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510(k) Data Aggregation
(29 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 guide a conduit for the delivery of saline or contrast solutions.
The Rubicon™ 14, 18 and 35 Support Catheters (Rubicon) are multipurpose intravascular device that can be used for wire exchanges, saline or contrast injection and to support a guidewire or other devices to cross peripheral lesions. They are available in 65cm, 90cm, 135cm, and 150cm shaft lengths.
To use the Rubicon Support Catheter, the physician backloads the distal tip of the support catheter over a pre-positioned guidewire, ensuring the guidewire exits the proximal hub/luer and advances the support catheter to the target area.
The Rubicon Support Catheter may also be introduced through a previously positioned, appropriately sized introducer sheath or guide sheath/catheter, advancing the Rubicon Support Catheter to its desired location while using fluoroscopic imaging.
The provided text describes a 510(k) premarket notification for the Rubicon 14, 18, and 35 Support Catheters. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct acceptance criteria and proving performance through a study in the same way a new, innovative device might.
Therefore, the requested information elements related to a study proving acceptance criteria are largely not applicable in this context. The acceptance criteria for this type of submission are typically met by demonstrating that the device is substantially equivalent to a legally marketed predicate device and that it performs as expected for its intended use, supported by bench testing where necessary.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" as you might define for an AI/algorithm (e.g., sensitivity, specificity, AUC) are not present in this document because it's for a physical medical device (support catheter) and focuses on substantial equivalence. Instead, the "performance" is demonstrated through bench testing and comparison to existing predicate devices.
| Acceptance Criterion (Nature of Demonstration) | Reported Device Performance (Summary) |
|---|---|
| Pouch Seal Strength | Bench testing performed (results indicate conformance to requirements for intended use). |
| Catheter Withdrawal from Carrier Tube | Bench testing performed (results indicate conformance to requirements for intended use). |
| Angle Clip Retention | Bench testing performed (results indicate conformance to requirements for intended use). |
| Angled Clip Removal | Bench testing performed (results indicate conformance to requirements for intended use). |
| Pouch Sterile Barrier Integrity - Bubble | Bench testing performed (results indicate conformance to requirements for intended use). |
| Pouch Sterile Barrier Integrity – Visual | Bench testing performed (results indicate conformance to requirements for intended use). |
| Shelf Carton Condition | Bench testing performed (results indicate conformance to requirements for intended use). |
| Master Shipping Carton Condition | Bench testing performed (results indicate conformance to requirements for intended use). |
| Label Adhesion and Print Quality | Bench testing performed (results indicate conformance to requirements for intended use). |
| Substantial Equivalence | The device (Rubicon™ 14, 18 and 35 Support Catheters) is considered substantially equivalent to the predicate devices (K112303 and K122394) based on identical intended use, scientific technology, design, materials, and sterilization method. Minor modifications to packaging dimensions and pouch materials were identified and tested for conformance. No new safety or performance issues were raised during bench testing. The proposed packaging changes did not require new biocompatibility or device bench testing; thus, predicate device testing results still apply. |
2. Sample size used for the test set and the data provenance
The document specifies "bench testing" was performed. For a physical device, this usually involves a specific number of units for each test (e.g., a certain number of pouches for seal strength, or catheters for withdrawal force). However, the specific sample sizes for each of these bench tests are not provided in the document.
Data provenance: The testing was performed by Boston Scientific Corporation, the device manufacturer. The nature of the testing is physical/mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a physical support catheter undergoing bench testing, "experts" in the sense of clinical specialists establishing ground truth (as in an AI/imaging study) are not typically involved in evaluating the primary test results (e.g., seal strength, withdrawal force). These are objective, measurable physical properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, often in clinical or image-based studies. Bench testing relies on objective measurements against pre-defined specifications.
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 physical medical device (catheter), not an AI algorithm or a diagnostic imaging device requiring human reader interpretation or assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the usual sense for clinical studies. For bench testing, the "ground truth" would be the engineering specifications and established industry standards (e.g., ISO standards mentioned like ISO 10555-1 and ISO 10555-4) that the device must meet. The tests objectively measure device properties against these pre-defined, measurable criteria.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model that requires a training set.
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