(113 days)
The Vanguard Dx™ catheter is intended for use in the delivery of radiopaque contrast media and common flushing agents to the vascular system.
The Vanguard Dx™ is a sterile, single patient use diagnostic catheter for use in cardiology and radiology during angiography. Vanguard Dx™ is the proprietary name for a family of 30 angiographic catheters. The Vanguard Dx™ is similar to other diagnostic catheters on the market in that it delivers radiopaque fluids and common flushing agents to a specific artery in the cardiovascular system for the purpose of differentiating the vessel from the surrounding anatomy during diagnostic imaging procedures. Vanguard Dx™ is available in 4 French and 5 French sizes. It is offered in both flush and selective styles.
The Vanguard Dx™ catheter was designed to enable the effective use of power injection using smaller diameter catheters while reducing the negative effects seen with many similar catheters such as jetting, whip, and endovascular damage. The differentiating elements of the of Vanguard Dx™ lies in the combination of small holes near the stem/tip interface and a soft tip with an incorporated restrictor that combine to produce clinically beneficial effects. These effects include the creation of a "cloud" of contrast gently exiting through the side holes, which envelops the tip, rather than a single stream of contrast exiting the tip. This reduces the likelihood of vascular injury and has the potential to enhance image quality. Another effect is that a restrictor is incorporated into the tip that limits the flow through the catheter tip thereby encouraging flow through the catheter side holes. The reduction of forward flow through the tip and resulting dispersion of fluid through the side holes produces more balanced hydraulic forces on the catheter during injections so that random oscillations of the tip and rearward motion of the catheter are effectively reduced or eliminated. The result is a more uniform distribution of fluid around the catheter, reduced trauma to the catheterized artery, increased catheter tip stability during a procedure, and potential for enhanced image quality.
Vanguard DxTM catheters are designed to mate with commercially available fluid delivery products. The finished catheter is compatible with common contrast agents such as Omnipaque 350. Isovue 370. Optiray 350. Ultravist 370, Renografin 76, and Visipaque 320. Vanguard Dx™ is fully biocompatible including compatibility with human blood, saline, and heparinized saline.
The provided text describes the safety and effectiveness of the MEDRAD Vanguard Dx™ Angiographic Catheter based on various tests conducted for its 510(k) submission.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Vanguard Dx™ catheter are primarily based on established biocompatibility standards (ISO 10993-1 through 11) and performance benchmarks against a predicate device (Cordis Infiniti) and internal design requirements. The reported device performance consistently indicates "Pass" for all tested criteria.
Below are tables summarizing the acceptance criteria (implied by the tests performed) and the reported performance for each type of study:
Biocompatibility Testing (Vanguard Dx Biocompatibility Tests)
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Cytotoxicity: L929-MEM Elution Test | Pass |
| Irritation or Intracutaneous Reactivity: Intracutaneous Injection Test | Pass |
| Systemic Toxicity: System Injection Test | Pass |
| Material Mediated Pyrogens: Rabbit Pyrogen Test | Pass |
| Sensitization: Kligman Maximization Test | Pass |
| Hemocompatibility: In-Vitro Hemocompatibility Assay | Pass |
| Hemocompatibility: Hemolysis - Rabbit Blood | Pass |
| Hemocompatibility: Prothrombin Time Assay | Pass |
| Hemocompatibility: Lee & White Clotting Test | Pass |
| In-Vivo Thrombogenicity: Thrombogenicity Assay in Dogs | Pass |
Biocompatibility Chemical Tests (Vanguard Dx Biocompatibility Chemical Tests)
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Infra Red Spectroscopic Analysis (IR Scan) | Pass |
| USP Physical/Chemical Tests: | |
| *Non-Volatile Residual | Pass |
| *Residue on Ignition | Not applicable |
| *Heavy Metals | Pass |
| *Buffering Capacity | Pass |
In-Vitro Verification Testing (Vanguard Dx In-Vitro Verification)
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Dimensional Analysis | Pass |
| Hub Durability & Compatibility: | |
| Liquid Leakage | Pass |
| Air Leakage During Aspiration | Pass |
| Unscrewing Torque | Pass |
| Ease of Assembly | Pass |
| Resistance to Overriding | Pass |
| Stress Cracking | Pass |
| Catheter Joint Strength | Pass |
| Catheter Seal Integrity | Pass |
| Catheter Burst Pressure | Pass |
| Flow Characterization | Pass |
| Catheter Tip Stability | Pass |
| Restrictor Deformation | Pass |
| Restrictor Durability | Pass |
| Guidewire Insertion Force | Pass |
| Catheter Insertion Force | Pass |
| Stiffness | Pass |
| Torquability | Pass |
| Radiopacity | Pass |
Shelf Life & Packaging Tests (Vanguard Dx Two-Year Shelf Life & Packaging)
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Pouch Seal Strength | Pass |
| Pouch Integrity | Pass |
| Hub Durability & Compatibility: | |
| Liquid Leakage | Pass |
| Air Leakage During Aspiration | Pass |
| Unscrewing Torque | Pass |
| Ease of Assembly | Pass |
| Resistance to Overriding | Pass |
| Stress Cracking | Pass |
| Catheter Joint Strength | Pass |
| Catheter Seal Integrity | Pass |
| Guidewire Insertion Force | Pass |
| Catheter Burst Pressure | Pass |
| Catheter Tip Stability | Pass |
| Restrictor Durability | Pass |
| Stiffness | Pass |
| Torquability | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of catheters) used for each individual test. It mentions that "the 4 French and 5 French Vanguard Dx™ catheters" for biocompatibility and "the following Vanguard Dx™ and control catheter (Cordis) styles were tested: 4 French (Fr) Judkins Right 4.0, 4 Fr Judkins Left 4.0, 4 Fr Pigtail, 5 Fr Judkins Right 4.0, 5 Fr Judkins Left 4.0, and 5 Fr Pigtail" for In-Vitro and Shelf Life/Packaging tests. This implies a representative set of various configurations was tested.
- Data Provenance:
- Biocompatibility: The document refers to ISO 10993-1 through 11, which are international standards. The specific location of testing is not mentioned, but the results are reported by MEDRAD, Inc.
- In-Vitro Testing: Conducted at Teleflex Medical in Limerick, Ireland. Dates: December 1, 2004, through December 15, 2004.
- Shelf Life & Packaging Tests: Preconditioning and distribution simulation conducted at DDL, Inc from October 15 through December 22, 2004. Catheter performance testing conducted at Teleflex Medical in Limerick, Ireland from January 15 through January 20, 2005.
- Retrospective or Prospective: All studies described appear to be prospective testing designed specifically for the 510(k) submission of the Vanguard Dx™ catheter, prior to its marketing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies are device performance tests, not human interpretation studies requiring expert ground truth establishment in the conventional sense (e.g., for image analysis). The "ground truth" for these tests is defined by the objective performance criteria outlined in the ISO standards, internal design specifications, and comparative performance against a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable. As these are objective physical and chemical tests, there is no need for human adjudication of results in the way it would be applied to a diagnostic AI system output. The outcomes are binary (Pass/Fail) based on predetermined numerical or qualitative criteria.
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
No, an MRMC comparative effectiveness study was not done. This document describes the safety and performance testing of a physical medical device (angiographic catheter), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This document concerns a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the various tests were:
- Biocompatibility: Compliance with international standards (ISO 10993-1 through 11), specifically defined pass/fail criteria for each test (e.g., cytotoxicity level, absence of irritation, pyrogenicity).
- In-Vitro Testing & Shelf Life/Packaging: Compliance with internal design requirements, engineering specifications, and functional equivalence or superiority to the predicate device (Cordis Infiniti) for performance attributes like dimensional accuracy, leak resistance, burst pressure, flow rates, tip stability, and material properties. The comparison chart (Section X) explicitly shows numerical comparisons for many performance metrics.
8. The Sample Size for the Training Set
This information is not applicable. This document describes the testing of a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as 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).