(28 days)
The TRUSELECTM Microcatheters are intended for peripheral vascular use. The microcatheter can be used for selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
The TRUSELECT™ Microcatheter is a low profile 2.0F microcatheter intended for use in the peripheral vasculature. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
Diagnostic, therapeutic and embolic agents such as heparinized saline, contrast media, chemotherapy agents such as doxorubicin and irinotecan, polyvinyl alcohol (PVA) flakes and polymer and hydrogel spherical embolics (microspheres) can be delivered to targeted vessels. The microcatheter maintains chemotherapy chemical compatibility.
It has a straight internal diameter design (021" ID, (0.53 mm)) with a 2.0F OD tapered tip. The microcatheter includes eight UPNs, covering a range of lengths (105, 130, 155 and 175cm) and tip shapes (straight or bern), and is compatible with 0.040" ID guide catheters and 0.014" & 0.016" quidewires. It is compatible with embolic particles of up to 700 microns and 0.018" (0.46 mm) embolic coils.
The TRUSELECT™ Microcatheters are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize HydroPass Hydrophillic Coating for the reduction of surface friction during placement.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the TRUSELECT™ Microcatheter in the form of thresholds or target values. Instead, it details a comprehensive list of non-clinical (bench) tests and biocompatibility tests that were performed to demonstrate conformance to requirements for its intended use and substantial equivalence to the predicate device (Direxion™ Microcatheter, K163701).
The "reported device performance" is summarized by the statement: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." This implies that the device met the internal design and performance specifications that correspond to each test.
Here's a table based on the tests conducted:
| Test Category | Specific Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | No significant cytotoxic effects beyond acceptable limits | Met acceptable limits |
| Sensitization (ISO 10993-10) | No significant sensitization potential | Met acceptable limits | |
| Irritation (ISO 10993-10) | No significant irritation | Met acceptable limits | |
| Material Mediated Pyrogenicity (ISO 10993-11) | No significant pyrogenicity | Met acceptable limits | |
| Acute Systemic Toxicity (ISO 10993-11) | No significant acute systemic toxicity | Met acceptable limits | |
| Hemocompatibility (ISO 10993-4) | Acceptable blood compatibility (e.g., no excessive hemolysis) | Met acceptable limits | |
| Genotoxicity (ISO 10993-3) | No significant genotoxic effects | Met acceptable limits | |
| In-Vitro Performance | Manifold Connection | Secure connection, no leaks | Conformed to requirements |
| Guidewire Compatibility | Compatible with specified guidewire sizes | Achieved compatibility | |
| Guide Catheter Compatibility | Compatible with specified guide catheter sizes | Achieved compatibility | |
| Proximal OD/Outside Diameter | Met specified dimensions | Conformed to requirements | |
| Catheter ID | Met specified dimensions | Conformed to requirements | |
| Microcatheter Coating Lubricity & Durability | Maintained lubricity and durability for intended use | Conformed to requirements | |
| Microcatheter Coating Length | Met specified length | Conformed to requirements | |
| Distal End Flexibility (Distal 5cm) | Met specified flexibility requirements | Conformed to requirements | |
| Proximal End Stiffness | Met specified stiffness requirements | Conformed to requirements | |
| Proximal Shaft Kink | Resisted kinking under defined conditions | Conformed to requirements | |
| Distal Shaft Kink | Resisted kinking under defined conditions | Conformed to requirements | |
| Effective Length | Met specified effective length | Conformed to requirements | |
| Tip OD | Met specified dimensions | Conformed to requirements | |
| Steam Shaping Mandrel Compatibility | Compatible with steam shaping mandrels | Achieved compatibility | |
| Shapability | Maintained desired shape after manipulation | Conformed to requirements | |
| Infusion Stability | Maintained stable infusion characteristics | Conformed to requirements | |
| Marker Band Location/Tip Length | Met specified location and length | Conformed to requirements | |
| Microcatheter to Microspheres Compatibility | Compatible with microspheres up to 700 microns | Achieved compatibility | |
| Microcatheter to PVA particle Compatibility | Compatible with PVA particles | Achieved compatibility | |
| Microcatheter to Gelfoam Compatibility | Compatible with Gelfoam | Achieved compatibility | |
| Microcatheter to 0.018 Embolic Coil Compatibility | Compatible with 0.018" embolic coils | Achieved compatibility | |
| Dead Space Volume | Met specified volume | Conformed to requirements | |
| Max Infusion Pressure (Dynamic Burst) | Withstood specified dynamic burst pressure | Conformed to requirements | |
| Static Burst | Withstood specified static burst pressure | Conformed to requirements | |
| Chemical Compatibility | Compatible with specified diagnostic/embolic/therapeutic agents | Achieved compatibility | |
| Flow Rate | Met specified flow rate performance | Conformed to requirements | |
| Marker Band Tensile | Maintained integrity under specified tensile forces | Conformed to requirements | |
| Full Catheter Tensile | Maintained integrity under specified tensile forces | Conformed to requirements | |
| Tip Tensile | Maintained integrity under specified tensile forces | Conformed to requirements | |
| Tip Shape | Met specified tip shapes (straight or bern) | Conformed to requirements | |
| Particulate Matter | Met acceptable particle limits | Met acceptable limits | |
| Corrosion Resistance | Exhibited resistance to corrosion in simulated physiological environment | Conformed to requirements |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for each individual test. It mentions "bench testing and biocompatibility testing were performed," implying that appropriate sample sizes were used for each test according to relevant standards (e.g., ISO, ASTM, or internal test protocols).
- Data Provenance: This was a non-clinical study (bench and biocompatibility testing). Therefore, there is no "country of origin of the data" in the sense of patient data. The tests were conducted in a lab setting, presumably by Boston Scientific or a contracted lab. The data is prospective in the sense that the tests were specifically conducted for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This was a non-clinical (bench) study, not a clinical study involving experts establishing ground truth from patient data. The "ground truth" for these tests would be the established scientific and engineering principles, material specifications, and regulatory standards (e.g., ISO 10993 series) against which the device's performance was measured.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers or observers. This document describes non-clinical testing where objective measurements and observations are made against predetermined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done. This document focuses solely on non-clinical (bench) testing and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a physical medical device (microcatheter), not a software algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used
For the biocompatibility tests, the ground truth is based on the requirements and methodologies outlined in the ISO 10993 series of standards. For the in-vitro performance tests, the ground truth would be the engineering specifications, design requirements, and relevant industry standards for microcatheters, ensuring the device performs as intended for its specified uses. It's essentially "conformance to specifications."
8. The Sample Size for the Training Set
N/A. This is not a study involving machine learning or AI where a "training set" would be used. The document describes a physical medical device submission based on non-clinical testing.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for an AI/ML algorithm involved, this question is not applicable.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).