The MCT-Diabetes™ software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT Diabetes is designed for home use and professional healthcare settings.

Device Description

MCT-Diabetes software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT-Diabetes is designed for home use and professional healthcare scttings. It is an accessory device to most manufactured models homc-use blood glucose monitors, including glucose monitoring devices by Roche Diagnostics, Bayer, BD, Johnson & Johnson, Abbott, and Nova Biomedical. The list of supported devices is located at www.mycareteam.com.

The purpose of the electronic diabetes management system is to help the user manage their own blood sugar information to better regulate diabetes treatments and control blood glucose. The MCT-Diabetes system holds a convenience function, as the user can upload blood glucose data from a variety of currently marketed blood glucose monitors into one location for viewing.

Finally, after the user transmits and stores blood glucose data to the secure database, the MCT-Diabetes system allows family members and/or hcalthcare professionals who have permission from the primary user and a password to view and monitor the user's data and reports. Four different types of chart displays are available, and the user selects the time period and the type of output. The subject can view their blood glucose information over time and can compare to previous time periods, to help the subject better manage their disease over time. The subject can also enter and track other health-rclated information such as body weight, blood pressure, and level of exercise.

The MCT-Diabetes device is an Internet-based software device that has physical requirements common to most home personal computers users (Pentium 4 microprocessor or greater, 256Mb of RAM memory, 10Gb secondary storage, Microsoft Internet Explorer v6.0 or later, etc.). The MCT-Diabetes device is a sccure device and meets or exceeds HIPAA Guidelines for data and patient security.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MCT-Diabetes™ device, based on the provided 510(k) summary:

Please note: This 510(k) summary focuses on software verification and validation and usability testing to demonstrate substantial equivalence to a predicate device, rather than a clinical performance study measuring diagnostic accuracy. Therefore, many standard acceptance criteria and study aspects related to diagnostic performance (like sensitivity, specificity, or AI-assisted improvement) are not applicable or not detailed in this document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Software Functionality	Not explicitly stated as acceptance criteria, but implied through verification and validation. The software should perform its intended function as an interface to retrieve, store, and display blood glucose data from various monitors.	"Software verification and validation testing were conducted in compliance with FDA Quality System Guidelines." The device was considered a "Moderate level of concern," suggesting it met established V&V protocols for this risk level. The outcome of these tests is not explicitly quantified but is stated to support substantial equivalence.
Usability	The device should be usable by its target audience (home users and healthcare professionals) to effectively manage blood glucose information. This implies ease of use, clarity of information, and ability to perform intended tasks. Specifically, adherence to ISO 15197:2003 (which often includes usability aspects for blood glucose monitoring systems).	Two surveys conducted by the American Diabetes Association (ADA) (independent of MyCareTeam Inc) assessed usability.
	- First Survey: Used for initial system improvements. "the vast majority of responses were positive."
	- Second Survey: "revealed positive outcomes regarding the user interaction with the device and its operation."
	Overall: "The overall results from user testing demonstrate that the MCT-Diabetes performs according to its intended use and reliably transmits blood glucose data in a way that is understandable to the user and fits the Intended Use of the device." User testing was conducted in accordance with ISO 15197:2003.
Security/Compliance	Meet or exceed HIPAA Guidelines for data and patient security.	"The MCT-Diabetes device is a secure device and meets or exceeds HIPAA Guidelines for data and patient security." (No specific audit reports or metrics are provided in this summary).
Compatibility	Act as an interface for "most manufactured models home-use blood glucose monitors" from specified brands (Roche Diagnostics, Bayer, BD, Johnson & Johnson, Abbott, and Nova Biomedical).	The device description implies this capability, stating it is an "accessory device to most manufactured models home-use blood glucose monitors." The list of supported devices is located at www.mycareteam.com. The 510(k) doesn't specify testing details or acceptance criteria for compatibility across all these devices within the summary itself.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the usability surveys. It refers to "Two surveys" and "the first survey respondents" and "the second survey."
- Data Provenance: The usability surveys were conducted by the American Diabetes Association (ADA) "independent of MyCareTeam Inc." This suggests a prospective, independent data collection, though the country of origin isn't explicitly stated, it's implied to be within the US given the ADA's role.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) summary. The device is a data management software, not a diagnostic device requiring expert interpretation of medical images or data to establish a ground truth for diagnostic accuracy. The "ground truth" here is user experience and software functionality, assessed via user surveys and software testing, not expert consensus on medical findings.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving multiple expert readers. Here, the "test set" refers to usability survey responses and software verification/validation results, which are not adjudicated in that manner. The ADA independently tabulated the survey results.
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. This device is not an AI-powered diagnostic tool; it's a data management and display software. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "standalone performance" of the software was assessed through "Software verification and validation testing." These tests would ensure the software's algorithms correctly process, store, and display information as programmed, without direct human intervention in the data processing itself, though the overall system relies on human users entering and viewing data. It's a "standalone" software in the sense it performs its core functions independently of direct human oversight of its internal computations. However, it's not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Software Verification and Validation: The ground truth is implied to be the software requirements and design specifications. The software is tested against these predefined functional and non-functional requirements to ensure it performs as intended.
- For Usability Testing: The "ground truth" is user feedback (positive or negative outcomes regarding interaction and operation) and adherence to usability standards (ISO 15197:2003). There isn't a medical "ground truth" like pathology for this type of device.
The sample size for the training set:
- Not applicable. The MCT-Diabetes™ is not described as an AI/ML-driven device that learns from a "training set" of data. It's software that performs pre-programmed functions for data management and display.
How the ground truth for the training set was established:
- Not applicable. As there is no described training set for an AI/ML model.

Summary

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K073699

510(k) Summary MCT-Diabetes™

MAR 2 6 2008

Name of Device:	MCT Diabetes TM, Version 2.0
Product Code, Class No. 1:	NBW, Class II
Classification No. 1:	862.1345 (System, Test, Blood Glucose, Over the Counter)
Product Code, Class No. 2:	JQP, Class I
Classification No. 2:	862.2100 (Calculator/data processing module, for clinical use)
Review Panel:	Clinical Chemistry Devices
Sponsor:	MyCareTeam, Inc.40 Nagog ParkActon, MA 01720
Contact:	John Paglierani
Telephone:	(978) 635-6960, Ext. 5122
Fax:	(508) 347-0242
Date Prepared:	December 31, 2007

A. LEGALLY MARKETED PREDICATE DEVICE

Name of Predicate:	K070593, TrackRecord Data Management Software,Home Diagnostics Inc.
Product Code, Class No. 1:	NBW, Class II
Classification No. 1:	862.1345 (System, Test, Blood Glucose, Over the Counter)
Product Code, Class No. 2:	JQP, Class I
Classification No. 2:	862.2100 (Calculator/data processing module, for clinical use)

B. DEVICE DESCRIPTION

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510(k) Summary (Continued) MCT-DiabetesTM

can upload blood glucose data from a variety of currently marketed blood glucose monitors into one location for viewing.

ﺯ INTENDED USE

The MCT-Diabetes software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT-Diabetes is designed for home use and professional healthcare settings.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The MCT-Diabetes is not substantially different from the predicate device, the TrackRecord Data Management Software. Both this and the predicate device, which has the same classification numbers as the MCT-Diabetes, is intended to serve as an interface between personal glucose monitoring devices and a health management database to assist in the monitoring of an individual's blood glucose levels. Both devices are designed for both home use and use by healthcare professionals.

The MCT-Diabetes has the same technological characteristics as the predicate device with small exceptions (e.g., the predicate device program is distributed on a CD while this device is Internet-based only), but those exceptions do not affect safety or effcctiveness. Any differences in tcchnology have been addressed by software validation and verification testing, and usability testing (conducted in accordance with ISO 15197: 2003). The decision algorithm brings us to a determination of Substantial Equivalence, as defined in the Federal Food, Drug, and Cosmetic Act.

E. TECHNOLOGICAL CHARACTERISTICS

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510(k) Summary (Continued) MCT-Diabetes™M

Microsoft Internet Explorer v6.0 or later, etc.). The MCT-Diabetes device is a sccure device and meets or exceeds HIPAA Guidelines for data and patient security.

TESTING F.

Software verification and validation testing were conducted in compliance with FDA Quality System Guidelines. MCT-Diabetes was considered a Moderate level of concern.

The MCT-Diabetes device was tested for usability by the American Diabetes Association (ADA). Two surveys were sent to the users independent of MyCareTeam Inc and only tabulated by the American Diabetes Association to test the usability of the system. Results from the first survey respondents were used for system improvements, although the vast majority of responses were positive. Results from the second survey revealed positive outcomes regarding the user interaction with the device and its operation. The overall results from user testing demonstrate that the MCT-Diabetes performs according to its intended use and reliably transmits blood glucose data in a way that is understandable to the user and fits the Intended Usc of the device.

G. CONCLUSIONS

MyCareTeam, Inc. has demonstrated through its comparison of characteristics of MCT-Diabetes with the predicate device, and through software controls and Usability Testing, that MCT-Diabetes is substantially equivalent to the predicate device.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 6 2008

MyCare Team, Inc. c/o Diane Mandell Horwitz, Ph.D. Mandell Horwitz Consultants LLC P.O. Box 2552 Fairfax, VA 22031

Re: K073699 Trade/Device Name: MCT-DiabetesTM Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: NBW, JQP Dated: December 31, 2007 Received: December 31, 2007

Dear Dr. Horwitz:

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); and good manufacturing practice requirements as set fo th in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 - -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. 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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Indication for Use

510(k) Number (if known): K073699

Device Name: MCT-Diabetes™

Indication For Use:

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)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073699

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.