(130 days)
Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
GentleCath Glide intermittent catheter is intended for adult use only.
A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water.
The document provided is a 510(k) premarket notification for a medical device called "GentleCath Glide Intermittent Catheter." It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain a study that establishes acceptance criteria for specific performance metrics and then reports the device's performance against those criteria in the format requested.
The "Performance Testing - Bench" section (Page 4) mentions that the following comparison tests were performed to demonstrate equivalence:
- Flow Rate
- Catheter Tensile properties
- Coefficient of Friction
It states: "The laboratory testing shows no differences that would indicate the GentleCath Glide Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter."
However, detailed numerical acceptance criteria for these tests or specific reported performance values for the GentleCath Glide, linked to a formal study with defined sample sizes, ground truth, or expert involvement, are not provided in this document. The document focuses on demonstrating substantial equivalence through a feature-by-feature comparison with predicates rather than presenting a performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted directly from this document.
Missing Information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
- Details of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document only broadly states that the device's flow rate, tensile properties, and coefficient of friction were "similar or superior" to predicate devices, without providing specific quantitative data or acceptance thresholds for these performance parameters.
§ 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.