(132 days)
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No
The document describes a digital logbook and data management tool for blood glucose readings, with no mention of AI or ML capabilities.
No
The device is a digital logbook and diabetes management tool designed to aid in the review, analysis, and evaluation of blood glucose readings. It helps individuals and healthcare professionals manage diabetes by providing data, but it does not directly treat or cure the condition, which is characteristic of a therapeutic device.
No
The device is described as a "digital logbook and diabetes management tool" used to "review, analyze and evaluate blood glucose readings." It is not stated to diagnose a condition, but rather to manage an already existing one.
No
The device description explicitly states that the application "can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled Blood Glucose Meter (BGM)". This indicates that while the core functionality is software, it is designed to interact with and potentially rely on external hardware components (cable and BGM) for its full intended use, thus not being solely software.
Based on the provided information, the WaveSense Diabetes Manager (WDM) application is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the application is for the review, analysis, and evaluation of blood glucose readings. It is a digital logbook and diabetes management tool. It does not perform any diagnostic testing itself.
- Device Description: The description reinforces that it's a digital logbook and management tool. While it can connect to a blood glucose meter (which is an IVD), the application itself is not performing the measurement or diagnosis.
- Lack of Diagnostic Function: The description does not mention any function that would involve analyzing biological samples or providing a diagnostic result. It processes data from an IVD (the blood glucose meter), but it is not an IVD itself.
- Predicate Device: The predicate device listed (K062434 Zero-Click Data Management System) is also a data management system, not a diagnostic device.
In summary, the WaveSense Diabetes Manager application is a software tool that helps users manage and analyze data generated by an IVD (the blood glucose meter). It does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The AgaMatrix WaveSense Diabetes Manager (WDM) application (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.
Product codes
NBW, JQP
Device Description
The WaveSense Diabetes Manager (WDM) application (app) is a digital logbook and diabetes management tool for the iPhone operating system platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled Blood Glucose Meter (BGM) with a mini-USB port.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
home and professional settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
An evaluation of the WaveSense Diabetes Manager was studied in house and in a Clinical setting by persons with diabetes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of clinical evaluations of the WaveSense Diabetes Manager application demonstrate that the application is equivalent in performance to the predicate device and suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191
510(k) SAFETY AND EFFECTIVENESS SUMMARY
OCT 1 8 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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- Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.
Submitter's Name: Address:
- Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.
AgaMatrix, Inc. 10 Manor Parkway Salem, NH 03079 (603) 328-6000
Contact Person:
Connie Hertel Director Quality & Regulatory Affairs chertel @agamatrix.com
Date the summary prepared:
August 31, 2010
- Device Name
Trade/Proprietary Name: Common/Usual Name: Classification Name: Class
AgaMatrix WaveSense Diabetes Manager WaveSense Diabetes Manager None unclassified
Trade/Proprietary Name: Common/Usual Name: Classification Name: Class II
AgaMatrix WaveSense BGM meters AgaMatrix WaveSense BGM meters NBW, JQP
- Predicate Device 3.
Zero-Click Data Management System 510(k) number: K062434
- Device Description
The WaveSense Diabetes Manager (WDM) application (app) is a digital logbook and diabetes management tool for the iPhone operating system platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled Blood Glucose Meter (BGM) with a mini-USB port.
Image /page/0/Picture/20 description: The image shows the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the word, starting below the "A" and ending near the "t". To the right of the word, there is a series of four squares, decreasing in size from right to left, forming a curved line above the word.
1
Image /page/1/Picture/0 description: The image shows the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the text, starting below the "A" and ending near the "M". To the right of the word, there are four small, solid squares and circles arranged in a curved line, decreasing in size from right to left.
-
- Intended Use:
The AgaMatrix WaveSense Diabetes Manager (WDM) application (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 WaveSenseenabled 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.
- Intended Use:
-
- Assessment of Performance:
An evaluation of the WaveSense Diabetes Manager was studied in house and in a Clinical setting by persons with diabetes. The studies demonstrated the ease of operating the WaveSense Diabetes Manager application as intended.
- Assessment of Performance:
| | Zero-Click Data Management Software | WaveSense Diabetes
Management Application |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | The AgaMatrix WaveSense Diabetes
Manager (WDM) application (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 | same |
| Accessory to | WaveSense Blood Glucose Monitoring
Meters | same |
| Log book for | Blood glucose readings | Blood glucose readings
and Insulin and
Carbohydrates intake |
| Use on | PC | iPhone Operating System
platform |
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- Comparison to Predicate device
8. Conclusions
The results of clinical evaluations of the WaveSense Diabetes Manager application demonstrate that the application is equivalent in performance to the predicate device and suitable for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Agamatrix c/o Connie Hertel 10 Maor Parkway, Salem, NH 03079
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
OCT 18 2010
Re: K101597
Trade/Device Name: WaveSense Diabetes Manager-application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: September 22, 2010 Received: September 24, 2010
Dear: Ms. Hertel:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for AgaMatrix. The logo consists of the word "AgaMatrix" in a simple, sans-serif font. There is a curved line underneath the word, and a series of squares to the right of the word, which appear to be getting larger as they move to the right.
10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191
Indications for Use
510(k) Number (if known): KID|597
Device Name: WaveSense Diabetes Manager application
OCT 1 8 2010
Indications for Use:
The WaveSense Diabetes Manager (WDM) application (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 readings to support an effective diabetes management program. The WaveSense Diabetes Manager application is a digital logbook and diabetes management tool designed to operate using the iPhone Operating System platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled blood glucose meter (BGM) with a mini-USB port.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use X . (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Ciis
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 1101597
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