(114 days)
The Twin-Pass .023″ catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and other infuse/deliver diagnostic or therapeutic agents.
The Twin-Pass .023" catheter is additionally intended to be used to measure intraarterial pressure within the peripheral and coronary vasculature.
The Twin-Pass .023" catheter has a polymeric dual-lumen design. The over-the wire lumen extends from the luer hub to the catheter's distal end and accommodates ≤0.018 guidewires. The rapid-exchange lumen is on the distal 20cm of the catheter and accommodates ≤0.014 guidwires. The Twin-Pass .023" catheter is compatible with ≥6F guide catheters and has a working length of approximately 135cm. Each catheter has a single radiopaque markerband near its distal tip and printed positioning marks at 95cm and 105cm from the catheter's distal tip. Each catheter is supplied with a stiffening mandrel assembly that is inserted into the over-the-wire lumen to provide added support while placing the catheter at its desired location. The Twin Pass .023" catheter is provided sterile and intended for a single use.
The Twin-Pass™ .023" Dual Access Catheter is a medical device, and its acceptance criteria are established through a series of bench tests. These tests assess the physical properties and functional performance of the device to ensure it meets its intended use and is substantially equivalent to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it lists the types of bench tests performed and a general statement that "The results of the tests confirmed the suitability of the device for its intended use." Therefore, the reported device performance for each criterion is implicitly passing the respective test, indicating suitability for intended use.
| Acceptance Criterion (Bench Test) | Reported Device Performance |
|---|---|
| Tortuosity | Confirmed suitability for intended use |
| Catheter Kink Resistance | Confirmed suitability for intended use |
| Hub-to-proximal-shaft Bond Strength | Confirmed suitability for intended use |
| Proximal-to-distal-shaft Bond Strength | Confirmed suitability for intended use |
| Stiffening Mandrel Assembly Bond Strength | Confirmed suitability for intended use |
| Stiffening Mandrel Removal Force | Confirmed suitability for intended use |
| Fluid Leak Under Pressure | Confirmed suitability for intended use |
| Air Leak During Aspiration | Confirmed suitability for intended use |
| Frequency Response | Confirmed suitability for intended use |
| Flow Rate | Confirmed suitability for intended use |
| Guidewire Interface | Confirmed suitability for intended use |
| Guide Catheter Interface | Confirmed suitability for intended use |
| Packaging - Packaging Mandrel Removal Force | Confirmed suitability for intended use |
| Packaging - Pouch Visual Appearance after Distribution Testing | Confirmed suitability for intended use |
| Packaging - Product Containment after Distribution Testing | Confirmed suitability for intended use |
| Packaging - Product Visual Appearance after Distribution Testing | Confirmed suitability for intended use |
| Packaging - Labeling Legibility after Distribution Testing | Confirmed suitability for intended use |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each bench test. It generally states that "Bench testing was conducted on the Twin-Pass .023" catheter." The data provenance can be inferred as prospective, laboratory-based testing performed by the manufacturer, Vascular Solutions, Inc., in the United States (Minneapolis, MN).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The acceptance criteria are based on objective bench tests, not expert interpretation of diagnostic images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in this context is not directly applicable in the way it might be for AI-driven diagnostic devices. The ground truth for device performance is established by the ability of the device to meet predefined physical and functional specifications during testing.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads) to resolve discrepancies and establish a consensus ground truth. Since the acceptance criteria are based on objective bench tests, there is no need for such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, often with AI assistance) to assess the improvement in human performance with the device. The Twin-Pass .023" catheter is an interventional/diagnostic catheter, and its evaluation focuses on its physical and functional properties, not on improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This question is not applicable. The Twin-Pass .023" catheter is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device. Its performance is inherent to its physical design and manufacturing.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements and observations from controlled bench tests against pre-defined engineering specifications and functional requirements. This is analogous to "engineering specifications and functional performance data." It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic imaging device might be.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. The Twin-Pass .023" catheter is a manufactured physical device, not an AI or software product. Its design and development would involve engineering prototypes and testing, not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).