(45 days)
K770432, pre-amendment
Not Found
No
The device description focuses on mechanical flow restriction and flushing functions, with no mention of AI/ML terms or capabilities.
No
The device primarily maintains patency of a pressure line and isolates pressure transducers, which are diagnostic and monitoring functions, not direct therapeutic interventions.
No
The device is described as an attachment to a catheter-transducer system for continuous intravascular flushing to maintain patency and clear lines. Its functions are related to fluid management within a catheter system, not to diagnose a medical condition.
No
The device description clearly describes physical components (metering flushes) that act as flow restrictors and allow for "fast flushes." This indicates a hardware-based device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to permit continuous intravascular flushing to prevent clotting, backleakage, and waveform damping in a catheter-transducer system. This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description details the device's function as a flow restrictor and a mechanism for "fast flushes" within the vascular system. It does not mention any analysis of biological samples or diagnostic measurements.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly within the patient's vascular system to maintain the functionality of a catheter-transducer system, which is a procedural support function.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Sample sizes: Button Flush N=40, MICROFLUSH N=10 (except for metering rates), INTRAFLO N=10 (except for metering rates).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study type: Performance testing for substantial equivalence.
Sample size: Button Flush N=40, Microflush N=10, Intraflo N=10.
Key results: In all cases, the MX703/MX730 met or exceeded the performance of the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K770432, pre-amendment
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
il l
1
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/hr | |
| MX730 = 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 |
2
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 Flush
N=40
99% Confidence
t(.995,40)=2.704 | MICROFLUSH
N=10
99% Confidence
t(.995,10)=3.169 -
except as indicated
for metering rates | INTRAFLO N=10
99% Confidence
t(.995,10)=3.169 -
except as indicated
for 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 |