MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM

K061128 · Medrad, Inc. · FRN · May 22, 2006 · General Hospital

Device Facts

• Record ID: K061128
• Device Name: MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
• Applicant: Medrad, Inc.
• Product Code: FRN · General Hospital
• Decision Date: May 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDRAD Continuum MR Compatible Infusion System (3T Proximity) is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Device Story

Peristaltic infusion pump; microprocessor-controlled; delivers maintenance medications/fluids during MR procedures. Operates in MR environments up to 2000 gauss; requires caster brakes engaged during use. Input: user-programmed flow rates, bolus settings, and occlusion pressure limits. Output: controlled fluid delivery; visual/audible alarms for air-in-line, occlusion, low battery, and system errors. Used by trained medical staff in clinical settings (critical care, ER, radiology). Benefits patient by enabling continuous infusion therapy during MR imaging without interrupting treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Peristaltic pump; ABS housing; Li-Ion rechargeable battery; ultrasonic air sensor. Flow rates 1-1200 ml/h; accuracy +/- 10%. Microprocessor-controlled. MR compatible up to 2000 gauss. Connectivity: standalone. Sterilization: not specified.

Indications for Use

Indicated for patients requiring maintenance medications and fluids during MR procedures; intended for use immediately prior to, during, and after MR procedures. For use by trained medical staff (critical care, ER, radiology nurses). Not for long-term care outside MR environment.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• MEDRAD Continuum MR Compatible Infusion System (K032771)

Submission Summary (Full Text)

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K061128

## 510(k) Summary

OFFICIAL CONTACT:

John M Kiste Regulatory Affairs Analyst MEDRAD, Inc. One Medrad Drive Indianola, PA 15051 [phone] ext. 3444

Infusion Pump & Accessories [21 CFR 880.5725] CLASSIFICATION NAME:

MEDRAD

Peristaltic Pump System

COMMON NAME(S):

PROPRIETARY NAME:

PREDICATE DEVICE:

INTENDED USE:

(K032771) MEDRAD Continuum MR Compatible The Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

MR Continuum Infusion System

MEDRAD Continuum MR Infusion System

DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The Medrad Continuum Infusion System maintains the same intended use, similar operational parameters, similar labeling and is essentially used in a manner similar to the predicate device.

A label will be affixed to the system stating that when using the Continuum Infusion System in the MR environment it's casters brakes should be on and the system should not be placed in a static magnetic field exceeding 2000 gauss. The user's manual has also been updated to include this warning.

The Continuum MR Compatible Infusion System (3.0T) is comprised of the same components as the predicate device. Differences between the predicate device and the new Continuum MR Compatible Infusion System (3.0T) are detailed in the table below. The following Comparison Matrix identifies the similarities and differences between the new device and the predicate device.

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| Parameter | MEDRAD Continuum<br>MR Compatible Infusion<br>System - 1.5T | MEDRAD Continuum<br>MR Compatible Infusion<br>System - 3.0T |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Classification | Type CF | Same |
| Compatible IV<br>Administration Set | Standard PVC<br>Single Use<br>Y-Site Set<br>Free Flow Protection | Same |
| Flow Rate | Continuous: 1 to 99.9 ml/h<br>in 0.1 ml/h increments,<br>100 to 1200 ml/h in 1 ml/h<br>increments | Same |
| Total Infused Volume | Continuous: 1 to 9,999 ml | Same |
| Housing | ABS | Same |
| Microprocessor<br>Controlled | Yes | Same |
| KVO Infusion Rate | 1 to 5 ml/h | Same |
| System Accuracy | +/- 10% | Same |
| Occlusion Pressure | User Selectable:<br>Low-0.3 bar (5 psi)<br>Medium-0.5 bar (7.5 psi)<br>High-0.7 bar (10 psi) | Same |
| Battery | Li-Ion Rechargeable | Same |
| Battery Operation | 4 hr @ 1200 ml/h | Same |
| Battery Charging | ~6 hr to 95% maximum<br>battery capacity | Same |
| Air-In-Line Detector | User Selectable | Same |
| Total Time Setting | 100 hours | Same |
| Air Sensor | Ultrasonic | Same |
| Prime Rate | 1600 to 1800 ml/h | Same |
| Bolus Rate | 0.1 to 1200 ml/h | Same |
| Bolus Volume | 0.1 to 100 ml | Same |
| Alarm Conditions | | |
| > Air-In-Line | Yes | Yes |
| > Down<br>Occlusion | Yes | Yes |
| > Pump<br>Unattended | Yes | Yes |
| > Low Battery | Yes | Yes |
| > End Battery | Yes | Yes |
| > Fatal Error | Yes | Yes |
| > End Program | Yes | Yes |
| > Missing Key | Yes | Yes |
| > Lock Mode | Yes | Yes |
| Program Modes | | |
| > Continuous | Yes | Yes |
| > Dose | Yes | Yes |
| > Non-Weight<br>Dose | Yes | Yes |
| Integrated Mounting<br>Clamp for IV Pole | Yes | Yes |
| Built in Free Flow<br>Protection | Yes | Yes |
| Automatic Bolus Function<br>(Safety Feature) | Yes | Yes |
| User Selectable Alarm<br>Volume | Yes | Yes |
| Comprehensive Safety<br>Features | Yes | Yes |
| Low Battery | Yes | Yes |
| MRI Compatible | Yes | Yes (up to 2000 gauss) |

.

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and the comments of the comments of

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2006

Mr. John M. Kiste Regulatory Affairs Analyst MEDRAD, Incorporated One Medrad Drive Indianola, Pennsylvania 15051

Re: K061128

Trade/Device Name: MEDRAD Continuum MR Compatible Infusion System (3T Proximity) Regulation Number: 21 CFR 880.5725

Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 20, 2006 Received: April 25, 2006

Dear Mr. Kiste:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Kiste

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Syette y. Michael Smis.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ MEDRAD Continuum MR Compatible Infusion System (3T Proximity)

Indications For Use:

The MEDRAD Continuum MR Compatible Infusion System (3T Proximity) is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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