MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP

K040899 · Medex, Inc. · FRN · Apr 30, 2004 · General Hospital

Device Facts

• Record ID: K040899
• Device Name: MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
• Applicant: Medex, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows: - in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. - in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral. - in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. - in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician. - inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less. The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

Device Story

Medex 3000 Series MRI Syringe Infusion Pump; electromechanical device for precise fluid delivery. Inputs: user-programmed infusion parameters (rate, volume, mode). Operation: syringe-based infusion mechanism designed for compatibility with MRI environments; must be mounted outside 150 Gauss line; restricted to 1.5 Tesla or lower field strength magnets. Outputs: controlled fluid infusion. Used in clinical settings (critical care, anesthesia, neonatal/pediatric units) by clinicians. Provides continuous, intermittent, or bolus delivery. Benefits: enables safe, precise medication/fluid administration during MRI procedures without interference from or to the magnetic field.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design specifications for MRI compatibility.

Technological Characteristics

Syringe infusion pump; electromechanical drive mechanism. Designed for MRI compatibility (1.5 Tesla or less, 150 Gauss line limit). Supports multiple delivery modes (continuous, bolus, mass, body weight).

Indications for Use

Indicated for patients requiring precisely controlled infusion of fluids (blood, lipids, drugs, antibiotics, enteral solutions) via arterial, epidural, intravenous, spinal, subcutaneous, or enteral routes. Suitable for critical care, anesthesia, neonatal, and pediatric applications. Contraindicated for use on the inlet side of ECMO systems with negative pressure > -100mm Hg.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

Ms. Barbara Law Regulatory Affairs Manager Medex, Incorporated 6250 Shier-Rings Road Dublin, Ohio 43016

Re: K040899

Trade/Device Name: Medex 3000 Series MRI Syringe Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 19, 2004 Received: April 6, 2004

Dear Ms. Law:

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 111 (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 - Ms. Law

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 (QS) 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 (301) 594-46. 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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

K040899 510(k) Number (if known):

Device Name:

Medex 3000 series MRI Syringe Infusion Pump

Indications for Use:

The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:

- · in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
- · in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
- · in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
- in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
- · inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.

The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

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

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vick Hubbard for ADW

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number: K