(263 days)
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for:
· quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
· single person measurement only and should not be shared
• 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 BG3 Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS10001 test strips are intended for use with the iHealth BG3 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter
iHealth BG3 Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG3 Smart Gluco-Monitoring System is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The appearance of iHealth BG3 meter is different from the predicate device. More over, the new device iHealth BG3 Smart Gluco-Monitoring System can not display the test results itself, it has to connect an iPhone or iPod touch to complete its function.
The iHealth BG3 Smart Gluco-Monitoring System's acceptance criteria are based on ISO 15197 for in vitro diagnostic test systems, specifically for blood-glucose monitoring systems used for self-testing in managing diabetes mellitus. The information provided does not contain specific numerical acceptance criteria (e.g., accuracy percentages or error grids) or detailed study results to demonstrate compliance with these criteria beyond a general statement that "Non-clinical test and the clinical test are done according to the above standard."
Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numbers.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on ISO 15197) | Reported Device Performance |
|---|---|
| Accuracy (specific metrics, e.g., % within ±X mg/dL or % within Y%) | Not explicitly detailed in the provided text. The document states "Non-clinical test and the clinical test are done according to the above standard [ISO 15197]," implying compliance but not providing specific performance data. |
| Precision | Not explicitly detailed in the provided text. |
| Measurement Range (20-600 mg/dL) | The device's measurement range is 20mg/dL-600mg/dL (1.1mmol/L~33.3mmol/L). This aligns with a common range for blood glucose meters. |
| Hematocrit Range (20-60%) | The device's hematocrit range is 20-60%. |
| Operating Temperature Range | The device's operating temperature range is 10℃~35℃(50°-95°F). |
| Test Time (5 seconds) | The device's test time is 5 seconds. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that "Non-clinical test and the clinical test are done according to the [ISO 15197] standard."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the given text.
4. Adjudication method for the test set
- This information is not provided in the given text.
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
- This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The iHealth BG3 Smart Gluco-Monitoring System is an in-vitro diagnostic device that provides a direct numerical measurement of glucose. Its performance is inherently standalone in the sense that the device itself generates the glucose reading. It connects to an iPhone or iPod touch to display results, but the measurement itself is performed by the device and test strip. The performance evaluation would measure the accuracy of these readings against a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For blood glucose monitoring systems complying with ISO 15197, the "ground truth" (or reference method) typically involves laboratory-grade glucose analyzers, often using methods like hexokinase or glucose oxidase reactions, which are considered highly accurate for quantitative glucose measurement. While not explicitly stated, it's highly probable that a laboratory reference method was used for comparison in the clinical and non-clinical tests.
8. The sample size for the training set
- This information is not provided in the given text. Blood glucose meters do not typically have "training sets" in the same way machine learning algorithms do. Instead, their development involves calibration and characterization using a range of known glucose concentrations.
9. How the ground truth for the training set was established
- As mentioned above, the concept of a "training set" with ground truth in the context of machine learning isn't directly applicable here. The development and calibration of blood glucose meters involve rigorous testing against laboratory reference methods across the device's intended measurement range and various interfering substances to ensure accuracy.
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iHealth BG3 Smart Gluco-Monitoring System FDA 510(k) Files
Additional information for K120813
510(k) Summary
DEC 0 7 2012
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 Hangn Yu Road, Tianjin Airport Economic Area,Tianjin, P.R. China |
| Phone number: | 86-22-8761 2426 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Yi Liu |
| Date of Application: | 03/15/2012 |
2.0 Device information
| Trade name: | iHealth BG3 Smart Gluco-Monitoring System |
|---|---|
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3.0 Classification
NBW- Blood Glucose Monitoring System. Production code: Regulation number: 862.1345 Classification: II Clinical Chemistry Panel:
4.0 Predicate device information
| Manufacturer: | Andon Medical Co., Ltd. |
|---|---|
| Device: | AG-608N Single Blood Glucose Monitoring System |
| 510(k) number: | K110017 |
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Additional information for K 120813
iHealth BG3 Smart Gluco-Monitoring System FDA 510(k) Files
5.0 Device description
iHealth BG3 Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG3 Smart Gluco-Monitoring System is based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The appearance of iHealth BG3 meter is different from the predicate device. More over, the new device iHealth BG3 Smart Gluco-Monitoring System can not display the test results itself, it has to connect an iPhone or iPod touch to complete its function.
6.0 Intended use
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for:
- · quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
- · single person measurement only and should not be shared
• 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 BG3 Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly.
The AGS10001 test strips are intended for use with the iHealth BG3 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter
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Additional information for K120813
iHealth BG3 Smart Gluco-Monitoring System FDA 510(k) Files
7.0 Summary comparing technological characteristics with predicate device
| NEW DEVICE: | PREDICATE: | |
|---|---|---|
| CHARACTERISTICS | iHealth BG3 SmartGluco-Monitoring System | AG-608N Single Blood.Glucose MonitoringSystem (K110017) |
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood fromAST(Alternative site testing)and finger | Capillary whole blood fromAST(Alternative sitetesting) and finger |
| Sample Application | Blood sample is placeddirectly to the test strip afterfinger or AST is lanced. | Blood sample is placeddirectly to the test stripafter finger or AST islanced. |
| Hematocrit Range | 20-60% | 20-60% |
| OperatingTemperature Range | 10℃~35℃(50°-95°F) | 10℃~40℃(50°-104°F) |
| Dimensions | 102mm×58mm ×22mm | 52mmx 92mmx 21mm |
| Display | Connect to iPhone or iPodtouch to displaymeasurement results | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 10000 times with time anddate displaying | 500 times with time anddate displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3.3V (Powered by iOSdevice connected to themeter) | DC 3V (CR2032) |
| Battery Life | N/A | Approx. 500 normal tests |
| Measurement Range | 20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L) | 20mg/dL-600mg/dL(1.1mmol/L~33.3mmol/L) |
| Qualified Test Strip | AGS-1000I Test Strip | AGS-1000N Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Other function | N/A | USB function.Voice function |
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iHealth BG3 Smart Gluco-Monitoring System FDA 510(k) Files
8.0 Performance summary
iHealth BG3 Smart Gluco-Monitoring System conforms to the following standards:
- · ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Non-clinical test and the clinical test are done according to the above standard.
9.0 Comparison to the predict device and the conclusion
iHealth BG3 Smart Gluco-Monitoring System is similar with the predicate device AG-608N Single blood pressure monitor, the two devices are both for single people use, they use the same test strip, and can test the blood glucose at the alternative site. The hematocrit range, the altitude and the use function are all the same. The appearance of the two device is different, and iHealth BG3 meter does not have a LCD itself, it must be connected to an iPone or iPod touch to display measurement results. More over, the memory capability of the new device is changed, and the new device i neither has the USB function nor Voice function.
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 the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Andon Medical Co., Ltd. c/o Yi Liu No.26 Hang Yu Road Tianjin, P.R. China 300381
December 7. 2012
Re: K120813
Trade/Device Name: iHealth BG3 Smart Gluco-Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JQP Dated: November 26, 2012 Received: November 29, 2012
Dear Mr. 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 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Yi Liu
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Yung W. Chan
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): _ K120813
Device Name: iHealth BG3 Smart Gluco-Monitoring System
Indication For Use:
iHealth BG3 Smart Gluco-Monitoring System is intended to be used for:
· quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf or thigh
· single person measurement only and should not be shared
· 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 BG3 Smart Gluco-Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use.
Alternative Site Testing (AST) should be done only during steady state times when qlucose levels are not changing rapidly.
The AGS10001 test strips are intended for use with the iHealth BG3 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealthBG3 meter
Prescription Use J (21 CFR Part 801 Subpart D) Over the Counter Use J (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Lathes
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120813
Page 1 of /
§ 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.