(36 days)
The Arrow Central Venous Access Product permits venous access and catheter introduction to the central circulation. The ARROWg+ard Blue® antimicrobial surface is intended to help provide protection against access device-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
The Arrow MAC™ with ARROWg+ard Blue® is a venous access catheter with the functionality of three segregated internal pathways. The hemostasis valve and distal lumen can accommodate a thermodilution catheter, or similar device, 7 to 8 Fr in size while the remaining space is utilized as a flow lumen through the distal port.
The provided 510(k) summary for the MAC™ 3 Lumen Central Venous Access Kit with ARROWg+ard Blue® Antimicrobial Surface (K032962) indicates that the device's acceptance criteria and the study proving it meets these criteria are based on performance tests demonstrating substantial equivalence to legally marketed predicate devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Tests) | Reported Device Performance (Conclusion) |
|---|---|
| Flow rate | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. |
| Leak test | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. |
| Tensile test | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. |
| Fatigue test | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. |
| Flex modulus test | The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. |
Note: The document only lists the types of tests performed and a general conclusion of substantial equivalence. Specific quantitative acceptance criteria (e.g., "flow rate must be > X mL/min") and the exact results achieved for each test are not detailed in this 510(k) summary. The "reported device performance" is essentially that it met the unspecified criteria for substantial equivalence to the predicate devices in these areas.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the performance tests.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's a submission of lab test results to demonstrate equivalence, rather than a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is a series of laboratory performance tests rather than an evaluation of a diagnostic device requiring expert interpretation of results. The "ground truth" for these engineering tests would be the established scientific and engineering principles for evaluating medical device performance.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., reading medical images) to resolve discrepancies among experts.
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
An MRMC comparative effectiveness study was not done. This type of study is entirely irrelevant for the device described, which is a physical catheter and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance test in the context of an algorithm or AI was not done. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for these performance tests would be established engineering and material science standards and specifications for intravascular catheters and introducers. These are objective measurements against defined physical properties and functionalities (e.g., material strength requirements, acceptable leak rates, flow rate specifications).
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of a physical medical device undergoing performance testing. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).