(35 days)
The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.
The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.
The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.
The provided text describes a medical device, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, and its 510(k) submission for substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, I cannot fulfill the request as it pertains to AI/ML device testing and acceptance criteria based on the provided input.
The document details:
- Device Description and Indications for Use: What the catheter is and its intended purpose.
- Substantial Equivalence Claim: The manufacturer's claim that the device is substantially equivalent to previously cleared devices (Mentor Self-Cath Plus Catheter and Mentor Self-Cath Closed System).
- Summary of Testing (Biocompatibility): This section describes the tests performed to ensure the device is safe for biological contact. These are standard biocompatibility tests, not performance studies as would be conducted for an AI/ML algorithm.
The biocompatibility testing results essentially serve as the "acceptance criteria" and "reported performance" in this context, demonstrating that the materials are safe for their intended use.
Here's how I would present the available information if forced to apply the request's structure, while highlighting the mismatch:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Biocompatibility) | Reported Device Performance |
|---|---|
| Cytotoxicity (Agar Diffusion – ISO Method): No cytotoxicity or |
§ 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.