Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Device Description

Andon Health Care Management System Software is an optional software accessory for use with AG-608 Single Blood Glucose Monitoring System and AG-608 Multi Blood Glucose Monitoring System, AG-6081 Single Blood Glucose Monitoring System and AG-6081 Multi Blood Glucose Monitoring System, AG-6951Single Blood Glucose Monitoring System and AG-6951 Multi Blood Glucose Monitoring System. When used with the above Blood Glucose Monitoring Systems, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management.

AI/ML Overview

Here's an analysis of the provided text regarding the Andon Health Care Management System Software's acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or provide specific quantitative performance metrics beyond functional descriptions. The "Performance specifications, including any testing" section lists functionalities rather than measurable criteria with associated performance targets.

Acceptance Criteria (Inferred from "Performance specifications")	Reported Device Performance
Read memories in meter.	Implied: Functionality available
Delete all memories in meter.	Implied: Functionality available
Set time to meter.	Implied: Functionality available
Draw table and graph.	Implied: Functionality available
Print.	Implied: Functionality available
Set the personal information.	Implied: Functionality available
Auto-detect COM port.	Yes
Meter Compatibility: AG-608 Series, AG-6081 Series, AG-6951 Series	Demonstrated compatibility with listed meters.
Installation method: Exe file	Exe file
Language capabilities: English, Spanish	English, Spanish
Types of graphs: Coordinates graph	Coordinates graph
System components: PC, USB cable, meter	PC, USB cable, meter
Software platform: Microsoft	Microsoft
Hardware requirements: CPU: optimal at 1,2 GHz+, Main memory: optimal at 256 MB+ RAM, Disk space: optimal 200 MB+ free space - at least 100 MB, Graphic resolution starting from 1024 x 768, CD-ROM drive, USB interface	Meets listed hardware requirements (optimal values provided)
Technology: Visual Basic	Visual Basic

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test set or the data provenance. It only states, "Testing of Andon Health Care Management System Software included system test and unit test."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As the device is for data management and not diagnostic interpretation, it's unlikely a ground truth established by medical experts in the traditional sense would be applicable for the software's functional testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported. The device is a data management software, not an AI-powered diagnostic or assistive tool for human readers. Its purpose is to transfer, store, and display blood glucose data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the software's inherent functional performance. The document states, "Testing of Andon Health Care Management System Software included system test and unit test," which implies standalone testing of the software's functions (e.g., data transfer, storage, display, printing). However, no specific details on the methodology or results of these tests are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For software like this, "ground truth" would typically refer to the expected functional behavior and data integrity. The document does not explicitly state how this ground truth was established, but it would presumably be based on software requirements and specifications (e.g., if the meter stores X data points, the software should always accurately display X data points).

8. The sample size for the training set

This information is not provided. The software described does not appear to be an AI/machine learning model that would require a "training set" in the conventional sense. It's an application for data management.

9. How the ground truth for the training set was established

Not applicable as the device is not described as an AI/machine learning model requiring a training set.

Summary

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SEP 3 0 2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.

1.0 submitter's information

Name:	Andon Medical Co., Ltd.
Address:	No.26 HangYu Road, Tianjin Airport Economic Area,TIANJIN
Phone number:	86-22-8761 2426
Fax number:	86-22-6052 6162
Contact:	Yi Liu
Date of Application:	9/10/2011

2.0 Device information

Trade name: Andon Health Care Management System Software Common name: Data management software Classification name: Data management software

3.0 Classification

Production code: NBW- Blood Glucose Monitoring System. Regulation number: 862.1345 Classification: II Panel: Clinical Chemistry

4.0 Predict device information

Manufacturer: Andon Medical Co., Ltd. Andon Health Care Management System Software Device: 510(k) number: K102678

5.0 Device description

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Management System Software transfers data from the device's memory into a computer for enhanced data management.

6.0 Intended use

Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management. Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

item	Andon Health CareManagementSoftware	Andon Health CareManagementSoftware(K102678)
Indications for use	The ANDON Health CareManagement SystemSoftware is intended for useinhome and clinical settings asan aid for people with usersand their healthcare professionals to review,analyze and evaluate thehistorical test resultsto support healthmanagement effectively.	The ANDON Health CareManagement SystemSoftware is intended for useinhome and clinical settings asan aid for people with usersand their healthcare professionals to review,analyze and evaluate thehistorical test resultsto support healthmanagement effectively.
	Installation method	Exe file	Exe file
	Package Contents	N/A	N/A
	Capable of deleting results	Delete all results in meter	Delete all results in meter
	Language capabilities	English, Spanish	English, Spanish
	Customizable schedule	N/A	N/A
	Types of graphs etc.	Coordinates graph	Coordinates graph

	Auto-detect COM port	Yes	Yes
	System components	PC, USB cable, meter	PC, USB cable, meter
	Software platform	Microsoft	Microsoft
	Hardware requirements	CPU: optimal at 1,2 GHz+Main memory: optimal at 256 MB+ RAMDisk space: optimal 200 MB+ free space - at least 100 MBGraphic resolution starting from 1024 x 768, CD-ROM drive, USB interface	CPU: optimal at 1,2 GHz+Main memory: optimal at 256 MB+ RAMDisk space: optimal 200 MB+ free space - at least 100 MBGraphic resolution starting from 1024 x 768, CD-ROM drive, USB interface
	Technology	Visual Basic	Visual Basic
	Performance specifications, including any testing	Read memories in meter.Delete all memories in meterSet time to meterDraw table and graphPrintSet the personal information	Delete all memories in meterSet time to meterDraw table and graphPrintSet the personal information
Meter Compatibility	AG-608 Single Blood Glucose Monitoring Systemand AG-608 Multi Blood Glucose Monitoring System,AG-6081 Single Blood Glucose Monitoring Systemand AG-6081 Multi Blood Glucose Monitoring System,AG-6951Single Blood Glucose Monitoring Systemand AG-6951 Multi Blood Glucose Monitoring System	AG-608 Single Blood Glucose Monitoring Systemand AG-608 Multi Blood Glucose Monitoring System

7.0 Summary comparing technological characteristics with predicate device

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8.0 Performance summary

Testing of Andon Health Care Management System Software included system test and unit test.

9.0 Comparison to the predict device and the conclusion

Andon Health Care Management System Software is very similar with the predicted device

Andon Health Care Management System Software(K102678), However, they are intended to use together with 4 additional BGMS: AG-6081 Single Blood Glucose Monitoring System and AG-6081 Multi Blood Glucose Monitoring System, AG-6951Single Blood Glucose Monitoring System and AG-6951 Multi Blood Glucose Monitoring System.

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows a logo with a stylized bird in the center. The bird is depicted with abstract lines, suggesting movement or flight. Encircling the bird is text arranged in a circular pattern, likely the name of an organization or department. The text is in all caps and appears to be a government agency.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Andon Medical Co., Ltd. c/o Yi Liu President No.26 HangYu Rd., Tianjin Airport Economic Area Tianjin, 300381 CH - CHINA

SEP 30 2011

Re: K112738

Trade/Device Name: Andon Health Care Management System Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: 11 Product Code: NBW, JQP Dated: September 20. 2011 Received: September 20. 2011

Dear: Mr. Liu:

We have reviewed your Section 310(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 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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Page 2 -

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,

signature

Courtney H. Lias, 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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Indication for Use

K112738 510(k) Number (if known):

Device Name: Andon Health Care Management System Software

Indication For Use:

Prescription Use Yes (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use Yes (21 CFR Part 801 Subpart C)

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(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)

Ruttle Charles

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

112738 510(k)

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.