(31 days)
These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
The Intermittent Urethral Catheters consist of a tubular shaft with attached funnel as the connecting device. PVC material used in the catheter. The product sizes range from 10 Ch. to 24 Ch. The device shaft is uncoated.
This document, a 510(k) summary from the FDA for the Rusch Intermittent Urethral Catheter, does not contain the information requested about acceptance criteria and a study proving a device meets them for an AI/ML medical device.
The document is a submission for a traditional medical device (a catheter), not an AI/ML diagnostic or prognostic tool. Therefore, it discusses:
- Substantial Equivalence: The primary focus is on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K173596).
- Device Description: Details on the physical characteristics and materials of the catheter.
- Indications for Use: What the catheter is intended for (routine drainage of urine).
- Changes: The only change mentioned is to the labeling (adding contraindications to the Instructions for Use).
None of the requested information regarding AI/ML device performance studies, such as:
- Table of acceptance criteria and reported device performance: This would be relevant for an AI's accuracy, sensitivity, specificity, etc., which is not applicable here.
- Sample size, data provenance, experts for ground truth, adjudication method: These are specific to evaluating AI model performance on a test dataset.
- MRMC study, standalone performance, type of ground truth, training set details: These are all methodologies used to validate AI models.
In summary, this document is about a low-risk, non-AI medical device and therefore does not include the details of an AI/ML performance study.
§ 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.