(132 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AgaMatrix WaveSense Diabetes Manager application:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting specific analytical or clinical performance acceptance criteria for the WaveSense Diabetes Manager application itself. The study's focus was on the ease of use and functional equivalence as a data management tool.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ease of Operation | Demonstrated ease of operating the WaveSense Diabetes Manager application as intended. |
| Intended Use Equivalence to Predicate | The application is equivalent in performance to the predicate device for its intended use (review, analysis, evaluation of blood glucose results to support diabetes management). |
| Accessory to BGM Equivalence | Shares the same accessory relationship with WaveSense Blood Glucose Monitoring Meters as the predicate. |
| Logbook Functionality | Provides blood glucose readings logbook; adds insulin and carbohydrate intake logging compared to predicate. |
| Platform Compatibility | Operates on the iPhone Operating System platform (predicate operated on PC). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "Clinical setting by persons with diabetes," but does not provide a number for the participants in this evaluation.
- Data Provenance: The study was conducted "in house and in a Clinical setting." The country of origin is not specified but is presumed to be the USA, given the submission to the FDA. The study appears to be prospective in nature, as it involved actively evaluating the device.
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 study primarily focused on user experience and functional equivalence rather than a diagnostic performance evaluation requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the study (ease of use and functional equivalence), a formal adjudication method for diagnostic accuracy would likely not be relevant or necessary.
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, an MRMC comparative effectiveness study was not done. The WaveSense Diabetes Manager application is a data management tool, not an AI-powered diagnostic device, and therefore this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a standalone application in the sense that it collects and displays data. However, it's not an "algorithm-only" device for diagnostic or predictive purposes without human interaction. Its function is to facilitate human review and analysis of blood glucose data. The performance assessment was based on its operational ease and functional equivalence.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, expert consensus) is not applicable to this device. The "ground truth" for this application would be the accurate transfer and display of blood glucose readings, which are generated by an external BGM, and the user's ability to easily navigate and utilize the app's features. The study implicitly evaluated the functional correctness and user experience as its "ground truth."
8. The Sample Size for the Training Set
This information is not applicable/not provided. The WaveSense Diabetes Manager is an application for data management, not a machine learning or AI model that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this device does not utilize a "training set" in the context of an AI/ML model.
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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.
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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.
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- 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:
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- 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 DiabetesManagement Application | |
|---|---|---|
| Intended Use | The AgaMatrix WaveSense DiabetesManager (WDM) application (app) isintended for use in the home andprofessional settings to aid individualswith diabetes and their healthcareprofessionals: in the review, analysis andevaluation of blood glucose test results tosupport an effective diabetesmanagement program | same |
| Accessory to | WaveSense Blood Glucose MonitoringMeters | same |
| Log book for | Blood glucose readings | Blood glucose readingsand Insulin andCarbohydrates intake |
| Use on | PC | iPhone Operating Systemplatform |
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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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§ 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.