ALARIS SYSTEM PC UNIT, MODEL 8001

K051641 · Cardinal Health, Alaris Products · FRN · Oct 20, 2005 · General Hospital

Device Facts

• Record ID: K051641
• Device Name: ALARIS SYSTEM PC UNIT, MODEL 8001
• Applicant: Cardinal Health, Alaris Products
• Product Code: FRN · General Hospital
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healtheare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Afaris System module is specified in it's respective submission,

Device Story

Alaris System PC Unit (Model 8001) acts as the central interface and power supply for modular infusion and monitoring devices. This enhanced version features an upgraded processor, increased memory, and a color display. Used in professional healthcare settings, it enables clinicians to manage and power various infusion/monitoring modules. The device does not alter the function of connected modules; it provides the hardware platform for user interaction and system power. Benefits include improved processing and visual interface for clinical staff managing patient therapy.

Clinical Evidence

No clinical data. Performance information provided indicates the device meets specified requirements and is substantially equivalent to the predicate device.

Technological Characteristics

Modular infusion/monitoring system PC unit. Features upgraded processor, increased memory, and color screen. Serves as power supply and user interface for Alaris System modules. Connectivity via modular interface. Class II device.

Indications for Use

Indicated for use in professional healthcare facilities utilizing infusion and/or monitoring devices. The device serves as the primary user interface and power supply for modular Alaris System components.

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

• Alaris System (originally submitted as IMED Orion Infusion System) (K950419)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the text "K051641" in a handwritten style. The text is written in black ink on a white background. The numbers and letters are clearly legible. There is a line underneath the text.

## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® Alaris System with Enhanced PC Unit

#### 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<br>Cardinal Health, Alaris Products |
| E. | Date Summary Prepared: | June 15, 2004 |

#### DEVICE IDENTIFICATION

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

#### DEVICE DESCRIPTION

The Alaris System is a modular system that consists of a point-of-care unit (PC Unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. The Enhanced PC Unit will include a faster processor, increased memory, and a color screen. This update is only for the Alaris PC Unit and does not require any change to the associated modules, systems, or accessories of the Alaris System.

{1}------------------------------------------------

## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products® Alaris System with Enhanced PC Unit Page 2 of 3

## SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris Products Alaris System with Enhanced PC Unit is substantially equivalent to the following predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-----------------------------------------------------------------------------|-------------------------------------|------------|---------------|
| Alaris System<br>(originally submitted as<br>IMED Orion Infusion<br>System) | Cardinal Health, Alaris<br>Products | K950419 | June 21, 1995 |

## INTENDED USE

The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healtheare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Afaris System module is specified in it's respective submission,

## TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Alaris System with Enhanced PC Unit and the predicate device has been performed. The results of this comparison demonstrate that the Alaris System with Enhanced PC Unit is equivalent to the marketed predicate device in technological characteristics.

## PERFORMANCE INFORMATION

The performance information provided indicates that the Alaris System with Enhanced PC Unit meets specified requirements, and is substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051641

Trade/Device Name: ALARIS SYSTEM PC UNIT, MODEL 8001 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 22, 2005 Received: September 23, 2005

Dear Ms. Lewis:

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 Devicc 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 cither 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.

{3}------------------------------------------------

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. 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 dcvice 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 yours,

Suette Y. Michie MD

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

{4}------------------------------------------------

# INDICATIONS FOR USE

510(k) Number:

K051641 (To Be Assigned By FDA)

Device Trade Name:

Alaris System PC Unit

Indications For Use: The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules (aka Medley System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris System module is specified in its respective submission.

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cisa Vur

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ._