(186 days)
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a Luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.
The provided text describes the regulatory filing for the Trevo Trak 21 Microcatheter (K211594), which is a device intended for selective placement of devices and/or fluids in vasculature. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192122), particularly concerning a change in the recommended minimum inner diameter of the guide catheter.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria specified are primarily related to general device performance and safety rather than a specific algorithmic output, as this is a physical medical device (microcatheter) and not an AI/ML powered device. The "reported device performance" refers to the results of bench testing.
| Test | Acceptance Criteria Statement (Implied/Explicit) | Reported Device Performance |
|---|---|---|
| Simulated Use/Compatibility | The user will assess Trevo Trak™ 21 Microcatheter with a worst-case compatible guide catheter in the in vitro simulated use model. (Implicit: Device must function acceptably and compatibly within the simulated use environment, particularly with the new 0.046 inch ID guide catheter). | Simulated Use testing met acceptance criteria. |
| Particulate Characterization | Use light obscuration particle counting to measure the total number of particulates generated during simulated use. (Implicit: Particulate generation must be within acceptable limits and comparable to the predicate device to ensure safety). | Particulate generation was acceptable and comparable to the predicate device. |
| Coating Integrity | Use visual inspection to identify the location, size, and number of occurrences of anomalies on the coated surface of the Trevo Trak™ 21 Microcatheter before and after simulated use. (Implicit: Coating integrity must be maintained before and after simulated use to prevent embolization or other issues). | Coating integrity was acceptable both before and after simulated use. |
| Track Force Testing | Use a Track Tester Model to measure the Trevo Trak™ 21 Microcatheter track force through a guide catheter during simulated use. (Implicit: The device must have an acceptable track force, indicating ease and safety of navigation through the vasculature, especially with the changed guide catheter diameter). | Track Testing results met acceptance criteria. |
| Shelf-Life | Product shelf-life testing was performed and results met established criteria. (Implied: Device must maintain its functional and safety characteristics for its labeled shelf-life of six months). | Product shelf-life testing met established criteria. |
| Sterilization | Sterility assurance level (SAL) of $10^{-6}$ demonstrated. Meets EO residuals per EN ISO 10993-7 for limited contact delivery system – externally communicating. (Implied: Device must be sterile and have acceptable residual levels of sterilant). | SAL of $10^{-6}$ demonstrated. Meets EO residuals per EN ISO 10993-7. |
| Biocompatibility | Meets biological safety requirements per EN ISO 10993-1 for an externally communicating medical device with circulating blood contact for less than 24 hours. (Implied: Device materials must be safe for human contact). | Meets biological safety requirements per EN ISO 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for each bench test conducted on the Trevo Trak 21 Microcatheter (K211594). It mentions that the testing was performed to assess compatibility with a 0.046 inch inner diameter (ID) guide catheter.
- Test Set Sample Size: Not explicitly stated for K211594's current submission. The wording "User will assess Trevo Trak™ 21 Microcatheter with a worst case compatible guide catheter" suggests a focus on representative scenarios but not a specific 'n' number.
- Data Provenance: The bench testing appears to be prospective and conducted by Stryker Neurovascular themselves, as part of their submission for K211594. The location of the testing is not specified, but the manufacturer is based in Fremont, California, USA. The shelf-life, sterilization, and biocompatibility data referenced previous testing in K192122, suggesting retrospective use of that data for the current submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the device is a physical medical instrument, not an AI/ML algorithm requiring expert interpretation of results for ground truth establishment. The "ground truth" for the performance tests relies on established engineering and materials science principles and validated test methods.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. The assessment of bench test results involves direct measurements, visual inspections, and adherence to predefined engineering specifications, not expert consensus or adjudication.
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. The Trevo Trak 21 Microcatheter is a physical medical device, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device and does not involve any algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on engineering specifications, recognized national/international standards (e.g., ISO 14971 for risk assessment, ISO 10993-1 for biocompatibility), and validated test methods. The successful meeting of these criteria serves as the basis for claiming safety and effectiveness.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).