SYNDEO PCA SYRINGE PUMP, MODEL 2L3113

K031566 · Baxter Healthcare Corp · MEA · Aug 19, 2003 · General Hospital

Device Facts

• Record ID: K031566
• Device Name: SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
• Applicant: Baxter Healthcare Corp
• Product Code: MEA · General Hospital
• Decision Date: Aug 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications. The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings. The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.

Device Story

Syndeo PCA Syringe Pump delivers analgesic, sedative, and anesthetic solutions via continuous, intermittent, or continuous-plus-intermittent infusion. Device accepts 60 mL plastic or 50 mL prefilled syringes; includes locking cover and patient-controlled bolus button. Operated by clinicians in hospital or alternate medical sites; not for home use. Microprocessor-controlled system features color touch-screen GUI for programming. Sensors monitor syringe loading and door closure for safety. Device supports wireless communication with infrared printers or Palm OS-compatible computing tools. Powered by 4 D-size alkaline batteries or optional AC rechargeable pack. Output allows clinicians to manage patient pain regimens; provides controlled medication delivery to improve patient comfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled syringe infusion pump. Materials: plastic syringes. Energy: 4 D-size alkaline batteries or optional AC rechargeable pack. Interface: color touch-screen GUI. Connectivity: wireless (infrared/Palm OS compatible). Safety features: sensors for syringe loading and door closure.

Indications for Use

Indicated for patients requiring controlled delivery of analgesic, sedative, and anesthetic solutions via intravenous, subcutaneous, spinal, epidural, or regional anesthesia routes in hospital or alternate medical site environments. Not for homecare use. Not for use with blood or 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

• PCA II Syringe Infusion Pump
• Ipump Pain Management System

Submission Summary (Full Text)

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K03/566

# 510(k) Summary of Safety and Effectiveness

## Submitted by:

Jennifer M. Paine Manager, Requlatory Affairs Baxter Healthcare Corporation Medication Delivery Rte. 120 and Wilson Road Round Lake, IL 60073

### Name/Classification of Device:

Infusion Pump/ Class II, 80MEA - 21 CFR 880.5725

#### Trade Name:

Syndeo PCA Syringe Pump

### Predicate Devices:

PCA II Syringe Infusion Pump Ipump Pain Management System

### Statement of Intended Use:

The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.

The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.

The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.

#### Device Description:

The Syndeo PCA Syringe Pump consists of a syringe infusion pump with locking cover, and a PCA button for delivery of bolus doses of medication upon request. The pump accommodates 60 mL plastic syringes or 50 mL prefilled syringes. The pump can communicate with wireless accessories such as commercially available infrared printers or computing tools with device communications that are compatible with the Palm Operating System.

The Syndeo pump is capable of continuous, intermittent, or continuous plus intermittent infusion of small volumes of medications, following standard patientrequest PCA regimens. The pump operates on 4 D-size alkaline batteries or the

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optional AC rechargeable pack. The pump uses microprocessor electronics for control of all functions. A large, color touch-screen display provides a userfriendly graphic user interface (GUI), and simple programming steps that lead the operator through programming. As an added safety feature, the pump employs a variety of sensors to ensure appropriate syringe loading and door closure prior to allowing initiation of infusion.

# Summary of Technological Characteristics of New Device to Predicate Devices:

The new and predicate devices have similar materials and basic design. The new device uses a touchscreen, color display and wireless communications technology.

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#### Public Health Service

AUG 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer M. Paine Manager, Regulatory Affairs Baxter Healthcare Corporation 7511 114" Avenue North Largo, Florida 33773

Re: K031566

Trade/Device Name: Syndeo PCA Syringe Pump Regulation Number: 880. 5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: May 16, 2003 Received: May 19, 2003

## Dear Ms. Paine:

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, an 1 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. Iisting 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. Paine

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,

fiscing the first of the many of the successfully be

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 Statement

510(k) Number (if known):

Syndeo PCA Syringe Pump Device Name:

Indications For Use:

The Syndeo PCA Syringe Pump is designed for the controlled delivery (continuous, intermittent, and continuous plus intermittent) of analgesic, sedative, and anesthetic solutions through clinically acceptable routes of administration including intravenous, subcutaneous, spinal (or intrathecal), epidural (or subarachnoid), and for regional anesthesia applications.

The Syndeo PCA Syringe Pump is appropriate for use in hospital or alternate medical site environments, but it is not intended for use in homecare settings.

The Syndeo PCA Syringe Pump is not indicated for use with blood or blood products.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Counter Use _

Over-the-

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Paltare Cuccente

Division of Anesthesiology, General Hospital. Infection Control. Den

510(k) Number: K031564

SYNDEO 510(K) -- INDICATIONS FOR USE

BAXTER CONFIDENTIAL

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