The Zero-Click™ Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix's Liberty™ Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

Device Description

The Zero-Click™ Data Management System is an optional data management software accessory for use with the AgaMatrix's Liberty "M Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows the transfer of data from the AgaMatrix's Liberty™ Blood Glucose meter to a personal computer for enhanced data management capability. The Zero-Click1131 Data Management System eliminates the need for manual data logs and provides enhance glucose reading trends and statistics. Using the unique Zero-Click™ USB cable, glucose readings are automatically downloaded from the Liberty™ Meter to a PC without pressing a button.

AI/ML Overview

The provided document describes the AgaMatrix Zero-Click™ Blood Glucose Management System and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or information typically found in a clinical performance study for an AI/ML medical device.

The document states:

"System testing was performed with the Zero-ClickTM Data Management System to ensure the optional accessory is equivalent to a currently marketed device (FreeStyle'™ Connect Data Management System)."
"These tests consisted of system, hardware, software, and electrical safety (EMC, EMI, and ESD) and clinical user study which consisted of lay users with diabetes and Health Care Professionals (HCPs) to demonstrate the ease of operating the Zero-Click Data Management Software as intended."
"Software verification and validation testing demonstrated that the Zero-Click™ Data Management System meets the performance requirements for the intended use of the optional accessory device and the resultant modification has not affected safety of effectiveness."

Based on the provided text, I cannot extract the information required for your request in the format you specified, as the document focuses on regulatory submission and stating that testing was done, rather than providing the detailed results and methodology of a clinical AI/ML performance study.

Therefore, many sections of your request will be marked as "Not provided in the document."

Here's the breakdown based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not provided in the document	"Software verification and validation testing demonstrated that the Zero-Click™ Data Management System meets the performance requirements for the intended use of the optional accessory device and the resultant modification has not affected safety of effectiveness."

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

Sample Size (Test Set): Not provided in the document. The document mentions "clinical user study which consisted of lay users with diabetes and Health Care Professionals (HCPs)" but does not specify the number of participants.
Data Provenance: Not provided in the document.

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

Number of Experts: Not applicable, as the device is a data management software, not an AI/ML diagnostic tool that establishes ground truth on medical images or signals. The "clinical user study" involved "lay users with diabetes and Health Care Professionals (HCPs)" to demonstrate ease of operation, not to establish ground truth for an algorithm's diagnostic performance.
Qualifications of Experts: Not specifically provided for ground truth establishment. HCPs were involved in the user study to evaluate ease of operation.

4. Adjudication Method for the Test Set

Adjudication Method: Not provided in the document. Not applicable in the context of this device's function (data management software).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: Not applicable/Not provided in the document. This is a data management software, not a diagnostic AI that would typically be evaluated in an MRMC study.

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

Standalone Performance: Not applicable/Not provided in the document. The device's primary function is to transfer and manage data, not to perform independent diagnostic or analytical functions in a standalone fashion. Its effectiveness is tied to its integration with the blood glucose monitoring system and user interaction.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. The "clinical user study" focused on ease of operation and meeting performance requirements for data management, not on establishing a diagnostic ground truth.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not provided in the document. This is a data management software, and the concept of "training set" in the context of AI/ML algorithms is not relevant to the described verification and validation.

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

Ground Truth for Training Set: Not applicable/Not provided in the document for the reasons stated above.

Summary

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AgaMatrix

10 Manor Parkway Salem, NH 03079 ()ffice: +1 (603) 328-6000 Fax: +1 (603) 893-4191

510 (k) SUMMARY

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.

NOW 1 3 2006

The assigned 510(k) number is:

K062434

1. Submitter's Name, Address, Telephone Number, Contact Person, and date the summary was prepared.

Submitter's Name:	AgaMatrix, Inc.10 Manor ParkwaySalem, NH 03079
Contact Person:	Connie HertelDirector Quality & Regulatory Affairs
Telephone:	(603) 328-6000
Fax:	(603) 893-4191

Date the summary prepared:

August 17, 2006

2. Device Name

Classification Name:	None 1,2
Common/Usual Name:	Data Management Software
Proprietary Name:	Zero-Click™ Blood Glucose Management System

l Zero-Click™ Blood Glucose Management System is considered an "unclassified" accessory to a blood glucose test system, Product Code NBW

2 The regulation for the parent device (blood glucose monitor, Class II) is 21 CFR 862.1345, System Test , Blood Glucose.

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10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

3. Legally Marketed Device to which Substantial Equivalence is Claimed:

Predicate Device	510(k) number
FreeStyle™ Connect DataManagement System	k9944333

4. Intended Use of the Device

5. Device Description

6. Principle of Operation

The Zero-Click™ Data Management System uploads each blood glucose test result and the date and time of the measurement from the memory of the AgaMatrix Liberty "M Blood Glucose meter through a unique USB cable, automatically without having to click a button.

The Zero-Click™ Data Management System operates in a Microsoft Windows Operating System platform and creates reports allowing the user to display a Variety of graphs and statistics based on user-selectable date intervals and blood glucose target ranges.

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Image /page/2/Picture/0 description: The image shows the word "AgaMatrix" in a simple, sans-serif font. A curved line underlines the word, and a series of dots trails off to the upper right of the word. The dots appear to be arranged in an arc shape.

10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

7. Summary of Data Demonstrating Substantial Equivalence

System testing was performed with the Zero-ClickTM Data Management System to ensure the optional accessory is equivalent to a currently marketed device (FreeStyle'™ Connect Data Management System). These tests consisted of system, hardware, software, and electrical safety (EMC, EMI, and ESD) and clinical user study which consisted of lay users with diabetes and Health Care Professionals (HCPs) to demonstrate the ease of operating the Zero-Click Data Management Software as intended.

Software verification and validation testing demonstrated that the Zero-Click™ Data Management System meets the performance requirements for the intended use of the optional accessory device and the resultant modification has not affected safety of effectiveness.

8. Conclusions

Software verification and validation testing demonstrates that the Zero-Click™ Data Management System is safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The eagle's head is turned to the right, and its body is composed of flowing lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Connie Hertel AgaMatrix, Inc. 10 Manor Parkway Salem, NH 03079

NOV 1 3 2006

Re: K062434

Trade/Device Name: AgaMatrix Liberty™ Blood Glucose Monitoring System AgaMatrix Liberty™ Blood Glucose Monitoring System with an Optimal Accessary the Zero-Click™ Blood Glucose Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system

Regulatory Class: Class II Product Code: NBW. CGA, JJX Dated: October 16, 2006 Received: October 17, 2006

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); and good manufacturing practice requirements as set forth 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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Gutz

Alberto Gutierrez, 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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10 Manor Parkway Salem, NH 03079 Office: +1 (603) 328-6000 Fax: +1 (603) 893-4191

Indications For Use

510(k) Number (if known):	K062434
Device Name:	AgaMatrix Liberty TM Blood Glucose Monitoring System

AgaMatrix Liberty™ Blood Glucose Monitoring System:

AgaMatrix LibertyTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix LibertyTM Blood Glucose Meter:

AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix LibertyTM Blood Glucose Test Strips:

AgaMatrix Liberty TM Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix Liberty™ Control Solution:

AgaMatrix Liberty " Control Solution is intended for use with the AgaMatrix Liberty™ Meter and AgaMatrix Liberty™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription(21 CFR 801 Subpart D)	X	AND/OR	Over the Counter(21 CFR 801 Subpart C)	X
----------------------------------------	---	--------	--------------------------------------------	---

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carl Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 2

Ro62434

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10 Manor Parkway Salem, NH 03079 Office: +} (603) 328-6000 Fax: +1 (603) 893-4191

Indications For Use

510(k) Number (if known):

lo2434

Device Name:

AgaMatrix Liberty 111 Blood Glucose Monitoring System with an Optional Accessary the Zero-Click™ Blood Glucose Data Management Software

Zero-Click™ Blood Glucose Data Management Software

AgaMatrix Zero-Click™ Blood Glucose Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix LibertyTM Blood Glucose Monitoring System. The Zero-Click™ Blood Glucose Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

Prescription (21 CFR 801 Subpart D)

AND/OR

Over the Counter (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ()N ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson

sion Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safety

K062434

Page 272

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.