(148 days)
LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.
The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available.
The provided text is a 510(k) Summary for the LoFric® Single Use Urinary Catheter. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific, quantitative acceptance criteria through a study with a test set, ground truth, or expert review in the way that an AI/ML medical device submission would.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided 510(k) summary.
Here's why and what information is provided:
- 510(k) for Catheters vs. AI/ML Devices: The LoFric® catheter is a physical medical device. Its submission focuses on demonstrating that it is "substantially equivalent" to an existing, legally marketed device (the Astra Tech LoFric® Single Use Urinary Catheter - K896750) in terms of intended use, operating principle, design, materials, manufacturing, and sterilization. This is a comparison against a similar existing device, not a performance evaluation against pre-defined statistical acceptance criteria for a new algorithmic output.
- Performance Testing: The summary mentions "Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device." However, it does not provide any details about:
- Specific acceptance criteria for these tests.
- The quantitative results of these tests.
- The sample sizes for these tests.
- How "ground truth" was established (as it's not relevant for a physical device's performance like this).
- Expert involvement or adjudication methods.
- Multi-reader multi-case studies or standalone algorithm performance.
In summary, none of the specific details you requested (points 1-9) are available in this 510(k) summary because it pertains to a physical, non-AI medical device and follows the substantial equivalence pathway, not a performance study pathway that would typically involve such metrics.
§ 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.