(188 days)
The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.
The SuperCross™ microcatheter (SuperCross) is a single-lumen catheter designed for use in the coronary and peripheral vasculature. The SuperCross tubing consists of a braided shaft that tapers distally to create a low profile. SuperCross is compatible with a 0.014 inch diameter guidewire with a minimum length of 180 cm. The SuperCross has a single gold marker band located 0.035 inch (0.89 mm) from the distal tip of the catheter. The distal 40 cm of the SuperCross has a hydrophilic coating to enhance deliverability to the target vasculature. The device has positioning marks located at 95 cm and 105 cm from the distal tip, respectively. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing, wire insertion, and accessory attachment.
The provided text describes a 510(k) summary for the SuperCross™ microcatheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the format requested.
Here's an attempt to extract and interpret the information based on the provided text, while acknowledging that the direct format for acceptance criteria and a study proving those are not fully detailed:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Results of the verification testing and biomaterial assessments met the specified acceptance criteria and did not raise new safety or performance questions." However, the specific numerical or quantitative acceptance criteria for each test are not provided in the document. The performance is generally stated as "met the specified acceptance criteria."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Simulated anatomy/concomitant device use | Met specified acceptance criteria |
| Liquid leak | Met specified acceptance criteria |
| Kink | Met specified acceptance criteria |
| Static pressure | Met specified acceptance criteria |
| Air aspiration | Met specified acceptance criteria |
| Tensile | Met specified acceptance criteria |
| Torque | Met specified acceptance criteria |
| Dimensional verification | Met specified acceptance criteria |
| Radiopacity | Met specified acceptance criteria |
| Material/Coating Performance | |
| Hydrophilic coating integrity and particulates | Met specified acceptance criteria |
| Biocompatibility | |
| Cytotoxicity | Met specified acceptance criteria |
| Sensitization | Met specified acceptance criteria |
| Irritation/intracutaneous reactivity | Met specified acceptance criteria |
| Acute systemic toxicity | Met specified acceptance criteria |
| Material mediated pyrogens | Met specified acceptance criteria |
| Hemocompatibility (Hemolysis, Coagulation, Prothrombin time, Hematological parameters, Complement activation, Thrombogenicity) | Met specified acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample sizes used for any of the verification tests.
- Data Provenance: The tests conducted appear to be retrospective engineering/laboratory bench tests performed by the manufacturer (Vascular Solutions, Inc.) to qualify the device design. Country of origin for data is not explicitly stated but implied to be internal testing by a US-based company.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This type of information (number of experts, qualifications, ground truth establishment for a medical image or diagnostic device) is relevant for studies involving human interpretation or clinical endpoints. The SuperCross microcatheter is an interventional device, and its approval is based on engineering and biocompatibility testing against predefined specifications, not human interpretation of data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set:
- Not Applicable. As explained above, this concept typically applies to studies involving human reading or interpretation of data, which is not the nature of the tests described for the microcatheter. The "adjudication" in this context would likely be internal quality control and regulatory review to ensure test results meet specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not mention a multi-reader, multi-case comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, assessing the impact of AI assistance on human performance (e.g., radiologists' accuracy). The SuperCross microcatheter is an interventional device.
6. Standalone Performance Study:
- Yes, implicitly. The verification tests listed (e.g., tensile, torque, liquid leak, biocompatibility) represent standalone performance evaluations of the device's physical and biological characteristics. The device's performance was assessed independently against a set of predetermined criteria. The studies are described as "verification testing and biomaterial assessments."
7. Type of Ground Truth Used:
- The "ground truth" in this context refers to predefined engineering specifications, international standards, and internal quality control criteria for device performance and safety (e.g., specific tensile strength values, leak rates, biocompatibility assay results). These are objective, measurable parameters rather than expert consensus, pathology, or outcomes data, which are typically used for diagnostic or predictive devices.
8. Sample Size for the Training Set:
- Not Applicable. This device is a traditional medical device (catheter), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable. Since there is no AI/machine learning component and thus no "training set," this question is not relevant.
§ 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).