SE INFUSION SYSTEM WITH MMS

K043590 · Cardinal Health, Alaris Products · FRN · Mar 25, 2005 · General Hospital

Device Facts

• Record ID: K043590
• Device Name: SE INFUSION SYSTEM WITH MMS
• Applicant: Cardinal Health, Alaris Products
• Product Code: FRN · General Hospital
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The incorporation of the Medication Management System (MMS) with the Alaris SE Infusion System provides wired or wireless communication between the SE Infusion System and external devices. This is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps to enter infusion data. All data entry and validation of infusion parameters using MMS is performed by the trained healthcare professional. The SE Infusion System with MMS is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The SE Infusion System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Device Story

SE Infusion System with MMS adds wireless bi-directional communication to existing infusion pump technology; enables connectivity with Alaris Server and external devices via Inter-Server Interface Protocol (ISIP). System automates programming of infusion parameters; reduces manual data entry steps. Operated by trained healthcare professionals in clinical environments. Healthcare providers use system to receive/transmit infusion data; automates parameter entry to improve workflow efficiency and reduce manual entry errors. Benefits include streamlined clinical workflow and enhanced accuracy in medication administration.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and performance data demonstrating the system meets specified requirements.

Technological Characteristics

Infusion pump with integrated Medication Management System (MMS). Features RF communication module and proprietary Inter-Server Interface Protocol (ISIP) software for bi-directional data exchange with Alaris Server. Connectivity: Wired/wireless. Class II device.

Indications for Use

Indicated for use in professional healthcare facilities for the delivery of fluids, medications, blood, and blood products. Intended for use by trained healthcare professionals to automate infusion parameter programming based on physician orders.

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

• Medley System with MMS (K030459)

Submission Summary (Full Text)

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CARDINAL HEALTH, ALARIS PRODUCTS

# SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SE Infusion System with MMS

## SUBMITTER INFORMATION

| A. | Company Name: | Cardinal Health, Alaris Products |
|----|--------------------------------|-----------------------------------------------------|
| B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Stacy L. Lewis<br>Sr. Regulatory Affairs Specialist |
| E. | Date Summary Prepared: | December 23, 2004 |

#### DEVICE IDENTIFICATION

| A. | Generic Device Name: | Pump, Infusion |
|----|-------------------------|-----------------------------|
| B. | Trade/Proprietary Name: | SE Infusion System with MMS |
| C. | Classification: | Class II |
| D. | Product Code: | FRN, Infusion Pump |

## DEVICE DESCRIPTION

.

The addition of the Medication Management System (MMS) to the SE Infusion System will allow wireless bi-directional communication with the Alaris Server and external devices. MMS is the combination of RF communication from the SE Infusion System to/from the Alaris Server and the Alaris Proprietary software called the Inter-Server Interface Protocol (ISIP). The ISIP allows for communication between the SE Infusion System, the Alaris Server, and external devices.

The SE Infusion System with MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps

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## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SE Infusion System with MMS Page 2 of 3

#### DEVICE DESCRIPTION (Continued)

necessary to enter infusion data. All data entry and verification of infusion or monitoring parameters using MMS is performed by trained healthcare professionals prior to administration of medication(s).

#### SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris Products SE Infusion System with MMS is of comparable type and is substantially equivalent to the following predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---------------------------|----------------------------------------------------------------------------------------------|------------|---------------|
| Medley System with<br>MMS | Cardinal Health, Alaris<br>Products<br>(previously known as Alaris<br>Medical Systems, Inc.) | K030459 | April 4, 2003 |

#### INTENDED USE

The incorporation of the Medication Management System (MMS) with the Alaris SE Infusion System provides wired or wireless communication between the SE Infusion System and external devices. This is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps to enter infusion data. All data entry and validation of infusion parameters using MMS is performed by the trained healthcare professional. A separate Indications for Use page is located in Section 6.

#### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the SE Infusion System with MMS and the predicate device has been performed. The results of this comparison demonstrate that the SE Infusion System with MMS is equivalent to the marketed predicate device in technological characteristics.

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SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SE Infusion System with MMS Page 3 of 3

## PERFORMANCE DATA

The performance data indicate that the SE Infusion System with MMS meets specified

requirements, and is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, California 92121-2772

Re: K043590

R045990
Trade/Device Name: SE Infusion System with MMS Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 23, 2004 Received: December 28, 2004

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becatermined the device is substantially equivalent (for the relerenced above und navo acternialso re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrstate commerce prior to tray ============================================================================================================================================= Antichuntens, or to actives and Cosmetic Act (Act) that do not require approval of a premarket the redelar I vou, Drag, and Commay, therefore, market the device, subject to the general approval uppression (the Act. The general controls provisions of the Act include controls providents of 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 (1 vir ), it hay of back 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. Lewis

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. or the rever may 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 and insting (2) see t 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 vour 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 yours,

Juitte Michain Oms.

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

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# INDICATIONS FOR USE

| 510(k) Number: | K043590 |
|----------------|---------|
|----------------|---------|

(To Be Assigned By FDA)SE Infusion System with MMS Device Trade Name:

Indications For Use: The SE Infusion System with MMS is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The SE Infusion System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anita V. mic

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