MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600

K041241 · Alaris Medical Systems, Inc. · FRN · Jul 6, 2004 · General Hospital

Device Facts

• Record ID: K041241
• Device Name: MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
• Applicant: Alaris Medical Systems, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jul 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medley System with Bar Code Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products. The Medley System with Bar Code Module is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Device Story

Medley Bar Code Module attaches to Medley Infusion System; functions as fifth module. Inputs: bar code data from patient wristbands, medication/device packaging via integrated or handheld scanner. Operation: module routes data through dedicated communications channel to Medley System; software performs error checking to ensure data integrity. Output: automated infusion parameter programming. Used in clinical settings by trained healthcare professionals. Benefit: reduces manual data entry steps; improves accuracy of infusion programming. Does not alter core infusion pump performance.

Clinical Evidence

Bench testing only. Performance data confirms the module meets specified requirements and functions equivalently to predicate devices regarding data acquisition, exchange, and integrity.

Technological Characteristics

Modular infusion system component; handheld or integrated scanner; dedicated communications interface channel; software-based error checking for data integrity; power supplied by Medley System host.

Indications for Use

Indicated for use in professional healthcare facilities by trained caregivers for the automated programming of infusion parameters for the delivery of fluids, medications, blood, and blood products.

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 System w/ MMS (K030459)
• Horizon Outlook 200 (K011975)

Submission Summary (Full Text)

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# JUL - 6 2004

ORIGINAL PREMARKET 510(K) NOTIFIC MEDLEY SYSTEM w/BAR CODE MODULE

## SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" System with Bar Code 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>Sr. Regulatory Affairs Specialist<br>ALARIS Medical Systems, Inc. | |
| E. | Date Summary Prepared: | May 10, 2004 | |

#### DEVICE IDENTIFICATION

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

#### DEVICE DESCRIPTION

The Medley Bar Code Module functions as part of the Medley System and can operate as a fifth module (when all four infusion and/or monitoring positions are in use). The Medley Bar Code Module attaches to and receives its power from the Medley System consistent with the modular design. The Bar Code Module does not directly interface with the Medley System; all communications are routed using a separate and dedicated communications interface channel resident in the Medley System.

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# SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" System with Bar Code Module Page 2 of 3

Through the dedicated communications channel, the Medley Bar Code Module exchanges information between itself and other sources, such as the patient wristband, medication or device packaging, Medley, or MMS System components such as the ALARIS Server and Hospital Information Management Systems. As with the Medley System with MMS, there is an information protocol for proprietary data exchange and a method to verify the integrity of the information sent or received prior to programming a Medley System infusion module. The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data.

All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s). The Medley Bar Code Module does not affect the operation of the Medlev System. All Medley System functionality and performance specifications remain unchanged.

An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.

#### SUBSTANTIAL EQUIVALENCE

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

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|----------------------|---------------------------------|------------|----------------|
| Medley System w/ MMS | ALARIS Medical<br>Systems, Inc. | K030459 | April 4, 2003 |
| Horizon Outlook 200 | B. Braun | K011975 | Sept. 19, 2001 |

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## SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ System with Bar Code Module Page 3 of 3

### INTENDED USE

The Medley System with Bar Code Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Medley System with Bar Code Module is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

## TECHNOLOGICAL CHARACTERISTICS

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

## PERFORMANCE DATA

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

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Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2004

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772

Re: K041241

Trade/Device Name: Medley™ System with Bar Code Module Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 10, 2004 Received: May 11, 2004

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

Sincerely yours,

Shih-Liang P1.D.

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

Enclosure

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# Indications for Use

510(k) Number (if known):

Medley™ System with Bar Code Module Device Name:

## Indications For Use:

The Medley System with Bar Code Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Medley System with Bar Code Module is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Anta V.m.

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

510(k) Number: K041241

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