The AgaMatrix Health Manager is intended for single patient use. It is an accessory to blood glucose monitoring systems to assist in the review, analysis and evaluation of glucose results to aid in diabetes and health management. The AgaMatrix Health Manager collects data from AgaMatrix manufactured glucose meters and allows adding, editing, and viewing additional health data. 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 advice.

Device Description

The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose meters manufactured by AgaMatrix. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the app installed on an iPhone or iPod touch from the AgaMatrix meter by using the AgaMatrix Cable to connect the meter to the connector of the iPhone or iPod touch. The app will allow the user to manually enter carbohydrate, insulin, and weight information. Users will have the ability to have their data from the AgaMatrix Health Manager automatically uploaded to the AgaMatrix Health Manager cloud portal for back-up. The cloud portal will enable access to the health information in a web browser. Users will have the ability to create and edit their profile, set goals, and download their information as a .csv file.

AI/ML Overview

The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose meters manufactured by AgaMatrix. It functions as a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. Users can manually enter blood glucose readings or download readings directly from an AgaMatrix meter via a connecting cable. The app also allows for manual entry of carbohydrate, insulin, and weight information. Data can be automatically uploaded to the AgaMatrix Health Manager cloud portal for backup and web browser access, enabling users to create/edit profiles, set goals, and download data as a .csv file. This device is intended for use in the home to aid individuals with diabetes and their healthcare professionals in reviewing, analyzing, and evaluating blood glucose test results to support effective diabetes management. It is not intended to provide automated treatment guidance or decisions, nor to substitute for professional healthcare judgment.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Data transmission accuracy (meter to application)	100% accuracy: 100% of readings downloaded from the meter to the AgaMatrix Health Manager were confirmed by users.
Data transmission accuracy and integrity (application to cloud backup – csv file)	100% accuracy: 100% of readings uploaded to the cloud backup account were confirmed by study evaluators.
Ease of use for uploading, reviewing, and managing meter readings in the app	Users evaluated and demonstrated the ability to successfully use these functions.
Ability to successfully register for a cloud account	Users demonstrated the ability to successfully register for a cloud account.
Device performs appropriately per defined specifications.	All predetermined acceptance criteria were met.
Device meets all input requirements.	All predetermined acceptance criteria were met.
Device fulfills the device's intended use.	All predetermined acceptance criteria were met.
Device correctly incorporates all required safety mitigations.	All predetermined acceptance criteria were met.

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

Sample Size: The document does not explicitly state a specific numerical sample size for the usability study participants. It generally refers to "Users."
Data Provenance: Not explicitly stated, though the context of an FDA submission for a US market suggests the study was likely conducted in the USA. The study appears to be prospective as it involved users actively performing tasks with the device during the study.

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

This information is not provided in the document. The "ground truth" for data accuracy was established by user confirmation (meter to app) and study evaluators' confirmation (app to cloud). The qualifications of these evaluators are not mentioned.

4. Adjudication Method for the Test Set:

The document describes a method of confirmation rather than an adjudication method. For the meter-to-app data transmission, "Users had to confirm that 100% of the readings downloaded." For the app-to-cloud data transmission, "study evaluators confirmed that 100% of the readings uploaded." There is no mention of a multi-reader or multi-reviewer adjudication process.

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:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a data management software, not an AI-powered diagnostic tool requiring human interpretation comparison.

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

The study described focuses on the usability and data integrity of the software when used by an "intended population" (i.e., human users). It specifically tests aspects like data transmission from a physical meter to the app, and from the app to a cloud portal, which inherently involves the human user interacting with the system. While the "accuracy" figures refer to the software's ability to transfer data correctly, the overall evaluation is of the human-in-the-loop performance for these tasks rather than a purely standalone algorithm's performance on a dataset.

7. The Type of Ground Truth Used:

The ground truth for the test set was based on direct comparison and confirmation:
- For meter-to-application data transmission: User confirmation that 100% of readings downloaded.
- For application-to-cloud data transmission: Study evaluator confirmation that 100% of readings uploaded, comparing downloaded CSV files.

8. The Sample Size for the Training Set:

This information is not provided. The AgaMatrix Health Manager is described as software, and the document focuses on its verification and validation testing, not on a machine learning model that would typically require a training set. If there were any internal development and testing, details about such a "training set" are not disclosed here.

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

Not applicable, as details about a training set for a machine learning model are not provided or implied by the information given.

Summary

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K15282/

AgaMatrix.

AgaMatrix, Inc. · 7C Raymond Avenue · Salem, NH 03079 USA

510(k) Summary

This summary of 510k) substantial equivalence is being submitted in accordance with the requirements of 21 CFR 807.92.

Prepared:	05 September 2013
Submitter:	AgaMatrix, Inc.
Address:	7C Raymond Ave.Salem, NH 03079Phone: (603) 328-6000	NOV 2 0 2013
Contact:	William H. McGrailVice President, Engineering and Quality Assurancewmcgrail@agamatrix.comPhone: 603-328-6051Fax: 603-836-4025
Device Name:	Product Name: AgaMatrix Health ManagerCommon Name: Diabetes Management Software

Device Classification:

Product Code	Classification	Regulation Section	Panel
JQP - Calculator/data processingmodule for clinical use	Class I	21 CFR 862.2100	75, Clinical Chemistry
NBW – system, test, bloodglucose, over the counter	Class II	21 CFR 862.1345	75, Clinical Chemistry

Predicate Device:

WaveSense Diabetes Manager application (WDM), K101597

AgaMatrix, Inc. 7C Raymond AvenueSalem, New Hampshire 03079 USA	TEL+1 (603) 328 6000	FAX+1 (617) 588 0430	WEBwww.agamatrix.com
---------------------------------------------------------------------	--------------------------	--------------------------	--------------------------

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Image /page/1/Picture/0 description: The image shows the logo for AgaMatrix. The logo is in black and white and features a stylized font. Above the "matrix" portion of the logo, there is a series of dots that form an arc.

AgaMatrix, Inc. · 7C Raymond Avenue · Salem, NH 03079 USA

Device Description:

Users will have the ability to have their data from the AgaMatrix Health Manager automatically uploaded to the AgaMatrix Health Manager cloud portal for back-up. The cloud portal will enable access to the health information in a web browser. Users will have the ability to create and edit their profile, 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 and instructions for the updated user interface, as well as instructions for the added features of user weight tracking, data back-up to the cloud and emailing from the cloud. See Attachment I for the AgaMatrix Health Manager User's Guide.

Intended Use:

The AgaMatrix Health Manager App has the same Intended Use as the predicate device (WaveSense Diabetes Manager App in 510(k) premarket notification K101597) except the AgaMatrix Health Manager is intended for use in the home and not in a professional setting. The proposed indications for use are:

The AgaMatrix Health Manager is intended for use in the home to aid individuals with diabetes and their healthcare professionals in the review, analysis and evaluation of blood glucose test results to support an effective diabetes management program. The AgaMatrix Health Manager App is an optional data 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.

AgaMatrix, Inc. 7C Raymond Avenue	TEL	FAX	WEB
Salem, New Hampshire 03079 USA	+1 (603) 328 6000	+1 (617) 588 0430	www.agamatrix.com

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Image /page/2/Picture/0 description: The image shows the logo for AgaMatrix. The logo is in black and white and features a stylized font. There is a curved line under the first part of the logo and a series of dots above the second part of the logo.

AgaMatrix, Inc. • 7C Raymond Avenue • Salem, NH 03079 USA

Comparison to Predicate:

Characteristic	WaveSense Diabetes Manager App(K101597) Predicate	AgaMatrix Health ManagerCandidate
Intended Use	The 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.	Same as predicate except for use inthe home only.
Where Used	At home, single patient use and in a professionalsetting.	Same as predicate except for use inthe home only.
Operating systemcompatibility	Compatible with iPhone Operating System platform	Same
Meter Compatibility	Compatible with WaveSense enabled blood glucosemeters (BGM)	Same
Installation	Installation through Apple App Store	Same
Management Tools	Logbook, Statistics, and Trend Charts	Same. Updated user interface.Added feature to track the user'sweight.
Data Backup andStorage	Data 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).
Results and Reportssharing	Email data directly from the app	Same and view and email datafrom the cloud with authorizedlogin.
User ManualAvailability	Accessed through the Application	Same

AgaMatrix, Inc. 7C Raymond Avenue	STEL	- FAX	WEB
Salem, New Hampshire 03079 USA---------------------------------------------------------------CHANAGER A CHANGER AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND	+1 (603) 328 6000	+1 (617) 588 0430100 Annual Annual Property	www.agamatrix.com

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Image /page/3/Picture/0 description: The image shows the logo for AgaMatrix. The logo is in black and white and features the word "AgaMatrix" in a stylized font. There is a curved line under the "Aga" portion of the word, and a series of dots above the "Matrix" portion. A period is placed at the end of the word.

AgaMatrix, Inc. · 7C Raymond Avenue · Salem, NH 03079 USA

AgaMatrix Meter Clearance Information:

The AgaMatrix Diabetes Manager User's Guide references the proprietary names of the cleared devices compatible with the application. The table below summarizes the clearance information for all meters referenced in the User's Guide.

Blood Glucose Meter Clearance:

Device Name	510k	Proprietary Names
WAVESENSEKEYNOTECODELESSBLOODGLUCOSEMONITORINGSYSTEM	K073573	• AgaMatrix/WaveSense Presto Blood Glucose Meter• AgaMatrix/WaveSense 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 Meter
JAZZ BLOODGLUCOSEMONITORINGSYSTEM	K072413	• AgaMatrix/WaveSense Jazz Blood Glucose Meter• Up & 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 Meter

AgaMatrix, Inc. 7C Raymond Avenue	TEL	FAX	WEB
Salem, New Hampshire 03079 USA	+1 (603) 328 6000	+1 (617) 588 0430	www.agamatrix.com

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Image /page/4/Picture/0 description: The image shows the logo for "AgaMatrix". The logo is in black and white, with the text "AgaMatrix" in a stylized font. There is a curved line under the "Aga" portion of the word, and a series of dots above the "Matrix" portion of the word. The logo appears to be for a company or product named AgaMatrix.

AqaMatrix, Inc. · 7C Raymond Avenue · Salem. NH 03079 USA

Assessment 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 per defined specifications, meets all input requirements, fulfills the device's intended use, and correctly incorporates all required safety mitigations. Results demonstrate substantial equivalence to the predicate system.

A usability study was performed with the AgaMatrix Health Manager (see Attachment 2). Users evaluated data transmission with the AgaMatrix Cable to upload data from a supported AgaMatrix blood glucose meters (Jazz and Presto). Users evaluated uploading, reviewing and managing meter readings in the AgaMatrix Health Manager for ease of use. Users demonstrated the ability to successfully register for a cloud account. Data transmission accuracy and integrity was demonstrated through download comparison 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 Health Meter and the study evaluators confirmed that 100% of the readings uploaded to the cloud back up account. The study confirmed that the system is 100% accuracy with respect to data accuracy and integrity when used by the intended population.

Conclusion:

The results the performance assessments demonstrate that the candidate AgaMatrix Health Manager performs in a substantially equivalent manner to that of the predicate. We conclude that the AgaMatrix Health Manager is substantially equivalent the predicate devices.

AgaMatrix, Inc. 70 Raymond Avenue	TEL	FAX	WEB
Salem, New Hampshire 03079 USA	+1 (603) 328 6000	+1 (617) 588 0430	www.agamatrix.com

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Image /page/5/Picture/0 description: The image shows a black and white seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring an abstract design of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

November 20, 2013

AGAMATRIX, INC. WILLIAM H. McGRAIL 7C RAYMOND AVE SALEM NH 03079

Rc: KI32821

Trade/Device Name: AgaMatrix Health Manager Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: October 21, 2013 Received: October 23, 2013

Dear Mr. McGrail:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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.

Please be advised that FDA's issuance of a substantial couivalence 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2-Mr. McGrail

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDeviees/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S
for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K132821

Device Name: AgaMatrix Health Manager

Indications for Use:

AgaMatrix Health Manager

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use × (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Division Sign-Off Office of In Vitro Diagnostic Devices and Radiologic Health

510(k) K132821

Stayce Beck

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Page 41 of 121

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.