that would answer the requested questions. Its primary purpose is to inform of the FDA's decision regarding market clearance, not to be a scientific report of the device's performance characteristics.
§ 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.