SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES

K032147 · Alaris Medical Systems, Inc. · FRN · Jul 25, 2003 · General Hospital

Device Facts

• Record ID: K032147
• Device Name: SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
• Applicant: Alaris Medical Systems, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Signature Edition Infusion System (infusion pumps and administration sets) is 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 Infusion System is 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.

Device Story

Signature Edition Infusion System consists of electrical volumetric pumps and administration sets. Device controls flow rate or monitors delivery of fluids, medications, and blood products. Used when higher accuracy or flow rates are required compared to gravity-fed sets. Operated by healthcare professionals in facilities, home care, or medical transport. Provides precise fluid delivery for applications including continuous epidural anesthesia, IV cardiovascular drugs, chemotherapy, and blood transfusions. Output allows clinicians to manage patient therapy; benefits include improved accuracy and consistency of medication/fluid administration.

Clinical Evidence

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

Technological Characteristics

Electrical volumetric infusion pump and administration sets. Fundamental scientific technology and materials are identical to predicate devices. System is designed for professional healthcare, home care, and medical transport environments.

Indications for Use

Indicated for continuous or intermittent delivery of fluids, medications, blood, and blood products via IV, IA, 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

• EZ 1 and EZ 2 Infusion Pumps (K931549)
• EZ Administration Sets (K931550)

Submission Summary (Full Text)

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

JUL 25 2003

K032147

SIGNATURE EDITION INFIJSION SY

## ATTACHMENT D

### SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems, Inc. Signature Edition Infusion System

| SUBMITTER'S NAME: | ALARIS Medical Systems, Inc.<br>10221 Wateridge Circle<br>San Diego, CA 92121-2772<br>[phone]<br>[phone] FAX |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
|-------------------|----------------------------------------------------------------------------------------------------------------------------|

#### CONTACT PERSON: Stacy L. Lewis Regulatory Affairs Associate

July 10, 2003 DATE PREPARED:

#### DEVICE NAME: Proprietary Name Signature Edition Infusion System

Common Name Infusion Pump IV Administration Sets

Classification Name Pump. Infusion and accessories, FRN (880.5725) Administration Sets, Intravascular, FPA (880-5440)

- EZ 1 and EZ 2 Infusion Pumps, K931549 PREDICATE DEVICES: EZ Administration Sets, K931550
#### DEVICE DESCRIPTION

This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid

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

#### SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2

delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions. See Section 5 for a detailed device description and comparison.

#### SUBSTANTIAL EQUIVALENCE

The Signature Edition Infusion System is essentially the same as the predicate devices in that they have the same intended use, operating principles, technological design, incorporate similar materials and manufacturing processes. The changes as described in this Special 510(k) pose no new issues of safety or efficacy. The Signature Edition Infusion System as described in this submission is substantially equivalent to the predicate devices. See Section 6 for substantial equivalence details and a comparison table.

#### INTENDED USE

The intended use of this device has not changed from the original submissions in terms of content or intent. The Signature Edition Infusion System (infusion pumps and administration sets) is 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. A separate Indications for Use statement is provided in Attachment B.

#### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Signature Edition Infusion System and the predicate devices has been performed. The results of this comparison demonstrate that the Signature Edition Infusion System is equivalent in technological characteristics and the fundamental scientific technology of the predicate devices has not been altered.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure or a caduceus, with three curved lines representing the body and a wavy line at the bottom.

Public Health Service

JUL 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Regulatory Affairs Associate Alaris Medical Systems Incorporated Worldwide Headquarters 10221 Wateridge Circle San Diego, California 92121-2772

Re: K032147

Trade/Device Name: Signature Edition Infusion Pump Regulation Number: 880.5275, 880. 5440 Regulation Name: Infusion Pump and Administration Set Regulatory Class: II Product Code: FRN, FPA Dated: July 10, 2003 Received: July 14, 2003

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, and Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

#### 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/dsma/dsmamain.html

Sincerely yours,

S.A. Winchester

for

Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Attachment B

# INDICATIONS FOR USE

510(k) Number: (To Be Assigned By FDA)

Device Trade Name: Signature Edition Infusion System

#### Indications For Use:

The Signature Edition Infusion System (infusion pumps and administration sets) is 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 Infusion System is 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.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE). The Concertion (Carro as the | |
|--------------------------------------------------------------------------------------|--|
| | |
| | |
| | |

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

5100 Number. K032147

Prescription Use __ U

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)