(119 days)
The SpeediCath catheter 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 SpeediCath Catheter is a single use, disposable polyurethane catheter. It is coated and placed in a saline solution, packed and sealed in a foil bag and sterilized. The catheter is prelubricated with a coating containing polyvinylpyrrolidone, which binds the water molecules to the surface of the catheter creating a smooth and even lubricating film.
1. Acceptance Criteria and Reported Device Performance for SpeediCath
The SpeediCath 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, and safety testing rather than a specific clinical performance study with predefined acceptance criteria. The acceptance criteria for the device are therefore implicit in meeting the requirements for general safety and effectiveness and showing equivalence to legally marketed devices.
The "studies" conducted are primarily non-clinical safety tests to ensure biocompatibility and absence of toxicity.
Here's a table summarizing the "acceptance criteria" (implied by the test objective) and the reported device performance for the safety testing:
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intracutaneous Test in the Rabbit | Negligible irritation according to ISO 10993, Part 10, Section 5.4. | "Negligible" according to ISO 10993, Part 10, Section 5.4. |
| Systemic Injection Test in the Mouse | No clinical signs of toxicity, meeting the requirements of USP 24 (2000). | No clinical signs of toxicity, meeting the requirements of USP 24 (2000). |
| Vaginal Irritation Test - ISO Method | Meets the requirements of Vaginal Irritation Test ISO Method (ISO 10993-10:1995). | Meets the requirements of Vaginal Irritation Test ISO Method (ISO 10993-10:1995). |
| Test for Delayed Contact Hypersensitivity Using the Guinea Pig Maximization Test | No evidence of delayed contact hypersensitivity according to ISO 10993, Part 10. | No evidence of delayed contact hypersensitivity according to ISO 10993, Part 10. |
| In Vitro Cytotoxicity Assay (Elution test) | Cytotoxicity grade ≤2, meeting USP 24 requirements. | Passed the requirements of USP 24 (cytotoxicity grade ≤2). |
| Agar overlay (Cytotoxicity Assay) | Cytotoxicity grade ≤2, meeting USP 25 requirements. | Meets requirements of USP 25 (cytotoxicity grade ≤2). |
| Ames test | Not mutagenic according to OECD guideline no. 471 (1997) and ICH Tripartite Harmonised Guidelines (1995 and 1997). | Not mutagenic (OECD guideline no. 471 (1997) and ICH Tripartite Harmonised Guidelines (1995 and 1997)). |
Conclusion: All tests were passed, indicating the device meets the safety criteria established for these specific biological compatibility assessments.
2. Sample Size for Test Set and Data Provenance
The provided document describes safety testing rather than a diagnostic performance study that would typically involve a "test set" of patient data.
- Sample Size for Test Set: Not applicable in the context of the provided safety testing. The "samples" were biological subjects (rabbits, mice, guinea pigs) or in-vitro cell cultures used for biocompatibility assessments, not a test set of patient data. Specific numbers for animals used are not detailed but are implied by the standard test methods (e.g., "the Rabbit," "the Mouse," "the Guinea Pig").
- Data Provenance: The tests were conducted by independent laboratories:
- Scantox, DK (Denmark) for most tests.
- Sterilization Technical Services, USA for the Vaginal Irritation Test.
- Nelson Laboratories, US for the Agar overlay (Cytotoxicity Assay).
- These were prospective tests conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The studies are biological safety tests, not diagnostic studies requiring expert review of results to establish ground truth for a medical condition.
- Qualifications of Experts: N/A. The interpretation of these biological safety tests is performed by qualified laboratory personnel following established international and national standards (ISO, USP, OECD).
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among multiple experts in diagnostic studies. For these safety tests, results are objectively measured and interpreted against predefined criteria in the respective standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document does not describe an MRMC comparative effectiveness study. This type of study is used for diagnostic algorithms to assess the impact of AI assistance on human reader performance. The SpeediCath is an intermittent urinary catheter, a medical device for direct physiological intervention (draining urine), not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: No. This concept is for AI algorithms and is not applicable to an intermittent urinary catheter. The "performance" of the catheter is related to its physical and biological properties to facilitate urine drainage safely and effectively, which is assessed through bench testing, biocompatibility studies, and comparison to predicate devices, not an algorithm's standalone accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: For the safety studies, the "ground truth" is established by the objective outcomes of the standardized biological and chemical tests themselves, as per the specified international (ISO, OECD) and national (USP) guidelines. For example, "no clinical signs of toxicity" during a systemic injection test, or "not mutagenic" in an Ames test. This is not clinical ground truth like pathology or outcomes data in humans, but rather biological safety endpoints.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. The SpeediCath is a physical medical device, not an AI algorithm that requires a training set of data.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.
§ 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.