SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X

K063288 · Cardinal Health 303,Inc. · FRN · Nov 28, 2006 · General Hospital

Device Facts

• Record ID: K063288
• Device Name: SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
• Applicant: Cardinal Health 303,Inc.
• Product Code: FRN · General Hospital
• Decision Date: Nov 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

Device Story

Electrical volumetric infusion pump; controls flow rate/monitors delivery of fluids, medications, blood, and blood products. Used in professional healthcare facilities, home care, and medical transport. Operated by clinicians/healthcare providers. Device transforms electrical power into mechanical pumping action to deliver precise volumes. Output allows providers to manage drug/fluid administration; supports continuous or intermittent therapy. Benefits include controlled, reliable delivery of therapeutic agents across various clinical routes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate.

Technological Characteristics

Electrical volumetric infusion pump. Fundamental scientific technology and principles of operation are identical to the predicate device. No specific materials, connectivity, or software architecture details provided.

Indications for Use

Indicated for continuous or intermittent delivery of fluids, medications, blood, and blood products via IV, intra-arterial, subcutaneous, epidural, enteral, or irrigation routes in professional healthcare, home care, and medical transport 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

• Signature Edition® Infusion System (K032147)

Reference Devices

• Models EZ 1 and EZ 2 Infusion Pumps (K931549)

Submission Summary (Full Text)

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## ATTACHMENT D

063288

## SUMMARY OF SAFETY AND EFFECTIVENESS

#### Cardinal Health Alaris Products

#### Signature Edition® Gold Infusion System

(a.k.a. Alaris® SE Pump)

NOV 2 8 2006

| SUBMITTER'S NAME: | Cardinal Health 303, Inc.<br>dba Cardinal Health, Alaris Products<br>10221 Wateridge Circle<br>San Diego, CA 92121-2772<br>[phone]<br>[phone] FAX |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|

| CONTACT PERSON: | Stacy L. Lewis |
|-----------------|-----------------------------------------|
| | Principal Regulatory Affairs Specialist |

October 31, 2006 DATE PREPARED:

- DEVICE NAME: Proprietary Name: Signature Edition® Gold Infusion System (a.k.a. Alaris® SE Pump) Common Name: Infusion Pump Classification Name: Pump, Infusion, FRN (880.5725)
PREDICATE DEVICE: Signature Edition® Infusion System (K032147), July 25, 2003

### DEVICE DESCRIPTION

The subject of this 510(k) submission is the Signature Edition® Gold Infusion System, which is also known as the Alaris® SE Pump (collectively referred to herein as "SE Gold Pump"). This device is essentially the same as the originally submitted predicate device, Signature Edition® Infusion System, K032147, July 25, 2003 (first submitted as the Models EZ 1 and

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## SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 3

EZ 2 Infusion Pumps, K931549, October 12, 1993), with the exception of the device modification provided in this submission.

The electrical volumetric pumps are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. Infusion pumps have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.

## SUBSTANTIAL EQUIVALENCE

With the exception of the device modification presented in this submission, the SE Gold Pumps are essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same.

### INTENDED USE

The intended use of this device has not changed from the original submissions in terms of content or intent:

The SE Gold Pumps are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.

The SE Gold Pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

5063288 2 of 3

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## SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 3

## TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the SE Gold Pump and the predicate devices has been performed. The results of this comparison demonstrate that the modified SE Gold Pump is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered.

063288 3 of 3

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2006

Ms. Stacey L. Lewis Principal Regulatory Affairs Specialist Cardinal Health 303, Incorporated 10221 Wateridge Circle San Diego, California 92121

Re: K063288

Trade/Device Name: Signature Edition® Gold Infusion System Alaris® SE Pumps Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 31, 2006 Received: November 1, 2006

Dear Ms. Lewis:

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. Lewis

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,

Sasa Junn
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

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# Attachment B INDICATIONS FOR USE

510(k) Number:

KOG 32888 (To Be Assigned By FDA)

Device Trade Names:

## Signature Edition® Gold Infusion System Alaris® SE Pumps

#### Indications For Use:

The Signature Edition® Gold Infusion Systems, which are also known as the Alaris® SE Pumps, are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.

The Signature Edition® Gold Infusion Systems are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

Prescription Use X OR (Per 21 CFR 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joell for now for CSL

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