ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP

K983838 · Abbott Laboratories · FRN · Nov 20, 1998 · General Hospital

Device Facts

• Record ID: K983838
• Device Name: ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: Nov 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device is intended for intravenous fluid, 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

Abbott LifeCare Standard Tubing Infusion Pump is a medical device designed for the controlled delivery of intravenous fluids, blood products, enteral feeding solutions, and short-term epidural medications. Used in both hospital and home care settings, the device facilitates fluid management for patients requiring precise administration. It operates as a mechanical infusion system to deliver prescribed therapies. Healthcare providers or patients use the device to ensure accurate delivery rates, which directly impacts clinical outcomes by maintaining therapeutic fluid levels and medication dosing. The device serves as a delivery mechanism for various clinical applications, supporting patient care through reliable fluid and medication administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical infusion pump system for fluid and medication delivery. Designed for intravenous, epidural, and enteral use. Operates via standard tubing sets.

Indications for Use

Indicated for patients in hospital and home care environments requiring intravenous fluid, blood products, short-term epidural administration (up to 96 hours), or enteral feeding solutions.

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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NOV 20 1900

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jerry Jennings Director, Regulatory Operations Abbott Laboratories Hospital Products Division D-389 Building, AP30 200 Abbott Park Road Abbott Park, Illinois 60064-3537

K983838 Re : Abbott LifeCare Standard Tubing Infusion Trade Name: Pump Regulatory Class: II Product Code: FRN October 20, 1998 Dated: October 21, 1998 Received:

Dear Mr. Jennings:

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 The general controls provisions of the Act 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. ਸ 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 - Mr. Jennings

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" (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.fda.gov/cdrh/dsmamain.html".

sincerely yours,

Timothý /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): ____________________________________________________________________________________________________________________________________________________ K983838

DEVICE NAME: _Abbott_LifeCare Standard Tubing Infusion Pump

INDICATIONS FOR USE:

The subject device is intended for intravenous fluid, 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)

Prescription Use (Per 21 CFR 801.109)

OR

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

Patrici Caserite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 3838 510(k) Number _