ABBOTT GEMSTAR IV INFUSION PUMP

K974778 · Abbott Laboratories · FRN · Mar 17, 1998 · General Hospital

Device Facts

• Record ID: K974778
• Device Name: ABBOTT GEMSTAR IV INFUSION PUMP
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: Mar 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device, the GEMSTAR Infusion Pump, is indicated for intravencus, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

Device Story

GEMSTAR Infusion Pump; electromechanical device for controlled delivery of fluids/medications. Inputs: user-programmed infusion parameters (rate, volume, time). Operation: pump mechanism regulates flow of I.V. fluids, medications, nutritional fluids, or blood products via intravenous, arterial, or short-term epidural routes. Output: controlled fluid delivery to patient. Used in hospital and home care environments; operated by clinicians or patients/caregivers. Provides precise fluid management; supports therapy administration; reduces manual dosing errors.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Electromechanical infusion pump; supports intravenous, arterial, and epidural delivery. Designed for hospital and home care use. Includes tracking requirements per 21 CFR 821.

Indications for Use

Indicated for intravenous, arterial, short-term epidural, and parenteral administration of I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David T. Guzek ·Director, Requlatory Affairs Abbott Laboratories 15330 Avenue of Science, Suite 100 San Diego, California 92128

MAR 17 1998

Re : K974778 Abbott GEMSTAR IV Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN Dated: December 19, 1997 Received: December 22, 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 qeneral 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. ਦੇ 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, 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 Requlations.

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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 Be advised that under Section 519(e) of the Act as enclosed) . amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires Because the device is subject to tracking, you are tracking. 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 Reqister beginning on page 43447.

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 regulation (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/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 Radioloqical Health

## Enclosure

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## INDICATIONS FOR USE STATEMENT

N/A ----------510(k) Number:

GEMSTAR Infusion Pump Device Name:

Indications for Use:

The subject device, the GEMSTAR Infusion Pump, is indicated for intravencus, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products 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 __

Patricia Cassavitz
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K974778

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