ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB

K994039 · Abbott Laboratories · FRN · Dec 22, 1999 · General Hospital

Device Facts

• Record ID: K994039
• Device Name: ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
• Applicant: Abbott Laboratories
• Product Code: FRN · General Hospital
• Decision Date: Dec 22, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GemStar™ Infusion Pump is indicated for intravenous, 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™ I.V. Infusion Pump is a portable device for controlled delivery of fluids, medications, nutritional fluids, and blood products. Used in hospital and home care settings; operated by clinicians or patients. Device manages infusion rates and volumes; provides therapy configuration for various clinical needs. Benefits include precise, automated fluid/medication delivery, reducing manual administration errors and supporting diverse clinical environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable infusion pump; electromechanical fluid delivery system. Designed for intravenous, arterial, epidural, and parenteral administration. Supports multiple therapy configurations. Connectivity and specific material standards not detailed in provided text.

Indications for Use

Indicated for patients in hospital and home care environments requiring intravenous, arterial, short-term epidural, or parenteral administration of fluids, medications, nutritional fluids, or blood/blood products.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a stylized caduceus, with three curved lines representing the snakes and a central staff-like element.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 1999

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

K994039 Re : Trade Name:

Abbott GemStar™ I.V. Infusion Pump-7 Therapy Configuration Requlatory Class: II Product Code: FRN Dated: November 24, 1999 Received: November 29, 1999

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, qood manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

{1}------------------------------------------------

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.

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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

{2}------------------------------------------------

## Attachment 2

## Indications for Use Statement

| 510(k)<br>Number<br>(if known) | Unknown |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K994039 |
| Device Name | GemStar™ I.V. Infusion Pump |
| Indications for<br>Use | The GemStar™ I.V. Infusion Pump intended use is: |
| | The GemStar™ Infusion Pump is indicated for intravenous, arterial, short-<br>term epidural, and parenteral administration of general I.V. fluids,<br>medications, nutritional fluids, and blood/blood products to patients in<br>hospital and home care environments. |

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

.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K994039 |

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use |
|---------------------------------------|------------------------------------------|----------------------|
|---------------------------------------|------------------------------------------|----------------------|

র না