MEDLEY PCA MODULE, MODEL 8120

K032233 · Alaris Medical Systems, Inc. · MEA · Sep 9, 2003 · General Hospital

Device Facts

• Record ID: K032233
• Device Name: MEDLEY PCA MODULE, MODEL 8120
• Applicant: Alaris Medical Systems, Inc.
• Product Code: MEA · General Hospital
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

Device Story

Medley PCA Module functions as a component of the Medley Medication Safety System. Used in conjunction with the Medley Programming Module (PM) to deliver fluids via syringe-based infusion. Accepts standard non-dedicated, single-use administration sets and syringes with luer-lock connectors. Operated by healthcare professionals in clinical environments. Provides controlled medication delivery to patients; supports intravenous, subcutaneous, and epidural administration. Enhances medication safety through integration with the broader Medley system.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Syringe-type infusion pump; utilizes standard non-dedicated, single-use administration sets and syringes with luer-lock connectors. Designed for integration with the Medley Programming Module. Class II device.

Indications for Use

Indicated for adults, pediatrics, and neonates requiring continuous or intermittent delivery of medications or fluids via intravenous, subcutaneous, or epidural routes.

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

• Medley Syringe Module (K023264)
• Baxter PCA II Pump (K921994)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA Module

#### SUBMITTER INFORMATION

| A. | Company Name: | ALARIS Medical Systems, Inc. |
|----|--------------------------------|--------------------------------------------------------------------------------|
| B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Stacy L. Lewis<br>Regulatory Affairs Associate<br>ALARIS Medical Systems, Inc. |
| E. | Date Summary Prepared: | July 17, 2003 |

#### DEVICE IDENTIFICATION

| A. | Generic Device Name: | PCA Infusion Pump |
|----|-------------------------|------------------------|
| B. | Trade/Proprietary Name: | MedleyTM PCA Module |
| C. | Classification: | Class II |
| D. | Product Code: | MEA, PCA Infusion Pump |

#### DEVICE DESCRIPTION

The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.

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### SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA Module Page 2 of 2

#### SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems® Medley" PCA Module is of comparable type and is substantially equivalent to the following predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-----------------------|----------------------------------|------------|--------------|
| Medley Syringe Module | ALARIS Medical<br>Systems, Inc. | K023264 | 12/19/02 |
| Baxter PCA II Pump | Baxter Healthcare<br>Corporation | K921994 | 8/3/92 |

#### INTENDED USE

The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.

The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

#### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Medley" PCA Module and the predicate devices has been performed. The results of this comparison demonstrate that the Medley" PCA Module is equivalent to the marketed predicate devices in technological characteristics.

#### PERFORMANCE DATA

The performance data indicate that the Medley" PCA Module meets specified requirements, and is substantially equivalent to the predicate devices.

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Public Health Service

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032233

Trade/Device Name: PCA Infusion Pump Regulation Number: 880.5275 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA, FRN Dated: July 17, 2003 Received: July 21, 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, 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/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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:

K032233 (To Be Assigned By FDA)

Device Trade Name:

Medley™ PCA Module

Indications For Use: The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.

The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

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)

Patricio Cucenite

ivision Sian-Off ion of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

0002