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

Device Description

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.

AI/ML Overview

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.

TEST PARAMETER	SPECIFICATION	Button Flush (MX703/MX730) Reported Performance	Meets Spec?
1. Vacuum
# Leaks / Total	0 / Total	0/40	Yes
2. Metering Rate - Adult (cc/hr) - 10°C
Mean (Approximate)	3.0 @ 15°C	2.34	No*
Minimum (99% Lower Tail)	1.4 @ 15°C	1.61	Yes
Maximum (99% Upper Tail)	7.3 @ 15°C	3.07	Yes
Std. Dev.		0.27	N/A
3. Metering Rate - Adult (cc/hr) - 45°C
Mean (Approximate)	3.0 @ 40°C	4.11	No*
Minimum (99% Lower Tail)	1.4 @ 40°C	2.57	Yes
Maximum (99% Upper Tail)	7.3 @ 40°C	5.65	Yes
Std. Dev.		0.57	N/A
4. Metering Rate - Neonate (cc/hr) - 15°C
Mean (Approximate)	30.0 @ 15°C	22.83	No*
Minimum (99% Lower Tail)	18.7 @ 15°C	18.07	Yes
Maximum (99% Upper Tail)	47.8 @ 15°C	27.59	Yes
Std. Dev.		1.76	N/A
5. Metering Rate - Neonate (cc/hr) - 40°C
Mean (Approximate)	30.0 @ 40°C	34.64	No*
Minimum (99% Lower Tail)	18.7 @ 40°C	27.83	Yes
Maximum (99% Upper Tail)	47.8 @ 40°C	41.45	Yes
Std. Dev.		2.52	N/A
6. Flush Rate - Adult (cc/min) - 10°C
Mean (Approximate)	N.A.	110.64	N/A
Minimum (99% Lower Tail)	40.0	84.06	Yes
Maximum (99% Upper Tail)	N.A.	137.22	N/A
Std. Dev.		9.83	N/A
7. Flush Rate - Adult (cc/min) - 45°C
Mean (Approximate)	N.A.	79.53	N/A
Minimum (99% Lower Tail)	40.0	51.95	Yes
Maximum (99% Upper Tail)	N.A.	107.11	N/A
Std. Dev.		10.20	N/A
8. 40 Psi Withstand	≥ 40 psi
# of Failed units	0/Total	0/40	Yes
9. Low Pressure Withstand	≥ 15 psi
# Bypassed below 15 psi	0/Total	0/40	Yes
10. Vacuum Test - 720 mm Hg	≤ -700 mm Hg
# of Failed units	0/Total	0/40	Yes

*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.

Summary

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510(k) Summary

JUN - 6 19

Image /page/0/Picture/1 description: The image shows the logo for Medex Inc. The logo consists of a symbol to the left of the word "medexinc". The symbol is made up of four smaller symbols, each resembling a person with outstretched arms. The word "medexinc" is written in a bold, sans-serif font, with the "i" in "inc" having a square dot.

This summary regarding 510(k) safety and effectiveness and being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

§ 807.92 (a)(1) Submitter's (and Contact) Names, Address, Telephone No., Summary Date

· John Toomey Senior Project Engineer Medex, Inc. 6250 Shier-Rings Road Dublin, Ohio 43017 (614) 791 5415
· 04.19.96

$ 807.92 (a)(2) Device Name (Including Trade Name), Common Name, Classification Name

· MX703/MX730
· Continuous flush device, fast flush
· Catheter, Continuous Flush (CV, 74 KRA)

$ 807.92 (a)(3) Legally Marketed Predicate Device to Which Equivalence is Claimed

· Medex, Inc.'s MicroflushTM ( K770432).
· Sorenson Research Company, Inc. C.F.S. INTRAFLO® (pre-amendment)

$ 807.92 (a)(4) Description of the Premarket Notification Device

· 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.

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510(k) Summary

Image /page/1/Picture/1 description: The image shows the logo for "medexinc". The logo consists of a symbol on the left, followed by the word "medexinc" in a bold, sans-serif font. There is a line underneath the word. The symbol on the left appears to be a stylized representation of people.

This MX703 and MX730 continuous flush devices and their intended use have been thoroughly reviewed against the ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" document per the blue book memorandum #G95-1. All materials have successfully met these standards.

§ 807.92 (a)(5) Intended Use

· 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

§ 807.92 (a)(6) Technical Characteristics Summary

Property	Microflush™	MX703/MX730	Intraflo®
Intended Use	The Microflush 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.	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, back-leakage, and waveform damping.	The Intraflo 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.
Biocompatibility	Unknown	ISO-10993	Unknown
Flow Restrictor Material	High density polyethylene (HDPE)	Silicone elastomer	Natural rubber
Method of Flush Actuation	Rotating plug	Push button	Pull tab
Momentary Flush Actuation	No	Yes	Yes
Flush Actuation	Two-hand operation	One hand operation	Two-hand operation
Nominal Metering Rate	3cc/hr	MX703 = 3cc/hrMX730 = 30cc/hr	3cc/hr
Operating Temperature	Unknown	+10° C to +45° C	Unknown
Clear Fluid Path	Yes	Yes	Yes
Vacuum Withstand	≤-700mmHg	≤-700mmHg	≤-700mmHg
Fluid Path Configuration	Tortuous	Straight-through	Tortuous

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510(k) Summary

807.92 (b)(1), (b)(3) Performance Testing Assessment

The MX703/MX730 devices were aggressively tested for substantial equivalence to the two predicates (i.e. primary: Medex, Inc. Microflush; and secondary: Sorenson Research Co., Inc. Following a conditioning period (which included EtO sterilization, C.F.S. Intraflo). temperature cycling, and impact exposure), the units were tested under the following tests: vacuum, metering rate, flush rate, 40 psi withstand, and low pressure withstand tests. In all cases, the MX703/MX730 met or exceeded the performance of the predicates. The following table lists the test parameters and the respective performance of the MX703/MX730 (i.e. Button Flush), Microflush and the Intraflo.

TEST PARAMETER	SPECIFICATION	Button FlushN=4099% Confidencet(.995,40)=2.704	MICROFLUSHN=1099% Confidencet(.995,10)=3.169 -except as indicatedfor metering rates	INTRAFLO N=1099% Confidencet(.995,10)=3.169 -except as indicatedfor metering rates
1. Vacuum
# Leaks / Total	0 / Total	0/40	0/10	0/10
2. Metering Rate - Adult (cc/hr) - 10°C			t(.995,8)=3.355
Mean (Approximate)	3.0 @ 15°C	2.34	2.85	2.25
Minimum (99% Lower Tail)	1.4 @ 15°C	1.61	1.51	1.46
Maximum (99% Upper Tail)	7.3 @ 15°C	3.07	4.19	3.04
Std. Dev.		0.27	0.4	0.25
3. Metering Rate - Adult (cc/hr) - 45°C			t(.995,7)=3.499	t(.995,9)=3.250
Mean (Approximate)	3.0 @ 40°C	4.11	4.10	3.93
Minimum (99% Lower Tail)	1.4 @ 40°C	2.57	-0.56	2.88
Maximum (99% Upper Tail)	7.3 @ 40°C	5.65	8.76	4.98
Std. Dev.		0.57	1.47	0.33
4. Metering Rate - Neonate (cc/hr) - 15°C
Mean (Approximate)	30.0 @ 15°C	22.83	N.A.	N.A.
Minimum (99% Lower Tail)	18.7 @ 15°C	18.07	N.A.	N.A.
Maximum (99% Upper Tail)	47.8 @ 15°C	27.59	N.A.	N.A.
Std. Dev.		1.76	N.A.	N.A.
5. Metering Rate - Neonate (cc/hr) - 40°C
Mean (Approximate)	30.0 @ 40°C	34.64	N.A.	N.A.
Minimum (99% Lower Tail)	18.7 @ 40°C	27.83	N.A.	N.A.
Maximum (99% Upper Tail)	47.8 @ 40°C	41.45	N.A.	N.A.
Std. Dev.		2.52	N.A.	N.A.
6. Flush Rate - Adult (cc/min) - 10°C
Mean (Approximate)	N.A.	110.64	327.73	121.25
Minimum (99% Lower Tail)	40.0	84.06	302.76	90.73
Maximum (99% Upper Tail)	N.A.	137.22	352.70	151.77
Std. Dev.		9.83	7.88	9.63
7. Flush Rate - Adult (cc/min) - 45°C
Mean (Approximate)	N.A.	79.53	365.99	143.81
Minimum (99% Lower Tail)	40.0	51.95	331.73	98.97
Maximum (99% Upper Tail)	N.A.	107.11	400.25	188.65
Std. Dev.		10.20	10.81	14.15
8. 40 Psi Withstand	≥ 40 psi
# of Failed units	0/Total	0/40	0/10	0/10
9. Low Pressure Withstand	≥ 15 psi
# Bypassed below 15 psi	0/Total	0/40	0/10	0/10
10. Vacuum Test - 720 mm Hg	≤ -700 mm Hg
# of Failed units	0/Total	0/40	0/10	0/10

Regulation Number and Section

§ 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).