MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110

K023264 · Alaris Medical Systems, Inc. · FRN · Dec 19, 2002 · General Hospital

Device Facts

• Record ID: K023264
• Device Name: MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
• Applicant: Alaris Medical Systems, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MEDLEY" Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products. The MEDLEY" Syringe Pump is indicated for use on adults, pediatrics and neonates 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

MEDLEY Syringe Pump Module functions as part of MEDLEY Medication Safety System; connects up to four modules to a Programming Module (PM). Delivers fluids, medications, blood, and blood products using standard, single-use administration sets and luer-lock syringes. Features include back-off, fast start, customizable pressure alarm settings, pressure tracking display, and auto pressure when using administration sets with pressure discs. Used in professional healthcare environments by clinicians. Provides controlled fluid delivery to patients; enhances medication safety through integration with the MEDLEY system.

Clinical Evidence

Bench testing only. Performance data indicates the device meets specified requirements and is substantially equivalent to predicate devices.

Technological Characteristics

Syringe infusion pump; uses standard single-use administration sets and luer-lock syringes. Optional pressure disc integration enables back-off, fast start, customizable pressure alarms, pressure tracking, and auto pressure features. Modular design allows connection of up to four units to a Programming Module.

Indications for Use

Indicated for adults, pediatrics, and neonates requiring continuous or intermittent delivery of fluids, medications, blood, and blood products via IV, IA, subcutaneous, epidural, enteral, or irrigation 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

• Model P7000 Variable Syringe Pump (K974332)
• Medex 3000 Series Syringe Infusion Pump, Model 3010a (K982640)

Submission Summary (Full Text)

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

#### K023264 SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® MEDLEY™ Syringe Pump 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: | Renée L. Fluet<br>Principal Regulatory Affairs Specialist<br>ALARIS Medical Systems, Inc. | | | |
| E. | Date Summary Prepared: | September 27, 2002 | | | |
| DEVICE IDENTIFICATION | | | | | |
| A. | Generic Device Name: | Syringe Infusion Pump | | | |
| B. | Trade/Proprietary Name: | MEDLEY™ Syringe Pump Module | | | |
| C. | Classification: | Class II | | | |

- Product Code: FRN, Infusion Pump D.
#### DEVICE DESCRIPTION

The MEDLEY Syringe Pump Module functions as part of the MEDLEY™ Medication Safety System. In combination with the MEDLEY™ Programming Module (PM), the Syringe Module will deliver fluids in a manner similar to current syringe pumps on the market. Up to four Syringe Modules may be connected to each PM.

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

# SUMMARY OF SAFETY AND EFFECTIVENESS Page 2

#### DEVICE DESCRIPTION (Continued)

The MEDLEY™ Syringe Pump uses standard, single-use, administration sets (with and without pressure disc) and syringes with luer-lock connectors, of type designed for use on syringe pumps. The MEDLEY™ Syringe Pump may be used with administration sets that contain a pressure disc. If the pressure disc is used, the following features are available:

- Back-off .
- . Fast Start
- Customizable Pressure Alarm Settings ●
- Pressure Tracking Display ●
- Auto Pressure .

# SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems® MEDLEY™ Syringe Pump is of comparable type and is substantially equivalent to the following predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date<br>Cleared |
|---------------------------------------------------------|---------------------------------|------------|-----------------|
| Model P7000 Variable Syringe<br>Pump | ALARIS Medical<br>Systems, Inc. | K974332 | 12/29/98 |
| Medex 3000 Series Syringe<br>Infusion Pump, Model 3010a | Medex. Inc. | K982640 | 4/6/99 |

# INTENDED USE

The MEDLEY" Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.

The MEDLEY" Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration

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

# SUMMARY OF SAFETY AND EFFECTIVENESS Page 3

#### INTENDED USE (Continued)

such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces

#### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the MEDLEY™ Syringe Pump and the predicate devices has been performed. The results of this comparison demonstrate that the MEDLEY™ Syringe Pump is equivalent to the marketed predicate devices in technological characteristics.

PERFORMANCE DATA - The performance data indicate that the MEDLEY™ System Syringe Pump meets specified requirements, and is substantially equivalent to the predicate devices.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Renée L. Fluet Principal Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2733

Re: K023264

Trade/Device Name: MEDLEY™ Syringe Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 27, 2002 Received: September 30, 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 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.

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

Page 2 - Ms. Fluet

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 appliedble, 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]. 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runser

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

ALARIS MEDICAL SYSTEMS*, INC.

.

# INDICATIONS FOR USE

510(k) Number:

| K 023264 | (To Be Assigned By FDA) |
|----------|-------------------------|
|----------|-------------------------|

Device Trade Name:

MEDLEY™ Syringe Pump

Indications For Use: The MEDLEY™ Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.

The MEDLEY™ Syringe Pump is indicated for use on adults, pediatrics and neonates 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)

Prescription Use __

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Tittina Cucurita

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

Confidential

510(k) Number. _K023264