COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION by BAXTER HEALTHCARE CORP.

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 Description

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 feature is a clinical support tool that allows the clinician to compare pump programming with hospital-defined guidelines at the point of care. If the clinician programs any values outside of the rule sets established by the hospital, an out-of-limits warning occurs. These Configurations, including Personality Feature Sets and associated Labels, can be transferred to or from a 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 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.

AI/ML Overview

The provided text describes two software accessories for the COLLEAGUE Volumetric Infusion Pump: the COLLEAGUE GUARDIAN Configuration Tool and the COLLEAGUE DL2 Event History Download Software Application.

The document indicates "Non-clinical testing associated with intended use claims was performed according to the Baxter Healthcare Corporation Product Development Process." and that "The proposed COLLEAGUE GUARDIAN Configuration Tool and the COLLEAGUE DL2 Event History Download Software Application have been verified against product design requirements and validated against defined user needs/intended uses and instructions for use." However, it does not provide specific acceptance criteria or detailed study results in terms of numerical performance metrics. It concludes that the devices "are safe and effective in their use with the COLLEAGUE Volumetric Infusion Pump, and perform as well as or better than their predicates."

Here's an analysis based on the information provided, highlighting what is present and what is absent:

Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in numerical terms. The general criterion is that the software accessories are "safe and effective" and "perform as well as or better than their predicates."	Verified against product design requirements.
	Validated against defined user needs/intended uses and instructions for use.
	Minimizes the potential to transcribe wrong data values from paper documents (for Configuration Tool).
	Provides access, download, viewing, printing, and copying of event history (for DL2 Software).

Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing is described as "Non-clinical testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document mentions "defined user needs/intended uses," suggesting input from stakeholders, but no details on expert involvement or qualifications for ground truth establishment.
Adjudication method for the test set
- Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. These are software accessories for an infusion pump, facilitating configuration and data download, not AI software for interpretation tasks typically associated with MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The testing described is "Non-clinical testing" and involves verification against design requirements and validation against user needs/intended uses. Given the nature of the software (configuration and data download tools), this implicitly represents standalone algorithm performance in executing its defined functions. However, a formal "standalone study" with detailed metrics is not described.
The type of ground truth used
- The "ground truth" for these types of software accessories would typically be the correct execution of their programmed functions and accurate transfer/storage of data, as defined by "product design requirements" and "user needs/intended uses." It's not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic or predictive devices.
The sample size for the training set
- Not applicable. These are software accessories, not machine learning algorithms that typically require training sets. They are rule-based or function-based software tools.
How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set or machine learning components.

Summary

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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-ALMcGaw Park, IL 60085
Phone:	(847) 473-6273
Fax:	(847) 785-5116
Date Prepared:	01/12/07
Trade Names:	COLLEAGUE GUARDIAN Configuration ToolCOLLEAGUE DL2 Event History Download SoftwareApplication
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 SoftwareAccessories, K041191 and K010566
Device Description:	The COLLEAGUE GUARDIAN Configuration Tool is aproprietary, Personal Computer (PC) based softwareaccessory that is used to define, create and maintain theCOLLEAGUE Personality Feature Sets, Labels and rulesets (COLLEAGUE GUARDIAN Configurations)associated with the COLLEAGUE GUARDIAN feature.This feature is a clinical support tool that allows theclinician to compare pump programming with hospital-defined guidelines at the point of care. If the clinicianprograms any values outside of the rule sets established bythe hospital, an out-of-limits warning occurs. TheseConfigurations, including Personality Feature Sets andassociated Labels, can be transferred to or from a

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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.

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:

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Summary of TechnologicalCharacteristics:	The main features of the COLLEAGUE GUARDIANConfiguration Tool are: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 COLLEAGUEGUARDIAN Configurations Print reports Transfer approved COLLEAGUE GUARDIANConfigurations from the COLLEAGUE GUARDIANConfiguration Tool to the COLLEAGUE VolumetricInfusion Pump Transfer COLLEAGUE GUARDIAN Configurationsfrom the COLLEAGUE Volumetric Infusion Pump tothe COLLEAGUE GUARDIAN Configuration Tool The main features of the COLLEAGUE DL2 Event HistoryDownload Software Application are:Downloading and viewing of event historyinformation Copying of downloaded information to the Windowsclipboard Printing of downloaded information
Non-Clinical Testing:	Non-clinical testing associated with intended use claimswas performed according to the Baxter HealthcareCorporation Product Development Process.
Conclusions:	The proposed COLLEAGUE GUARDIAN ConfigurationTool and the COLLEAGUE DL2 Event History DownloadSoftware Application have been verified against product

Summary of TechnologicalCharacteristics:

The main features of the COLLEAGUE GUARDIANConfiguration Tool are: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 COLLEAGUEGUARDIAN Configurations Print reports Transfer approved COLLEAGUE GUARDIANConfigurations from the COLLEAGUE GUARDIANConfiguration Tool to the COLLEAGUE VolumetricInfusion Pump Transfer COLLEAGUE GUARDIAN Configurationsfrom the COLLEAGUE Volumetric Infusion Pump tothe COLLEAGUE GUARDIAN Configuration Tool The main features of the COLLEAGUE DL2 Event HistoryDownload Software Application are:Downloading and viewing of event historyinformation Copying of downloaded information to the Windowsclipboard Printing of downloaded information

Non-Clinical Testing:

Non-clinical testing associated with intended use claimswas performed according to the Baxter HealthcareCorporation Product Development Process.

Conclusions:

The proposed COLLEAGUE GUARDIAN ConfigurationTool and the COLLEAGUE DL2 Event History DownloadSoftware Application have been verified against product

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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.

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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.

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

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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:

Device Name:

Indications for Use:

COLLEAGUE DL2 Event History Download Software Application

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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).