MX703 AND MX730 CONTINUOUS FLUSH DEVICES

K961527 · Medex, Inc. · KRA · Jun 6, 1996 · Cardiovascular

Device Facts

• Record ID: K961527
• Device Name: MX703 AND MX730 CONTINUOUS FLUSH DEVICES
• Applicant: Medex, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Jun 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

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, back-leakage, and waveform damping

Device Story

MX703/MX730 are continuous flush devices for catheter-transducer systems; MX703 provides 3cc/hr flow; MX730 provides 30cc/hr flow. Devices connect to pressure infusors to maintain patency of cannulated vasculature; isolate pressure transducers from pump-generated waveform noise. Clinicians operate devices via flush button to perform 'fast flushes' for line clearing after blood draws or medication administration. One-hand operation; straight-through fluid path; silicone elastomer flow restrictor. Benefits include reduced clotting and improved pressure monitoring accuracy.

Clinical Evidence

Bench testing only. Performance evaluated against predicates (N=40 for subject, N=10 for predicates) following EtO sterilization, temperature cycling, and impact exposure. Metrics included vacuum integrity, metering rates (at 10°C and 45°C), flush rates, and pressure withstand (40 psi). Results confirm subject device performance is equivalent or superior to predicates.

Technological Characteristics

Silicone elastomer flow restrictor; straight-through fluid path; flush button actuation; one-hand operation. Operating temperature range: ±10°C to +45°C. Vacuum withstand: ≤ -700mmHg. Pressure withstand: ≥ 40 psi. Sterilization: EtO. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients requiring continuous intravascular flushing via catheter-transducer systems to maintain patency and prevent clotting, back-leakage, and waveform damping.

Regulatory Classification

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.

Predicate Devices

• Microflush (K770432)
• C.F.S. INTRAFLO (pre-amendment)

Submission Summary (Full Text)

{0}

JUN - 6 1996
K961527

# 510(k) Summary

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
[phone]

- 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 Microflush™ (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 flush". 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 operation. Secondly, the MX730 is used to perform “fast flushes” under the same conditions and requirements as the MX703 above.

Page 1 of 3
6250 Shier-Rings Road Dublin, Ohio 43017-1295 [phone] Fax: [phone]

{1}

medexinc

510(k) Summary

- 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, back-leakage, and waveform damping

## § 807.92 (a)(6) Technical Characteristics Summary

| Property | Microflush™ | MX703/MX730 | Intraflu® |
| --- | --- | --- | --- |
| 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 Intraflu 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 | Flush 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 |

Page 2 of 3

6250 Shier-Rings Road Dublin, Ohio 43014-8895 (44) 889-2220 Fax: [phone]

{2}

medexinc

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. C.F.S. Intrafl). Following a conditioning period (which included EtO sterilization, 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 Intrafl.

| 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 |

6250 Shier-Rings Road Dublin, Ohio 43017-1295 [phone] Fax [phone]