CONTINUOUS FLUSH DEVICE

K962129 · Merit Medical Systems, Inc. · KRA · Apr 15, 1997 · Cardiovascular

Device Facts

• Record ID: K962129
• Device Name: CONTINUOUS FLUSH DEVICE
• Applicant: Merit Medical Systems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Apr 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to maintain catheter patency.

Device Story

Continuous flush device acts as accessory to extravascular blood pressure transducer; maintains catheter patency via continuous fluid flow. Available in adult (3 ml/hr) and neonate (30 ml/hr) configurations. Features include manual fast flush (via squeeze tabs) for line filling/debubbling, pull-tab mechanism for pressure spike generation (frequency response verification), and pressure relief (bypass >600 mmHg) for transducer protection. Used in clinical settings by healthcare providers; device is single-use, sterile, and disposable.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Seven ultrasonically welded components; silastic control component for flow restriction and pressure relief. Flow rates: 3 ml/hr (adult) or 30 ml/hr (neonate) at 250 mmHg. Over-pressure protection at >600 mmHg. Sterilization: Ethylene Oxide gas. Single-use, pyrogen-free.

Indications for Use

Indicated for use in physiological pressure monitoring systems requiring continuous flow to maintain catheter patency in adult and neonate patient populations.

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

• Spectramed Flush Device (K873168)
• Baxter Healthcare Corporation Flush Device (K792141)

Submission Summary (Full Text)

{0}

Merit Medical Systems, Summary of Safety and Effectiveness, Flush Device, Page 1
APR 15 1997
K962129

# 510(k) SUMMARY OF SAFETY and EFFECTIVENESS

| Date of Summary: | May 31, 1996 | MERIT MEDICAL |
| --- | --- | --- |
| Submitter’s name: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2415
[phone] | SYSTEMS, INC. |
| Contact Person: | Dennis (Dan) Reigle | 1600 WEST |
| Name of device: | Continuous Flush Device | MERIT PARKWAY |
| Class: | Class II | |
| Classification name: | The flush device is an accessory to an extravascular blood pressure transducer (product code 74DRS). | SOUTH JORDAN. |
| Predicate device: | Predicate devices are flush device manufactured by: | UTAH 84095 |
| Spectramed, Inc.
Critical Care Division
1900 Williams Blvd
Oxnard, CA 93030
[phone]
K873168 | Baxter Healthcare Corporation
Edwards Critical Care Division
17221 Red Hill Avenue
Irvine, CA 92714
[phone]
K792141 | 801-253-1600
FAX [phone] |

## INDICATIONS FOR USE

A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to maintain catheter patency.

## DEVICE DESCRIPTION

The flush device is comprised of seven small components which, when ultrasonically welded together, constitute the finished product. The device is supplied in two configurations; adult and neonate. The adult configuration differs from the neonate configuration by flow rate and color. The adult flow specification is a nominal 3 milliliters per hour (ml/hr) with a static head pressure of 250 millimeters of mercury (mmHg). The neonate flow specification is a nominal 30 ml/hr at 250 mmHg static head pressure.

C:\wp51\data\510ks\flush_510(053196.shrindr)
113

{1}

Merit Medical Systems, Summary of Safety and Effectiveness, Flush Device, Page 2

The device has a fast flush feature which can be momentarily actuated by squeezing the tabs on either side of the device. The fast flush feature is used to aid in filling and debubbling the pressure monitoring lines.

The device has the capability of creating a momentary pressure spike to verify the frequency response of the pressure monitoring system. The pressure spike is created by pulling up and releasing (snapping) the pull tab on top of the device.

The device incorporates a pressure relief capability to provide over-pressure protection to the transducer. At pressures greater than 600 mmHg (11.6 psi), the silastic control component stretches and allows fluid to by-pass the flow restrictor thereby providing over-pressure protection.

SUBSTANTIAL EQUIVALENCE COMPARISON

| Feature | Merit Flush Device | Spectromed Flush Device | Baxter Flush Device |
| --- | --- | --- | --- |
| Intended Use | For use in physiological pressure measurements which require continuous flow to maintain catheter patency. | For use in physiological pressure measurements which require continuous flow to maintain catheter patency. | For use in physiological pressure measurements which require continuous flow to maintain catheter patency. |
| Adult flow rate | 3±1 ml/hr @ 250 mmHg pressure | 3±1 cc/hr @ 300 mmHg | 3±1 ml/hr (blue Snap-Tab™) |
| Neonate flow rate | 30±10 ml/hr @ 250 mmHg pressure | 30 cc/hr | 30±10 ml/hr (yellow Snap-Tab™) |
| Fast flush mode | Yes | Yes | Yes |
| Bypass pressure | >600 mmHg (11.6 psi) | Yes - unknown bypass pressure | Yes - >500 mmHg (9.7 psi) |
| Sterilization | Ethylene Oxide Gas | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Single Use | Yes | Yes | Yes |
| Pyrogen Free | Yes | Yes | Yes |
| Packaging | Tyvek™ pouch | Tyvek™ pouch | Tyvek™ pouch |
| Step response capability | Yes - via pull tab | Yes - by bouncing lever | Yes - via the Snap-Tab™ |
| Adult Colors | Adult devices supplied with squeeze tabs in white, red, blue or green. | Different models for adults, neonate applications | Blue color |
| Neonate Colors | Neonate devices supplied with squeeze tabs in yellow color. | Different models for adults, neonate applications | Yellow color |
| 510k | This submission | K873168 | K792141 |

C:\wp51\data\510ka\flush.510d053196.shr(adr)