(90 days)
The Rubicon Support Catheter is intended to facilitate placement and support of guidewires and other interventional devices within the peripheral vasculature and to allow for exchange of guidewires, and provide a conduit for the delivery of saline or contrast solutions.
The Boston Scientific Rubicon Support Catheters are multipurpose intravascular devices. The catheters feature an ultra low profile tip, a lubricious hydrophilic coating that is applied to the surface of the distal 40 cm of the catheter, and 3 radiopaque markers spaced equally along the distal shaft which aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned approximately 2mm away from the distal catheter tip. The proximal portion of the catheter includes one female luer-lock port connected to the proximal end of the catheter for guidewire entry and fluid injection. The Rubicon Support Catheters are available in 135cm and 150cm lengths. The shafts have varying stiffness and diameters. The device has a proximal shaft diameter of 3.4 Fr. tapering to a distal shaft diameter of 2.1Fr. The catheter is compatible with 0.014 in (0.36 mm) guidewires.
The provided document is a 510(k) summary for a medical device called the "Rubicon™ Support Catheter." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results in the same way a PMA or de novo submission might.
Therefore, much of the requested information regarding clinical studies, expert-established ground truth, sample sizes for training/test sets in AI/ML contexts, and reader study effect sizes is not applicable to this document. This submission relies on bench testing (in-vitro performance) and leveraged/screening biocompatibility testing to establish substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it lists the tests performed, implying that the device was deemed to have acceptable performance relative to its intended use and comparison with the predicate device. The performance data section states, "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."
Here's a table summarizing the performance tests completed and the general conclusion:
| Performance Characteristic | Test Performed | Reported Device Performance / Outcome |
|---|---|---|
| Biocompatibility | MEM Elution Cytotoxicity | Conformance demonstrated, no new safety/performance issues |
| Hemolysis Assay Indirect Extraction | Conformance demonstrated, no new safety/performance issues | |
| Guinea Pig (Maximization) Sensitization | Conformance demonstrated, no new safety/performance issues | |
| Partial Thromboplastin Time | Conformance demonstrated, no new safety/performance issues | |
| Intracutaneous Reactivity | Conformance demonstrated, no new safety/performance issues | |
| In Vitro Hemocompatibility Assay | Conformance demonstrated, no new safety/performance issues | |
| Systemic Toxicity (Acute) | Conformance demonstrated, no new safety/performance issues | |
| Complement Activation | Conformance demonstrated, no new safety/performance issues | |
| Materials Mediated Rabbit Pyrogen | Conformance demonstrated, no new safety/performance issues | |
| USP Physicochemical | Conformance demonstrated, no new safety/performance issues | |
| Hemolysis Assay Direct Contact | Conformance demonstrated, no new safety/performance issues | |
| Natural Rubber Latex | Conformance demonstrated, no new safety/performance issues | |
| In-Vitro Performance | Effective Length | Conformance demonstrated, no new safety/performance issues |
| Sheath Insertion and Withdrawal Force | Conformance demonstrated, no new safety/performance issues | |
| Inner Diameter - Distal Shaft | Conformance demonstrated, no new safety/performance issues | |
| Catheter Shaft Burst Pressure | Conformance demonstrated, no new safety/performance issues | |
| Outer Diameter - Proximal Shaft | Conformance demonstrated, no new safety/performance issues | |
| Catheter Tensile | Conformance demonstrated, no new safety/performance issues | |
| Outer Diameter - Distal Shaft | Conformance demonstrated, no new safety/performance issues | |
| Shaft Kink Resistance | Conformance demonstrated, no new safety/performance issues | |
| Marker Band Spacing | Conformance demonstrated, no new safety/performance issues | |
| Torque Strength | Conformance demonstrated, no new safety/performance issues | |
| Contrast Flow Rate | Conformance demonstrated, no new safety/performance issues | |
| Radiopacity | Conformance demonstrated, no new safety/performance issues | |
| Flow rates for DFU labeling | Conformance demonstrated, no new safety/performance issues | |
| Coating Integrity | Conformance demonstrated, no new safety/performance issues |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The performance testing described is bench testing (in-vitro) and biocompatibility testing, not human clinical trials. The number of samples for each bench test is not detailed in this summary.
- Data Provenance: Not applicable. The data comes from internal Boston Scientific laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission does not involve expert-established ground truth in a clinical or AI/ML context. Performance was evaluated against engineering specifications and industry standards during bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This type of adjudication is typically used in clinical studies or AI/ML evaluations with human interpretation, neither of which are described here.
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:
- Not Applicable. This is a hardware medical device (catheter) and the submission predates widespread AI/ML integration in such devices. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering specifications and industry standards for medical device performance. For biocompatibility, the ground truth refers to established guidelines and standards for acceptable biological response to materials. For in-vitro performance, it refers to design specifications and expected mechanical/fluidic properties.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML device.
§ 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).