(150 days)
The Cruzar Medsystems Houdini Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
The Houdini Catheter is indicated for use in the illac, femoral, ilio-femoral and popliteal arteries.
The Houdini Catheter is a single use, dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.014" - 0.035" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. In addition, the Houdini Catheter can provide distal anchoring and supports the advancement of the guidewire.
The effective length of the Houdini Catheter is a nominal 100cm. The distal tip incorporates a radiopaque marker to aid in visualization under fluoroscopy. The inner diameter of the Houdini Catheter shaft will accommodate a standard commercially available 0.014" - 0.035" guidewire.
The balloon catheter is inflated to 6atm with radiopaque contrast media with a standard manual inflator to anchor the catheter. Internal forces are placed on the inner lumen to the point that it grips and stabilizes the guidewire. Once pressurized to 6 atm, the guidewire is advanced by manual control of the proximal Y-connector by the physician.
The Houdini Catheter requires the use of traditional manual inflation devices (not included).
Here's an analysis of the acceptance criteria and study information based on the provided text, structured according to your request:
Acceptance Criteria and Study Details for the Houdini Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail manner with specific numerical thresholds. Instead, it describes various performance tests and states that the device "satisfies functional performance requirements." For some characteristics, it provides specific values for the Houdini Catheter and compares them to the predicate device.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Houdini Catheter) |
|---|---|---|
| Biocompatibility | Compliant with ISO 10993 and FDA G95-1 | Biocompatible (based on cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and thrombogenicity testing) |
| Simulated Use (Insertion, Deployment, Removal) | Functional and as intended | Device insertion, deployment, and removal were assessed and found satisfactory ("satisfies functional performance requirements"). |
| Radio-detectability | Compliant with ASTM F640-12 | Satisfies functional performance requirements |
| Peak Tensile Force | Compliant with ISO 10555-1 Annex B | Satisfies functional performance requirements |
| Freedom from Fluid Leakage | Compliant with ISO 10555-1 Annex C | Satisfies functional performance requirements |
| Freedom from Air Leakage (Hubs) | Compliant with ISO 10555-1 Annex D | Satisfies functional performance requirements |
| Burst Pressure | Compliant with ISO 10555-1 Annex F | 16 atm (compared to predicate's 10 atm) |
| Inflation Pressure vs. Diameter | As specified | Satisfies functional performance requirements |
| Peak Delivery Force vs. Inflation Pressure | As specified | Satisfies functional performance requirements |
| Dimensional Verification | Within specified tolerances | Satisfies functional performance requirements |
| Tensile Strength | As specified | Satisfies functional performance requirements |
| Torque Load | As specified | Satisfies functional performance requirements |
| Crossing Profile | As specified | Satisfies functional performance requirements |
| Kink Resistance | As specified | Satisfies functional performance requirements |
| Nominal Balloon Diameter | As specified for each model | CM-3400: 4mm; CM-3500: 5mm; CM-3600: 6mm; CM-3700: 7mm; CM-3800: 8mm |
| Catheter Effective Length | 100cm | 100cm |
| Maximum Balloon Working Length | 2cm | 2cm |
| Anchoring Inflation Pressure | 6atm | 6atm (compared to predicate's 1.5 atm) |
| Maximum Working Pressure | 12atm | 12atm (compared to predicate's 6 atm) |
| Catheter Shaft Diameter | 5Fr | 5Fr |
| Guidewire Size | 0.014 - 0.035 inches | 0.014 - 0.035 inches |
| Introducer Sheath Size | 6Fr | 6Fr (compared to predicate's 7 Fr) |
| Peak Force Delivery | 0.35kgf to 0.71kgf | 0.35kgf to 0.71kgf (compared to predicate's 0.026Kgf to 0.185) |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the performance bench tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The testing conducted appears to be primarily in vitro (bench testing) and in silico (simulated use) rather than involving human or animal subjects that would typically have country of origin relevance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The testing described is primarily physical and mechanical performance testing, with ground truth established by adherence to recognized standards (e.g., ISO, ASTM, FDA Blue Book Memorandum) and measurement/engineering best practices, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This is not applicable as the testing involves objective measurements against engineering specifications and international standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typical for diagnostic AI devices involving human readers and interpretations of medical images. The Houdini Catheter is a physical medical device (catheter) and the performance data provided relates to its mechanical and biocompatible properties.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable in the context of the Houdini Catheter as it is a physical medical device, not an algorithm or AI. The performance studies described are "standalone" in the sense that they evaluate the device's physical and functional characteristics in a bench setting without a human operator's performance being studied, but it's not "algorithm only" as there's no algorithm involved.
7. The Type of Ground Truth Used
The "ground truth" for the performance data is established by:
- Adherence to International Standards: For biocompatibility (ISO-10993), radio-detectability (ASTM F640-12), peak tensile force (ISO 10555-1 Annex B), fluid/air leakage (ISO 10555-1 Annex C/D), and burst pressure (ISO 10555-1 Annex F).
- Engineering Specifications: For dimensional verification, inflation pressure vs. diameter, peak delivery force, tensile strength, torque load, crossing profile, and kink resistance.
- Functional Assessment: For simulated use (insertion, deployment, removal).
8. The Sample Size for the Training Set
This is not applicable and not provided. The Houdini Catheter is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical medical 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).