HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5

K052052 · Hospira, Inc. · FRN · Aug 24, 2005 · General Hospital

Device Facts

• Record ID: K052052
• Device Name: HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products.

Device Story

Hospira Plum A+ and Plum A+ 3 are electromechanical, volumetric, piston-driven infusion pumps. Devices use stepper motors and inline cassettes to meter/deliver fluids via dedicated sterile PlumSet administration sets. Systems are pole-mounted and used in clinical settings for parenteral, enteral, and epidural therapies, including blood product administration. Healthcare providers operate the pumps to manage fluid delivery rates and volumes. Software v11.5 includes an improved battery charge monitoring algorithm and removes/disables support for optional barcode wand capability. Output consists of controlled fluid delivery; providers monitor pump status and alarms to ensure therapy accuracy and patient safety.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and functional performance comparisons to predicate devices.

Technological Characteristics

Volumetric, piston-driven electromechanical infusion pump. Uses stepper motor and dedicated inline cassette (PlumSet). Pole-mounted form factor. Software-controlled. v11.5 includes improved battery charge monitoring algorithm. No specific materials standards (e.g., ASTM) cited beyond general description of sterile, non-pyrogenic fluid contact materials.

Indications for Use

Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

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

• Plum A+ Infusion System with Hospira MedNet™ Software (v. 13.x) (K042081)
• Abbott Plum A+ Infusion Pump, Model 12391 (K024084)
• Abbott Plum A+3 Multichannel Infusion Pump (K021350)
• Plum A+ Infusion Pump (K011442)

Submission Summary (Full Text)

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## AUG 2 4 2005

# 510(K) Summary

1. Name of Submitter: Hospira, Inc. 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 Devices:

Hospira Plum A+ Infusion Pump System, v11.5

Hospira Plum A+ 3 Infusion Pump System, v11.5

4. Common Name: Infusion Pump with IV Administration Sets

- 5. Device Classification, Pancode and ProCode: Class II, FRN (Infuser) Class II, FPA (IV 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:

Intended for use in parenteral, enteral, and epidural therapies and the administration of whole blood and blood products.

#### 8. Indications for Use:

Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

#### 9. Proposed Device Description:

The Hospira Plum A+ and Hospira Plum A+ 3 Infusion Pump Systems are a family of single channel and triple channel software controlled, electromechanical infusion pumps that operate on a volumetric, piston-driven, fluid displacement principle. The infusers use a stepper motor in conjunction with an inline cassette to meter and deliver IV fluids through sterile intravenous administration sets desirent to be used exclusively with both the Plum A+ and Plum A+ 3. The infusers can be pole nounted.

As of May 03, 2004, both the infusers and the dedicated PlumSet® Administration Sets are manufactured and distributed by Hospira Incorporated, formerly the Hospital Products Division of Abbott Laboratories.

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K052052
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### 10. Predicate Device Information:

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

| Submission History | | |
|--------------------|-----------------------------------------------------------------|---------------|
| 510(k) # | Title | Decision Date |
| K042081 | Plum A+ Infusion System with Hospira MedNet™ Software (v. 13.x) | 08/24/2004 |
| K024084 | Abbott Plum A+ Infusion Pump, Model 12391 | 12/31/2002 |
| K021350 | Abbott Plum A+3 Multichannel Infusion Pump | 05/14/2002 |
| K011442 | Plum A+ Infusion Pump | 06/05/2001 |

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

| Factors | Subject Device(s) | Primary Predicate<br>Device(s) |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Hospira Plum A+® Infusion Pump System, v11.5<br>Hospira Plum A+®3 Infusion Pump System, v11.5 | Hospira Plum A+®/<br>Plum A+®3 Infusion<br>Pump Systems<br>V10.3, v11.3, v13.x |
| Intended Use | Intended for use in parenteral, enteral, and epidural therapies<br>and the administration of whole blood and blood products. | Same |
| Indications | Indicated for use in parenteral, enteral, and epidural therapies<br>and the administration of whole blood and blood products. | Same |
| Operating<br>Principle | Volumetric, piston driven, fluid displacement principle.<br>Stepper motor in conjunction with an in-line cassette to meter<br>IV fluids through a dedicated intravenous administration set. | Same |
| Administration<br>Sets and Fluid<br>Contact<br>Materials | Sterile, dedicated, non-pyrogenic, PlumSet® Administration<br>Sets. | Same |
| Physical<br>Features | Materials, Size, Weight, Input Lines, Output Lines, Power<br>Sources, Battery Type, Power Cord | Same |
| Environmental<br>Features | Operating Temperature, Storage Temperature, Relative<br>Humidity, Pressure | Same |

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| Factors | Subject Device(s) | Primary Predicate Device(s) |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Features | Delivery Rates, VTBI Range, Dose Units, Delivery Accuracy,<br>Delivery Modes, Therapies, Distal Occlusion Limits, Proximal<br>Occlusion Limits, Alarm Types and Conditions, Default Drug<br>Library. | Similar<br>(Improved Battery Charge<br>Monitoring Algorithm in<br>v11.5 and v13.x only) |
| BioMed<br>Settings | Configuration settings available for customization. | Similar<br>(Supporting software<br>code for optional<br>barcode wand<br>capability removed in<br>v11.5, disabled in<br>v13.x) |

#### 12. Statement of Substantial Equivalence:

Compatible Hospira Plum A+ and Hospira Plum A+ 3 Infusion Systems when upgraded with v11.5 software are substantially equivalent to the current predicate devices identified in the submission.

Similarities:

- Same intended use and indications for use. 1)
- 2) Same fundamental scientific technology.
- Same physical, operational, and performance specifications. 3)
- Same materials of construction for all infuser components and administration sets. 4)

#### 13. Statement of Safety and Effectiveness

Compatible Hospira Plum A+ and Hospira Plum A+ 3 Infusion Systems, when upgraded to v11.5, meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate devices described in this submission.

Prepared and submitted by: 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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Public Health Service

AUG 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive Building H-2, Dept. - 389 Lake Forest, Illinois 60045

Re: K052052

Trade/Device Name: Hospira Plum A+® Infusion Pump System, v11.5 Hospira Plum A+ 3 Infusion Pump System, v11.5 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 28, 2005 Received: July 29, 2005

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/industry/support/index.html.

Sincerely yours,

Susan Runner

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 Statement

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

Hospira Plum A+ Infusion Pump System, v11.5 Device Name:

Hospira Plum A+ 3 Infusion Pump System, v11.5

Indications for Use:

Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Prescription Use _ X (Part 21 801 Subpart D) AND/OR

Over-The Counter Use (Part 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)

Clint Druk

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

510(k) Number. K152453