AgaMatrucxAga arix,nc.-7CRamond-venu,007S510(k) SumnmaryThis summary of 510k) substantial equivalence is being submitted in accordance with the requirementsof 21 CER 807.92.Prepared:05 September 2013Submitter:AgaMatrix, Inc.Address:7C Raymond Ave.NV2Salem, NH 030794oz2 211Phone: (603) 328-6000Contact:William H. McGrailVice President, Engineering and Quality Assurancewmcgrail agamatnix.comPhone: 603-328-6051Fax: 603-836-4025Device Name:Product Name: AgaMatrix Health ManagerCommon Name: Diabetes Management SoftwareDevice Classification:Product CodeClassificationRegulation SectionPanelJQP - Calculator/data processingmodule for clinical useClass 121 CFR 862.2 10075, Clinical ChemistryNBW - system, test, bloodglucose, over the counterClass 1121 CFR 862.134575, Clinical ChemistryPredicate Device:WaveSense Diabetes Manager application (WDM), K1 01597AgaMatrix Health ManagerSpecial 510(k) Device Modification toPage 33 of 121
AgaJWa6iixAga tri-7CIn.RymodAvnue-,007,SDevice Description:The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose metersmanufactured by AgaMatrix. It is a digital logbook and diabetes tool designed to operate using aniWhone or iPod touch. An individual can manually enter blood glucose readings or can downloadreadings directly to the app installed on an iPhone or iPod touch from the AgaMatrix meter by using theAgaMatrix Cable to connect the meter to the connector of the iPhone or iPod touch. The app will allowthe user to manually enter carbohydrate, insulin, and weight information.Users will have the ability to have their data from the AgaMatrix Health Manager automaticallyuploaded to the AgaMatrix Health Manager cloud portal for back-up. The cloud portal will enableaccess to the health information in a web browser. Users will have the ability to create and edit theirprofile, set goals, and download their information as a .csv file.Labeling:The AgaMatrix Health Manager User's guide has been updated for clarity to include the images andinstructions for the updated user interface, as well as instructions for the added features of user weighttracking, data back-up to the cloud and emtailing from the cloud. See Attachment I for the AgaMatrixHealth Manager User's Guide.Intended Use:The AgaMatrix Health Manager App has the same Intended Use as the predicate device (WaveSenseDiabetes Manager App in 510(k) premarket notification k101597) except the AgaMatrix HealthManager is intended for use in the home and not in a professional setting. The proposed indications foruse are:The AgaMatrix Health Manager is intended for use in the home to aid individuals with diabetes andtheir healthcare professionals in the review, analysis and evaluation of blood glucose test results tosupport an effective diabetes management program. The AgaMatrix Health Manager App is an optionaldata management software accessory that connects to AgaMatrix blood glucose meters.The AgaMatrix Health Manager is not intended to provide automated treatment guidance or decisions;nor is it to be used as a substitute for professional healthcare judgment.Technological Characteristics:There were no changes to the fundamental scientific technology.-g txIn.7C RaymonAvnuAgaMatrix Health ManagerTELSpecial 510O(k) Device Modification toFAXWEPage 34 of 121
AgaikitfixAga tri,In.-7CRymodAvnue-.H007.Se,Comparison to Predicate:Substantial Equivalence InformationChrateisicWaveSense Diabetes Manager AppChaactrisic(k][01597) PredicateThe WaveSense Diabetes Manager App is intendedfor use in the home and professional settings to aidindividuals with diabetes and their healthcareprofessionals; in the review, analysis and evaluationof blood glucose test results to support an effectivediabetes management program. It is an optionaldata management software accessory for use withthe WaveSense enabled blood glucose meter(BGM) with a mini-USB port. The WaveSenseDiabetes Manager allows users to download bloodglucose reading automatically from the meter to aniPhone Operating System platform.Intended UseAgaMatrix Health ManagerCandidateSame as predicate except for use inthe home only.Major Features of DeviceAt home, single patient use and in a professionalWheeUedWhee UedSetting.Same as predicate except for use inthe home only.Operating systemcompatibilityCompatible with i Phone Operating System platformSameMeter CompatibilityCompatible with WaveSense enabled blood glucosemeters (BGM)SmSmInstallationInstallation through Apple App StoreSameManagement ToolsLogbook, Statistics, and Trend ChartsSame. Updated user interface.Added feature to track the user'sweight.Data Backup andStorageData stored on host Apple Device (locally) and isbacked up through itunes.Local storage same as predicate,with optional backup to the secureremote server (AgaMatrix HealthManager cloud).RslsarndgeotResutsUser ManualAvailabilityAg-txIn-c.Ramnand view and email datafrom the cloud with authorizedReortsSameadEmail data directly from the appsharinglogin.Acse hog hplctoAcesdtruhteApiainSame,AvnuAgaMatrix Health ManagerTEL.Special 510(k) Device Modification toFAWEBPage 35 of 121
AgoMtRix Aga atrix, amnvneIn.-7ae,N37SAgaMatrix Meter Clearance Information:The AgaMatrix Diabetes Manager User's Guide references the proprietary names of the cleared devicescompatible with the application. The table below summarizes the clearance information for all metersreferenced in the User's Guide.Blood Glucose Meter Clearance:Device SYSTEM510kK073573Proprietary Names* AgaMatrix/WaveSense Presto Blood Glucose Meter* AgaMatrixiWaveSense Presto Pro Blood Glucose Meter* Up & Up Blood Glucose Meter* Kroger Blood Glucose Meter* Leader Blood Glucose Meter* Meijer Blood Glucose Meter* Top Care Blood Glucose Meter* Diabetes Care Club Presto Blood Glucose Meter* Liberty Blood Glucose Meter* Liberty Codeless Blood Glucose MeterJAZZ ense Jazz Blood Glucose MeterUp & Up Premium Blood Glucose Meter* Kroger Premium Blood Glucose Meter* Leader Premium Blood Glucose Meter* Meijer Premium Blood Glucose Meter* Top Care Premium Blood Glucose MeterAga atixIn.mnSalem,NeHapsire037.eneUSAAgaMatrix Health Manager**E(63 FX2*00 ;.1Special 510(k) Device Modification to67E840wwaantiPage 3601f121
AgaJcitrxAssessment of Performance:Verification and validation tests were successfully executed on the AgaMatrix Health Manager. All predetermined acceptance criteria were met, demonstrating that the device performs appropriately perdefined specifications, meets all input requirements, fulfills the device's intended use, and correctlyincorporates all required safety mitigations. Results demonstrate substantial equivalence to the predicatesystem.A usability study was performed with the AgaMatrix Health Manager (see Attachment 2). Usersevaluated data transmission with the AgaMatrix Cable to upload data from a supported AgaMatrix bloodglucose meters (Jazz and Presto). Users evaluated uploading, reviewing and managing meter readings inthe AgaMatrix Health Manager for ease of use. Users demonstrated the ability to successfully registerfor a cloud account. Data transmission accuracy and integrity was demonstrated through downloadcomparison between meter to application and application to cloud (csv. file).Users had to confirm that 100% of the readings downloaded from the meter to the AgaMatrix HealthMeter and the study evaluators confirmed that 100% of the readings uploaded to the cloud back upaccount. The study confirmed that the system is 100% accuracy with respect to data accuracy andintegrity when used by the intended population.Conclusion:The results the performance assessments demonstrate that the candidate AgaMatrix Health Managerperforms in a substantially equivalent manner to that of the predicate. We conclude that the AgaMatrixHealth Manager is substantially equivalent the predicate devices.AgaMatrix Health ManagerSpecial 510(k) Device Modification to,Page 37 of 121
DEPARTM'NENT'OF HEALTh & HLJNIAN SERN'iCESiPublic iHeAhISSniceIoW . d [).g Ad,nini,,trtion10903 New I Inmprlire t CnUCIDoc.mcnt Crntml ('enter - %V6b-G609SiI'cr Spring. Mi) 209)93-0O02AGAMATRIX, INC.WILLIAM 1-. MeGRAIL7C RAYMOND AVESALEM NH 03079November 20. 2013Re: K132821Trade/Device Name: AgaMatrix Health ManagerRegulation Number: 21 CFR 862.1345Regulation Name: Glucose test systemRegulatory Class: 11Product Code: NBW, JQPDated: October 21, 2013Received: October 23. 2013Dear Mr. McGrail:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food. Drug,and Cosmetic Act (Act) that do not require approval ofa premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.If your device is classified (see above) into either class 11(Special Controls) or class Ill (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Pails 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does nlot meanthat FDA has made a determination that your device complies with other requirements ofthe Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements. including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting ofmedical device-related adverse events) (21 CFR 803); good manufacturing practice requirementsas set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, theelectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 10001050.
Page 2-Mr. McGrailIFyou desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and809), please contact the Division or'Srnall Manufacturers, International and ConsumnerAssistance at its toll-free number (800) 638 2041 or (301) 796-7 100 or at its Internet rYot/ndL]strv/(lelhult.lhtim. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Pait807.97). For questions regarding the reporting of adverse events under the MVDR regulation (21CFR Part 803), please go tohittp://www.ifda. Lov/Mcd icalI Devices/Snf1et V/Renorra Probilem/d eaulIt.hltmi for the CDRH's Officeof Surveillance and Biometrics/Division of Posirnarket Surveillance.You may obtain other general infbrnation on your responsibilities under the Act Fromt theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free numnbet(800) 638-2041 or (301) 796-7100 or at its Internet addresshittn://www. (efut.lt!1i.Sincerely yours,CaroLC-:. Benson -SfoCourtney H. Lias. Phi.D.DirectorDivision of Chemnistry and Toxicology DevicesOffice ofln Vitro Diagnosticsand Radiological HealthCenter for Devices and Radiological HealthEnclosure
Indications for Use Form510(k) Number (if known): k132821Device Name: AaaMatrix Health ManagerIndications for Use:AaaMatrlx Health ManagerThe AgaMatrix Health Manager is intended for single patent use. It is an accessory to bloodglucose monitoring systems to assist in the review, analysis and evaluation of glucose resultsto aid in diabetes and health management. The AgaMatrix Health Manager collects data fromAgaMatrix manufactured glucose meters and allows adding, editing, and viewing additionalhealth data. The AgaMatrix Health Manager is not intended to provide automated treatmentguidance or decisions, nor is it to be used as a substitute for professional healthcare advice.Prescription Use X(Part 21 CFR 801 S-ubpartD)AND/OROver-The-Counter Use X(21 CFR 801 Subpart C(PLEASE DO NOT WRITE BELOW THIS UINE-CONTINUE ON ANOTHERPAGE OF NEEDED)Concurrence of CDRH, Office of InVitro Devices and Radiolagic Health (Of R)Division Sign-OffOffice of In Vitro Diagnostic Devices and Radiologic Health510(k) k132821AgaMatrix Health ManagerStayce BeckSpecial 510(k) Device Motillicalion to k1011697Page Ilof 1Page 41 of1121