ABBOTT PLUM A+ INFUSION PUMP

K982159 · Abbott Laboratories · FRN · Jan 12, 1999 · General Hospital

Device Facts

• Record ID: K982159
• Device Name: ABBOTT PLUM A+ INFUSION PUMP
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: Jan 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Plum A+ Infusion Pump is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Device Story

The Abbott Plum A+ Infusion Pump is an electromechanical device designed for the controlled delivery of fluids, including parenteral, enteral, and epidural solutions, as well as whole blood and blood products. It is intended for use in clinical environments by healthcare professionals. The device operates by regulating the flow rate and volume of infused substances to ensure accurate delivery to the patient. It serves as a critical tool for managing patient hydration, nutrition, and medication administration. By automating the infusion process, the device reduces the risk of manual dosing errors and ensures consistent delivery, thereby supporting therapeutic efficacy and patient safety.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Electromechanical infusion pump for parenteral, enteral, and epidural delivery. Supports whole blood and blood product administration. Operates via controlled fluid displacement. Complies with 21 CFR Part 820 Quality System Regulation.

Indications for Use

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

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1999

Mr. David T. Guzek Director, Regulatory Affairs Hospital Products Division Abbott Laboratories 1401 Sheridan Road North Chicago, Illinois 60064

K982159 Re : Abbott Plum A+ Infusion Pump Trade Name: Requlatory Class: ı i Product Code: FRN October 14, 1998 Dated: Received: October 15, 1998

Dear Mr. Guzek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Guzek

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain\html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : N/A

DEVICE NAME: Abbott Plum A+ Infusion Pump

## INDICATIONS FOR USE:

The Plum A+ Infusion Pump is indicated for use in i parenteral, enteral and epidural therablem ramp 13 indicated for use in parenteral, enti
epidural the administration of whole blood and blood products.

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Concurrence Office of Device Evaluation (ODE) or CORH.

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

: OR

Over - The - Counter - Use (Optional Format 1-2-96)

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of

Patrice Cucenta

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________