The SE Infusion 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 SE Infusion 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

The addition of the Medication Management System (MMS) to the SE Infusion System will allow wireless bi-directional communication with the Alaris Server and external devices. MMS is the combination of RF communication from the SE Infusion System to/from the Alaris Server and the Alaris Proprietary software called the Inter-Server Interface Protocol (ISIP). The ISIP allows for communication between the SE Infusion System, the Alaris Server, and external devices.

The SE Infusion System with MMS is intended to provide 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 verification of infusion or monitoring parameters using MMS is performed by trained healthcare professionals prior to administration of medication(s).

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the Cardinal Health, Alaris Products SE Infusion System with MMS. It primarily focuses on the device description, its intended use, and its substantial equivalence to a predicate device. The "Performance Data" section states broadly that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device," but it does not provide any quantitative data, study design, or specific acceptance criteria.

Therefore, I cannot fulfill most of your request from the given information. Below is a response based on what can be extracted and a clear indication of what information is missing.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not specified in the provided text.
Reported Device Performance: Not quantified in the provided text. The document only states that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no specific test set and ground truth establishment is described in the provided text. The document mentions "trained healthcare professionals" for data entry and validation, but this pertains to the device's intended use in clinical practice, not a study's ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no specific test set and adjudication method is described.

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. The device is an infusion pump system with a Medication Management System (MMS) for automating programming parameters, not an AI diagnostic tool involving human readers interpreting cases.

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

Not explicitly described as a standalone study in the context of an algorithm's performance. The device's primary function is to automate programming parameters, and it is intended for use by "trained healthcare professionals." The functionality of the MMS relies on communication and software, which could be considered algorithmic, but its performance is always in conjunction with a user.

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

Not applicable as no specific ground truth for a study is described. The device's functionality is about accurately processing and delivering infusion parameters according to orders, validated by healthcare professionals.

8. The sample size for the training set

Not applicable as no machine learning model or training set is described.

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

Not applicable as no machine learning model or training set is described.

Summary of what is available from the text:

The provided text describes the Cardinal Health, Alaris Products SE Infusion System with MMS as a device intended to automate the programming of infusion parameters, thereby reducing manual steps. It communicates wirelessly with an Alaris Server using proprietary software. The document asserts that "The performance data indicate that the SE Infusion System with MMS meets specified requirements, and is substantially equivalent to the predicate device," which is the Medley System with MMS (K030459). However, no specific performance data, acceptance criteria, or study details are provided to support this claim in the given excerpts. The review by the FDA (K043590) confirms substantial equivalence, allowing the device to be marketed.

Summary

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CARDINAL HEALTH, ALARIS PRODUCTS

SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SE Infusion System with MMS

SUBMITTER INFORMATION

A.	Company Name:	Cardinal Health, Alaris Products
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisSr. Regulatory Affairs Specialist
E.	Date Summary Prepared:	December 23, 2004

DEVICE IDENTIFICATION

A.	Generic Device Name:	Pump, Infusion
B.	Trade/Proprietary Name:	SE Infusion System with MMS
C.	Classification:	Class II
D.	Product Code:	FRN, Infusion Pump

DEVICE DESCRIPTION

The SE Infusion System with MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps

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SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SE Infusion System with MMS Page 2 of 3

DEVICE DESCRIPTION (Continued)

necessary to enter infusion data. All data entry and verification of infusion or monitoring parameters using MMS is performed by trained healthcare professionals prior to administration of medication(s).

SUBSTANTIAL EQUIVALENCE

The Cardinal Health, Alaris Products SE Infusion System with MMS is of comparable type and is substantially equivalent to the following predicate device:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Medley System withMMS	Cardinal Health, AlarisProducts(previously known as AlarisMedical Systems, Inc.)	K030459	April 4, 2003

INTENDED USE

The incorporation of the Medication Management System (MMS) with the Alaris SE Infusion System provides wired or wireless communication between the SE Infusion 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. A separate Indications for Use page is located in Section 6.

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the SE Infusion System with MMS and the predicate device has been performed. The results of this comparison demonstrate that the SE Infusion System with MMS is equivalent to the marketed predicate device in technological characteristics.

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SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SE Infusion System with MMS Page 3 of 3

PERFORMANCE DATA

The performance data indicate that the SE Infusion System with MMS meets specified

requirements, and is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris Products 10221 Wateridge Circle San Diego, California 92121-2772

Re: K043590

R045990
Trade/Device Name: SE Infusion System with MMS Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: December 23, 2004 Received: December 28, 2004

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becatermined the device is substantially equivalent (for the relerenced above und navo acternialso re) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrstate commerce prior to tray ============================================================================================================================================= Antichuntens, or to actives and Cosmetic Act (Act) that do not require approval of a premarket the redelar I vou, Drag, and Commay, therefore, market the device, subject to the general approval uppression (the Act. The general controls provisions of the Act include controls providents of 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 (1 vir ), it hay of back 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. 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. or the rever may 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 and insting (2) see t 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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Juitte Michain Oms.

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

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INDICATIONS FOR USE

510(k) Number:	K043590
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(To Be Assigned By FDA)SE Infusion System with MMS Device Trade Name:

Indications For Use: The SE Infusion 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.

Prescription Use (Per 21 CFR 801.109)

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)

Anita V. mic

an Sch-C43 ision of Enesthersclogy General Hospital, ection Control. Dental Devices

DER) Number K

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).