VARIABLE PRESSURE SYRINGE PUMP

• K Number: K974332
• Device Name: VARIABLE PRESSURE SYRINGE PUMP
• Manufacturer: ALARIS MEDICAL SYSTEMS, INC.
• Date Cleared: 1998-12-29 ( 406 days)
• Product Code: FRN
• Regulation Number: 880.5725

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

Device Description

The P7000 is a variable pressure syringe pump 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.

Predicate Devices

K940147

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard microprocessor-controlled syringe pump and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is for administering drugs, not for treating any specific condition.

Diagnostic

No
Explanation: The device is described as a syringe pump for intravenous and epidural administration of drugs, blood, and blood products. Its function is to administer substances, not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical syringe pump with mechanical components (accepts syringes, uses extension sets, microprocessor controlled) and does not indicate it is solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the administration of drugs, blood, and blood products intravenously and epidurally. This is a therapeutic or delivery function, not a diagnostic one.
• Device Description: The description focuses on the mechanical function of a syringe pump for delivering fluids. It doesn't mention any analysis of biological samples or diagnostic testing.
• Lack of Diagnostic Language: The text does not use any language typically associated with IVD devices, such as "diagnosis," "testing," "analysis," "measurement of analytes," or "in vitro."

IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to deliver substances into the body, not to analyze substances from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The P7000 Syringe Pump is intended to be used for intravenous and epidural administration of drugs and fluids. 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. The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.

Product codes

FRN

Device Description

The P7000 is a variable pressure syringe pump suitable for critical care applications.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

K974332

3

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.