(138 days)
SpeediCath Compact Set is indicated for use by patients with chronic 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 device is intended for males only.
The SpeediCath Compact Set (Male) is a sterile, single use, disposable polyurethane catheter for males with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.
This document is a 510(k) summary for a medical device (SpeediCath Compact Set) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics typically found in clinical trial reports for novel devices.
Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be found in the provided text. The document describes a regulatory filing for marketing clearance, not a primary research study.
However, I can extract the information that is present and explain why other information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices. |
| Physical/Mechanical Properties (e.g., lubricity, material strength, dimensional integrity) | Complies with relevant sections of ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, and ISO 8669-2. |
| Sterility | "sterile" (mentioned in device description) |
| Functionality (e.g., ease of use, drainage, collection) | "allows easy drainage and collection of urine" (implied functional performance, not quantified) |
| Substantial Equivalence | Believed to be substantially equivalent in form and function to Coloplast's SpeediCath (K023254 and K973070 are referenced as similar). |
Explanation: The document states that the device "complies with relevant sections" of several standards. These standards themselves contain specific acceptance criteria for various aspects (e.g., biocompatibility testing, material properties, catheter dimensions, lubricity). However, the specific numerical or qualitative acceptance criteria from these standards and the exact numerical performance results of the SpeediCath Compact Set against those criteria are not detailed here. This is typical for a 510(k) summary, which generally affirms compliance rather than presenting raw data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "testing" against various standards, which would involve samples, but the specific number of units tested is not provided.
- Data Provenance: This information is not provided. The testing refers to compliance with international standards, but where the testing was conducted or whether it involved human subjects (beyond usability aspects) is not detailed. The primary purpose of this filing is to demonstrate substantial equivalence based on material and design characteristics and adherence to recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a urinary catheter, not an AI or diagnostic imaging device that typically requires expert consensus for ground truth establishment on a "test set" from a clinical perspective. The "ground truth" for this device's performance would be its adherence to engineering and biocompatibility standards, and its functional design for urine drainage, which is verified by laboratory testing and design review, not clinical expert consensus in the way an AI algorithm for diagnosis would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, the nature of this device and its testing doesn't involve expert adjudication for ground truth in a clinical sense. Compliance with standards is typically verified through laboratory testing and quality assurance processes.
5. 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
Not applicable. This is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's regulatory clearance is its compliance with established international and national engineering, safety, and biocompatibility standards (ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, ISO 8669-2, ISO 10993) and its substantial equivalence to a predicate device. This is determined through laboratory testing, design documentation, and comparison of specifications.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable. As above, no training set in the AI sense was used. The "ground truth" for the predicate device (SpeediCath, K023254) would have been established through its own regulatory pathway, which would also involve compliance with standards and demonstration of safety and effectiveness for its intended use.
§ 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.