VARIABLE PRESSURE SYRINGE PUMP

K974332 · Alaris Medical Systems, Inc. · FRN · Dec 29, 1998 · General Hospital

Device Facts

• Record ID: K974332
• Device Name: VARIABLE PRESSURE SYRINGE PUMP
• Applicant: Alaris Medical Systems, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Dec 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.

Device Story

P7000 is a microprocessor-controlled variable pressure syringe pump for critical care. Accepts standard single-use luer-lock syringes (5, 10, 20, 30, 50, 100ml). Operates with dedicated extension sets (including pressure-sensing discs) or non-dedicated standard sets. Used by clinicians in hospital settings for controlled delivery of fluids, drugs, and blood products. Microprocessor manages infusion parameters; pressure sensing provides additional safety/monitoring features. Output allows precise drug/fluid administration, supporting clinical decision-making in critical care environments.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Microprocessor-controlled syringe pump. Compatible with 5-100ml luer-lock syringes. Supports dedicated extension sets with pressure-sensing discs and standard non-dedicated sets. Class II device.

Indications for Use

Indicated for intravenous and epidural administration of drugs, blood, and blood products in patients requiring critical care infusion therapy. No specific contraindications identified.

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

• Baxter Corporation, Auto Syringe AS40A Infusion Pump (K940147)

Submission Summary (Full Text)

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K974332

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## Model P7000 Variable Pressure Syringe Pump 510(k) Premarket Notification

### SUMMARY OF SAFETY AND EFFECTIVENESS

- ALARIS Medical Systems, Inc. SUBMITTER'S NAME: 1. 10221 Wateridge Circle San Diego, CA 92121-2733 [phone] [phone] FAX CONTACT PERSON: Renée L. Fluet Sr. Regulatory Affairs Specialist November 17, 1997 DATE PREPARED: Variable Pressure Syringe 2. Proprietary Name: DEVICE NAME: Pump Syringe Pump Common Name: Classification Name: Infusion Pump Baxter Corporation, Auto Syringe AS40A Infusion PREDICATE DEVICE: 3. Pump, K940147 DEVICE DESCRIPTION: The P7000 is a variable pressure syringe pump 4. suitable for critical care applications.< This instrument functions with a range of standard, single use, disposable. Iuer-lock svringes of various types and accepts syringe sizes of 5, 10, 20, 30, 50, and 100ml. The P7000 is a microprocessor controlled device designed to use standard, single use, disposable extension sets with luer-lock connectors, of type designed for use on the P7000 syringe pump. The pump can be used with either dedicated or nondedicated syringe extension sets. The dedicated sets include a pressure sensing disc which can be used for additional features. Or, non-dedicated sets (standard sets) can be utilized for standard syringe pump needs. The P7000 Syringe Pump is intended to be used ട. INTENDED USE: for intravenous and epidural administration of drugs and fluids.
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# SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

#### 6. TECHNOLOGICAL CHARACTERISTICS:

The P7000 is similar to the Baxter Corporation Auto Syringe AS40A Infusion Pump, K940147. Both devices have the same intended use, general design and incorporate similar technologies, software, materials, electronics, energy sources, and mechanical components.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 29 1998

Ms. Renee L. Fluet Senior Regulatory Affairs Specialist ALARIS™ Medical Systems, Incorporated Corporate Office 10221 Wateridge Circle San Diego, California 92121-2733

Re : K974332 Variable Pressure Syringe Pump Trade Name: Requlatory Class: II Product Code: FRN October 30, 1998 Dated: November 2, 1998 Received:

Dear Ms. Fluet:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Fluet

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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## Model P7000 Variable Pressure Syringe Pump 510(k) Premarket Notification

## INDICATIONS FOR USE

Page 1 of 1

510(k) Number (if known):

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: MODEL P7000 VARIABLE PRESSURE SYRINGE PUMP

The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.

ALARIS Medical Systems' policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the P7000. No such contraindications have been identified.

The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use
(Per 21 CFR 801.109)

OR Over-The-Counter

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number