(72 days)
No
The summary describes a digital logbook and data management tool for blood glucose readings, with no mention of AI or ML capabilities for analysis or interpretation beyond basic data display and storage.
No.
The device is described as an accessory to blood glucose monitoring systems intended to assist in the review, analysis, and evaluation of glucose results. It is explicitly stated that it is "not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare advice," which indicates it does not directly provide therapy.
No
This device is designed to assist in the review, analysis, and evaluation of glucose results to aid in diabetes and health management. It explicitly states it is not intended to provide automated treatment guidance or decisions, nor is it a substitute for professional healthcare advice. This indicates it is a data management tool, not a diagnostic one.
Yes
The device is described as an "optional software accessory" and "digital logbook and diabetes tool designed to operate using an iPhone or iPod touch." While it interacts with a physical glucose meter and cable, the device itself, as described in the summary, is the software application. The performance studies focus on the software's functionality and data handling, not the hardware components.
Based on the provided information, the AgaMatrix Health Manager is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states 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." It explicitly states it is "not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare advice." IVD devices are used to perform tests on biological samples to provide diagnostic information. The AgaMatrix Health Manager does not perform any diagnostic tests itself.
- Device Description: The description details it as a "digital logbook and diabetes tool" that collects and displays data from a glucose meter. It allows manual entry of other health data. It does not describe any components or functions related to performing in vitro diagnostic tests.
- Lack of Diagnostic Function: The core function is data management, visualization, and storage. It does not analyze biological samples or produce diagnostic results.
In summary, the AgaMatrix Health Manager is a software accessory that helps users manage and review data from an IVD device (the blood glucose meter), but it is not an IVD device itself.
N/A
Intended Use / Indications for 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.
Product codes
JQP, NBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Accuracy: 100% data transmission accuracy and integrity.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 03079 | ||
| Phone: (603) 328-6000 | NOV 2 0 2013 | |
| Contact: | William H. McGrail | |
| Vice President, Engineering and Quality Assurance | ||
| wmcgrail@agamatrix.com | ||
| Phone: 603-328-6051 | ||
| Fax: 603-836-4025 | ||
| Device Name: | Product Name: AgaMatrix Health Manager | |
| Common Name: Diabetes Management Software |
Device Classification:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| JQP - Calculator/data processing | |||
| module for clinical use | Class I | 21 CFR 862.2100 | 75, Clinical Chemistry |
| NBW – system, test, blood | |||
| glucose, over the counter | Class II | 21 CFR 862.1345 | 75, Clinical Chemistry |
Predicate Device:
WaveSense Diabetes Manager application (WDM), K101597
| AgaMatrix, Inc. 7C Raymond Avenue
Salem, New Hampshire 03079 USA | TEL
+1 (603) 328 6000 | FAX
+1 (617) 588 0430 | WEB
www.agamatrix.com |
| --------------------------------------------------------------------- | -------------------------- | -------------------------- | -------------------------- |
|---|
1
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:
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.
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 |
2
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 Manager
Candidate |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The WaveSense Diabetes Manager App is intended
for use in the home and professional settings 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. It is an optional
data management software accessory for use with
the WaveSense enabled blood glucose meter
(BGM) with a mini-USB port. The WaveSense
Diabetes Manager allows users to download blood
glucose reading automatically from the meter to an
iPhone Operating System platform. | Same as predicate except for use in
the home only. |
| Where Used | At home, single patient use and in a professional
setting. | Same as predicate except for use in
the home only. |
| Operating system
compatibility | Compatible with iPhone Operating System platform | Same |
| Meter Compatibility | Compatible with WaveSense enabled blood glucose
meters (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's
weight. |
| Data Backup and
Storage | Data stored on host Apple Device (locally) and is
backed up through iTunes. | Local storage same as predicate,
with optional backup to the secure
remote server (AgaMatrix Health
Manager cloud). |
| Results and Reports
sharing | Email data directly from the app | Same and view and email data
from the cloud with authorized
login. |
| User Manual
Availability | 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 0430
100 Annual Annual Property | www.agamatrix.com |
.
/
3
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 |
|---|---|---|
| WAVESENSE | ||
| KEYNOTE | ||
| CODELESS | ||
| BLOOD | ||
| GLUCOSE | ||
| MONITORING | ||
| SYSTEM | 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 BLOOD | ||
| GLUCOSE | ||
| MONITORING | ||
| SYSTEM | 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 |
4
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 |
5
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.
6
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
7
Indications for Use Form
510(k) Number (if known): K132821
Device Name: AgaMatrix Health Manager
Indications for Use:
AgaMatrix Health Manager
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.
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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