ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE

K031185 · Abbott Laboratories · FRN · Apr 30, 2003 · General Hospital

Device Facts

• Record ID: K031185
• Device Name: ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: Apr 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Abbott Plum A+® Infusion Pump will be used to administer fluids into a patient's vascular system. The pump is intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products. The pump must be used with sterile, dedicated, intravenous Plum® administration sets.

Device Story

Electromechanical infusion pump; uses stepper motor and in-line cassette to meter IV fluids via dedicated administration sets. Operates in clinical settings; managed by healthcare practitioners. Input: user-programmed fluid delivery parameters (weight/medication-based units). Output: controlled fluid delivery; visual display of pump operations, alarms, and flow parameters. Modification: updated plug-and-play module with increased memory and medication error management alert feature; added confirmation step for simple delivery programming. Benefits: aids in medication error reduction.

Clinical Evidence

No clinical data; substantial equivalence based on design, technological characteristics, and intended use comparisons.

Technological Characteristics

Electromechanical infusion pump; stepper motor actuation; in-line cassette mechanism. Requires dedicated sterile Plum® administration sets. Software-based medication error management system. Connectivity via PC for library download. Class II device.

Indications for Use

Indicated for parenteral, enteral, and epidural therapies, and administration of whole blood and blood products in patients requiring fluid delivery.

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

• Abbott Plum A+™ Infusion Pump (K011442)
• Abbott Plum A+® Infusion Pump (K024084)

Submission Summary (Full Text)

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Abbott Laboratories, Inc. Confidential

3/5/03

APR 3 0 2003

Original 510(k) Premarket Notification Modification of Plug and Play Module

#### 510(k) SUMMARY ব

K031185

- Abbott Laboratories, Inc. 1. Submitted by: D-389. Blda. J-45 200 Abbott Park Rd Abbott Park, IL 60064
Phone: [phone] [phone] Fax: Contact: Patricia Melerski

- March 5, 2003 2. Date Prepared:
- Infusion Pump, Class II 3. Name/Classification 80 FRN - 21 CFR Parts 880.5725 of Device:
- Abbott Plum A+® Infusion Pump with HPL/RS Plug-and-4. Trade Name of Play Module Proposed Device:
- Abbott Plum A+™ Infusion Pump (K011442) 5. Predicate Device: Abbott Plum A+® Infusion Pump (K024084)

### 6. Proposed Device Description:

The Abbott Plum A+ Infusion Pump is an electromechanical infusion pump that uses a stepper motor in coniunction with an in-line cassette to meter IV fluids through a dedicated intravenous administration set that is also manufactured and distributed by Abbott Laboratories.

The subject and predicate devices have identical indications for use. Abbott proposes to modify the plug-and-play module of the predicate device to provide a medication error management alert feature through software changes and increasing the memory capacity of the module. The plug-and-play module will be available as a kit. In addition, there will be a separate kit that contains the software on a CD-ROM to develop the library as well as connectors to download the library from the Personal Computer (PC) to the pump. In addition, a confirmation step is being added after programming of simple delivery. These proposed changes are intended to aid in medication error reduction.

The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units such as micrograms/kg/hour, grams/hr and other delivery specifications.

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Like the predicate device, the display on the pump provides visible indication of several functions including active pump operations, alarm and program status and the parameters of fluid flow for one or both incoming fluid lines.

Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery. TThere are no new issues of safety or effectiveness raised by the proposed Abbott Plum A+® Infusion Pump with HPL/RS Module.

#### 7. Statement of Intended Use:

The Abbott Plum A+® Infusion Pump will be used to administer fluids into a patient's vascular system. The pump is intended for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

This is the same intended use as the predicate device.

The pump must be used with sterile, dedicated, intravenous Plum® administration sets.

#### 8. Summary of Technological Characteristics of New Device Compared to Predicate Device

The proposed Abbott Plum A+® Infusion Pump with HPL/RS with the plug-and-play Module and the marketed Abbott Plum A+® Infusion Pump are similar in design. materials of construction, components, intended use, labeling and manufacturing Therefore, the Abbott Plum A+® Infusion Pump with HPL/RS with the processes. plug-and-play Module and the Abbott Plum A+ Infusion Pump are substantially equivalent. The modifications do not raise new issues of safety and effectiveness

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

APR 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Abbott Laboratories C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548

Re: K031185

Trade/Device Name: Abbott Plum A+® Infusion Pump with a HPL/RS plug-andplay module Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 15, 2003 Received: April 15, 2003

Dear Mr. Devine:

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 - Mr. Devine

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,

Susan Ruases

Susan Runner, DDS, MA Interim 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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Abbott Laboratories, Inc. Confidential

3/5/03

# Indications for Use Statement

| 510(k)<br>Number<br>(if known) | |
|--------------------------------|------------------------------------------------------------------------------------------------------------|
| Device<br>Name: | Abbott Plum A+® Infusion Pump with a HPL/RS plug-and-play<br>module |
| Indications<br>For Use: | Abbott Plum A+® Infusion Pump with a HPL/RS plug and play<br>module has the following indications for use: |

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

Patara Cacceniti

nesthesio ontrol. Der Infection Co

510(k) Number: *K031185*

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(per 21 CFR 801.109)

OR

Over-The_Counter Use