COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)

K965214 · Coeur Laboratories, Inc. · DTX · Mar 28, 1997 · Cardiovascular

Device Facts

• Record ID: K965214
• Device Name: COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
• Applicant: Coeur Laboratories, Inc.
• Product Code: DTX · Cardiovascular
• Decision Date: Mar 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4300
• Device Class: Class 2

Intended Use

The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Injector Ram during the injection of contrast media into the vascular system for diagnostic purposes.

Device Story

Accessory kit for Medrad MCT/MCT Plus injectors; enables use of Coeur 200 mL Front Load Syringe. Components: machined aluminum face plate, stainless-steel ram tip extension, brass-tipped set screws. Face plate attaches via standard bayonet mount to injector base; ram tip extension secures to existing ram tip. Used in clinical imaging settings by radiology staff. Facilitates contrast media delivery; ensures syringe stability during injection. Benefits: allows compatibility between Coeur syringes and Medrad injector hardware.

Clinical Evidence

Bench testing and simulated clinical usage tests performed. No human clinical trials conducted. Verification data confirmed components meet design specifications. Simulated usage demonstrated performance equivalent to predicate Coeur Front Load Injector Turret.

Technological Characteristics

Materials: machined aluminum (face plate), stainless-steel (ram tip), brass (set screws). Mechanical attachment: standard bayonet mount. Non-sterile; does not contact fluid path. No software or electronics.

Indications for Use

Indicated for use with Medrad MCT and MCT Plus Injectors to facilitate contrast media injection into the vascular system for diagnostic imaging procedures.

Regulatory Classification

Identification

A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.

Predicate Devices

• Coeur Front Load Injector Turret and Front Load Syringe
• Medrad MCT and MCT Plus Injector with Front Load Syringe

Submission Summary (Full Text)

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C

COEUR®

LABORATORIES INC.

K965214

# 510(k) Summary
Coeur Front Load Injector Retrofit Kit
December 23, 1996

MAR 28 1997

## Official Contact:
James M. Clinton, Dir. Regulatory Affairs and Quality Assurance
Coeur Laboratories, Inc.
5301 Departure Drive
Raleigh, NC 27616

## Proprietary Name:
Coeur Front Load Injector Retrofit Kit

## Common Name:
Injector Face Plate

## Classification Name:
Injector and Syringe, Angiographic

## Predicate Devices:
Coeur Front Load Injector Turret and Front Load Syringe
Medrad MCT and MCT Plus Injector with Front Load Syringe

## Device Description:
The Coeur Front Load Retrofit Kit consists of two accessory pieces for use with Medrad MCT and MCT Plus Injector Systems and older models of Medrad injectors upgraded by Medrad to resemble the MCT and MCT Plus. The kit contains a face plate and ram tip extension that allow easy use of the Coeur 200 mL Front Load Syringe on the modified versions of Medrad injectors. This premarket notification describes the Coeur Face Plate Retrofit Kit, which is a modification of the Coeur Front Load Injector Turret, which allows use of the Coeur 200 mL Front Load Syringe on older models of Medrad injectors.

The Face Plate uses a standard bayonet mount to attach directly onto the Medrad injector-base on the MCT and MCT Plus injectors. The ram tip extension is then attached to the existing ram tip and tightened into place to prevent slippage. Once in place, the Coeur 200 mL Front Load Syringe may be used easily on the injectors.

## Intended Use:
The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Injector Ram during the injection of contrast media into the vascular system for diagnostic purposes.

510(k) Summary
Page 1 of 2

5301 Departure Drive, Raleigh, North Carolina 27604, [phone]
FAX Number [phone]

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# Technological Characteristics:

**Materials:** The Coeur Front Load Injector Retrofit Kit contains a machined aluminum face plate, a stainless-steel ram tip, and two brass-tipped set screws.

**Packaging / Sterilization:** Retrofit Kit is packaged individually in a polyethylene bag inside a corrugated cardboard outer carton. The face plate does not come into contact with the fluid path during operation, and is not a sterile device.

# Performance Test Data / Conclusions:

Verification data was summarized to demonstrate that the Coeur Front Load Injector Retrofit Kit components could be produced to specification. Additionally, simulated clinical usage tests showed that a Medrad injector fitted with the Retrofit Kit and the Coeur 200 mL Front Load Syringe performed as well as the Medrad injector fitted with the previously cleared Coeur Front Load Injector Turret and Coeur 200 mL Front Load Syringe.

510(k) Summary
Page 2 of 2
5301 Departure Drive, Raleigh, North Carolina 27604, [phone]
FAX Number [phone]