ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP

K965230 · Abbott Mfg., Inc. · FRN · Jul 3, 1997 · General Hospital

Device Facts

• Record ID: K965230
• Device Name: ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
• Applicant: Abbott Mfg., Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jul 3, 1997
• 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 and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to adult patients in hospital and home care environment.

Device Story

Abbott LifeCare Standard Tubing Pump/ACCLAIM Infusion Pump is an electromechanical device for controlled delivery of fluids, blood products, and enteral nutrition. Used in hospital and home care environments by clinicians or patients. Device operates via standard tubing sets to regulate flow rates. Provides infusion therapy to support patient hydration, nutrition, and medication administration. Output is controlled fluid delivery; healthcare providers monitor infusion status to ensure therapeutic goals. Device requires tracking per 21 CFR 821.

Clinical Evidence

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

Technological Characteristics

Electromechanical infusion pump; utilizes standard tubing sets for fluid delivery. Designed for intravenous, epidural (short-term), and enteral applications. Operates as a standalone unit for hospital and home care use.

Indications for Use

Indicated for adult patients requiring intravenous fluid, blood/blood product administration, short-term epidural administration (up to 96 hours), or enteral feeding solutions in hospital or home care 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. David T. Guzek
Director, Regulatory Affairs
Abbott Manufacturing, Incorporated
One Abbott Park
Abbott Park, Illinois 60064

JUL - 3 1997

Re: K965230
Trade Name: Abbott Lifecare Standard Tubing Infusion Pump
Regulatory Class: II
Product Code: FRN
Dated: April 4, 1997
Received: April 7, 1997

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 section 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. Guzek

On August 16, 1993 the Final Rule for Device Tracking was published in the *Federal Register*, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 *Federal Register* beginning on page 43447.

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA *approves* your device. Therefore, you may not promote or in anyway represent your device or its labeling as being *approved* by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR part 801 and additionally 809.10 for *in vitro* diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. 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 at [phone].

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

Enclosures

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510(k) Number (if known): K965230

Device Name: Abbott LifeCare Standard Tubing Pump / ACCLAIM™ Infusion Pump

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 adult patients in hospital and home care environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Tobacco Cecconte
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K965230

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

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