The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (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 Medley™ 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 Medley *** System (K950419) is a currently marketed modular infusion and monitoring system that consists of a Programming Module (PM) and attachable/detachable modules. Current infusion modules available are a Pump Module (K950419) and a Syringe Module (K023264). Monitoring modules currently include Pulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (K010966) technology.

This traditional 510(k) Premarket Notification is being submitted to assist our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to the currently marketed device, the Medley" Medication Safety System (Medley System) K950419. This Medication Management System (MMS) adds communication capability to the Medley" System thereby providing our customers with a "safety net" at the bedside to help reduce the number of programming errors at the point of care. This product will be called the Medley System with MMS.

As with the predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™) this submission adds wireless communication to a server and to an existing infusion device. The Medley System was originally cleared with the capability of wired or wireless communication to include receiving infusion protocol information, uploading/downloading system configuration information and reporting infusion or system status. However, this capability was not well defined and did not include communication with a Server. It was also not clear about the local retrieval of data using optical laser scanning (bar-coding) or RF detection of information contained in documents, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 510(k) indications for use for the Medley System. This submission will allow the Medley 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

The provided text is a 510(k) Premarket Notification for the ALARIS Medical Systems, Inc. Medley System with MMS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of typical AI/ML device evaluations.

Here's a breakdown based on the information provided and what is missing:

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

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document as quantitative metrics. The overall acceptance criterion appears to be "substantially equivalent to the predicate device."	"The performance data indicate that the Medley™ 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: Not specified. The document states "performance data" was used but doesn't detail the nature or size of the dataset.
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)

Number of Experts: Not applicable. This device is an infusion pump system with communication capabilities, not an AI/ML diagnostic or prognostic device that typically requires expert-established ground truth for performance evaluation.
Qualifications of Experts: Not applicable. The "ground truth" for this type of device would likely involve functional testing against specifications and comparison to the predicate device's operational characteristics, rather than expert interpretation of medical images or patient data.

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

Adjudication Method: Not applicable. As noted above, this is not an AI/ML diagnostic device requiring expert adjudication.

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

MRMC Study: No. An MRMC study is typically for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. This device is an infusion pump system, which does not involve "human readers" in this context.

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

Standalone Performance: The performance data assessed the device's ability to "meet specified requirements" and be "substantially equivalent to the predicate device." This implies an evaluation of the system's functionalities, including its communication capabilities and automation features, as a standalone entity in relation to its intended purpose. However, the exact methodology is not detailed. The automation of programming infusion parameters is a key function described.

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

Type of Ground Truth: Not explicitly stated as "ground truth" in the AI/ML sense. For this device, the "ground truth" would likely be based on:
- Functional specifications: Whether the device performs as designed (e.g., transmits and receives data correctly, automates programming accurately).
- Comparison to predicate device: Demonstrating that its technological characteristics and performance are equivalent to the legally marketed predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™).
- Safety standards: Adherence to relevant safety and performance standards for infusion pumps.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is a hardware/software system for infusion and communication, not an AI/ML model that undergoes a "training" phase with a dataset in the typical sense.

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

Ground Truth for Training Set: Not applicable, as this is not an AI/ML device that requires a training set with associated ground truth for model development.

In summary: The provided 510(k) document focuses on establishing substantial equivalence for an infusion pump system with added communication capabilities. It references "performance data" indicating the device meets "specified requirements" and is "substantially equivalent" to a predicate device. However, it does not provide the detailed quantitative acceptance criteria, study design, or AI/ML-specific evaluation metrics (like sample sizes for test/training sets, expert adjudication, or MRMC studies) that would typically be found in a submission for an AI/ML-enabled diagnostic or prognostic device. The nature of this device means these AI/ML-specific questions often do not directly apply.

Summary

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APR 0 4 2003

ORIGINAL PREMARKET NOTIFICATION MEDLEY SYSTEM WITH MMS

SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems, Inc. Medley System with MMS

K030459

SUBMITTER INFORMATION

A.	Company Name:	ALARIS Medical Systems, Inc.
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7563(858) 458-6114
D.	Contact Person:	Renée L. FluetPrincipal Regulatory Affairs SpecialistALARIS Medical Systems, Inc.
E.	Date Summary Prepared:	February 3, 2003
VICE IDENTIFICATION
A.	Generic Device Name:	Pump, Infusion
B.	Trade/Proprietary Name:	Medley™ System with MedicationManagement System (Medley™ System with

MMS)

Class II C. Classification:

FRN, Infusion Pump Product Code:

DEVICE DESCRIPTION

DEV

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SUMMARY OF SAFETY AND EFFECTIVENESS DEVICE DESCRIPTION, Continued

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems Inc., Medley™ System with MMS is substantially equivalent to the following predicate device:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Horizon OutlookTMwith Dose ComTM	B. Braun Medical, Inc.	K011975	09/19/01

In further support of a substantial equivalence determination, Section 9.2 provides a comparison chart of the Medley" System with MMS and the predicate device.

INTENDED USE

The incorporation of the Medication Management System (MMS) with the ALARIS Medley Medication Safety System provides wired or wireless communication between the Medley 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 Medley System with MMS is integrated into an existing hospital network infrastructure and allows communications to and from external devices, including personal computers (PC's), 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 Medley 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.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

TECHNOLOGICIAL CHARACTERISTICS

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

PERFORMANCE DATA

The performance data indicate that the Medley™ System with MMS meets specified requirements and is substantially equivalent to the predicate device.

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APR 0 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030459

Trade/Device Name: Medley™ System with Medication Management System (Medley™ System with MMS) Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 3, 2003 Received: February 11, 2003

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 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. Fluet

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 (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), please contact the Office of Compliance at (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runner, DDS, M/A

Interim 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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INDICATIONS FOR USE

510(k) Number:	K 030459 (To Be Assigned By FDA)
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Device Trade Name: Medley" System with Medication Management System (Medley" System with MMS)

Indications For Use: The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number: _

Prescription Use _
OR
Over-The-Counter Use _
(Per 21 CFR 801.109) /ellua Cucente
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: 403045-9
0034

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).