COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 by BAXTERHEALTHCARE, INC.

The COLLEAGUE Volumetric Infusion Pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components.
The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes.
The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal patients. The COLLEAGUE pump facilitates the delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback infusion modes.

The COLLEAGUE pump can be used in the following care areas:

General Floor of the Hospital
Critical / Intensive Care
Neonatal Intensive Care
Pediatric Care
Labor / Delivery / Postpartum
Operating Room / Anesthesia
Post Anesthesia / Recovery
Cardiac Catheterization Lab
Emergency Room
Ground Ambulance
Hospice Facility
Outpatient / Subacute Facilities
Nursing Facilities
Long Term Care / Rehabilitation Facilities
Diagnostic Nuclear Medicine
Oncology Floor
Burn Unit / Trauma

Device Description

The COLLEAGUE Volumetric Infusion Pump product is a software controlled, electromechanical, large volumetric infusion pump that includes either one or three infusion channels. The COLLEAGUE Volumetric Infusion Pump product provides the necessary infusion therapy modes to deliver medications and solutions through a Baxter standard administration set. The pump uses a shuttle pumping mechanism to achieve flow. None of the pump device materials come in contact with the solution path.

The COLLEAGUE Volumetric Infusion Pump is designed to accept Baxter standard administration sets equipped with keyed slide clamps that are labeled as being COLLEAGUE pump compatible. The unidirectional slide clamp helps ensure proper set loading. The pump will accept a variety of currently marketed solution containers including flexible containers, glass bottles, and syringes (with an accessory adapter).

The pump is intended to operate primarily on AC power and is equipped with a rechargeable battery to facilitate use during transport.

The COLLEAGUE GUARDIAN feature is a configurable option that helps to reduce the potential for medication programming errors by allowing program limits to be predefined for labels in the pump's label library, including custom labels, based on hospital or care area protocols.

The COLLEAGUE GUARDIAN feature (Monochrome and CX devices) is available for dose mode programming only. The COLLEAGUE GUARDIAN feature allows the facility to set up labels for programming standard concentrations of a dose mode infusion.

The COLLEAGUE Enhanced GUARDIAN feature (CXE devices) is a configurable option that is available for both rate/volume and dose mode programming. The COLLEAGUE Enhanced GUARDIAN feature allows the facility to set up labels set up for programming nonstandard concentrations of a dose mode infusion (modifying the Drug Amount, Diluent Volume and/or Concentration from the default.

The COLLEAGUE Volumetric Infusion Pump supports the use of a proprietary software accessory; COLLEAGUE GUARDIAN Configuration Tool. The configuration tool supports the creation and maintenance of Personalities (custom feature set for individual care area or for specific therapies), as well as the clinical labels and parameters established by the hospital using the COLLEAGUE GUARDIAN dose error reduction software. This software accessory is not required to operate the pump.

The COLLEAGUE Volumetric Infusion Pump also supports the use of proprietary software accessory: COLLEAGUE DL2 Event History Download Software Application. The COLLEAGUE DL2 Event History Download Software Application is a service application that downloads the event history log. This software accessory is not required to operate the pump.

The COLLEAGUE Volumetric Infusion Pump has the ability to communicate externally via a data communications interface.

AI/ML Overview

Here's an analysis of the provided text regarding the COLLEAGUE Volumetric Infusion Pump, focusing on acceptance criteria and supporting studies:

A. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain a specific table detailing numerical acceptance criteria for performance metrics (e.g., flow rate accuracy, pressure limits, alarm response times) alongside reported device performance. Instead, it offers a more general statement:

Acceptance Criteria	Reported Device Performance
All tests successfully passed the acceptance criteria.	"The upgrades to the COLLEAGUE Volumetric Infusion Pump have been verified against design requirements and validated against defined user needs and intended uses. This demonstrates that the device is at least as safe, as effective, and performs as well as or better than the predicate COLLEAGUE Volumetric Infusion Pump."

B. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific numerical sample size for any "test set" in the context of typical clinical or AI model validation studies. The testing described is "Non-clinical testing associated with compliance and safety software, and intended use claims."

Sample Size: Not explicitly stated in terms of a numerical count of patients, cases, or specific test scenarios.
Data Provenance: The document states that "Human Factors evaluation and use scenario testing was performed under simulated use and environmental conditions utilizing clinical care personnel from hospital environments." This implies a prospective, simulated environment with real clinical users, but it doesn't specify countries of origin for hospitals or personnel.

C. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The concept of "ground truth" as typically defined in AI/ML studies (e.g., expert labels on images) is not directly applicable here. The "ground truth" for the performance of an infusion pump would be its adherence to engineering specifications, safety standards, and intended functional behavior.

Number of Experts: Not specified. The testing involved "clinical care personnel from hospital environments" during Human Factors evaluation and use scenario testing. These personnel would serve as experts in the operational context of the device, validating its usability and functional aspects, rather than establishing diagnostic ground truth in an AI sense.
Qualifications of Experts: Described as "clinical care personnel from hospital environments." Specific qualifications (e.g., years of experience, specialty) are not detailed.

D. Adjudication Method for the Test Set

Again, the concept of adjudication in the context of expert consensus for ground truth (common in AI/ML) does not directly apply here. The document states that "All tests successfully passed the acceptance criteria," suggesting a pass/fail outcome based on pre-defined engineering and safety standards, rather than an adjudication process between conflicting expert opinions on data labels.

Adjudication Method: Not applicable in the traditional sense of expert adjudication for data labeling. The acceptance of test results would be based on exceeding or meeting pre-defined performance thresholds.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No, a traditional MRMC comparative effectiveness study, common for evaluating human reader performance with and without AI assistance, was not performed or mentioned.
Effect Size: Not applicable, as no MRMC study was conducted.

F. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done?: Yes, the primary testing described is "Non-clinical testing associated with compliance and safety software, and intended use claims." This refers to the standalone performance of the device's hardware and software against specifications. The "Human Factors evaluation and use scenario testing" also implicitly assesses the device's standalone functionality in a simulated user environment. The "COLLEAGUE GUARDIAN" and "COLLEAGUE Enhanced GUARDIAN" features are software functionalities whose performance would be tested in a standalone manner against their design requirements to reduce programming errors.

G. The Type of Ground Truth Used

The "ground truth" for this medical device (an infusion pump) is rooted in:

Engineering Specifications: Adherence to defined parameters for flow rate accuracy, pressure monitoring, alarm functionality, battery life, etc.
Safety Standards: Compliance with relevant national and international safety standards for medical devices.
User Needs and Intended Uses: Validation that the device fulfills its defined clinical functions and usability requirements in the specified care environments for various patient populations and types of infusions.
Predicate Device Equivalence: The ultimate ground truth being established is that the modified device performs "as well as or better than the predicate COLLEAGUE Volumetric Infusion Pump."

H. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning models. While the COLLEAGUE Volumetric Infusion Pump does contain software, the description does not indicate that it employs a machine learning algorithm that requires a distinct "training set" in the modern AI sense. The software functions (like GUARDIAN) are rule-based or pre-programmed to enforce limits and protocols.

Sample Size for Training Set: Not applicable/not mentioned, as the device doesn't appear to use machine learning requiring a training phase for its core functionality.

I. How the Ground Truth for the Training Set Was Established

Since there is no mention of a machine learning training set, the establishment of "ground truth" for it is not applicable. The integrity of the pump's software (including the Guardian features) would be established through a rigorous Software Development Life Cycle (SDLC), including requirements definition, design verification, unit testing, integration testing, and validation, rather than typical AI model training with labeled data.

Summary

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COLLEAGUE Volumetric Infusion Pump 510(k) Premarket Notification

K063696

Section 5.0, 510(k) Summary

Page 1 of 5

510(K) SUMMARY
FEB 27 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:	12/08/06
Trade Name:	COLLEAGUE, COLLEAGUE 3 1COLLEAGUE CX, COLLEAGUE 3 CX 1COLLEAGUE CXE, COLLEAGUE 3 CXECOLLEAGUE CX to CXE Pump Upgrade KitCOLLEAGUE 3 CX to 3 CXE Pump Upgrade Kit
Common Name:	COLLEAGUE Volumetric Infusion Pump
Classification Name:	Infusion Pump as defined in 21 CFR 880.5725
Class:	II
Procode:	80 FRN
Equivalent Predicate:	COLLEAGUE Volumetric Infusion Pump, currentlymarketed models: COLLEAGUE, COLLEAGUE CX,COLLEAGUE 3, COLLEAGUE 3 CX
Device Description:	The COLLEAGUE Volumetric Infusion Pump product is asoftware controlled, electromechanical, large volumetricinfusion pump that includes either one or three infusion

¹ COLLEAGUE pumps will be upgraded to include either COLLEAGUE GUARDIAN functionality (for COLLEAGUE and COLLEAGUE 3) or COLLEAGUE Enhanced GUARDIAN functionality (for COLLEAGUE CX and COLLEAGUE 3 CX).

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channels. The COLLEAGUE Volumetric Infusion Pump product provides the necessary infusion therapy modes to deliver medications and solutions through a Baxter standard administration set. The pump uses a shuttle pumping mechanism to achieve flow. None of the pump device materials come in contact with the solution path.

The pump is intended to operate primarily on AC power and is equipped with a rechargeable battery to facilitate use during transport.

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(modifying the Drug Amount, Diluent Volume and/or Concentration from the default.

The COLLEAGUE Volumetric Infusion Pump has the ability to communicate externally via a data communications interface.

Indications for Use:

The COLLEAGUE Volumetric Infusion Pump is designed to meet the fluid delivery needs of today's healthcare environment. The COLLEAGUE pump is capable of delivering medications, solutions, parenteral nutrition, lipids, blood and blood components.

The COLLEAGUE pump is designed to deliver infusion therapies via clinically acceptable routes of administration, including intravenous, intra-arterial, epidural, and subcutaneous routes.

The COLLEAGUE pump is intended for use in a wide variety of patient care environments for adult, pediatric and neonatal patients. The COLLEAGUE pump facilitates the

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delivery of routine and critical infusion therapies via continuous and intermittent delivery using primary and piggyback infusion modes.

The COLLEAGUE pump can be used in the following care areas:

· General Floor of the Hospital
· Critical / Intensive Care
· Neonatal Intensive Care
· Pediatric Care
· Labor / Delivery / Postpartum
· Operating Room / Anesthesia
· Post Anesthesia / Recovery
· Cardiac Catheterization Lab
· Emergency Room
· Ground Ambulance
· Hospice Facility
· Outpatient / Subacute Facilities
· Nursing Facilities
Long Term Care / Rehabilitation Facilities
Diagnostic Nuclear Medicine
· Oncology Floor
Burn Unit / Trauma

Summary of Technological

Characteristics:	The technological features of the modified COLLEAGUEVolumetric Infusion Pump do not significantly differ fromthe previously cleared COLLEAGUE Volumetric InfusionPump. The subject and predicate devices have the samefundamental technological characteristics regarding theoperating principle, use of administration sets, materials,physical features, intended use, and performance.
Non-Clinical Testing:	Non-clinical testing associated with compliance and safetysoftware, and intended use claims were performedaccording to the Baxter Healthcare Corporation Product

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Development Process. Human Factors evaluation and use scenario testing was performed under simulated use and environmental conditions utilizing clinical care personnel from hospital environments. All tests successfully passed the acceptance criteria.

Conclusions: The upgrades to the COLLEAGUE Volumetric Infusion Pump have been verified against design requirements and validated against defined user needs and intended uses. This demonstrates that the device is at least as safe, as effective, and performs as well as or better than the predicate COLLEAGUE Volumetric Infusion Pump.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeme Wallace Associate Director, Global Regulatory Affairs Baxter Healthcare, Incorporated One Baxter Parkway Deerficid, Illinois 60015-4633

FEB 2 7 2007

Re: K063696

Trade/Device Name:	COLLEAGUE Infusion Pump (2M8151)COLLEAGUE 3 Infusion Pump (2M8153)COLLEAGUE CX Infusion Pump (2M8161)COLLEAGUE 3 CX Infusion Pump (2M8163)COLLEAGUE CXE Infusion Pump (2M9161)COLLEAGUE 3 CXE Infusion Pump (2M9163)COLLEAGUE CXE Feature Kit (2M8580)COLLEAGUE 3 CXE Feature Kit (2M8583)
Regulation Number:	21 CFR 880.5725
Regulation Name:	Infusion Pump
Regulatory Class:	II
Product Code:	FRN
Dated:	December 9, 2006
Received:	December 13, 2006

Dear Ms. 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 -- Ms. 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 regaries. 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 (Scctions 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 6ver. 1) . Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chris Lipe, Director

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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4. INDICATIONS FOR USE STATEMENT

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

Device Name:	COLLEAGUE Volumetric Infusion Pump
Indications for Use:	The COLLEAGUE Volumetric Infusion Pump is capableof delivering medications, solutions, parenteral nutrition,lipids, blood and blood components.The COLLEAGUE pump is designed to deliver infusiontherapies via clinically acceptable routes of administration,including intravenous, intra-arterial, epidural, andsubcutaneous routes.The COLLEAGUE pump is intended for use in a widevariety of patient care environments for adult, pediatric andneonatal patients. The COLLEAGUE pump facilitates thedelivery of routine and critical infusion therapies viacontinuous and intermittent delivery using primary andpiggyback infusion modes.

Device Name:

COLLEAGUE Volumetric Infusion Pump

Indications for Use:

The COLLEAGUE Volumetric Infusion Pump is capableof delivering medications, solutions, parenteral nutrition,lipids, blood and blood components.The COLLEAGUE pump is designed to deliver infusiontherapies via clinically acceptable routes of administration,including intravenous, intra-arterial, epidural, andsubcutaneous routes.The COLLEAGUE pump is intended for use in a widevariety of patient care environments for adult, pediatric andneonatal patients. The COLLEAGUE pump facilitates thedelivery of routine and critical infusion therapies viacontinuous and intermittent delivery using primary andpiggyback infusion modes.

The COLLEAGUE pump can be used in the following care areas:

General Floor of the Hospital
· Critical / Intensive Care
Neonatal Intensive Care
· Pediatric Care
Labor / Delivery / Postpartum
· Operating Room / Anesthesia
· Post Anesthesia / Recovery
· Cardiac Catheterization Lab
· Emergency Room
Ground Ambulance
· Hospice Facility
· Outpatient / Subacute Facilities
· Nursing Facilities

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Long Term Care / Rehabilitation Facilities
Diagnostic Nuclear Medicine
· Oncology Floor
Burn Unit / Trauma
- Table 1.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) ivision of A = sthesiology, General Hospital, Infection Contiol, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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).