HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY

K051079 · Hospicare, Inc. · MRZ · May 19, 2005 · General Hospital

Device Facts

• Record ID: K051079
• Device Name: HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
• Applicant: Hospicare, Inc.
• Product Code: MRZ · General Hospital
• Decision Date: May 19, 2005
• 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® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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

The Hospira GemStar® Infusion Pump System is a single-channel, electromechanical, volumetric, piston-driven pump. It uses an in-line cassette to meter fluids through dedicated sterile administration sets. The device is programmable by healthcare practitioners for various weight- and medication-based delivery units. It functions as both a pole-mounted and ambulatory pump, powered by AC adapter, rechargeable battery, or disposable AA batteries. The system includes a Spring Assist Mechanism (SAM) Lockbox for secure pain management. The pump displays operational status, alarms, and flow parameters. It is used in hospital, ambulatory, and home care environments to deliver fluids and medications, aiding clinical decision-making by providing precise, controlled infusion therapy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-channel, electromechanical, volumetric, piston-driven infusion pump. Materials: sterile, non-pyrogenic, latex-free administration sets. Power: AC, rechargeable battery, or 2x AA batteries. Connectivity: optional GemStar ConnectTM remote communication software. Software: programmable, weight/medication-based units. Form factor: pole-mounted or ambulatory.

Indications for Use

Indicated for patients requiring intravenous, arterial, subcutaneous, or short-term epidural infusion and parenteral administration of fluids, medications, nutritional fluids, and blood/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

• Hospira GemStar® Infusion Pump System with Hospira GemStar ConnectTM Software (K042980)
• Abbott GemStar® Infusion Pump System (K023062)
• Lifeshield® Primary IV Pump Set with Two Pressure Activated Anti-Siphon Valves (K033576)

Submission Summary (Full Text)

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# MAY 1 9 2005

### Hospira GemStar® Infusion Pump System Special 510(k) / March 2005

Confidential

### 510(K) Summary

Hospira, Inc. 1. Name of Submitter: 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

Southmedic, Inc 50 Alliance Blvd. Barrie Ontario L4M 5K3 Canada

Establishment Registration # 8022032

Hospira Holdings de Costa Rica Ltd Zona Franca Global La Aurora De Heredia Costa Rica

Establishment Registration # 9615050

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

Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox

Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves and Y-Extension with Backcheck Valve, 97 inch -SL

Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch-SL

Infusion Pump with Infusion Pump Lockbox 4. Common Name: IV Administration Sets

5. Device Classification, Pancode and ProCode: Class II, FRN (Infuser)

Class II, FPA (IV Administration Sets)

Class II, MRZ (Infusion Pump Lockbox)

- 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.

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### Confidential

#### 7. Intended Use:

The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar Spring Assist Mechanism Lockbox 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 Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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.

#### 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 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, 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 | Pain Management Only |
| Continuous | Weight-Dosed | |
| Weight-Dosed | mL/hr Only | |
| Variable Time | | |
| ML/hr Only | Variable Time | |

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# 10. Predicate Device Information:

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<br>Date |
|----------|-----------------------------------------------------------------------------------|-------------------|
| K042980 | Hospira GemStar® Infusion Pump System with Hospira<br>GemStar ConnectTM Software | 11/17/2004 |
| K023062 | Abbott GemStar® Infusion Pump System | 09/30/2002 |
| K033576 | Lifeshield® Primary IV Pump Set with Two Pressure<br>Activated Anti-Siphon Valves | 12/09/2003 |

# 11. Comparison to Legally Marketed Device(s)

| Factors | Subject Device(s)<br>Hospira GemStar® Infusion Pump System with<br>Hospira GemStar® Spring Assist Mechanism Lockbox | Predicate Device(s)<br>Hospira GemStar®<br>Infusion Pump System<br>with Lockbox |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 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. | Same as PCA Lockbox<br>(For pain management<br>using PCA Vials only) |
| Indications for 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.<br>The indications for use include hospital, ambulatory, and home care environments. The pump must be used with<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 program status, and the parameters of fluid flow. | Same |
| Administration Sets<br>and Fluid Contact<br>Materials | Sterile, dedicated, non-pyrogenic, latex-free "GemStar"<br>administration sets. | Different<br>(Two new dedicated<br>pain management sets<br>for use with the SAM<br>Lockbox only) |
| Physical Features | Materials, Size, Weight, Input Lines, Output Lines,<br>Power Sources, Battery Type, Power Cord | Same |
| Environmental<br>Features | Operating Temperature, Storage Temperature, Relative<br>Humidity, Pressure | Same |

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### Confidential

### Hospira GemStar® Infusion Pump System Special 510(k) / March 2005

| Factors | Subject Device(s)<br>Hospira GemStar® Infusion Pump System with<br>Hospira GemStar® Spring Assist Mechanism Lockbox | Predicate Device(s)<br>Hospira GemStar®<br>Infusion Pump System<br>with Lockbox |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 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. | Same |
| BioMed Settings | Configuration settings available for customization. | Same |
| Accessories<br>(Optional) | GemStar ConnectTM Remote Communication Software<br>(Clinician Kit, Patient Kit), Docking Station (2), Bolus<br>Cord, Pole Clamps (2), Battery Pack (2), Lockboxes (4),<br>AC Mains Adapters (2), Carrying Cases (4) and Carrier,<br>Serial Cable | Different<br>(New SAM Lockbox) |

### 12. Statement of Substantial Equivalence:

Statelinent of Substantial Equivalenes.
Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox, the Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves the Hospira Gentiour - Painp Soctively, 97 inch -SL and the Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch are substantially equivalent to the predicate devices identified in the submission.

#### Similarities:

- Same intended use and indications for use. 1)
- Same fundamental scientific technology. 2)
- Same physical, operational, and performance specifications. 3)
- Same materials of construction for all infuser components and administration sets. 4)

#### 13. Statement of Safety and Effectiveness

Statement of Sarey and Enectivelless
Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox, Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves the Hospira Gemocal - Panietar - Valve, 97 inch -- SL and the Hospira GemStar Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch-SL meet the functional claims ngeover, you an as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate devices described in the submission.

Prepared and submitted by: Yuliya Matlin Senior Specialist, Global Device Regulatory Affairs Hospira, Inc. 275 North Field Drive Lake Forest, IL 60045 Phone: [phone] Fax: [phone]

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three parallel lines extending from its head, resembling feathers or wings.

## MAY 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Yuliya Matlin Senior Specialist, Global Device Regulatory Affairs Hospira, Incorporated 275 North Field Drive Lake Forest, Illinois 60045

Re: K051079

Trade/Device Name: Hospira GemStar Infusion Pump System with Hospira GemStar Spring Assist Mechanism Lockbox Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA, MRZ Dated: April 26, 2005 Received: April 27, 2005

Dear Ms. Matlin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to review 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de rises and liertic Act (Act) that do not require approval of a premarket the rederal 1 ood, Drag, and Connenay, therefore, market the device, subject to the general approvin apprevances (the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 (1 MA), it may of subject to tax of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. Matlin

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA Sissualled of a substanter ice complies with other requirements
mean that FDA has made a determination that your device complies with organisa mean that FDA nas made a decemination administered by other Federal agencies. of the Act or any rederal statutes and registerents, including, but not limited to: registration
You must comply with all the Act's requirements of manufacturing programs You must comply with an the Fet 5 read 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Rest 800); god i and listing (21 CFR Part 807), laboring (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set fortif in the quality systems (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) This letter will anow you to begin mationing of substantial equivalence of your device to a premarket notification. The PDA midness of substantial of any 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), If you desire specific advice for your de received in a miplease contact the Other of Other of Other and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain offer general information on Jour Cep-DIVIsion of Simall Manufactar [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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) | K051079 |
| Device Name: | Hospira GemStar® Infusion Pump System with Hospira GemStar® Spring Assist Mechanism Lockbox |
| | Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves and Y-Extension with Backcheck Valve, 97 inch -SL |
| | Hospira GemStar® Pump Set with Injector, Two Integral Pressure-Activated Anti-Siphon Valves, 99 Inch-SL |
| Indications for Use | The Hospira GemStar® Infusion Pump System with Hospira GemStar® Pump Sets and Hospira GemStar® Spring Assist Mechanism Lockbox 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. |
| 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)

(Division Sign-Off)

(Division Sign-Off)
Division of Anesthesiblogy, General Hospital,
Infection Control, Dental Deviless

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