HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088

K060806 · Hospira, Inc. · FRN · Apr 21, 2006 · General Hospital

Device Facts

• Record ID: K060806
• Device Name: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Apr 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hospira GemStar® Infusion Pump System 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 Infusion Pump System is a single-channel, electromechanical, software-controlled pump. It utilizes a volumetric, piston-driven fluid displacement principle; a stepper motor meters fluids through an in-line cassette and dedicated sterile administration sets. The device supports various therapies including TPN, pain management, intermittent, continuous, weight-dosed, and variable time infusions. It is used in hospital, ambulatory, and home care environments by healthcare practitioners. The user interface allows programming of fluid delivery based on weight or medication units. The pump provides visual feedback on operation, alarms, and flow parameters. Power options include AC adapters, rechargeable battery packs, or disposable AA batteries. The device can be pole-mounted or used as an ambulatory pump. It assists clinicians in precise fluid and medication administration, potentially improving patient outcomes through controlled delivery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Electromechanical, single-channel, volumetric, piston-driven infusion pump. Powered by AC, rechargeable battery, or disposable AA batteries. Features include stepper motor control, in-line cassette, and dedicated administration sets. Software-controlled with programmable delivery modes (weight-based, medication-based). Connectivity via optional GemStar Connect™ software and serial cable. Sterilization of administration sets is required. Materials are consistent with previously cleared GemStar sets.

Indications for Use

Indicated for patients requiring intravenous, arterial, subcutaneous, or short-term epidural infusion of fluids, medications, nutritional fluids, or blood products in hospital, ambulatory, or home care settings. Must be used with dedicated GemStar administration sets.

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

• Hospira GemStar Infusion Pump System with Hospira GemStar Spring Assist Mechanism Lockbox (K051079)
• Hospira GemStar® Infusion Pump System with Hospira GemStar Connect™ Software (K042980)
• Abbott GemStar® Infusion Pump System (K023062)

Submission Summary (Full Text)

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

Kovosola

# 510(K) Summary

#### 1. Name of Submitter: Hospira, Inc. 275 North Field Drive Lake Forest, Illinois 60045

APR 2 1 2006

Owner/Operator # 9063339

2. Manufacturer and Establishment Registration Number:

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

#### 3. Proprietary or Trade Name of Proposed Device:

Hospira GemStar® Infusion Pump Systems

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

Class II, FPA (IV Administration Sets) Class II, MRZ (Infusion Pump Lockboxes)

- 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® Infusion Pump System with Hospira GemStar® Pump Sets and accessories 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.

### 8. Indications for Use:

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 AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The 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, alarms, program status, and the parameters of fluid flow. The infusers function as both pole

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

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 |
| TPN (Total Parenteral Nutrition) | TPN (Total Parenteral Nutrition) | |
| Pain Management | Intermittent | |
| Intermittent | Continuous | |
| Continuous | Weight-Dosed | Pain Management Only |
| Weight-Dosed | Variable Time | |
| Variable Time | | |
| mL/hr Only | mL/hr Only | |

## 10. Predicate Device Information:

Devices 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 |
|----------|----------------------------------------------------------------------------------------------|----------------|
| K051079 | Hospira GemStar Infusion Pump System with Hospira<br>GemStar Spring Assist Mechanism Lockbox | 05/19/2005 |
| K042980 | Hospira GemStar® Infusion Pump System with Hospira<br>GemStar Connect™ Software | 11/17/2004 |
| K023062 | Abbott GemStar® Infusion Pump System | 09/30/2002 |

### 11. Comparison to Legally Marketed Device(s)

| Factors | Subject Device(s)<br>Hospira GemStar® Infusion Pump Systems | Predicate Device(s) |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | Same |
| Indications for Use | Hospital, ambulatory, and home care environments using sterile, dedicated, GemStar® administration sets. | Same |
| Operating Principle | Volumetric, piston driven, fluid displacement principle.<br>Stepper motor with in-line cassette meters IV fluids through sterile dedicated administration sets.<br>Programmable fluid delivery through a variety of weight and medication based units. Visible indication of several functions, including active pump operations, alarm and program status, and the parameters of fluid flow. | Same |
| Factors | Subject Device(s) | Predicate Device(s) |
| Administration Sets<br>and Fluid Contact<br>Materials | Sterile, dedicated, non-pyrogenic, latex-free "GemStar"<br>administration sets. | Different |
| | | Addition of (3) new sets to<br>GemStar Set line since<br>last cleared 510(k)) |
| Physical Features | Materials, Size, Weight, Input Lines, Output Lines,<br>Power Sources, Battery Type, Power Cord | Different |
| | | 1) Slight increase in<br>Weight and Height |
| | | 2) Removal of the<br>disposable AA lithium<br>batteries, NiMH Battery<br>Pack, and NiMH Docking<br>Station as options. |
| | | 3) Change in Pump Top<br>Cap Material |
| Environmental<br>Features | Operating Temperature, Storage Temperature, Relative<br>Humidity, Pressure | Same |
| Performance<br>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. | Different<br>1) Addition of a<br>programming option<br>within Weight Dosed<br>Therapy to permit delivery<br>of Precedex®<br>(dexmedetomidine<br>hydrochloride<br>injection),<br>2) Increased programming<br>and delivery precision for<br>pain management<br>therapies.<br>3) Allowance for VTBI<br>titration without changing<br>container size. |
| BioMed Settings | Configuration settings available for customization. | Different |
| | | Option to custom<br>configure air sensitivity<br>default lockout. |
| Factors | Subject Device(s) | Predicate Device(s) |
| Key Accessories<br>(Optional) | Hospira GemStar Infusion Pump Systems<br>GemStar Connect™ Remote Communication Software<br>(Clinician Kit, Patient Kit), Docking Station (2), Bolus<br>Cord, Battery Pack (2), Lockboxes (4), AC Mains<br>Adapters (3), Carrying Cases (4) and Carrier, Serial Cable | Different<br>Addition of optional<br>Wall Mount Adapter,<br>100-240VAC since last<br>cleared 510(k). |

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

{3}------------------------------------------------

# Hospira GemStar® Infusion Pump System Special 510(k) / March 2006

### 12. Statement of Substantial Equivalence:

Hospira GemStar® Infusion Pump Systems with the Hospira GemStar® Pump Scts and accessories are substantially equivalent to the predicate devices identified in the submission.

Similarities:

- l ) Same intended use and indications for use.
- 2) Same fundamental scientific technology.
- Similar physical, operational, and performance specifications. 3)
- 4) Similar materials of construction for all infuser components.
- 5) Same materials of construction for new administration sets as previously cleared sets.

### 13. Statement of Safety and Effectiveness

Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and accessories meet the functional claims and intended use as described in the product labeling, and are as safe and edited in terms of substantial equivalence as the predicate devices described in the submission.

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

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2006

Ms. Patricia Melerski Manager, Global Device Regulatory Affairs Hospira, Incorporated 275 N. Field Drive, Building H-2, Dept. 389 Lake Forest, Illinois 60045

Re: K060806

Trade/Device Name: Hospira GemStar® Infusion Pump System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: March 23, 2006 Received: April 24, 2006

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

{5}------------------------------------------------

Page 2 -- Ms. Patricia 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/industry/support/index.html.

Sincerely yours.

Schutze by Miction Omd.

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

{6}------------------------------------------------

# Indications for Use Statement

| 510(k) Number (if known) | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Hospira GemStar® Infusion Pump System |
| Indications for Use | The Hospira GemStar® Infusion Pump System 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 メ (Part 21 801 Subpart D) AND/OR

Over-The_Counter Use_ (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)

Untam O. m

1994 (1980) grobogy, General Hospical instantel Dental Devices

K ф608ф6