ALARIS MEDICAL SYSTEMS, INC. ORIGINAL PREMARKET .

ALARIS MEDICAL SYSTEMS, INC.APR Q 4 2003ORIGINAL PREMARKET NOTIFICATIONMEDLEY SYSTEM WITH MMSSUMMARY OF SAFETY AND EFFECTIVENESSALARIS Medical Systems, Inc.Medley System with MMSSUBMITTER INFORMATIONA.Company Name:ALARIS Medical Systems, Inc.B.Company Address:1022 1 Wateridge CircleSan Diego, CA 92 121-2733C.Company Phone:Company Fax:(858) 458-7563(858) 458-61 14D.Contact Person:RenCe L. FluetPrincipal Regulatory Affairs SpecialistALARIS Medical Systems, Inc.E.Date Summary Prepared:February 3,2003DEVICE IDENTIFICATIONA.Generic Device Name:Pump, InfusionB.Trade/Proprietary Name:M e d l e y System with MedicationManagement System ( M e d l e y System withMMS)C.Classification:Class I1D.Product Code:FRN, Infusion PumpDEVICE DESCRIPTIONThe M e d l e y System (K9504 19) is a currently marketed modular infusion andmonitoring system that consists of a Programming Module (PM) andattachable/detachable modules. Current infusion modules available are a Pump Module(K950419) and a Syringe Module (K023264). Monitoring modules currently includePulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (KO 10966) technology.Page 1 of4-.0512

ALARIS MEDICAL SYSTEMS, INC.ORIGINAL PREMARKET NOTIFICATIONMEDLEY SYSTEM WITH MMSSUMMARY OF SAFETY AND EFFECTIVENESSDEVICE DESCRIPTION, ContinuedThis traditional 5 1O(k) Premarket Notification is being submitted to assist our customersin reducing the number of manual steps needed to program an infusion by allowingwireless communication capability to the currently marketed device, the M e d l e yMedication Safety System (Medley System) K9504 19. This Medication ManagementSystem (MMS) adds communication capability to the M e d l e y System thereby providingour customers with a “safety net” at the bedside to help reduce the number ofprogramming errors at the point of care. This product will be called the Medley Systemwith MMS.As with the predicate device (B. Braun Medical Inc., HorizonTMOutlook withDoseComTM)this submission adds wireless communication to a server and to an existinginfusion device. The Medley System was originally cleared with the capability of wiredor wireless communication to include receiving infusion protocol information,uploading/downloading system configuration information and reporting infusion orsystem status. However, this capability was not well defined and did not includecommunication with a Server. It was also not clear about the local retrieval of data usingoptical laser scanning (bar-coding) or RF detection of information contained indocuments, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply anexpansion of the original 5 1O(k) indications for use for the Medley System. Thissubmission will allow the Medley System to transmit and receive messages with theALARIS@Server which in turn allows communication capability with external devices,including personal computers, Personal Digital Assistants (PDA’s), hospital monitoringsystems and Hospital Information Management Systems (HIMS).Page 2 of4,.051.3

ORIGINAL P R E M A W T NOTIFICATIONMEDLEY SYSTEM WITH MMSALARIS MEDICAL SYSTEMS, INCSUMMARY OF SAFETY AND EFFECTIVENESS, ContinuedSUBSTANTIAL EQUIVALENCEThe ALARIS Medical Systems Inc., M e d l e y System with MMS is substantiallyequivalent to the following predicate device:Iwith Dose CornTMIIn further support of a substantial equivalence determination, Section 9.2 provides acomparison chart of the M e d l e y System with MMS and the predicate device.INTENDED USEThe incorporation of the Medication Management System (MMS) with the ALARISMedley Medication Safety System provides wired or wireless communication betweenthe Medley System and external devices. This is intended to provide a way to automatethe programming of infusion parameters, thereby decreasing the amount of manual stepsto enter infusion data. All data entry and validation of infusion parameters using MMS isperformed by the trained healthcare professional.The Medley System with MMS is integrated into an existing hospital networkinfrastructure and allows communications to and from external devices, includingpersonal computers (PC’s), Personal Digital Assistants (PDAs), hospital monitoringsystems and Hospital Information Management Systems (HIMS). Bi-directionalcommunication of data includes infusion parameters, system configuration, history,events, trending, alarms and status. In addition the Medley System with MMS has thecapability to transmit, receive and/or store: features, calibration data, datasets, andlibraries from external components or devices to the pump.Page 3 of40511

ALARIS MEDICAL SYSTEMS, INC.ORIGINAL PREMARKET NOTIFICATIONMEDLEY SYSTEM WITH MMSSUMMARY OF SAFETY AND EFFECTIVENESS, ContinuedTECHNOLOGICIAL CHARACTERISTICSA comparison of the technological characteristics of the M e d l e y System with MMS andthe predicate device has been performed. The results of this comparison demonstrate thatthe M e d l e y System with MMS is equivalent to the marketed predicate device intechnological characteristics.PERFORMANCE DATAThe performance data indicate that the M e d l e y System with MMS meets specifiedrequirements and is substantially equivalent to the predicate device.Page 4 of 4’0315

DEPARTMENT OF HEALTH &HUMAN SERVICESAPR c) 4 2003Public Health ServiceFood and Drug Administration9200 Corporate BoulevardRockville MD 20850Ms. Renee L. FluetPrincipal Regulatory Affairs SpecialistALARIS, Medical Systems, Incorporated10221 Wateridge CircleSan Diego, California 92 121-2733Re: KO30459Trademevice Name: MedleyTMSystem with Medication Management System(MedleyTMSystem with MMS)Regulation Number: 8 80.5725Regulation Name: Infusion PumpRegulatory Class: I1Product Code: FRNDated: February 3,2003Received: February 11,2003Dear Ms. Fluet:We have reviewed your Section 5 1O(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for theindications for use stated in the enclosure) to legally marketed predicate devices marketed ininterstate commerce prior to May 28, 1976, the enactment date of the Medical DeviceAmendments, or to devices that have been reclassified in accordance with the provisions ofthe Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarketapproval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. The general controls provisions of the Act includerequirements 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 I1 (Special Controls) or class 111(PMA), it may be subject to such additional controls. Existing major regulations affectingyour device can be found in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. Inaddition, FDA may publish further announcements concerning your device in the FederalRegister.

Page 2 - Ms. FluetPlease be advised that FDA’s issuance of a substantial equivalence determination does notmean that FDA has made a determination that your device complies with other requirementsof 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: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicerequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and ifapplicable, the electronic product radiation control provisions (Sections 53 1-542of the Act);21 CFR 1000-1050.This letter will allow you to begin marketing your device as described in your Section 5 1 O(k)premarket notification. The FDA finding of substantial equivalence of your device to alegally marketed predicate device results in a classification for your device and thus, permitsyour device to proceed to the market.If you desire specific advice for your device on our labeling regulation (21 CFR Part Sol),please contact the Office of Compliance at (301)594-4618.Also, please note the regulationentitled, “Misbranding by reference to premarket notification” (21 CFR Part 807.97). Youmay obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-freenumber (800)638-2041or (301)443-6597or at its Internet addressfda.gov/cdrh/dsma/dsmamain.htmlhttp ://m.Sincerely yours,/Interim DirectorDivision of Anesthesiology, General Hospital,Infection Control and Dental DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure

ALARIS MEDICAL SYSTEMS, MC.ORIGINAL PREMARKET 5 1 q K ) NOTIFICATIONMEDLEY SYSTEM WITH MMSINDICATIONS FOR USE5 1O(k) Number:Device Trade Name:K030Lt59(To Be Assigned By FDA)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 growingprofessional healthcare environment for facilities that utilize infusion devices for thedelivery of fluids, medications, blood and blood products.The Medley'" System with MMS is intended to provide trained healthcare caregivers away to automate the programming of infusion parameters, thereby decreasing the amountof manual steps necessary to enter infusion data. All data entry and validation of infusionparameters is performed by the trained healthcare professional according to a physician'sorder.PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)4&/ORO IL & m APrescription Use(Per 21 CFR 801.109)Over-The-Counter Use(Division Sign-off)Division of Anesthesiology, General Hospital,Infection Control, Dental Devices510(k) Number:3d "'/.5-?0034

APR Q 4 2003 MEDLEY SYSTEM WITH MMS SUMMARY OF SAFETY AND EFFECTIVENESS . RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 5 1 O(k) indications for use for the