(231 days)
Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.
The proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.
The provided text is a 510(k) Pre-market Notification for a medical device, the Actreen® Hi-Lite Intermittent Urinary Catheters. This document details the process for obtaining FDA clearance for a device by demonstrating its "substantial equivalence" to a predicate device already on the market.
It's important to understand that a 510(k) summary does not contain the detailed clinical study results or statistical analyses that would typically be required to answer your specific questions about acceptance criteria for an AI/ML medical device, especially regarding aspects like MRMC studies, human-in-the-loop performance, or the nuances of ground truth establishment for complex image analysis.
The "studies" described in this document are primarily non-clinical performance tests demonstrating the physical, chemical, and biological safety and functionality of a physical medical device (a catheter) compared to an existing, similar catheter.
Therefore, many of your questions are not applicable to the information provided in this 510(k) summary. I can, however, extract the relevant "acceptance criteria" and "performance data" as presented for this specific type of device.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for an AI/ML context:
Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)
The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K180801) through various non-clinical tests. The "performance" is the successful outcome of these tests, confirming that the new device performs similarly and safely to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are for a physical urinary catheter, not an AI/ML device. They relate to material compatibility, physical properties, and sterility, as outlined in the referenced standards. The "performance" is the successful meeting of these standards, which is stated as a conclusion rather than detailed results.
| Category | Acceptance Criteria Type (Standard Reference) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1: 2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) - *specifically for surface-contacting devices, mucosal membrane, prolonged exposure (24 hours to |
§ 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.