(167 days)
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is intended to be used for the controlled selective infusion of physician specified pharmacological agents and radiopaque contrast media into the general vasculature. It is not intended for coronary, neurological, pediatric or neonatal use.
The 2.9F Cragg-McNamara™ Valved Infusion Catheter is a single lumen plastic catheter suitable for infusion of physician-specified pharmacological agents or contrast media through its proximal luer adapter to infusion holes circumferentially placed in the distal portion of the catheter. The device is designed to be placed over a guide wire into the general vasculature. The device will be available in various catheter and infusion lengths. The 2.9F Cragg-McNamara™ Valved Infusion Catheter utilizes a plastic valve at the tip which will allow effective transmission of infusate through the side holes by effectively occluding infusion out the catheter. As a guide wire is introduced, the valve opens to permit smooth passage of the guide wire and closes again as the guide wire is removed. The recommended maximum guide wire OD is 0.018 inch. The 2.9F Cragg-McNamara™ Valved Infusion Catheter has two radiopaque markers that define fluoroscopically the location of the exit holes. The method of construction and materials used for these infusion catheters are substantially equivalent to previous infusion catheter products.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the 2.9F Cragg-McNamara™ Valved Infusion Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet qualifications for short-term use in the vascular system per ISO 10993-1:1992(E). | Device passed biocompatibility testing and is suitable for its application. (Specific test results or quantitative metrics are not provided in the summary.) |
| Physical Performance: | |
| - Dimensional inspection | Yielded acceptable results. (Specific dimensions or tolerance ranges are not provided.) |
| - Catheter tensile strength tests | Yielded acceptable results. (Specific strength values or thresholds are not provided.) |
| - Static burst pressure tests | Yielded acceptable results. (Specific pressure values or thresholds are not provided.) |
| - Dynamic burst pressure tests | Yielded acceptable results. (Specific pressure values or thresholds are not provided.) |
| - Flow rate test | Yielded acceptable results. (Specific flow rates or benchmarks are not provided.) |
| - Performance under simulated conditions | Yielded acceptable results. (Specific simulated conditions or performance metrics are not provided.) |
| Substantial Equivalence: | |
| - Constructed of same or substantially equivalent materials as predicate devices. | Constructed of the same or substantially equivalent materials as the Micro Therapeutics Infusion Catheters (K940634) and other legally marketed infusion catheters. |
| - Sizes and configurations equivalent to predicate devices. | Sizes and configurations available along with the packaging and sterilization methods are equivalent to predicate devices. |
| - Clinical indications for use identical to predicate devices. | Clinical indications for use are identical to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is for biocompatibility and physical performance, which are typically lab-based tests, not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the context of this device. The "tests" described are for product specifications (biocompatibility, physical properties), not diagnostic accuracy requiring expert interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing relates to physical and biological properties, not human interpretation or adjudication processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an infusion catheter, and the provided documentation focuses on its physical and biological equivalence to predicate devices, not on diagnostic or interpretative effectiveness that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this device. This is a physical medical device (an infusion catheter), not a software algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed was likely established by:
- Biocompatibility: Established by adhering to the standards outlined in ISO 10993-1:1992(E) and performing tests such as cytotoxicity, sensitization, irritation, etc., with negative results serving as the "ground truth" for biocompatibility.
- Physical Testing: Established by engineering specifications, material properties, and performance benchmarks for infusion catheters. For example, a tensile strength test would have a pre-defined passing threshold based on material science and expected stresses, and results exceeding this threshold would be the "ground truth" for acceptable strength. These are objective measures against predefined criteria.
8. The Sample Size for the Training Set
This concept is not applicable to this device. This is a physical medical device, not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable to this device, as it does not involve a training set.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).