MEDLEY PCA MODULE, MODEL 8120

K043299 · Alaris Medical Systems, Inc. · MEA · Dec 10, 2004 · General Hospital

Device Facts

• Record ID: K043299
• Device Name: MEDLEY PCA MODULE, MODEL 8120
• Applicant: Alaris Medical Systems, Inc.
• Product Code: MEA · General Hospital
• Decision Date: Dec 10, 2004
• 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 infusion devices 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. The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Device Story

Medley PCA Module is a modular infusion pump system for delivery of medications/fluids. System integrates PCA pump with monitoring modules (EtCO2/SpO2) on a single Point of Care Unit (PCU). New PCA/Monitoring Protocol feature adds hospital-configured Guardrails parameters to align with facility protocols for opioid therapy. Protocol uses pre-configured monitoring limits to detect potential opioid-induced respiratory depression. Trained healthcare professionals program, enter data, and validate parameters based on physician orders or hospital protocols. System provides safety net for clinicians; does not replace clinical assessment or therapy decision-making. Output allows clinicians to continuously monitor respiratory response during opioid infusion, potentially improving patient safety by identifying unsafe states of respiratory depression.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular infusion pump system; PCU-based architecture. Features hospital-configurable Guardrails software parameters. Integrates with EtCO2 and SpO2 monitoring modules. Connectivity via Medley platform. Software-based protocol for monitoring limits and opioid medication management.

Indications for Use

Indicated for adults, pediatrics, and neonates requiring continuous or intermittent infusion of medications or fluids via IV, subcutaneous, or epidural routes. Specifically intended for patients prescribed PCA pain management therapy with opioids (Fentanyl, Demerol, Morphine, Hydromorphone) in clinical environments.

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 PCA Module (K032233)

Submission Summary (Full Text)

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APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733

Re: K043299

Trade/Device Name: Medley™ PCA Module with PCA/Monitoring Protocol Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: November 29,2004 Received: November 30,2004

Dear Ms. Lewis:

This letter corrects our substantially equivalent letter of December 10, 2004.

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 (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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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.

Suitte Michael Jmd

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: | K043299 |
|--------------------|--------------------------------------------------------------|
| Device Trade Name: | Medley ^TM PCA Module with PCA/Monitoring Protocol |

Indications For Use: The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices 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.

The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am

n of Anesthesiolor Intection Control. Denta

510(k) Number: K943214

Confidential

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# DEC 1 0 2004 SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ PCA Module with PCA/Monitoring Protocol

### 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: | November 29, 2004 |

### 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

Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy.

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# SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" PCA Module with PCA/Monitoring Protocol Page 2 of 3

This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.

## SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems Medley" PCA Module with PCA/Monitoring Protocol is of comparable type and is substantially equivalent to the following predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|-------------------|---------------------------------|------------|---------------|
| Medley PCA Module | ALARIS Medical<br>Systems, Inc. | K032233 | Sept. 9, 2003 |

### INTENDED USE

The Medley PCA Module with PCA/Monitoring Protocol is intended for use with patients that are prescribed PCA pain management therapy with opioid medications, specifically: Fentanyl, Demerol, Morphine, and Hydromorphone. The Medley PCA Module with PCA/Monitoring Protocol is intended for use by healthcare professionals in clinical environments. The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care. All device programming, data entry and validation of the Medley PCA Module with PCA/Monitoring Protocol is performed by the trained healthcare professional according

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# SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" PCA Module with PCA/Monitoring Protocol Page 3 of 3

### INTENDED USE (continued)

to hospital-defined protocol or a physician's order. A separate Indications for Use page is located in Section 6.

# TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Medley™ PCA Module with PCA/Monitoring Protocol and the predicate device has been performed. The results of this comparison demonstrate that the Medley™ PCA Module with PCA/Monitoring Protocol is equivalent to the marketed predicate device in technological characteristics.

### PERFORMANCE DATA

The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device.

K043299