(23 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 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 provided text is a 510(k) Summary for a medical device (Rubicon™ 18 and 35 Support Catheter), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable to this document.
This document describes a conventional medical device and its regulatory submission, focusing on bench testing for physical characteristics and biocompatibility, and demonstrating substantial equivalence to a predicate device.
Key points from the document regarding device performance and acceptance criteria:
- Device Type: Rubicon™ 18 and 35 Support Catheters (conventional medical device, not AI/ML).
- Performance Data Basis: Substantial equivalence to the Boston Scientific Rubicon™ 14 Support Catheter (K112303).
- Biocompatibility: Leveraged from the predicate device (Rubicon 14) as the new devices are equivalent in design, materials, and manufacturing. The specific tests performed on the predicate device are listed.
- In-vitro Performance Bench Tests: A list of bench tests was conducted to confirm performance characteristics. The document states "All test results demonstrate that the materials, manufacturing process, and design of the Rubicon 18 and 35 Support Catheters meet the established specifications necessary for consistent performance according to its intended use."
A table formatted as requested, but with a note on its inapplicability for AI/ML, would look like this:
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly quantified in the document, implied by "meet established specifications") | Reported Device Performance (Summary from document) |
|---|---|---|
| Biocompatibility | Implied: Pass various biocompatibility tests (Cytotoxicity, Sensitization, Reactivity, Systemic Toxicity, Pyrogen, Hemolysis, Thromboplastin Time, Hemocompatibility, Complement Activation, USP Physicochemical, Natural Rubber Latex). | Demonstrated by leveraging results from the predicate Rubicon 14 Support Catheter, as Rubicon 18 and 35 are equivalent in design, materials, and manufacturing. |
| Physical Performance | Implied: Meet established specifications for a range of physical characteristics. | All test results demonstrated that materials, manufacturing, and design meet established specifications for consistent performance according to intended use. |
| Effective Length | (Not quantified in document) | |
| Inner Diameter - Distal Shaft | (Not quantified in document) | |
| Outer Diameter - Proximal Shaft | (Not quantified in document) | |
| Outer Diameter - Distal Shaft | (Not quantified in document) | |
| Marker Band Spacing | (Not quantified in document) | |
| Contrast Flow Rate | (Not quantified in document, used for DFU labeling) | |
| Flow rates for DFU labeling | (Not quantified in document, used for DFU labeling) | |
| Sheath Insertion and Withdrawal Force | (Not quantified in document) | |
| Catheter Shaft Burst Pressure | (Not quantified in document) | |
| Catheter Tensile | (Not quantified in document) | |
| Shaft Kink Resistance | (Not quantified in document) | |
| Torque Strength | (Not quantified in document) | |
| Radiopacity | (Not quantified in document) | |
| Coating Integrity | (Not quantified in document) |
Since this is not an AI/ML device, the following points are not applicable and cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not an AI/ML device; test sets for AI/ML are irrelevant here.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth for AI/ML is irrelevant here. Performance is based on bench testing and substantial equivalence to a predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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).