ACCLAIM INFUSION PUMP

K991501 · Abbott Laboratories · FRN · May 13, 1999 · General Hospital

Device Facts

• Record ID: K991501
• Device Name: ACCLAIM INFUSION PUMP
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: May 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device is intended for intravenous fluid, blood and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.

Device Story

Acclaim Infusion Pump; electromechanical device for controlled delivery of fluids. Inputs: user-programmed infusion parameters (rate, volume). Operation: peristaltic or similar pumping mechanism to deliver intravenous fluids, blood products, enteral solutions, or epidural medications. Output: controlled fluid delivery to patient. Used in hospital and home care settings; operated by clinicians or patients/caregivers. Provides precise fluid management; reduces risk of manual delivery errors; supports diverse clinical applications including short-term epidural therapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Electromechanical infusion pump; peristaltic pumping mechanism; supports intravenous, blood, enteral, and epidural delivery. Designed for hospital and home care environments. Connectivity and specific software architecture not detailed in provided documentation.

Indications for Use

Indicated for patients in hospital and home care environments requiring intravenous fluid, blood/blood product administration, short-term epidural administration (≤96 hours), or enteral feeding.

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 LifeCare Standard Tubing Pump (K965230)
• Abbott LifeCare Standard Tubing Pump (K983838)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

Ms. Jill Sacket Associate Director, Regulatory Affairs Abbott Laboratories, Incorporated Hospital Products Division D-389, Building AP30 200 Abbott Park Road Abbott Park, Illinois 60064-6157

Re: K991501 Acclaim™ Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN Dated: April 28, 1999 Received: April 29, 1999

Dear Ms. Sacket:

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 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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sackett

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 compliante as (advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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.fdaf.gov/cdrh/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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K991501

## Attachment 2

## Indications for Use Statement

K965230 Dated: 4/7/97 Cleared: 7/3/97 510(k) Number: K883838 Dated: 10/20/98 Cleared: 11/20/98 510(k) Number: Note: K983838 corrects original indications for use.

Abbott LifeCare Standard Tubing Pump (Acclaim) Device Name:

Indications for Use: The subject device is intended for intravenous fluid, blood and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.

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

Patrissa Cuccerite
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

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