The Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley™ System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alario® System module is specified in its respective submission.

Device Description

The Alaris® System is a modular system that consists of a point-of-care unit (PC Unit) that provides the main user interface and power supply for the associated infusion and monitoring modules. The enhanced PC Unit will include a faster processor, increased memory, and a color screen. This update is only for the Alaris® PC Unit and does not require any change to the associated modules, systems, or accessories of the Alaris® System.

AI/ML Overview

This document is a 510(k) premarket notification for an Alaris® PC Unit (Models 8000 and 8015). It details the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes a device modification for the Alaris® PC Unit, specifically including "a faster processor, increased memory, and a color screen." The submission's core argument is one of substantial equivalence to a previously cleared predicate device (Alaris® PC Unit K051641).

Therefore, the "acceptance criteria" are implicitly met by demonstrating that the modified device "is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered." This means the device is expected to perform at least as well as the predicate device in its intended function.

Since this is a 510(k) for a device modification and not a new diagnostic algorithm or AI, there are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the provided text. The performance is assessed by comparison to the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Substantial Equivalence to Predicate Device (K051641)	"With the exception of the device modification presented in this submission, the Alaris® PC Unit is essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same." and "The results of this comparison demonstrate that the modified Alaris® PC Unit is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered."
No change in intended use	"The intended use of this device has not changed from the original submissions in terms of content or intent."
Continued safety and effectiveness for infusion pump function	(Implicit, as the core function remains unchanged and the modifications are enhancements to the user interface/processor, not the core infusion mechanism)

2. Sample Size Used for the Test Set and Data Provenance:

This document is for a medical device modification (an infusion pump's control unit), not an AI/ML diagnostic or prognostic algorithm. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical studies (e.g., patient data, images) are not applicable here. The evaluation is based on engineering and design changes, and comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. As noted above, this is for a medical device modification, not a clinical diagnostic algorithm requiring expert-established ground truth from a test set of patient cases.

4. Adjudication Method for the Test Set:

Not applicable for the same reasons as points 2 and 3.

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 device is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" here is the performance and characteristics of the previous, cleared predicate device. The modified device's "truth" is established by demonstrating its equivalence to this predicate device in terms of function, safety, and effectiveness, as determined through engineering assessment against established standards and internal testing. No clinical "ground truth" from patient data is established or used in this specific regulatory submission for a device modification.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware modification for an infusion pump control unit, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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CARDINAL HEALTH

KC09/308

SPECIAL 510/k ALARIS® PC UNIT

ATTACHMENT D

SUMMARY OF SAFETY AND EFFECTIVENESS

Cardinal Health 303, Inc.

Alaris® PC Unit

Models 8000 and 8015

JUL - 9 2009

SUBMITTER'S NAME:	Cardinal Health 303, Inc.
	10020 Pacific Mesa Blvd.
	San Diego, CA 92121
	(858) 617-5925
	(858) 617-5977 FAX
CONTACT PERSON:	Michelle J. Badal, RAC
	Vice President, Regulatory Affairs
DATE PREPARED:	May 1, 2009
DEVICE NAME:	Proprietary Name: Alaris® PC Unit
	Common Name: Infusion Pump
	Classification Name: Pump, Infusion, FRN (880.5725)
PREDICATE DEVICE:	Alaris® PC Unit (K051641, October 20, 2005)

DEVICE DESCRIPTION

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SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2

SUBSTANTIAL EQUIVALENCE

With the exception of the device modification presented in this submission, the Alaris® PC Unit is essentially the same as the originally submitted predicate device. The intended use, principles of operation, fundamental scientific technology, method of manufacture, and application are essentially the same.

INTENDED USE

The intended use of this device has not changed from the original submissions in terms of content or intent:

The Alaris® PC Unit is the main user interface unit and power supply of the Alaris® System, a modular system to be used with Alaris® System modules (aka Medley " System modules) intended for use in today's growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices. The specific intended use for each Alaris® System module is specified in its respective submission

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Alaris® PC Unit and the predicate devices has been performed. The results of this comparison demonstrate that the modified Alaris® PC Unit is equivalent in technological characteristics to the unmodified device and that the fundamental scientific technology of the predicate device has not been altered.

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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 eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2009

Ms. Michelle J. Badal Vice President Regulatory Affairs Cardinal Health 303, Incorporated 10020 Pacific Mesa Boulevard San Diego, California 92121

Re: K091308

Trade/Device Name: Alaris® PC Unit Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 26, 2009 Received: July 1, 2009

Dear Ms. Badal:

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 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. Badal

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Anthony D. Watson
Susan Runner, D.D.S., M.A.

Acting 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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Attachment B INDICATIONS FOR USE

K091308 510(k) Number (if known):

Device Name: Alaris® PC Unit

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K091308

00069

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).