(10 days)
AG-608 Single Blood Glucose Monitoring System, AG-608 Multi Blood Glucose Monitoring System, AG-6081 Single Blood Glucose Monitoring System, AG-6081 Multi Blood Glucose Monitoring System, AG-6951Single Blood Glucose Monitoring System, AG-6951 Multi Blood Glucose Monitoring System
No
The description focuses on data transfer, storage, and basic analysis of blood glucose data, with no mention of AI/ML terms or capabilities like predictive modeling, pattern recognition beyond simple display, or automated insights derived from complex algorithms. The "Not Found" entries for AI/ML mentions and training/test sets further support this.
No
The software is explicitly stated to assist in uploading, storing, analyzing, and communicating historical blood glucose test results, and it "is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment." This indicates it's a data management tool, not a device providing therapy or treatment.
No
The software is explicitly stated to assist in uploading, storing, analyzing, and communicating historical blood glucose test results, but it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment." This indicates it's a data management tool supporting diabetes management, not a device directly performing diagnostic functions or making medical diagnoses.
Yes
The device is described as "software" and an "optional software accessory" that transfers data from existing hardware (blood glucose meters) to a computer for data management. It does not appear to include any hardware components itself.
Based on the provided text, the Andon Health Care Management System Software itself is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This software does not perform these tests.
- Software's Function: The software's primary function is to transfer, store, analyze, and communicate data from blood glucose meters (which are IVDs). It manages the data generated by the IVD, but it doesn't perform the diagnostic test itself.
- Intended Use: The intended use clearly states it's for "uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management." It explicitly states it's "not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment." This reinforces its role as a data management tool, not a diagnostic tool.
Therefore, while it is an accessory to IVD devices (the blood glucose meters), the software itself does not meet the definition of an IVD.
N/A
Intended Use / Indications for 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.
Product codes
NBW, JQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of Andon Health Care Management System Software included system test and unit test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
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
1
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 Care
Management
Software | Andon Health Care
Management
Software(K102678) | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The ANDON Health Care
Management System
Software is intended for use
in
home and clinical settings as
an aid for people with users
and their health
care professionals to review,
analyze and evaluate the
historical test results
to support health
management effectively. | The ANDON Health Care
Management System
Software is intended for use
in
home and clinical settings as
an aid for people with users
and their health
care professionals to review,
analyze and evaluate the
historical test results
to support health
management 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+ RAM
Disk space: optimal 200 MB+ free space - at least 100 MB
Graphic resolution starting from 1024 x 768, CD-ROM drive, USB interface | 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 |
| | Technology | Visual Basic | Visual Basic |
| | Performance specifications, including any testing | Read memories in meter.
Delete all memories in meter
Set time to meter
Draw table and graph
Print
Set the personal information | Delete all memories in meter
Set time to meter
Draw table and graph
Print
Set the personal information |
| Meter Compatibility | 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 | AG-608 Single Blood Glucose Monitoring System
and AG-608 Multi Blood Glucose Monitoring System | |
7.0 Summary comparing technological characteristics with predicate device
2
5- 3
3
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.
4
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).
5
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
6
Indication for Use
K112738 510(k) Number (if known):
Device Name: Andon Health Care Management System Software
Indication For 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.
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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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)