(142 days)
The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.
The Re-Trace Ureteral Access Sheath is comprised of the following components: Reinforced tube/sheath, Introducer/dilator, Connector, Clip. The reinforced introducer sheath is composed of a polyether block amide (PEBA) outer surface with a hydrophilic coating. The inner surface of the sheath is polytetralluoroethylene (PTFF). The sheath is reinforced with a stainless steel coil between the PEBA and PTFE materials. The distal tip of the sheath is fitted with a radiopaque ring. A white connector and orange clip is fitted on the proximal end of the sheath. The introducer/dilator is a radiopaque polyvinyl chloride (PVC). The introducer is fitted with a luer connector on the proximal end and has a hydrophilic coating on the distal end. A guidewire entry and exit eye and three exit holes for fluid delivery are located at the distal end of the introducer. A 4cm length Nitinol tube is inserted in the injection channel of the introducer to stiffen the guide wire exit eye section of this introducer.
The request concerns a 510(k) submission for the "Re-Trace Ureteral Access Sheath," focusing on modifications made to a previously cleared device. The provided text, however, details nonclinical (bench) testing and biocompatibility assessments, not a study evaluating device performance with human interaction or AI assistance. Therefore, many of the requested details about acceptance criteria, human study design, and AI elements are not present in the provided document.
Here's a breakdown of the information that can be extracted or inferred, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states that biocompatibility and performance testing were conducted, and the conclusions state that the modified device "is as safe and effective and performs as well as the predicate device." However, specific quantitative acceptance criteria or reported performance values for each test are not provided in the given text. The tests performed are listed as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity-MEM Elution | Met (Implied by conclusion) |
| Irritation-Intracutaneous Reactivity | Met (Implied by conclusion) |
| Sensitization-Guinea Pig Maximization | Met (Implied by conclusion) |
| Performance Testing: | |
| Break force/Tensile | Met (Implied by conclusion) |
| Fluid Delivery | Met (Implied by conclusion) |
| Coefficient of Friction | Met (Implied by conclusion) |
| Kink force/Folding Resistance | Met (Implied by conclusion) |
| Tip Flexibility | Met (Implied by conclusion) |
| Sterile Barrier/Dye Penetration | Met (Implied by conclusion) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document, as the tests described are nonclinical (bench testing) and biocompatibility studies, not human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the document describes nonclinical testing, not studies requiring expert interpretation or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes nonclinical testing.
5. 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 information is not applicable. The device is a ureteral access sheath, a physical medical device, not an AI-powered diagnostic tool or system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical tests described, the "ground truth" would be established by objective physical and chemical measurements and standard protocols for biocompatibility testing, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic or prognostic devices.
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm requiring a training set.
In summary, the provided document details a 510(k) submission for a modified physical medical device (Ureteral Access Sheath). The "study" referenced is a series of nonclinical bench tests and biocompatibility tests designed to demonstrate substantial equivalence to a predicate device. It does not involve human subjects, AI, or expert adjudication in the context of the requested questions.
§ 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.