(284 days)
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No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No
The device is described as a "Gluco-Monitoring System" intended for "quantitative measurement of glucose" and "aid to monitor the effectiveness of diabetes control," which points to a diagnostic and monitoring function rather than a therapeutic one.
No
The document explicitly states that the device "should not be used for the diagnosis of or screening of diabetes." It is intended for monitoring the effectiveness of diabetes control in people already diagnosed with diabetes, which is a management tool rather than a diagnostic one.
No
The device description explicitly states that the system consists of a glucose meter, test strips, control solution, lancet, and lancing device, which are all hardware components. While it connects to software on iOS and Android devices, the core functionality relies on physical hardware for blood glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being used for diagnostic purposes outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) consists of the iHealth Wireless Smart Glucose Meter (BG5S) and the iHealth Blood Glucose Test Strips (EGS-2003). The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used by a single person and should not be shared.
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
Product codes
NBW
Device Description
The iHealth Wireless Smart Gluco-Monitoring System ( iHealth Gluco+ ) consist of BG5S glucose meter, EGS-2003 test strip, iHealth® control solution(Level I, Level III), lancet and lancing device. The BG5S glucose meter can display test result on meter itself, and can also be connected to iOS device and Android device through bluetooth and display test result on iOS or Android device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
fingertip, palm, forearm, upper arm, calf, or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home
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)
User Evaluation was completed for the iHealth Wireless Smart Gluco-Monitoring System(iHealth Gluco+). The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) confirmed the proposed device to be substantially equivalent to the predicate device.
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.
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February 1, 2019
Andon Health Co., Ltd Yi Liu President No. 3 Jinping Street, Ya An Road Nankai District Tianjin 300190 China
Re: K181070
Trade/Device Name: iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: December 24, 2018 Received: December 27, 2018
Dear Yi Liu:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for Courtnev H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181070
Device Name
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
Indications for Use (Describe)
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) consists of the iHealth Wireless Smart Glucose Meter (BG5S) and the iHealth Blood Glucose Test Strips (EGS-2003). The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used by a single person and should not be shared.
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
510(k) Number: K181070
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No.3 Jinping Street,Ya'an Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-87611660 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Preparation: 4/18/2018 |
2.0 Device information
| Trade name: | iHealth Wireless Smart Gluco-Monitoring System (iHealth
Gluco+) |
|----------------------|--------------------------------------------------------------------|
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3.0 Classification
| Product code | classification | Regulation section | Panel |
|---|---|---|---|
| NBW | II | 862.1345 | Chemistry(75) |
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd.
iHealth BG5 WIRELESS SMART GLUCOSE MONITORING Device: SYSTEM
510(k) number: K170231
5.0 Test principle
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The blood glucose Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
They are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. For EGS-2003 test strip, the reactive enzyme is glucose dehydrogenase.
Capillary action at the end of the test strip draws the blood into the action chamber and the glucose in blood will take electrochemical reaction with the enzyme, the blood glucose result is displayed in 5 seconds.
6.0 Device description
The iHealth Wireless Smart Gluco-Monitoring System ( iHealth Gluco+ ) consist of BG5S glucose meter, EGS-2003 test strip, iHealth® control solution(Level I, Level III), lancet and lancing device. The BG5S glucose meter can display test result on meter itself, and can also be connected to iOS device and Android device through bluetooth and display test result on iOS or Android device.
7.0 Intended use
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) consists of the iHealth Wireless Smart Glucose Meter (BG5S) and the iHealth Blood Glucose Test Strips (EGS-2003). The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended to be used by a single person and should not be shared.
The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
8.0 Summary comparing technological characteristics with predicate device
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Specification Comparison
| CHARACTERISTICS | PREDICATE | NEW DEVICE |
|---|---|---|
| BG5 BGMS (K170231) | BG5S BGMS | |
| Detection Method | Amperometry | Same as predicate |
| Enzyme | Glucose Oxidase and Glucose | |
| dehydrogenase | Glucose dehydrogenase | |
| Type of Meter | Biosensor (Electrode) | Same as predicate |
| Sample Source | Capillary whole blood from | |
| AST(Alternative site testing) and | ||
| finger | Same as predicate | |
| Sample Application | Blood sample is placed directly to | |
| the test strip after finger or AST is | ||
| lanced. | Same as predicate | |
| Hematocrit Range | 20-60% | Same as predicate |
| Operating | ||
| Temperature Range | 10℃~40℃(50°-104°F) | 10℃~40℃(50°-104°F) |
| Dimensions | 9mm × 34.5mm ×19mm | Same as predicate BG5 |
| Display | LED display, | |
| Connect to iOS device and | ||
| android device to display | ||
| measurement results | Same as predicate, | |
| except the LED color is | ||
| changed | ||
| Result Presentation | mg/dL or mmol/L | Same as predicate |
| Memory Capabilities | 500 times with time and date | |
| displaying | Same as predicate BG5 | |
| Test Start | Automatic | Same as predicate |
| Test Time | 5 second | Same as predicate |
| Power Source | DC 3.7V d.c. | |
| li-ion 250mAh | Same as predicate BG5 | |
| Measurement Range | 20mg/dL-600mg/dL | |
| (1.1mmol/L~33.3mmol/L) | 50mg/dL-600mg/dL | |
| (2.8mmol/L~33.3mmol/L) | ||
| Qualified Test Strip | EGS-2003 and AGS-1000I Test | |
| Strip | EGS-2003 | |
| Sample Volume | Minimum 0.7 micro liter | Same as predicate |
| Connect Method | Connect to iOS device and | |
| Android device through bluetooth | ||
| 3.0 wireless radio technology | Connect to iOS device | |
| and Android device | ||
| through bluetooth 4.0 | ||
| wireless radio technology |
Discussion of Non-Clinical Tests Performed
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· Performance, functionality, and reliability of the proposed device has been evaluated. The performance evaluation include precision, altitude, temperature & humidity, linearity, interference, sample volume and hematocrit.
• Software: documentation was prepared and submitted for a moderate level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices;
Discussion of Clinical Tests Performed
User Evaluation was completed for the iHealth Wireless Smart Gluco-Monitoring System(iHealth Gluco+). The study results demonstrate that the user accuracy and ease of use (via participant questionnaire scoring) confirmed the proposed device to be substantially equivalent to the predicate device.
9.0 Comparison to the predicate device and the conclusion
The proposed device is similar with the predicate device, they are both for single patient use, can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same, and all the proposed device can be connected to not only the iOS device, but also the Android device.
Compared the predicate device, BG5S connect to iOS device and Android device through bluetooth 4.0 wireles radio technology, which is different from the predicate device, and new mobile phone is added to the device. BG5S only declare to use one qualified test strip.
More over, the LED display color of BG5S is change, and the declared measurement range is also changed.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.