The Alaris® System with Medication Management System (also known as the Medley™ System with MMS and the Alaris® System with MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Alaris® System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Device Description

As with the predicate device, the Alaris® System with MMS assists our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to a server and an existing infusion device (the Alaris® System). The wireless communication capability provides a "safety net" at the bedside to help reduce the number of programming errors at the point of care. It allows the Alaris® System to transmit and receive messages with the Alaris® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA;s), hospital monitoring systems and Hospital Information Management Systems (HIMS).

AI/ML Overview

Here's an analysis of the provided text regarding the Alaris® System with MMS, focusing on acceptance criteria and study details.

Based solely on the provided document snippets, it is not possible to provide a table of acceptance criteria, reported device performance, or detailed study information typically associated with AI/ML device evaluations.

This document is a 510(k) summary for a Special 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device for modifications that do not raise new issues of safety or efficacy. It is explicitly stated: "The changes as described in this Special 510(k) pose no new issues of safety or efficacy."

Therefore, the information you're asking for (acceptance criteria, specific study results for performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone AI performance, ground truth types) is not present in this type of submission for this particular device.

This device is an infusion pump system with wireless communication capabilities, designed to automate programming and reduce manual steps. It is a traditional medical device, not an AI/ML device that would typically undergo the kind of performance validation studies you're inquiring about. The "MMS" stands for "Medication Management System," implying software for managing medication regimens, but not necessarily AI for diagnosis or treatment recommendations.

To directly address your request, here's what can be inferred from the document and why other information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable and not provided in the document. A Special 510(k) for changes that maintain substantial equivalence does not typically present new performance criteria and results beyond what was established for the predicate device. The focus is on demonstrating that the changes do not degrade performance or introduce new risks.

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

Not applicable and not provided. Performance studies with test sets in the context of AI/ML are not detailed because this is not an AI/ML device.

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

Not applicable and not provided. "Ground truth" in the context of AI/ML for diagnostic or predictive tasks is not relevant here. The device automates infusion programming; its "accuracy" would be against a physician's order or internal calculations, not an expert panel.

4. Adjudication Method

Not applicable and not provided.

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 and not provided. This is not an AI diagnostic/interpretive device; therefore, MRMC studies are not relevant.

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

Not applicable and not provided. There's no "algorithm" in the AI/ML sense being evaluated independently. The device's function is to facilitate automated programming by "trained healthcare professional[s]".

7. The Type of Ground Truth Used

Not applicable and not provided.

8. The Sample Size for the Training Set

Not applicable and not provided. AI/ML training concepts are not relevant to this device's submission.

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

Not applicable and not provided.

Summary of Device and Acceptance Logic (based on the provided text):

Device Name: Alaris® System with MMS (Medication Management System)
Intended Use: To provide wired or wireless communication between the Alaris® System and external devices to automate programming of infusion parameters, decreasing manual steps. All data entry and validation are performed by a trained healthcare professional.
Predicate Device: Alaris® System with MMS (a.k.a. Medley™ System with MMS) K030459
Acceptance Logic (for this Special 510(k) submission): The device is substantially equivalent to its predicate device because it "has the same intended use, operating principles, method of operation, technology, materials and manufacturing processes." The changes described in this Special 510(k) "pose no new issues of safety or efficacy." This means the acceptance criterion for this specific submission was demonstrating that the modifications did not alter the fundamental safety and effectiveness already established for the predicate device. The "study" demonstrating this was likely a comparison of technical characteristics and an analysis showing that the changes (e.g., wireless communication capabilities) did not introduce new risks or alter the core functionality negatively.

In essence, this document is a regulatory approval for a non-AI medical device based on substantial equivalence, not a performance study report for an AI/ML system.

Summary

{0}------------------------------------------------

CARDINAL HEALTH

SPECIAL 510(K) ALARIS® SYSTEM WITH MMS

ATTACHMENT D

K072105

SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health 303, Inc. Alaris® System with MMS

SUBMITTER'S NAME:	Cardinal Health 303, Inc.d.b.a. Cardinal Health10221 Wateridge CircleSan Diego, CA 92121-2772(858) 458-7830(858) 458-6114 FAX	DEC 2 8 2007
CONTACT PERSON:	Stacy L. LewisPrincipal Regulatory Affairs Specialist
DATE PREPARED:	July 27, 2007
DEVICE NAME:	Proprietary NameAlaris® System with MMS
	Common NameInfusion Pump
	Classification NamePump, Infusion and accessories, FRN (880.5725)
PREDICATE DEVICE:	Alaris® System with MMS (a.k.a. Medley™ System withMMS) K030459

DEVICE DESCRIPTION

{1}------------------------------------------------

ALARIS® SYSTEM WITH MMS SUMMARY OF SAFETY AND EFFECTIVENESS Page 2 of 2

SUBSTANTIAL EQUIVALENCE

The Alaris® System with MMS is essentially the same as the predicate device in that they have the same intended use, operating principles, method of operation, technology, materials and manufacturing processes. The changes as described in this Special 510(k) pose no new issues of safety or efficacy. The Alaris® System with MMS as described in this submission is substantially equivalent to the predicate device.

INTENDED USE

The incorporation of the Medication Management System (MMS) with the Alaris® System (a.k.a. Medley™ System) provides wired or wireless communication between the Alaris® System and external devices. This is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps to enter infusion data. All data entry and validation of infusion parameters using MMS is performed by the trained healthcare professional.

The Alaris System with MMS is integrated into an existing hospital network infrastructure and allows communications to and from external devices, including personal computers, Personal Digital Assistants (PDAs), hospital monitoring systems and Hospital Information Management Systems (HIMS). Bi-directional communication of data includes infusion parameters, system configuration, history, events, trending, alarms and status. In addition the Alaris System with MMS has the capability to transmit, receive and/or store: features, calibration data, datasets, and libraries from external components or devices to the pump.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Alaris® System with MMS and the predicate device has been performed. The results of this comparison demonstrate that the Alaris® System with MMS is equivalent in technological characteristics and the fundamental scientific technology of the predicate device has not been altered.

$$
\begin{array}{ccc}
\mathsf{k}\mathsf{o}\mathsf{7}\mathsf{z}\mathsf{o}\mathsf{6} & \mathsf{p}\mathsf{4} & \mathsf{z}\mathsf{o}\mathsf{z} \
\mathsf{k}\mathsf{z}\mathsf{o}\mathsf{z} & \mathsf{p}\mathsf{z} & \mathsf{z}\mathsf{o}\mathsf{z} \
\end{array}
$$

00768

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the serpent winding around the staff.

DEC 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacey L. Lewis Principal Regulatory Affairs Specialist Cardinal Health 303, Incorporated 10221 Wateridge Circle San Diego, California 92121

Re: K072105

Trade/Device Name: Alaris System with MMS Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 3, 2006 Received: December 4, 2006

Dear Ms. Lewis:

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 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.

{3}------------------------------------------------

Page 2 - Ms. Lewis

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Shiela A Murphy, MD for Chu Lin, Ph D

Chu Lin, Ph D

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

CARDINAL HEALTH

Attachment B

INDICATIONS FOR USE

510(k) Number:

(To Be Assigned By FDA)

Device Trade Name:

Alaris® System with MMS

Indications For Use:

Prescription Use X

Over-Th

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Clint Damer

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

510(k) Number: K472145

00763

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).