(48 days)
For use in invasive physiological pressure measurements which require continuous regulated flow to maintain catheter patency.
Invasive physiological pressure monitoring requires a number of components that include an IV administration set, a pressure transducer, a monitoring line and a catheter. Because of the potential for clot formation over the course of physiologic monitoring, a continuous flush device can be included in these systems for slow flush of the monitoring line. This minimizes the possibility that blood clots will form within the catheter and at the catheter tip. The Argon Continuous Flush Device is a slow flush device that is intended to be used with the components identified above for slow and continuous flushing of indwelling lines to minimize the formation of clots that would interfere with monitoring integrity.
The Argon Continuous Flush Device is manufactured in two distinct configurations, a 3 ml/hr flow rate device and a 30 ml/hour flow rate device. The design difference which results in continuous flow rates of 3 ml/hr and 30 ml/hr for each of the two models of devices is achieved by the diameter of a laser-drilled flow control orifice in each unit. The orifice diameter is predefined for each version to correlate to the desired output flow rate. The two devices are distinguished from one another by the color of the flush device cap. The 3 ml/hr continuous flush device has a clear cap and the 30 ml/hr continuous flush device has a yellow cap.
Both devices are connected to an IV administration system including a pressurized bag of saline that typically is heparinized. Applied pressure from the bag (300 mmHg) initiates the flow through the IV administration set and the flush device. The slow flow prevents over-infusion, and minimizes clot formation. The "fast flush" feature of the device assists in priming and removing bubbles from the lines or catheters and supplying a fast flow of intravenous fluid to the patient to assess the integrity of the entire monitoring system. This feature is actuated by squeezing the tabs on either side of the device or by pulling up the pull tab on the top of the device.
The provided document, K070384, is a 510(k) summary for the Argon Continuous Flush Device. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not include a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or a performance validation study for a new algorithm would.
Instead, the document states: "Non-clinical performance data demonstrates that the Argon Continuous Flush Device performed in an equivalent manner to the predicate and is suitable for its intended use." This indicates that bench testing was performed to show equivalence to the predicate device, but the specifics of what was measured, what the acceptance criteria were, and the results against those criteria are not delineated in this summary.
Therefore, many of the requested fields cannot be filled directly from this document. I will fill in what can be inferred and explicitly state when information is not available.
Acceptance Criteria and Device Performance Study Analysis: Argon Continuous Flush Device (K070384)
The provided 510(k) summary for the Argon Continuous Flush Device describes bench testing to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving a device meets specific, quantitative acceptance criteria for an AI/algorithm. Thus, much of the requested information regarding complex studies, expert ground truth, and sample sizes for AI/algorithmic performance isn't present.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the 510(k) summary, the primary performance criteria revolve around the specified flow rates. The acceptance criteria would likely be a range around these nominal values, and the reported performance would be that the device achieved these rates.
| Acceptance Criteria (Inferred from device description) | Reported Device Performance (Inferred from 510(k) Summary) |
|---|---|
| Nominal continuous flush flow rate of 3 ml/hr | Device performs as specified (3 ml/hr nominal flow) |
| Nominal continuous flush flow rate of 30 ml/hr | Device performs as specified (30 ml/hr nominal flow) |
| Functionality of "fast flush" feature | Fast flush feature operates as intended |
| Compatibility with IV administration systems | Compatible with standard IV administration systems |
| Equivalence to predicate devices (Edwards Uniflow Flush Device, American Pharmaseal Blood Pressure Transducer) in material and design characteristics | Demonstrated equivalence to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The document states: "Non-clinical performance data demonstrates that the Argon Continuous Flush Device performed in an equivalent manner to the predicate and is suitable for its intended use." This indicates bench testing was performed to establish that the Argon device's flow rates and functional characteristics (e.g., fast flush) are comparable to the predicate devices. The exact details of this "non-clinical performance data" are not provided in this 510(k) summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary. As this is a physical medical device (a flush device, not an AI algorithm), the "test set" would refer to the number of individual devices tested during the non-clinical performance evaluation.
- Data Provenance: The testing would have been conducted by Argon Medical Devices, likely in the USA. The data would be prospective, gathered specifically for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device where performance is measured objectively (e.g., fluid flow rate). There is no "ground truth" requiring expert human interpretation or consensus in the context of an AI/ML study. Performance is validated through engineering and laboratory measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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:
- Not Applicable. This is a physical medical device (continuous flush device), not an AI or imaging diagnostic algorithm. Therefore, no MRMC study involving human readers or AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device. No algorithm is involved in its direct function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For this physical device, "ground truth" would be established by direct, objective physical measurements (e.g., volumetric flow rate measurements under specified pressure conditions) and comparison to the predicate device's established performance specifications.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. This is a physical medical device.
§ 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).