COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION

K070125 · Baxter Healthcare Corp · FRN · Apr 16, 2007 · General Hospital

Device Facts

• Record ID: K070125
• Device Name: COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
• Applicant: Baxter Healthcare Corp
• Product Code: FRN · General Hospital
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature. The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded, viewed, printed and copied to the Windows Clipboard for pasting into other programs.

Device Story

COLLEAGUE GUARDIAN Configuration Tool and DL2 Event History Download Software are PC-based accessories for COLLEAGUE Volumetric Infusion Pumps. Configuration Tool allows clinicians to define, create, and maintain pump personality feature sets, labels, and rule sets; these configurations are transferred to pumps to provide out-of-limits warnings when programming deviates from hospital guidelines; minimizes transcription errors compared to manual entry. DL2 Download Software retrieves, views, and prints pump event history (e.g., alarms, key presses) for clinical review. Used in clinical settings by healthcare staff; facilitates data management and compliance with hospital-defined infusion protocols.

Clinical Evidence

No clinical data. Verification and validation were performed via non-clinical testing according to the Baxter Healthcare Corporation Product Development Process, confirming the software meets design requirements and user needs.

Technological Characteristics

PC-based software applications. Configuration Tool manages personality feature sets, labels, and rule sets for infusion pumps. DL2 application facilitates data retrieval of pump event history. Connectivity via data transfer to/from COLLEAGUE Volumetric Infusion Pump. Software-based logic for configuration management and log extraction.

Indications for Use

Indicated for use as software accessories for the COLLEAGUE Volumetric Infusion Pump to manage pump configurations and download event history logs.

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

• COLLEAGUE Volumetric Infusion Pump and Software Accessories (K041191)
• COLLEAGUE Volumetric Infusion Pump and Software Accessories (K010566)

Submission Summary (Full Text)

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

COLLEAGUE Pump Software Accessories 510(k) Premarket Notification

K070125
Page 1 of 4
Section 5, 510(k) Summary

## 5. 510(K) SUMMARY

APR 1 6 2007

| Submitter/Contact Name: | Jeme Wallace |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd., MPGR-AL<br>McGaw Park, IL 60085 |
| Phone: | [phone] |
| Fax: | [phone] |
| Date Prepared: | 01/12/07 |
| Trade Names: | COLLEAGUE GUARDIAN Configuration Tool<br>COLLEAGUE DL2 Event History Download Software<br>Application |
| Common Names: | Software Accessories |
| Classification Name: | Accessories to Infusion Pump defined in 21 CFR 880.5725 |
| Class: | II |
| Equivalent Predicate: | COLLEAGUE Volumetric Infusion Pump and Software<br>Accessories, K041191 and K010566 |
| Device Description: | The COLLEAGUE GUARDIAN Configuration Tool is a<br>proprietary, Personal Computer (PC) based software<br>accessory that is used to define, create and maintain the<br>COLLEAGUE Personality Feature Sets, Labels and rule<br>sets (COLLEAGUE GUARDIAN Configurations)<br>associated with the COLLEAGUE GUARDIAN feature.<br>This feature is a clinical support tool that allows the<br>clinician to compare pump programming with hospital-<br>defined guidelines at the point of care. If the clinician<br>programs any values outside of the rule sets established by<br>the hospital, an out-of-limits warning occurs. These<br>Configurations, including Personality Feature Sets and<br>associated Labels, can be transferred to or from a |

יי

:

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

COLLEAGUE pump. In addition, the Configurations may be saved in a COLLEAGUE GUARDIAN Configuration Tool file, allowing the use of this tool to create and update Configurations. The tool also allows confirmation of new or modified Configurations, copying of Configurations and printing of Configuration reports. The COLLEAGUE GUARDIAN Configuration Tool, as compared to manual entry, minimizes the potential to transcribe the wrong data value from paper documents.

All COLLEAGUE Volumetric Infusion Pumps have an Event History that stores the most recent 1,000 sequential pump events, such as key presses, alarms and alerts. The COLLEAGUE DL2 Event History Download Software Application facilitates the Event History download to a PC. These events may be viewed, printed and copied to the Windows Clipboard for pasting into other programs.

The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature.

> The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded, viewed, printed and copied to the Windows Clipboard for pasting into other programs.

## Indications for Use:

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

发

.. .

| Summary of Technological<br>Characteristics: | The main features of the COLLEAGUE GUARDIAN<br>Configuration Tool are:<br>Enter, edit and delete Labels Enter, edit and delete Personalities Set/clear Personality-Label associations Save COLLEAGUE GUARDIAN Configurations Confirm COLLEAGUE GUARDIAN Configurations Retrieve previously saved COLLEAGUE<br>GUARDIAN Configurations Print reports Transfer approved COLLEAGUE GUARDIAN<br>Configurations from the COLLEAGUE GUARDIAN<br>Configuration Tool to the COLLEAGUE Volumetric<br>Infusion Pump Transfer COLLEAGUE GUARDIAN Configurations<br>from the COLLEAGUE Volumetric Infusion Pump to<br>the COLLEAGUE GUARDIAN Configuration Tool The main features of the COLLEAGUE DL2 Event History<br>Download Software Application are:<br>Downloading and viewing of event history<br>information Copying of downloaded information to the Windows<br>clipboard Printing of downloaded information |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Testing: | Non-clinical testing associated with intended use claims<br>was performed according to the Baxter Healthcare<br>Corporation Product Development Process. |
| Conclusions: | The proposed COLLEAGUE GUARDIAN Configuration<br>Tool and the COLLEAGUE DL2 Event History Download<br>Software Application have been verified against product |

.

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

design requirements and validated against defined user needs/intended uses and instructions for use. This demonstrates that these COLLEAGUE pump software accessories are safe and effective in their use with the COLLEAGUE Volumetric Infusion Pump, and perform as well as or better than their predicates.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baxter Healthcare, Corporation Mr. Jeme Wallace Associate Director, Regulatory Affairs Global Regulatory Affairs 1620 Waukegan Road McGaw Park, Illinois 60085-6730

APR 16 2007

Re: K070125

Trade/Device Name: COLLEAGUE GUARDIAN Configuration Tool: COLLEAGUE DL2 Event History Download Software Application Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 12, 2007

Received: January 16, 2007

Dear Mr. Wallace:

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.

{5}------------------------------------------------

## Page 2 -Mr. Wallace

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 [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,

Chiu-Ling, 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

{6}------------------------------------------------

COLLEAGUE Pump Software Accessories 510(k) Premarket Notification

## 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): New Traditional 510(k)

COLLEAGUE GUARDIAN Configuration Tool Device Name:

Indications for Use:

The COLLEAGUE GUARDIAN Configuration Tool is a proprietary, Personal Computer (PC) based software accessory that is used to define, create and maintain the COLLEAGUE Personality Feature Sets, Labels and rule sets (COLLEAGUE GUARDIAN Configurations) associated with the COLLEAGUE GUARDIAN feature. This software accessory can be utilized with product codes of the COLLEAGUE Volumetric Infusion Pump that contain the COLLEAGUE GUARDIAN feature.

Device Name:

Indications for Use:

COLLEAGUE DL2 Event History Download Software Application

The COLLEAGUE DL2 Event History Download Software Application is a proprietary, Personal Computer (PC) based software accessory. It provides access to event history information from all product codes of the COLLEAGUE Volumetric Infusion Pump, which can then be downloaded. viewed, printed and copied to the Windows Clipboard for pasting into other programs

Table 4-1.

| Prescription Use: | Over the Counter Use: |
|----------------------|-----------------------|
| 21 CFR 801 Subpart D | 21 CFR Subpart C |

Concurrence of CDRH, Office of Device Evaluation (ODE)

on Contre.

c(k) Numb K 070125

Baxter Confidential