(121 days)
The EquaFlow™ Multivalve Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents into the general vasculature. It is not intended for coronary, pediatric or neonatal use.
The EquaFlow Multivalve Infusion Catheter (MIC) is manufactured as a 4.0 or 5.0 French catheter, available in lengths of 40, 65, 100, or 130 centimeters (cm). The EquaFlow Multivalve Infusion Catheter is manufactured with distal and proximal platinum/iridium radiopaque markers, indicating the location of the side-valves' infusion segment. The infusion segments are in lengths of 5, 10, 15, 20, 30, 40, 50, and 60 cm. The number of side-valves is directly related to the length of the infusion segment, with holes 0.10 inches apart at the distal end and 0.25 inches apart as you move toward the proximal end. The distal tip of the EquaFlow Multivalve Infusion Catheter is straight and tapered. The catheter is manufactured with a nylon hub and strain relief at the proximal end.
The EquaFlow Multivalve Infusion Catheter is a single lumen catheter intended for delivering controlled infusions of intravascular therapeutic solutions. The catheter tip is designed with a tip valve, which allows occlusion of the catheter end hole without the use of a wire guide. The EquaFlow Multivalve Infusion Catheter is designed with side-valves spiraling along the specified infusion segment length of the distal portion of the catheter, providing a more even distribution of therapeutic solutions to the targeted location.
The provided text describes a medical device, the Cook Incorporated EquaFlow™ Multivalve Infusion Catheter, and its clearance through the FDA's 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or determining specific acceptance criteria for performance metrics in a clinical study. Therefore, much of the requested information (regarding clinical study design, sample sizes for test/training sets, expert involvement, and comparative effectiveness) is not available in the provided text, as it describes a premarket notification for a device that is not an AI/ML powered device.
However, the text does describe the mechanical and physical performance tests conducted to ensure reliable design and performance, equating these to the "acceptance criteria" for product release.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (Tests Conducted) and Reported Device Performance:
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Tensile | Supports substantial equivalence to predicate devices |
| Flow Restriction | Supports substantial equivalence to predicate devices |
| Flow Rate | Supports substantial equivalence to predicate devices |
| Burst Pressure | Supports substantial equivalence to predicate devices |
| Liquid/Air Leakage | Supports substantial equivalence to predicate devices |
| Biocompatibility | Supports substantial equivalence to predicate devices |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The document refers to "applicable testing" and does not detail the number of units tested for each criterion.
- Data Provenance: The tests were conducted internally by Cook Incorporated as part of their specified process controls and procedures, likely in a laboratory setting. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical context, as these are technical performance tests, not clinical efficacy studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these tests would be the established engineering standards and specifications for the device's physical and mechanical properties. These are measured objectively by testing equipment, not by expert consensus from clinicians.
4. Adjudication method for the test set:
- Not applicable. The results of the mechanical and physical tests are objective measurements against defined specifications. There is no mention of adjudication, as that is typically relevant for subjective assessments in clinical studies or image interpretation.
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. This is a medical device (infusion catheter), not an AI/ML powered device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or is relevant for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device, not an AI/ML algorithm.
7. The type of ground truth used:
- The ground truth for these tests would be objective engineering specifications and standards for material strength, flow characteristics, pressure resistance, leakage, and biological compatibility. The device was tested to ensure it met these predetermined physical and performance requirements.
8. The sample size for the training set:
- Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no "training set."
Summary of Study:
The "study" referenced for this device is a series of in-vitro engineering and biocompatibility tests. These tests were conducted by Cook Incorporated to demonstrate that the EquaFlow™ Multivalve Infusion Catheter met its design specifications and performed reliably. The results of these tests supported the conclusion of substantial equivalence to existing predicate devices (Cragg-McNamara™ Valved Infusion Catheters and Pulse*Spray® Infusion System) under the FDA's 510(k) pathway. The purpose of these tests was to ensure the device's physical integrity and functional performance in a lab setting, not its clinical efficacy or AI performance.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).