HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE

K042980 · Hospira, Inc. · FRN · Nov 17, 2004 · General Hospital

Device Facts

• Record ID: K042980
• Device Name: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect™ Software is intended for use in intravenous arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.

Device Story

Hospira GemStar is a single-channel, software-controlled, electromechanical infusion pump using a volumetric, piston-driven, fluid displacement principle. A stepper motor meters fluids through sterile, dedicated, non-pyrogenic, latex-free GemStar administration sets. Power options include AC adapter, rechargeable battery pack, or disposable AA alkaline/lithium batteries. Used in hospital, ambulatory, and home care environments by healthcare practitioners. User interface allows programming of fluid delivery via weight-based or medication-based units. Pump displays provide status of operations, alarms, and flow parameters. Functions as both pole-mounted and ambulatory device. GemStar Connect software provides remote communication capabilities. Output allows clinicians to manage therapy protocols, ensuring accurate fluid delivery to patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, performance specifications, and intended use to the predicate devices.

Technological Characteristics

Volumetric, piston-driven, fluid displacement principle; stepper motor actuation. Single-channel configuration. Power: AC mains, rechargeable battery, or disposable AA batteries. Materials: Sterile, dedicated, non-pyrogenic, latex-free administration sets. Connectivity: GemStar Connect software for remote communication. Software-controlled electromechanical system.

Indications for Use

Indicated for patients requiring intravenous, arterial, subcutaneous, or short-term epidural infusion of fluids, medications, nutritional fluids, or blood products. Suitable for use in hospital, ambulatory, 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.

Predicate Devices

• Abbott GemStar® Infusion Pump System (K023062)
• GemStar® I.V. Infusion Pump (K000821)

Submission Summary (Full Text)

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Confidential

# 510(K) Summary

1. Name of Submitter:

Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

Owner/Operator # 9063339

2. Manufacturer and Establishment Registration Number:

Hospira, Inc. - Morgan Hill 755 Jarvis Drive Morgan Hill, CA 95037

Establishment Registration # 2921482

3. Proprietary or Trade Name of Proposed Device: Hospira GemStar I.V. Infusion Pump

- 4. Common Name: Infusion Pump
5. Device Classification, Pancode and ProCode: Class II, 80-FRN (Infusion Pump) Class II, 80-FPA (Administration Sets)

- 6. Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for intravenous infusion pumps. Infusion pumps are listed in 21 CFR 880.5725.
## 7. Intended Use:

The Hospira GemStar IV Infusion Pump is intended for use in intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritionals fluids, and blood/blood products to patients.

#### 8. Indications for Use:

The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect™ is intended for use in Intravenous (central line or peripheral access), arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.

The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar® administration sets.

#### 9. Proposed Device Description:

The Hospira GemStar" Infusion Pump Systems are a family of single channel, software controlled, electromechanical infusion pumps that operate on a volumetric, piston driven, fluid displacement principle. An in-line cassette is used to meter IV fluids through sterile dedicated administration sets designed to be used exclusively with GemStar infusers. Power options included an AC main adaptor, a rechargeable battery pack, a docking station, and two disposable AA alkaline or lithium batteries. The

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user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. The pump displays provide visible indication of several functions, including active pump operations, alarm and program status, and the parameters of fluid flow. The infusers function as both pole mounted and ambulatory infusion pumps.

As of May 03, 2004, both the infusers and the dedicated GemStar® sets are manufactured and distributed by Hospira Incorporated, formerly the Hospital Products Division of Abbott Laboratories.

All Hospira GemStar® I.V. Infusion Pumps are single channel pumps that are available in the following configurations:

| | Overview of GemStar I.V. Infusion Pump Therapies and Configurations | |
|----------------------------------|---------------------------------------------------------------------|----------------------|
| 7 Therapy Pump | 6 Therapy Pump | Pain Management Pump |
| List #: 13000-04 | List #: 13100-04 | List #: 13150-04 |
| TPN (Total Parenteral Nutrition) | TPN (Total Parenteral Nutrition) | |
| Pain Management | Intermittent | |
| Intermittent | Continuous | |
| Continuous | Weight-Dosed | Pain Management Only |
| Weight-Dosed | mL/hr Only | |
| Variable Time | Variable Time | |
| ML/hr Only | | |

### 10. Predicate Device Information:

Infusion pumps cleared for commercial distribution and determined to be appropriate for use as predicates are summarized in the following table.

| 510(k)# | Product Name | Clearance Date |
|---------|--------------------------------------|----------------|
| K023062 | Abbott GemStar® Infusion Pump System | 09/30/2002 |
| K000821 | GemStar® I.V. Infusion Pump | 05/24/2000 |

#### 11. Statement of Substantial Equivalence:

The Hospira GemStar® Infusion Pump System with Hospira GemStar Connect® is substantially equivalent to the predicate Abbott GemStar® Infusion Pump Systems and Abbott GemStar Connect™ Software based on the following characteristics.

#### Similarities:

- 1) Same intended use and indications for use.
- 2) Same fundamental scientific technology.
- 3) Same physical, operational, and performance specifications,
- 4) Same features for programmability of therapy protocols.

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# 12. Comparison to Legally Marketed Device(s)

| Factors | Subject Device(s)<br>Hospira GemStar I.V. Infusion Pump System with<br>Hospira GemStar Connect | Predicate Device(s)<br>Abbott GemStar<br>Infusion Pump System |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Intended Use | Intended for use in intravenous arterial, subcutaneous,<br>short term epidural infusion and parenteral administration<br>of general I.V. fluids, medications, nutritional fluids, and<br>blood/blood products to a patient. | Same |
| Indications for Use | Hospital, ambulatory, and home care environments using<br>sterile, dedicated, GemStar® administration sets. | Same |
| Operating Principle | Volumetric, piston driven, fluid displacement principle.<br>Stepper motor with in-line cassette meters IV fluids<br>through sterile dedicated administration sets.<br>Programmable fluid delivery through a variety of weight<br>and medication based units. Visible indication of several<br>functions, including active pump operations, alarm and<br>program status, and the parameters of fluid flow. | Same |
| Administration Sets and<br>Fluid Contact Materials | Sterile, dedicated, non-pyrogenic, latex-free "GemStar"<br>administration sets. | Same |
| Physical Features | Materials, Size, Weight, Input Lines, Output Lines,<br>Power Sources, Battery Type, Power Cord | Same |
| Environmental Features | Operating Temperature, Storage Temperature, Relative<br>Humidity, Pressure | Same |
| Performance Features | Delivery Rates, VTBI Range, Dose Units, Delivery<br>Accuracy, Delivery Modes, Therapies, Distal Occlusion<br>Limits, Proximal Occlusion Limits, Alarm Types and<br>Conditions, Default Drug Library. | Same |
| BioMed Settings | Configuration settings available for customization. | Same |
| Accessories (Optional) | GemStar Connect™ Remote Communication Software<br>(Clinician Kit, Patient Kit), Docking Station, Bolus<br>Cord, Pole Clamps (2), Battery Pack, Lockboxes (3), AC<br>Mains Adapters (2), Carrying Cases (4) and Carrier,<br>Serial Cable | Same |

## 13. Summary of Substantial Equivalence

Summary of Subtainar Digar Micheles
The Hospira GemStar® I.V. Infusion Pump System with Hospira GemStar Connect" as described in This submission is substantially equivalent to the predicate Abbott GemStar® Infusion Pump System
this submission is substantially equivalent to the predicate Abbott GemStar"

- 1) intended use,
- 2) indication for use,
- 3) fundamental technology and operating principle,
- 4) physical, environmental and performance features, and
- 5) materials of construction for all infuser components and administration sets.

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# 14. Statement of Safety and Effectiveness

The Hospira GemStar® I.V. Infusion Pump System with Hospira GemStar Connect™ meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate Abbott GemStar® Infusion Pump System with Abbott GemStar Connect™.

Prepared and submitted on October 28, 2004 by:

Patricia Miderki

Patricia Melerski Manager Global Device Regulatory Affairs Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 Phone: [phone] Fax: [phone]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, which are meant to represent the human form.

Public Health Service

NOV 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Melerski Manager, Global Regulatory Affairs Hospira, Incorporated Dept. 389, Bldg. H-2 275 North Field Drive Lake Forest, Illinois 60045-5045

Re: K042980

Trade/Device Name: Hospira GemStar® Infusion Pump System Hospira GemStar Connect™ Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 28, 2004 Received: October 29, 2004

Dear Ms. Melerski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Melerski

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Clive
Shia-Lirn, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Indications for Use Statement | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K042980 |
| Device Name: | Hospira GemStar ^® Infusion Pump System<br>Hospira GemStar Connect ^™ Software |
| Indications for Use | The Hospira GemStar ^® Infusion Pump System with Hospira GemStar Connect ^™ Software is intended for use in intravenous arterial, subcutaneous, short term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.<br>The indications for use include hospital, ambulatory, and home care environments. The pump must be used with sterile, dedicated, GemStar ^® administration sets. |

| Prescription Use _X_<br>(Part 21 801 Subpart D) | AND/OR | Over-The Counter Use<br>(Part 21 CFR 807 Subpart C) |
|-------------------------------------------------|--------|-----------------------------------------------------|
|-------------------------------------------------|--------|-----------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)

A

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________