HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03

K043256 · Hospira, Inc. · MEA · Dec 6, 2004 · General Hospital

Device Facts

• Record ID: K043256
• Device Name: HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
• Applicant: Hospira, Inc.
• Product Code: MEA · General Hospital
• Decision Date: Dec 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hospira LifeCare® PCA3 Infusion System is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

Device Story

Hospira LifeCare® PCA3 Infusion System is a pole-mounted, microprocessor-controlled, electromechanical infusion pump. Device uses a stepper motor to drive a plunger against a pre-filled or pharmacy-filled drug vial, delivering analgesic medication into a sterile, dedicated administration set. Operated in hospital settings by clinicians; patients use a pendant to self-administer doses within physician-programmed parameters. Powered by AC source with internal battery backup. Output is controlled volumetric infusion of analgesics. Device lacks wireless or network capabilities and is not compatible with MedNet™ software. System provides controlled delivery to manage patient pain, ensuring accuracy through programmed limits.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and performance specifications to predicate devices.

Technological Characteristics

Microprocessor-controlled electromechanical infusion pump; stepper motor actuation; pole-mounted form factor; AC power with internal battery backup; uses sterile, dedicated, non-pyrogenic, latex-free administration sets. No wireless or network connectivity. Software is embedded firmware.

Indications for Use

Indicated for patients requiring continuous or patient-controlled analgesic (PCA) intravenous infusion, or short-term (less than 96 hours) continuous epidural analgesic administration in hospital clinical 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

• LifeCare PCA® Infusion System with Hospira MedNet™ Software (K042800)
• Abbott LifeCare® PCA3 infusion System (K022203)

Submission Summary (Full Text)

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DEC - 6 2004

1043256

Confidential

# 510(K) Summary

1. Name of Submitter:

Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

Owner/Operator # 9063339

### 2. Manufacturer and Establishment Registration Number:

Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037

Establishment Registration # 2921482

- 3. Proprietary or Trade Name of Proposed Device: Hospira LifeCare® PCA3 Infusion System
- 4. Common Name: Infusion Pump

5. Device Classification, Pancode and ProCode: Class II, 80-FRN (Infusion Pump) Class II, 80-FPA (Administration Sets)

- 6. Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for intravenous infusion pumps. Infusion pumps are listed in 21 CFR 880.5725.
- 7. Intended Use: The Hospira LifeCare® PCA3 Infusion System is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration.

#### 8. Indications for Use:

The LifeCare® PCA3 Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs. The epidural route can be used to provide anestbessa or analgesia. The pump must be used with sterile, dedicated, LifeCare PCA administrations sufer

#### 9. Proposed Device Description:

The Hospira LifeCare® PCA3 Infusion System is a microprocessor controlled, pole mounted, standalone, electromechanical infusion pump that allows a patient to self administer, analgeric usines, a patient pendant, within physician prescribed, programmed parameters. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. The infuser will accept a pre-filled drug vial manufactured by Haspire and includes one sterile empty vial that can be filled by a hospital's pharmacy.

As of May 03, 2004, both the infuser and the dedicated LifeCare® PCA administration sets are manufactured and distributed by Hospira Incorporated, formerly the Hospital Products Division of Abbott Laboratories.

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## 10. Predicate Device Information:

Infusion pumps cleared for commercial distribution and determined to be appropriate for use as predicates are summarized in the following table.

| 510(k) # | Product Name | Clearance Date |
|----------|----------------------------------------------------------------|----------------|
| K042800 | LifeCare PCA® Infusion System with Hospira MedNet™<br>Software | 10/28/2004 |
| K022203 | Abbott LifeCare® PCA3 infusion System | 08/01/2002 |

## 11. Comparison to Legally Marketed Device(s)

| Factors | Subject Device(s)<br>Hospira LifeCare® PCA3 Infusion System | Predicate Device(s)<br>Abbott LifeCare® PCA3<br>Infusion System<br>and<br>LifeCare® PCA Infusion<br>System with Hospira™<br>MedNet Software |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for volumetric, infusion of analgesic drugs by<br>continuous or patient-demanded (PCA) intravenous<br>administration. It is indicated for short-term (less than<br>96 hours) continuous epidural administration of<br>analgesic drugs. | Same |
| Indications for Use | Hospital clinical settings using sterile, dedicated,<br>LifeCare® PCA administration sets. | Same |
| Operating Principle | Advancement of a syringe-like drug vial by a stepper<br>motor driven plunger to expel drug from the vial into an<br>attached sterile intravenous administration set designed to<br>be used exclusively with LifeCare® PCA infusers. | Same |
| Administration Sets and<br>Fluid Contact Materials | Sterile, dedicated, non-pyrogenic, latex-free LifeCare®<br>PCA administration sets. | Same |
| Physical Features | Materials, Size, Weight, Power Sources, Battery Type,<br>Power Cord | Same |
| Environmental Features | Operating Temperature, Storage Temperature, Relative<br>Humidity, Pressure | Same |
| Performance Features | Delivery Rates, Dose Units, Delivery Accuracy,<br>Delivery Modes, Occlusion Pressure Limits, Alarm<br>Types and Conditions | Same |
| Wireless MedNet™<br>Software Compatibility | No wireless/network capability.<br>Not compatible with MedNet™ Software. | Same as Abbott<br>LifeCare® PCA3<br>Infusion System |

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### 12. Statement of Safety and Effectiveness

The Hospira LifeCare® PCA3 Infusion System meets the functional claims and intended use as described in the product labeling. The proposed modifications do not raise new issues of safety and/or effectiveness.

### 13. Statement of Substantial Equivalence:

The Hospira LifeCare® PCA3 infusion System is substantially equivalent in terms of safety and effectiveness to the predicate Abbott LifeCare® PCA3 Infusion System and the LifeCare PCA® Infusion System with Hospira MedNet™ Software based on the following characteristics.

- 1) Same intended use,
- 2) Same indication for use,
- 3) Same fundamental technology and operating principle.
- 4) Same physical, operational, environmental and performance attributes, and
- 5) Same materials of construction for infuser components and administration sets.

The claim for substantial equivalence is supported by the information provided in this 510(k) submission.

Prepared and submitted by:

Patricia Meleski 11/23/04

Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 Phone: [phone] Fax: [phone]

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2004

Ms. Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive, Dept. 389, Bldg. H2 Lake Forest, Illinois 60045

Re: K043256

Trade/Device Name: Hospira LifeCare® PCA3 Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: November 23, 2004 Received: November 24, 2004

Dear Ms. Melerski:

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. Melerski

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/dsma/dsmamain.html

Sincerely yours,

Suxen Runner
(Chin Lin, 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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:

:

:

| 510(k) Number (if known) | K043256 |
|--------------------------|----------------------------------------|
| Device Name: | Hospira LifeCare® PCA3 Infusion System |

Indications for Use

The Hospira LifeCare® PCA3 Infusion System is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

| Prescription Use _X_<br>(Part 21 801 Subpart D) | AND/OR | Over-The_Counter Use<br>(Part 21 CFR 807 Subpart C) |
|-------------------------------------------------|--------|-----------------------------------------------------|
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

| 510(k) Number | K043256 |
|---------------|---------|
|---------------|---------|

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