(265 days)
The AMSure® Bladder Irrigation Set is intended for the infusion of fluids to evacuate the bladder. It is also indicated for use in such procedures as cystoscopies and transurethral-resections as a means of continuous bladder irrigation.
The AMSure™ Bladder Irrigation Set is comprised of tubing with a catheter adapter at one end and “spikes” with protectors on the other end. The device is available in a single-lead (single spike), or multiple-lead (2 or 4 spikes) configuration. All configurations have a drip chamber and directly below the drip chamber is a roller clamp. There is a flexible, non-latex, synthetic rubber connecting tube, attached to the catheter adapter.
The provided 510(k) submission for the AMSure® Bladder Irrigation Set (K070873) describes a medical device and its non-clinical testing for safety and effectiveness. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/algorithm-driven device, nor does it detail a study that proves the device meets such criteria in the context of AI.
The information provided confirms that the AMSure® Bladder Irrigation Set is a urological irrigation system, and its submission indicates performance and biocompatibility testing were conducted. However, these tests are typical for a physical medical device and do not involve AI, machine learning, or software-driven diagnostic capabilities. Therefore, many of the questions regarding AI/algorithm performance, ground truth, expert review, and reader studies are not applicable to this submission.
Here's a breakdown of the requested information based on the provided document and why certain sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Performance and biocompatibility testing have demonstrated that the AMSure® Bladder Irrigation System is safe and effective for its intended use." However, it does not provide a table of specific acceptance criteria (e.g., fluid flow rates, pressure limits, material strength, sterility, etc.) or the quantitative results of these performance tests.
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical medical device, not an AI/algorithm. Performance testing would involve physical samples of the irrigation sets, not a "test set" of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI, refers to expert-validated labels for data. This device does not generate diagnostic outputs that require expert ground truth labeling.
4. Adjudication method for the test set
Not applicable. Adjudication methods are used in AI performance studies to resolve discrepancies in expert labeling or model outputs, which is not relevant here.
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
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. There are no "human readers" interpreting data with or without AI assistance for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm for this physical device that operates in a standalone capacity.
7. The type of ground truth used
Not applicable. As there's no AI/algorithm generating outputs to be evaluated against a ground truth, this concept doesn't apply. The "truth" for this device would be its physical properties and function meeting predefined engineering specifications and biological safety standards (e.g., non-toxic materials, sterile packaging).
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no "training set" in the AI sense.
9. How the ground truth for the training set was established
Not applicable. No AI training set.
§ 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.