IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT by IVAC MEDICAL SYSTEMS

The intended use of the MedSystem III Infusion Pump is to deliver a wide variety of drugs and fluids (e.g., bloods, lipids, saline, dextrose) over a broad range of infusion rates, at high levels of accuracy. IVAC's policy is to not indicate specific drugs and/or fluids. Specific intended uses include enteral, intravenous, and epidural deliveries.

The Drug Editing Software Kit (DESK) allows the user to customize the resident drug list for the Dose Rate Calculator (DRC) feature that is available in the legally marketed MedSystem III Infusion Pump. The current system allows custom changes on a one by one basis. The DESK system allows users to make permanent custom changes to the resident drug list.

Device Description

The DESK is a PC-based software tool operated under Microsoft Windows. This software tool will be used to customize the drug list for the Dose Rate Calculator (DRC) feature that is already available in the legally marketed MedSystem III Infusion Pump. The DESK allows the user to access the factory default druq list in the infusion pump via the Field Maintenance Software (FMS). After access the user can add, modify, or delete drug names and dosing parameters. The modified list can then be downloaded into the MedSystem III Infusion Pump via the FMS. The FMS is already available as a legally marketed accessory to the MedSystem III Infusion Pump.

AI/ML Overview

The provided text is related to a 510(k) submission for the IVAC MedSystem III™ Infusion Pump with Drug Editing Software Kit (DESK). However, it is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on:

Device Description: The DESK is PC-based software to customize the drug list for the Dose Rate Calculator (DRC) feature of the MedSystem III Infusion Pump.
Intended Use: To allow users to add, modify, or delete drug names and dosing parameters. The pump itself delivers fluids at high accuracy.
Technological Characteristics: States that the MedSystem III Infusion Pump has not changed and the DESK has the same technological characteristics as an existing software accessory (FMS). It highlights that a similar feature allowing single drug list customization already exists, and DESK enables permanent customization. Crucially, it states: "The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness."
Substantial Equivalence: The primary conclusion is that the device is substantially equivalent to existing legally marketed devices, and no new questions of safety and effectiveness are raised.

Because the submission claims substantial equivalence and states no new questions of safety and effectiveness are raised by the DESK software, no new performance studies are presented or required within this document. Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details.

Summary

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APR 17 1998

K96/486

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1.	SUBMITTER'S NAME:	IVAC Medical Systems, Inc.10221 Wateridge Circle
		San Diego, California 92121
		(619) 458-7563

Renée L. Fluet CONTACT PERSON: Requiatory Affairs Specialist
April 12, 1996 DATE PREPARED:

IVAC MedSystem III™ Infusion Proprietary Name: DEVICE NAME: 2. Pump with Drug Editing Software Kit (DESK)

Infusion Pump Common Name:

Classification Name: Infusion Pump

1. PREDICATE DEVICE: IVAC MedSystem III™ Infusion Pump
DEVICE DESCRIPTION: The DESK is a PC-based software tool operated 4. under Microsoft Windows. This software tool will be used to customize the drug list for the Dose Rate Calculator (DRC) feature that is already available in the legally marketed MedSystem III Infusion Pump. The DESK allows the user to access the factory default druq list in the infusion pump via the Field Maintenance Software (FMS). After access the user can add, modify, or delete drug names and dosing The modified list can then be parameters. downloaded into the MedSystem III Infusion Pump via the FMS. The FMS is already available as a legally marketed accessory to the MedSystem III Infusion Pump.
1. INTENDED USE: The intended use for the DESK is to allow users the ability to add, modify, or delete drug names and dosing parameters to the existing drug list for the Dose Rate Calculator feature in the MedSystem III Infusion Pump. The intended use for the MedSystem III Infusion Pump is to deliver a wide variety of fluids over a broad range of infusion rates, at high levels of accuracy.

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6. TECHNOLOGICAL CHARACTERISTICS:

The MedSystem III Infusion Pump has not changed. The DESK is a software accessory with the same technological characteristics as the FMS software accessory.

The primary function of the MedSystem III Infusion Pump with or without the DESK is the same: to deliver a wide variety of fluids over a broad range of infusion rates. A similar feature to the DESK is already available in the legally marketed MedSystem III Infusion Pump. This feature allows the user to customize the drug list on a single basis. DESK allows the user to customize the drug list on a permanent basis. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. IVAC Medical Systems, Inc. concludes that the MedSystem III Infusion Pump with or without the DESK are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 1998

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

Re : K961486 Trade Name: IVAC MedSystem III™, (MSIII) Infusion Pump with Drug Editing Software Kit, (DESK) Requlatory Class: II Product Code: MRZ Dated: January 14, 1998 Received: January 20, 1998

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Fluet

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance_ at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdal.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

hy A Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: MedSystem III Infusion Pump with Drug Editing Software Kit (DESK)

Indications for Use:

(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)

Patricia

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

510(k) Number

Over-The Counter Use

K 96 14866

(K) Number

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).