GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE

K083019 · Hospira, Inc. · FRN · Oct 22, 2008 · General Hospital

Device Facts

• Record ID: K083019
• Device Name: GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE
• Applicant: Hospira, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

GemStar™ SP Infusion System with GemStar™ SP Infusion Suite 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

GemStar™ SP Infusion System is a single-channel, volumetric, piston-driven electromechanical infusion pump. It delivers fluids via sterile, dedicated administration sets. The system includes GemStar™ SP Infusion Suite software, a PC-based application used to program the pump and enforce dosing limits. The pump features a user interface for weight- and medication-based programming and displays operational status and alarms. Power options include AC, rechargeable battery, docking station, or AA batteries. Used in hospital, ambulatory, and home care settings by healthcare practitioners. The software allows for the download of infusion protocols to the pump, facilitating standardized dosing and safety limit enforcement. This modification improves clinical safety by reducing programming errors through enforced dosing limits.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Volumetric, piston-driven electromechanical infusion pump. Materials of construction are identical to the predicate GemStar® system. Power: AC, rechargeable battery, docking station, or AA batteries. Connectivity: PC-based software (GemStar™ SP Infusion Suite) for protocol download. Form factor: Pole-mounted or ambulatory. Software: Protocol-based dosing limit enforcement.

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.

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 (K060806)
• LifeCare PCA ® Infusion System with Hospira MedNet™ Software (K042800)

Submission Summary (Full Text)

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| 1. Submitted by: | Hospira, Inc.<br>D-389 Bldg. H2<br>275 N. Field Drive<br>Lake Forest, IL 60045<br>Contact: Yuliya Matlin | Phone: [phone]<br>Fax: [phone] |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| 2. Date Prepared: | August 11, 2008 | |
| 3. Name/Classification<br>of Device: | Infusion Pump, Class II<br>80 FRN – 21 CFR Parts 880.5725<br>Administration Sets, Class II<br>80-FPA -21 CFR Parts 880.5725 | |
| 4. Trade Name of<br>Proposed Device: | GemStar™ SP Infusion System with<br>GemStar™ SP Infusion Suite software | |

- 5. Predicate Devices: Hospira GemStar® Infusion Pump System (K060806) LifeCare PCA ® Infusion System with Hospira MedNet™ Software (K042800)
### 6. Proposed Device Description:

GemStar™ SP Infusion System is a family of single channel electromechanical infusion pumps (7-therapy, 6-therapy and Pain Management Pumps). It operates 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. The pumps display provides visible indication of several functions, including active pump operations, alarms, program status and the parameters of fluid flow. The user interface allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units. Power options include AC main adaptors, a rechargeable battery pack, a docking station, and two disposable AA batteries. The infusers function as both pole mounted and ambulatory infusion pumps.

The subject device is based on modifications of the predicate infusion pumps. The modifications to the Hospira GemStar® Infusion System are made to allow for download of the Infusion Suite to the pump from the PC –based software (GemStar™ SP Infusion Suite) in order to facilitate the programming of the pump and to provide the ability to enforce dosing limits for applicable therapies. GemStar™ SP Infusion Suite software will be distributed separately as an accessory to the pump. No changes are made to the pump performance specifications or to the administration sets used with the pump.

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#### 7. Statement of Intended Use:

GemStar™ SP Infusion System with GemStar™ SP Infusion Suite 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 of the subject device are identical to the predicate Hospira GemStar® Infusion Pump System cleared under K060806.

### 8. Summary of Technological Characteristics of New Device Compared to Predicate Device

The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes.

#### 9. Statement of Substantial Equivalence

GemStar™ SP Infusion System with GemStar™ SP Infusion Suite is substantially equivalent to the predicate devices identified in the submission based on the following similarities:

Infuser similarities to Hospira GemStar® Infusion Pump System:

- 1. Same Intended Use and Indications for Use
- 2. Same fundamental scientific technology
- 3. Same physical operational and performance specifications
- Same materials of construction for all infuser components

Software application similarities to LifeCare PCA® Infusion System with Hospira MedNet™ software:

1. Similar concept of the protocol download from GemStar™ SP Infusion Suite PC application to the GemStar™ SP Infuser as from the Hospira MedNet™ application to LifeCare PCA® Infuser.

The proposed modifications do not raise new issues of safety and/or effectiveness. GemStar™ SP Infusion System with GemStar™ SP Infusion Suite meets the functional claims and intended use as described in product labeling and is as safe and effective in terms of substantial equivalence as the predicate devices described in the submission.

The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of an eagle, with three distinct lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2008

Hospira, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K083019

Trade/Device Name: GemStar™ SP Infusion System with GemStar™ SP Infusion Suite Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 9, 2008 Received: October 9, 2008

Dear Mr. Devine:

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 -- Mr. Devine

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Clus

Chiu S. Lin, Ph. D Division 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

| 510(k) Number (if known) | K483019 |
|--------------------------|----------------------------------------------------------------------|
| Device Name: | GemStar™ SP Infusion System with GemStar™ SP Infusion Suite software |
| Indications for Use: | |

The GemStar™ SP Infusion System with GemStar™ SP Infusion Suite 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.

Prescription Use _ × (Part 21 CFR 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)

Ctenn Uln

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

1 483419 510(k) Number: _______________________________________________________________________________________________________________________________________________________________