(109 days)
The AMSure ™ PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.
The AMSure ™ PVC Intermittent Catheter is a sterile, single- use patient device, compromising a PVC tubing and funnel.
This document describes a Special 510(k) Submission for the AMSure™ PVC Intermittent Catheter. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to its predicate device. As such, the focus of the submission is on demonstrating that the modifications do not raise new questions of safety or effectiveness.
Therefore, the provided text does not contain information about:
- Acceptance criteria in the context of specific performance metrics for a novel device.
- A "study that proves the device meets the acceptance criteria" in terms of clinical performance or diagnostic accuracy.
- Sample sizes for test sets or training sets in the context of algorithm development.
- Data provenance, expert ground truth establishment, or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Instead, the document focuses on:
- Non-Clinical Testing: "Performance and biocompatibility testing has demonstrated the safety and effectiveness of the AMSure™ PVC Intermittent Catheter for its intended use." This is very general and does not provide specific criteria or results.
- Comparison to Predicate: "The AMSure™ PVC Intermittent Catheter is a configuration and label modification of the AMSure™ Urethral Catheterization Tray (K030712) and is intended for the same use." This implies that the device meets the same performance standards as the predicate device by virtue of being a minor modification.
Based on the provided text, the specific information requested in your prompt cannot be extracted because the submission is for a medical device (catheter), not an AI/software device, and thus the acceptance criteria and study designs are fundamentally different.
The document confirms that:
- Device Name: AMSure™ PVC Intermittent Catheter
- Intended Use: For use in the drainage of urine from the bladder.
- Predicate Device: AMSure™ Urethral Catheterization Tray (K030712)
- Changes: Configuration and label modification.
- Testing: Performance and biocompatibility testing was performed to demonstrate safety and effectiveness. (No specific details provided).
§ 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.