ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS

K022209 · Alaris Medical Systems, Inc. · FPA · Aug 6, 2002 · General Hospital

Device Facts

• Record ID: K022209
• Device Name: ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
• Applicant: Alaris Medical Systems, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ALARIS Medical Infusion Systems 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.

Device Story

The ALARIS Medical Infusion Systems consist of various infusion pumps, controllers, and associated administration sets used to deliver fluids, medications, blood, and blood products. This submission specifically concerns a labeling update for the administration sets to improve consistency and clinical guidance. The systems are utilized in professional healthcare facilities, home care settings, and medical transport. Clinicians operate the systems to manage patient infusions. The device functions as a delivery mechanism for intravenous therapy; the updated labeling aims to better align with current clinical expectations and competitive standards. No changes were made to the fundamental scientific technology or intended use of the infusion systems.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

The device consists of intravascular administration sets (Class II, 21 CFR 880.5440). The submission involves no changes to the physical materials, sensing principles, or energy sources of the existing infusion pump systems. The systems include various pump models (IVAC Signature Edition, MedSystem III, IMED Gemini, and ALARIS Medication Safety System) and associated gravity, extension, and secondary administration sets.

Indications for Use

Indicated for use in professional healthcare environments, home care, and medical transport for the delivery of fluids, medications, blood, and blood products via ALARIS Medical Infusion Systems (pumps, controllers, and administration sets).

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Submission Summary (Full Text)

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ALARIS MEDICAL SYSTEMS

# SUMMARY OF SAFETY AND EFFECTIVENESS

ALARIS Medical Systems, Inc.

KC 2.2207

## SUBMITTER INFORMATION

Company: ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, CA 92121

Contact Person: Renée L. Fluet Principal Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Date Summary Prepared: July 3, 2002

## DEVICE CLASSIFICATION

This Special 510(k) premarket submission will not require a change to current device classification. This submission only affects the Administration Set portion of ALARIS Medical Infusion Systems. The Administration Sets remain in the same classifications:

- . Intravascular Administration Set, 21CFR 880.5440, Class II, Product Codes FPA and LHI (Fluid Transfer Set)
## DEVICE DESCRIPTION

The following ALARIS Medical Infusion Systems are included in this Special 510(k):

- . IVAC Signature Edition Infusion Pumps & Administration Sets.
- IVAC MedSystem III Multi-Channel Infusion Pump & IVAC MedSystem III Multi-Channel Infusion Pump with DLE & Administration Sets.
- . IMED Gemini Infusion Pumps/Controllers & Administration Sets.
- ALARIS Medical Medication Management System & Administration Sets.
- IVAC, IMED, and ALARIS Medical Gravity, Extension, Components, & Secondary Administration Sets.

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## SUMMARY OF SAFETY AND EFFECTIVENESS. Continued ALARIS Medical Systems, Inc. Page 2 of 2

This Special 510(k) submission only affects the labeling of the Administration Set portion of ALARIS Medical Infusion Systems. The labeling will be updated to improve consistency and customer satisfaction by removing non-essential information and providing guidance for the clinician that is unique to the infusion system being used and relevant to the clinician's expectations and needs. This modification will also serve to better represent ALARIS Medical Infusion System products as used in today's healthcare environment and provide a better competitive comparison with other infusion systems.

## SUBSTANTIAL EQUIVALENCE

The intended use, typical applications, and fundamental scientific technology for ALARIS Medical Infusion Systems have not changed with this Special 510(k) submission, therefore we believe substantial equivalence has been established.

### INTENDED USE

This Special 510(k) submission does not change the intended use for ALARIS Medical Infusion Systems. ALARIS Medical Infusion Systems 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.

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized waves or lines, possibly representing a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 0 6 2002

Ms. Renne L. Fluet Principal Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772

Re: K022209

Trade/Device Name: ALARIS Medical Infusion System Administration Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA and LHI Dated: July 3, 2002 Received: July 8, 2002

Dear Ms. Fluet:

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 vour 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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Ulatowsk Directo 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:

K022209 (To Be Assigned By FDA)

Device Trade Name: ALARIS Medical Infusion Systems

Indications for Use:

The following ALARIS Medical Infusion Systems 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:

- IVAC® Signature Edition® Infusion Pumps and Administration Sets. ●
- IVAC® MedSystem III® Multi-Channel Infusion Pump and IVAC MedSystem III® Multi-. Channel Infusion Pump with DLE and Administration Sets.
- IMED® Gemini Infusion Pumps/Controllers and Administration Sets. .
- ALARIS Medical Medication Safety System and Administration Sets. ●
- IVAC®, IMED®, and ALARIS® Gravity, Extension, Components, and Secondary . Administration Sets.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

Paloza Cusomte
(Division Sign Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Confidential

510(k) Number K 022207

0445