(29 days)
The MICROVERTER Ureteral Access Device is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The device is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.
The MICROVERTER Ureteral Access Sheath consists of a film membrane covering an outer tube, and a pusher tube that provides a lumen for the introduction of endoscopes and instruments. The outer tube is pre-loaded with the film membrane.
The provided text, a 510(k) summary for the MICROVERTER Ureteral Access Sheath, states that "Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath and the predicate device." However, it does not explicitly list acceptance criteria nor detail the study that proves the device meets specific criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that if the predicate devices were deemed to meet performance and safety requirements, and the new device is substantially equivalent, it is also considered to meet those requirements.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document. The basis of acceptance is substantial equivalence to predicate devices. | "Performance data demonstrated no significant difference in the performance of the MICROVERTER Ureteral Access Sheath and the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any performance testing or the provenance (e.g., country of origin, retrospective/prospective) of the data. It merely mentions "Performance data."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the involvement of experts to establish ground truth for any test set.
4. Adjudication Method:
The document does not describe any adjudication method as it does not detail a study involving expert assessment of a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention or describe a MRMC comparative effectiveness study. As such, no effect size for human reader improvement with AI assistance can be reported. The device itself is a medical tool, not an AI diagnostic system.
6. Standalone Performance Study:
The document does not explicitly describe a standalone (algorithm only) performance study. The "Performance data" mentioned is likely a comparison of the device's functional characteristics to the predicate device, rather than an "algorithm only" study, as this is a physical medical device.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used. Given the nature of the device (ureteral access sheath), "ground truth" would likely relate to objective measurements of physical properties, functionality (e.g., ease of introduction, lubricity, fluid injection capabilities, integrity), or potentially in-vivo performance in animal models, rather than expert consensus on images or pathology. However, specific details are not provided.
8. Sample Size for the Training Set:
The concept of a "training set" is generally applicable to machine learning or AI models. Since this is a physical medical device and the document doesn't indicate the use of AI, the notion of a training set as typically understood does not apply in this context. The document does not provide information on any "training set" sample size.
9. How Ground Truth for the Training Set Was Established:
As the concept of a training set is not applicable (see point 8), the document does not describe how ground truth for a training set was established.
Summary of the Study (as inferred from the 510(k) Summary):
The "study" referenced in the 510(k) summary is not described in detail but broadly refers to the generation of "Performance data." The primary objective of presenting this data was to demonstrate that the MICROVERTER Ureteral Access Sheath has "no significant difference in the performance" compared to its predicate devices (PSI SLIP Urology Introducer Sheath, Cook Flexor Ureteral Access Sheath, Boston Scientific Navigator Ureteral Access Sheath). This approach is standard for 510(k) submissions, where substantial equivalence to legally marketed predicate devices is the pathway to clearance. The specific methods, sample sizes, or detailed results of this performance evaluation are not provided in the publicly available summary.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.