COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163

K063696 · Baxterhealthcare, Inc. · FRN · Feb 27, 2007 · General Hospital

Device Facts

• Record ID: K063696
• Device Name: COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163
• Applicant: Baxterhealthcare, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Feb 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Software-controlled, electromechanical large volumetric infusion pump; uses shuttle pumping mechanism to deliver fluids via Baxter standard administration sets. Operates on AC power or rechargeable battery for transport. Features 'COLLEAGUE GUARDIAN' (dose error reduction software) to enforce predefined program limits based on hospital protocols; 'Enhanced GUARDIAN' supports nonstandard concentrations. Used by clinicians in diverse settings (ICU, OR, ER, ambulance, etc.). Output includes controlled fluid delivery; clinicians program infusion parameters via interface. Benefits include reduced medication programming errors and support for routine/critical therapies. Includes optional software accessories for configuration and event history download.

Clinical Evidence

No clinical data. Non-clinical testing performed, including compliance, safety, and software verification. Human factors evaluation and simulated use scenario testing conducted with clinical personnel to validate design requirements against user needs.

Technological Characteristics

Electromechanical large volumetric infusion pump; shuttle pumping mechanism. Powered by AC or rechargeable battery. Software-controlled with dose error reduction system (GUARDIAN). Connectivity via data communications interface. Compatible with flexible containers, glass bottles, and syringes.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring delivery of medications, solutions, parenteral nutrition, lipids, blood, and blood components via intravenous, intra-arterial, epidural, or subcutaneous routes in various clinical care settings.

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 (K063696 - Note: Predicate listed as currently marketed models of the same device line)

Submission Summary (Full Text)

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COLLEAGUE Volumetric Infusion Pump 510(k) Premarket Notification

K063696

Section 5.0, 510(k) Summary

Page 1 of 5

5. 510(K) SUMMARY
FEB 27 2007

| Submitter/Contact Name: | Jeme Wallace |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd., MPGR-AL<br>McGaw Park, IL 60085 |
| Phone: | [phone] |
| Fax: | [phone] |
| Date Prepared: | 12/08/06 |
| Trade Name: | COLLEAGUE, COLLEAGUE 3 ¹<br>COLLEAGUE CX, COLLEAGUE 3 CX ¹<br>COLLEAGUE CXE, COLLEAGUE 3 CXE<br>COLLEAGUE CX to CXE Pump Upgrade Kit<br>COLLEAGUE 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, currently<br>marketed models: COLLEAGUE, COLLEAGUE CX,<br>COLLEAGUE 3, COLLEAGUE 3 CX |
| Device Description: | The COLLEAGUE Volumetric Infusion Pump product is a<br>software controlled, electromechanical, large volumetric<br>infusion 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 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

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(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.

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 COLLEAGUE<br>Volumetric Infusion Pump do not significantly differ from<br>the previously cleared COLLEAGUE Volumetric Infusion<br>Pump. The subject and predicate devices have the same<br>fundamental technological characteristics regarding the<br>operating principle, use of administration sets, materials,<br>physical features, intended use, and performance. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Testing: | Non-clinical testing associated with compliance and safety<br>software, and intended use claims were performed<br>according 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)<br>COLLEAGUE 3 Infusion Pump (2M8153)<br>COLLEAGUE CX Infusion Pump (2M8161)<br>COLLEAGUE 3 CX Infusion Pump (2M8163)<br>COLLEAGUE CXE Infusion Pump (2M9161)<br>COLLEAGUE 3 CXE Infusion Pump (2M9163)<br>COLLEAGUE CXE Feature Kit (2M8580)<br>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 [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 6ver. 1) . 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 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 capable<br>of delivering medications, solutions, parenteral nutrition,<br>lipids, blood and blood components.<br>The COLLEAGUE pump is designed to deliver infusion<br>therapies via clinically acceptable routes of administration,<br>including intravenous, intra-arterial, epidural, and<br>subcutaneous routes.<br>The COLLEAGUE pump is intended for use in a wide<br>variety of patient care environments for adult, pediatric and<br>neonatal patients. The COLLEAGUE pump facilitates the<br>delivery of routine and critical infusion therapies via<br>continuous and intermittent delivery using primary and<br>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

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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)

i

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Baxter Confidential