(76 days)
SpeediCath Compact Male is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The catheter is for male patients.
The SpeediCath Compact Male is a sterile, single use, disposable polyurethane catheter for males. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. To prepare the catheter for use, the cover is removed and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter is then ready to use allowing easy drainage.
This document is a 510(k) Summary for the SpeediCath Compact Male urinary catheter. It describes the device, its intended use, and substantial equivalence to a predicate device. It also summarizes the testing performed to demonstrate its safety and effectiveness.
However, the provided text does not contain acceptance criteria or a detailed study description that presents the device's performance against specific acceptance criteria.
The document states:
- "SpeediCath Compact Male has been tested and complies with relevant sections of ASTM F 623-99, ASTM D1894-11, EN 1616, EN 1617 and EN 1618."
- "Performance Testing included: Flow Rate, Coefficient of Friction, Tensile Strength."
- "SpeediCath Compact Male has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices."
- "Biocompatibility Testing included: Cytotoxicity, Irritation, Sensitization, Colorant Leachable Study."
While these statements indicate that testing was performed and the device complied with standards, they do not provide the specific acceptance criteria (e.g., "flow rate must be > X mL/min") or the reported device performance values (e.g., "observed flow rate was Y mL/min"). Therefore, I cannot construct the requested table or answer the specific questions about sample size, ground truth, expert involvement, or MRMC studies for performance metrics.
Based on the provided text, the following information is either not available or cannot be fully extracted:
- A table of acceptance criteria and the reported device performance: Information about specific acceptance criteria (e.g., numerical thresholds for flow rate, friction, tensile strength) and the actual performance values obtained is not provided. The document only states compliance with standards.
- Sample sizes used for the test set and the data provenance: This information is not provided in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant for the type of device (urinary catheter) and the performance tests described (physical and biocompatibility). These tests do not involve expert interpretation of images or clinical data for ground truth establishment.
- Adjudication method for the test set: Not applicable for empirical physical and biocompatibility testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable as this is a medical device (urinary catheter), not an AI/software as a medical device for interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical and biological tests, "ground truth" would typically be established by validated test methods and reference standards, not expert consensus or pathology in the context of this device.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device (urinary catheter) and focuses on demonstrating substantial equivalence through compliance with recognized standards for physical and biocompatibility properties. It does not contain the detailed performance study results, acceptance criteria, or ground truth establishment relevant for AI-based or diagnostic devices.
§ 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.