ALARIS Medical Systems infusion pumps are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.

The following ALARIS Medical Systems infusion pumps are indicated 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:

IMED® Gemini Infusion Pump / Controllers model PC-1® ●
IMED® Gemini Infusion Pump / Controllers model PC-2® .
IMED® Gemini Infusion Pump/Controller model PC-2TX® .
IMED® Gemini Infusion Pump/Controller model PC-40 .
IVAC® Signature Edition® Infusion Pumps
IVAC® MedSystem III®, Multi-channel Infusion Pumps .
IVAC® MedSystem III® Multi-channel Infusion Pumps with DLE .
. ALARIS Medical Medley" Patient Care System

Note: See the appropriate Directions for Use (DFU) for infusion system specifications.

Device Description

ALARIS Medical Systems line of infusion pumps are electrical volumetric infusion pumps that are used to control the rate or monitor the flow of solution or medication. In general, infusion pumps are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion pumps have proven to be useful in applications such as continuous epidural anesthesia, enteral delivery, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.

AI/ML Overview

This document is a 510(k) Premarket Notification for ALARIS Medical Systems infusion pumps. It seeks to expand the intended use statements for existing devices to include more detailed information about administration routes, target populations, and intended users. The core claim is that this expansion does not alter the device's intended use, performance, safety, or efficacy.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not describe any new acceptance criteria or new device performance data. The submission indicates that the changes are solely to the intended use statements and do not impact the device's technical characteristics or performance.

Therefore, the table below reflects what is implied by the submission, rather than explicitly stated acceptance criteria for new performance:

Acceptance Criteria	Reported Device Performance
No change in intended use of the device. (As per submission)	The expanded indications for use, including administration route, target population, and intended user, do not alter the intended use of the device. (Explicitly stated in the submission)
No effect on performance, safety, or efficacy of any of the devices. (As per submission)	The expanded indications for use do not affect performance, safety, or efficacy of any of the devices. (Explicitly stated in the submission)
Technological characteristics remain equivalent to predicate devices. (As per submission, relying on previous 510(k) clearances)	A comparison of technological characteristics was performed, concluding that the ALARIS Medical line of infusion pumps with expanded indications are equivalent to the original 510(k) devices as well as predicate devices (Abbott Plum XL Infusion Pump K010924 and Baxter Healthcare's Colleague® Infusion Pumps K002211).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No new test set data was generated or analyzed for this 510(k) submission.
Data Provenance: Not applicable. As per the submission, "PERFORMANCE DATA: There are no changes to the devices to support the expansion of indications. Therefore performance data is not necessary." The original performance data for the predicate devices would have been generated during their respective 510(k) clearances, likely from various clinical and bench testing conducted by the manufacturers.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new ground truth was established for a test set as no new performance data was required. The "ground truth" for the existing devices' performance would have been established during their original clearance processes through a combination of engineering specifications, bench testing, and potentially clinical validation against established medical standards.

4. Adjudication method for the test set

Not applicable. No test set was used for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for infusion pumps, which are not AI-powered devices or diagnostic tools requiring MRMC studies with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm, and its functionality involves human interaction for setup and monitoring.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable to this specific submission. The "ground truth" for infusion pump performance generally relies on:

Engineering Specifications: Adherence to defined flow rates, accuracy, occlusion detection, alarm functionality, etc.
Bench Testing: Validation against calibrated instruments and simulated physiological conditions.
Clinical Studies (for initial device clearance): Demonstrating safe and effective fluid delivery in patients, potentially comparing to established methods.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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1 .45

K012383

SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems®, Inc.

SUBMITTER INFORMATION

A.	Company Name:	ALARIS Medical Systems, Inc.
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121
C.	Company Phone:Company Fax:	(858) 458-7563(858) 458-6223
D.	Contact Person:	Renée L. FluetPrincipal Regulatory Affairs Specialist
E.	Date Summary Prepared:	July 26, 2001

DEVICE IDENTIFICATION

B.C.	Trade/Proprietary Name:Classification	Pump, InfusionPump, Infusion, 21CFR 880.5725, Class IIProduct Code FRN

SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems line of infusion pumps as listed below are of comparable type and are substantially equivalent to the predicate devices, the Abbott Plum XL and Baxter's line of Colleague® Infusion Pumps.

ALARIS Medical Infusion Pumps	510(k) #	Date Cleared
IMED Gemini PC-1 Volumetric Infusion Pump	K883993	12/19/88
IMED Gemini PC-4 Volumetric Infusion Pump	K921370	06/09/92
IVAC Signature Edition Volumetric Infusion Pumps	K931549	10/12/93
IMED Gemini PC-2TX Volumetric Infusion Pump	K933144	10/12/93
IVAC MedSystem III Volumetric Infusion Pumps	K933545	09/29/94
ALARIS Medical Medley Patient Care System	K950419	6/21/95
IVAC MedSystem III Volumetric Infusion Pump withDLE	K961486	04/17/98

Confidential

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued ALARIS Medical Systems, Inc. Page 2 of 3

Predicate Device(s)

Manufacturer and Device	510(k) #	Date Cleared
Abbott Plum XL Infusion Pump	K010924	04/06/01
Colleague Volumetric and CX Volumetric InfusionPumps	K002211	08/28/00

DEVICE DESCRIPTION

This 510(k) Premarket Notification is being submitted to expand the intended use to include specific indications for ALARIS Medical infusion pumps. The current indications will expand to include detailed information such as administration route, target population, and intended user. This expansion will serve to better represent the ALARIS Medical infusion pump as used in today's healthcare environment, as well as, provide a better competitive comparison with other infusion pumps. Expansion of the indications as described in this submission does not alter the intended use of the device nor does it affect performance, safety, or efficacy of any of the devices.

07/26/01

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued ALARIS Medical Systems, Inc. Page 3 of 3

INTENDED USE

ALARIS Medical Systems infusion pumps are intended for use in today's growing professional healthcare environment including hospitals, healthcare facilities, home care professional fransport that utilize infusion pumps for the delivery of fluids, medications, blood and blood products.

The following ALARIS Medical Systems infusion pumps are indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intennitions (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces:

IMED® Gemini Infusion Pump / Controllers model PC-1® .
IMED Gemini Infusion Pump / Controllers model PC-2® ●
IMED Gemini Infusion Pump/Controller model PC-2TX® ●
IMED Gemini Infusion Pump/Controller model PC-4® ●
IVAC® Signature Edition® Infusion Pumps .
IVAC MedSystem III® Multi-channel Infusion Pumps .
IVAC MedSystem III* Multi-channel Infusion Pumps with DLE .
ALARIS Medical Medley™ Patient Care System ●

Note: See the appropriate Directions for Use (DFU) for infusion system specifications.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the ALARIS Medical line of infusion purps and the predicate devices has been performed. The results of this comparison pamps and that the ALARIS Medical Line of infusion pumps with expanded indications for use are equivalent to the original 510(k) devices as well as, the Abbott Plum XL Infusion Pump (K010924) and the Baxter Healthcare line of Colleague® Infusion Pumps (K002211).

PERFORMANCE DATA

There are no changes to the devices to support the expansion of indications. Therefore performance data is not necessary.

Confidential

07/26/01

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, with two wavy lines below it. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

OCT - 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012383

Trade/Device Name: ALARIS Medical Systems® Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: July 26, 2001 Received: July 27, 2001

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 vour 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.

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.

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Page 2 - Ms. Fluet

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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INDICATIONS FOR USE

510(k) Number:

K012383 (To Be Assigned By FDA)

Device Trade Name:

ALARIS Medical Systems Infusion Pumps

Indications for Use:

IMED® Gemini Infusion Pump / Controllers model PC-1® ●
IMED® Gemini Infusion Pump / Controllers model PC-2® .
IMED® Gemini Infusion Pump/Controller model PC-2TX® .
IMED® Gemini Infusion Pump/Controller model PC-40 .
IVAC® Signature Edition® Infusion Pumps
IVAC® MedSystem III®, Multi-channel Infusion Pumps .
IVAC® MedSystem III® Multi-channel Infusion Pumps with DLE .
. ALARIS Medical Medley" Patient Care System

Note: See the appropriate Directions for Use (DFU) for infusion system specifications.

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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

faltana Cicerati

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

Confidential

0029 07/20/01

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).