Search Results

The MX703/MX730 is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, backleakage, and waveform damping

The MX703 and the MX730 are 3cc/hr and 30cc/hr metering flushes, respectively. The MX703 3cc/hr flush has two (2) primary functions. First, it acts as a flow restrictor, allowing only a certain volume of flush solution to infuse per hour. This small hourly infused volume is necessary to maintain patency of a pressure line. The amount of volume infused per hour through the flush is maintained by pressure exerted on the flush solution by a pressure infusor. With the pressure gradient differences between the flush solution and the patient's physiological pressures, the volume of solution is infused through the flush and patency of the cannulated vasculature is maintained. The second function of the 3cc/hr flush is to give the clinician the ability to "fast flushes are necessary to clear the line following certain line manipulations (i.e. blood draws or medication administration). The MX730 30cc/hr flush has two (2) primary functions. First, it is used in pressure measurements which require continuous flow and the use of an infusion pump. The flush permits the fluid flow to be controlled by the infusion pump while it functions to isolate the pressure transducer from the pressure waveform noise generated by the pump. The 30cc/hr flow is great enough to allow the infusion pump complete control over the fluid flow while still restrictive enough to isolate the transducer from the noise generated by the pump during normal opperation. Secondly, the MX730 is used to perform "fast flushes" under the same conditions and requirements as the MX703 above.

The provided 510(k) summary describes the MX703/MX730 continuous flush devices and presents performance testing data to demonstrate their substantial equivalence to two predicate devices: Medex, Inc.'s MicroflushTM and Sorenson Research Company, Inc. C.F.S. INTRAFLO®.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "SPECIFICATION" in the table, and the reported device performance is shown for the "Button Flush" (MX703/MX730), "MICROFLUSH", and "INTRAFLO" devices.

*Note: For metering rates, while the mean values do not precisely match the "Approximate" specification, the device meets the critical Minimum (99% Lower Tail) and Maximum (99% Upper Tail) specifications, which define the acceptable range for the metering rate with high confidence. The "Approximate" specification might be a target mean, whereas the min/max define the regulatory acceptable range. The submission states "In all cases, the MX703/MX730 met or exceeded the performance of the predicates." indicating that the critical ranges were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • MX703/MX730 ("Button Flush"): N=40
  • MICROFLUSH: N=10 (except for metering rates, where N=8 or N=7 in some cases)
  • INTRAFLO: N=10 (except for metering rates, where N=9)
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of performance testing for medical devices, it is highly likely to be prospective laboratory testing of manufactured units rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This study involves laboratory performance testing of mechanical/fluidic properties of a device. It does not involve human expert interpretation of data (e.g., medical images). Therefore, there were no experts used to establish "ground truth" in the traditional sense of clinical decision-making. The ground truth is objective measurements derived from calibrated instruments and established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or clinical adjudication. The results are quantitative measurements against predefined specifications.

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 not a study evaluating a diagnostic or interpretive AI device with human readers. It is a performance test of a continuous flush device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm or AI. It is a mechanical medical device with fluidic properties. The tests performed are standalone tests of the device's physical performance, not algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used here is objective, quantitative laboratory measurements against predefined engineering specifications for device performance (e.g., flow rates, pressure withstand, leak tests).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Ask a specific question about this device