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510(k) Data Aggregation
(452 days)
The catheter is indicated for use by patients with chronic urine retents 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 the urine to drain.
The catheter is intended for males only.
The SpeediCath Compact Male is a sterile, ready to use intermittent catheter for males. It is a single use catheter and is sterilized using E-beam Irradiation.
The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact Male is available in one size FR/CH 12/18 and is for male users only.
The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a closure and plug make up the primary packaging and the sterile barrier.
The provided text is a summary of a 510(k) premarket notification for the SpeediCath Compact male urinary catheter (K210250). It details the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state "acceptance criteria" for each performance test in a quantitative manner. Instead, it describes the types of performance tests conducted and concludes that the subject device is "as safe and effective as the predicate device" based on these tests. The implied acceptance criterion for each test is that the performance of the subject device (with PEG swelling medium) is equivalent or non-inferior to the predicate device (with PVP swelling medium).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1:2018 and FDA Guidance | Passing results for cytotoxicity, irritation, sensitization, material-mediated pyrogenicity, and toxicological risk assessment based on chemical analysis. ("Biocompatibility testing...according to ISO 10993-1:2018 and FDA Guidance..."). The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying compliance. |
| Coefficient of Friction: Meet ASTM D1894:2014 | Testing conducted according to ASTM D1894:2014. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying satisfactory friction properties. |
| Accelerated & Real-Time Aged Shelf-Life: Meet ASTM F1980-16 | Testing conducted according to ASTM F1980-16. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying maintenance of performance over shelf-life. |
| Sterilization Dose Setting: Meet ISO 11137-1:2015 & ISO/TS 13004:2013 | Testing conducted according to ISO 11137-1:2015 and ISO/TS 13004:2013. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying effective sterilization. |
| Catheter Coating - Dry Out in Air: Verify lubrication post-5 min exposure | Test performed to verify that the coating is still lubricated and not dry at insertion after 5 minutes of exposure to air. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying satisfactory lubrication. |
| Catheters, Objective Friction Measurement: Measure immediate friction | Test performed to measure the friction immediately after opening and removal from primary packaging. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying satisfactory friction properties. |
| pH of the Swelling Medium: Measure pH | Test performed to measure the pH of the swelling medium using a calibrated pH measure. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying satisfactory pH levels. |
| Osmolality of the Swelling Medium: Measure salt/molecules | Test performed to measure salt/molecules in the swelling medium using an osmometer. The conclusion states, "The performance testing demonstrates the subject device is as safe and effective as the predicate device," implying satisfactory osmolality. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance tests. It lists the standards followed, implying that the sample sizes would be dictated by those standards.
The data provenance is not explicitly stated. These are laboratory performance tests, not clinical trials with patient data. Therefore, concepts like "country of origin of the data" and "retrospective or prospective" do not directly apply in the same way they would for a clinical study involving human subjects. The tests were likely conducted by Coloplast or a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The performance testing described is laboratory-based, comparing physical and chemical properties. It does not involve human expert interpretation of data to establish a "ground truth" in the way a diagnostic AI device would. The "ground truth" in this context is the objective measurement of the physical/chemical properties according to the specified standards.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. There is no human interpretation or adjudication involved in these laboratory performance tests.
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
This is not applicable as the device (urinary catheter) is not an AI-powered diagnostic tool, nor does it involve "human readers" or "AI assistance" in its direct function. The study summarized here is for the physical and chemical performance of the catheter itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable for the reasons stated above. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests, the "ground truth" is implied by the objective measurements and specified standards for each test (e.g., ISO 10993-1 for biocompatibility, ASTM D1894 for coefficient of friction). The device's performance is compared against the expected or acceptable range defined by these standards, or against the performance of the predicate device.
8. The Sample Size for the Training Set
This is not applicable. This is a 510(k) for a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
This is not applicable. There is no "training set" for this device.
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