COLLEAGUE VOLUMETRIC INFUSION PUMPS

K041191 · Baxter Healthcare Corp · FRN · Jun 25, 2004 · General Hospital

Device Facts

• Record ID: K041191
• Device Name: COLLEAGUE VOLUMETRIC INFUSION PUMPS
• Applicant: Baxter Healthcare Corp
• Product Code: FRN · General Hospital
• Decision Date: Jun 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Colleague Volumetric Infusion Pumps are electronic infusion pumps indicated for continuous or intermittent delivery of solutions through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces.

Device Story

Electronic volumetric infusion pump; utilizes shuttle and valve control mechanism for fluid delivery. Configurable input parameters allow institutions to pre-select operation modes and units of measure. Software modifications expand 'Colleague Guardian' feature to enhance safety. Used in diverse clinical environments (hospitals, homecare, etc.) by healthcare professionals to administer drugs, electrolytes, and blood products. Output is controlled fluid delivery; assists clinicians in precise medication management; benefits patients through accurate, continuous, or intermittent therapy.

Clinical Evidence

Bench testing only. Performance data indicates the device meets specified requirements and is substantially equivalent to the predicate devices.

Technological Characteristics

Volumetric infusion pump; shuttle and valve control mechanism. Configurable software for infusion modes and data entry units. Includes 'Colleague Guardian' safety software feature. Connectivity/integration details not specified. Sterilization and material specifications not provided.

Indications for Use

Indicated for continuous or intermittent delivery of parenteral fluids, drugs, electrolytes, whole blood, and blood products via IV, IA, subcutaneous, epidural, or irrigation routes. Suitable for patients across all clinical settings including hospitals (general, ICU, OR, ER, pediatrics/neonatal), mobile intensive care, nursing homes, and homecare (Colleague/CX models only). Prescription use only.

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 Pumps (K041191)

Submission Summary (Full Text)

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### JUN 2 5 2004

# 510(k) Summary of Safety and Effectiveness

### Submitted by:

K041191

Jennifer M. Paine Manager, Global Regulatory Affairs Baxter Healthcare Corporation Medication Delivery Rte. 120 and Wilson Road Round Lake, IL 60073

### Name/Classification of Device:

Infusion Pump/ Class II, 80FRN - 21 CFR 880.5725

#### Trade Name:

Colleague Volumetric Infusion Pump Colleague CX Volumetric Infusion Pump Colleague 3 Volumetric Infusion Pump Colleague 3CX Volumetric Infusion Pump

#### Predicate Devices:

Colleague Volumetric Infusion Pumps

#### Statement of Intended Use:

Colleague Volumetric Infusion Pumps are electronic infusion pumps indicated for continuous or intermittent delivery of solutions through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces.

#### Device Description:

Colleague pumps use a shuttle and valve control system mechanism to provide accurate, continuous infusions. Colleague provides continuous infusion and combined modes of operation. The pumps have configurable input parameters, which allow institutions to pre-select which modes of operation will be available to users and which units of measure will be used for data entry. Baxter Healthcare proposes to modify the Colleague family of infusion pumps with the addition of new software features to expand the Colleague Guardian feature and to further enhance the safety of the device.

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## Summary of Technological Characteristics of New Device to Predicate Devices:

A comparison of the technological characteristics of the Colleague pump to the predicate r companion of the results of this comparison demonstrate that the actions has boom performant to the marketed predicate device in technological characteristics.

### Performance Data:

The performance data indicate that the device will meet specified requirements and is substantially equivalent to the predicate devices.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines representing wings or snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2004

Ms. Amy Giertych Director, Global Regulatory Affairs Baxter Healthcare Corporation Medication Delivery Route 120 & Wilson Road Round Lake, Illinois 60073-0490

Re: K041191

Trade/Device Name: Colleague Volumetric Infusion Pumps Regulation Number: 880.5725 Regulation Name: Infusion Pumps Regulatory Class: II Product Code: FRN Dated: May 5, 2004 Received: May 6, 2004

Dear Ms. Giertych:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becament in 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 Interstate commerce prior to ria] 2007 reclassified in accordance with the provisions of Allientifications, of to devices that have act (Act) that do not require approval of a premarket the rederal I ood, Drag, therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the rion fisting 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 II your device is classified (500 above) with the major regulations affecting (PMA), it may be subject to Sach adatof Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Court in Concerning your device in the Federal Register.

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Page 2 - Ms. Giertych

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA 3 issualled on that your device complies with other requirements mean that FDA has made a decermination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administed to sectimited to sectimited to se of the Act of ally rederal statues and regulations, but not limited to: registration You must configity with an the Fict b required (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), mooiity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (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) I his letter will anow you to begin mailering your substantial equivalence of your device to a premarket nonification. The PDA miams of basessification 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), If you desire specific advice to: Jour de at [phone]. Also, please note the regulation please contact the Other or Ochiphanes and premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general mornist. International and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chi-Lien, 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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# Indications for Use

#### 510(k) Number (if known): K041191

Colleague Volumetric Infusion pumps Device Name:

Indications For Use:

Baxter Colleague Infusion Pumps are designed to meet the fluid delivery the little and aligically acceptable Baxter Colleague Intusion Pumps are not nervised on the more of bricaly of clinical acceptable routes
environment. These pumps can be utilized for continuous or internation environment. These pumps can be unized for continuous of misomation and or irrigation of fluid spaces applications.

Fluid delivery applications include:

- parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, analgesics, or . parenteral nulds, drugs and electrolytes (e.g. cardiovalial drago, and be surions for irrigation procedures, etc.); and
- whole blood and blood products. .

Colleague Infusion Pumps are designed to travel the continuum of care, following the patient into a variety of care areas, including, but not limited to:

- A Hospital:
- General Floor
- · Medical/Surgical
- · Critical/Intensive Care Areas
- · Pediatrics/Neonatal
- · Labor/Delivery/Post Partum
- · OR/Anesthesia
- · Post Anesthesia/Recovery · P
- Cardiac Cath Lab
- · Emergency Room
- · Burn/Trauma Units
-
-
- Mobile Intensive Care A Nursing Homes A
- Homecare* A

· Oncology

- *Colleague and Colleague CX pumps only.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shene Narence for ADW 6/24/04

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

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510(k) Number: K241191

- Blood Centers
- Nuclear Medicine A
- Hospice A
- Subacute Facilities A
- Outpatient/Surgical Centers A
- Long Term Care A