(113 days)
iHealth BG5 and BG5L wireless 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
iHealth BG5 and BG5L wireless 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 AGS1000I test strips are intended for use with the iHealth BG5 and BG5L meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 and BG5L meter.
The iHealth control solutions are intended for use with the iHealth BG5/BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
iHealth BG5 and BG5L Wireless 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 BG5 and BG5L Wireless Smart Glucose meters are 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 new device iHealth BG5 and BG5L meters can display the test results itself, it can also transmit the test results to the an iPhone, iPod touch or iPad through blue tooth.
Here's an analysis of the provided text regarding the iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the iHealth BG5 and BG5L systems are based on the international standard ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. The document explicitly states that the system "conforms to... ISO 15197."
While the document mentions adherence to ISO 15197, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) from that standard, nor does it present a detailed table of reported device performance against those specific criteria. It states that "Non-clinical test and the clinical test are done according to the above standard."
Therefore, based only on the provided text, we can infer the acceptance criteria are those outlined in ISO 15197, but the numerical targets and direct performance comparison are not presented.
Summary of the Study Information from the Provided Text
-
Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Based on ISO 15197) Reported Device Performance Not explicitly detailed in the document, but is implicitly the requirements of ISO 15197 for blood glucose monitoring systems. "Non-clinical test and the clinical test are done according to the above standard (ISO 15197)." (Specific performance metrics against ISO 15197 are not numerically provided in this summary.) Note: The document states the device "conforms to... ISO 15197," implying that it meets the standard's performance requirements, but the specific numerical accuracy data is not presented in this 510(k) summary.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). While it mentions "clinical test," it doesn't elaborate on the study design or patient demographics.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not specified in the provided text.
-
Adjudication Method for the Test Set:
- Not specified in the provided text.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. This device is a blood glucose monitoring system, not an imaging device typically subject to MRMC studies. The primary evaluation is device accuracy against a reference method.
-
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, a standalone performance evaluation was done. The document describes "Non-clinical test and the clinical test" performed to demonstrate conformity to ISO 15197. This includes evaluating the accuracy of the device itself (the meter and test strips) in measuring glucose levels against a reference method. The device is intended for "self-testing" and "in vitro diagnostic use," implying its accuracy is evaluated independently of a healthcare professional's interpretation where the result itself is the "output."
-
Type of Ground Truth Used:
- Not explicitly stated, but for blood glucose monitoring systems conforming to ISO 15197, the ground truth is typically a laboratory reference method (e.g., a YSI analyzer or similar). This is inferred from the standard's requirements for accuracy studies.
-
Sample Size for the Training Set:
- Not applicable/Not specified. Blood glucose meters do not typically use "training sets" in the same way machine learning algorithms do. Their performance is established through analytical and clinical accuracy studies where the device's measurements are compared to a reference method on a set of clinical samples.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as "training sets" are not typically used for this type of device. The accuracy of the device (meter and strips) would be assessed against a laboratory reference method during its development and validation.
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123935
510(k) Summary
APR 1 2 2013
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
ﺮ
| Name: | Andon Medical Co., Ltd. |
|---|---|
| Address: | No.26 Hang 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: | 12/14/2012 |
2.0 Device information
| Trade name: | iHealth BG5 Wireless Smart Gluco-Monitoring System |
|---|---|
| iHealth BG5L Wireless Smart Gluco-Monitoring System | |
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3.0 Classification
| Product Code | Classification | RegulationSection | Panel |
|---|---|---|---|
| NBW- Blood Glucose MonitoringSystem. | Class II | 862.1345 | ClinicalChemistry |
| CGA- test, blood glucose, over thecounter | Class II | 862.1345 | ClinicalChemistry |
| JQP- calculator/data processingmodule, for clinical use. | Class I | 862.2100 | ClinicalChemistry |
| JJX-single(specified)analytecontrols (assayed and unassayed) | Class I | 862.1660 | ClinicalChemistry |
5- I
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| 1 | Manufacturer: | Andon Medical Co., Ltd. |
|---|---|---|
| Device: | iHealth BG3 Smart Gluco-monitoring System | |
| 510(k) number: | K120813 | |
| 2 | Manufacturer: | Andon Medical Co., Ltd. |
| Device: | AG-608N Blood Glucose monitoring System | |
| 510(k) number: | K110017 |
4.0 Predicate device information
5.0 Device description
iHealth BG5 and BG5L Wireless 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 BG5 and BG5L Wireless Smart Glucose meters are 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 new device iHealth BG5 and BG5L meters can display the test results itself, it can also transmit the test results to the an iPhone, iPod touch or iPad through blue tooth.
6.0 Intended use
iHealth BG5 and BG5L wireless 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
iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System should
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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 AGS1000I test strips are intended for use with the iHealth BG5 and BG5L meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 and BG5L meter.
The iHealth control solutions are intended for use with the iHealth BG5/BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
| NEW DEVICE: | PREDICATE: | |
|---|---|---|
| CHARACTERISTICS | iHealth BG5 and BG5Lwireless SmartGluco-Monitoring System | iHealth BG3 SmartGluco-MonitoringSystem(K120813) |
| 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 site testing)and finger |
| Sample Application | Blood sample is placeddirectly to the test strip afterfinger or AST is lanced. | Blood sample is placeddirectly to the test strip afterfinger or AST is lanced. |
| Hematocrit Range | 20-60% | 20-60% |
| OperatingTemperature Range | 10℃~35℃(50°-95°F) | 10℃~35℃(50°-95°F) |
| Dimensions | 9mm × 34.5mm ×19mm | 102mm×58mm ×22mm |
| Display | LED display,Display on iPhone, iPod | Connect to iPone or iPodtouch to display |
7.0 Summary comparing technological characteristics with predicate device
5- 3
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| touch or iPad connectedthrough Bluetooth | measurement results | |
|---|---|---|
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 500 times with time and datedisplaying | 10000 times with time anddate displaying |
| Test Start | Automatic | Automatic |
| Test Time | 5 second | 5 second |
| Power Source | DC 3.7V d.c.li-ion 250mAh | DC 3.3V(Powered by iOS deviceconnected to the meter) |
| Battery Life | N/A | N/A |
| 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-1000I Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Other function | Transmit measure data toiPhone or iPod through bluetooth.iHealth BG5L use Bluetooth4.0 wireles radio technology;andiHealth BG5 use Bluetooth3.0 wireles radio technology | N/A |
| Control solution | iHealth Control solution(Level I / II / III )The control solution isexactly the same asAG-608N control solution,only the name is different | AG-608N control solution(cleared in K110017) |
8.0 Performance summary
.
・
.
.
iHealth BG5 and BG5L Wireless 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.
- IEC 61010-1 : 2001, Safety requirements for electrical equipment for
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measurement, control, and laboratory use Part 1: General requirements
- · EN 61326-1:2006Electrical equipment for measurement, control and laboratory use - EMC requirements part 1: General requirements
- · EN 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
- · IEC 61010-2-101 : 2002,Particular requirements for in vitro diagnostic (IVD) medical equipment
- · CLSI EP6-A:2003,Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
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 BG5 and BG5L Wireless Smart Gluco-Monitoring System is similar with the predicate device iHealth BG3 Smart Glucose Monitoring System, they are all 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 new devices is different, and iHealth BG5 and BG5L meter obtain LED display on the devices, and can complete the measurement function themselves. Moreover, the new device BG5 and BG5L can connect to an iPone, iPod touch or iPad to display measurement results through Bluetooth.
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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2013
Andon Medical Co., Ltd. C/O Yi Liu NO. 26 HANGYU ROAD TIANJIN AIRPORT ECONOMIC AREA TIANJIN, CHINA 300381
Re: K123935
Trade/Device Name: iHealth BG5 Wireless Smart Gluco-Monitoring System iHealth BG5L Wireless Smart Gluco-Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP, JJX Dated: March 08, 2013 Received: March 12, 2013
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 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. 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 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 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.
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Page 2— Yi Liu
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney 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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Indication for Use
510(k) Number (if known): K123935
Device Name: iHealth BG5 Wireless Smart Gluco-Monitoring System
Indications For Use:
iHealth BG5 wireless 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
iHealth BG5 wireless 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 BG5 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 meter.
The iHealth control solutions are intended for use with the iHealth BG5 Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Yunq W. Mahan -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
K123935 510(k) =
Page 1 of 2
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Indication for Use
510(k) Number (if known): K123935
Device Name: iHealth BG5L Wireless Smart Gluco-Monitoring System
Indications For Use:
iHealth BG5L wireless 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
iHealth BG5L wireless 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 AGS1000I test strips are intended for use with the iHealth BG5 meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5L meter.
The iHealth control solutions are intended for use with the iHealth BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
And/Or Prescription Use Over-The-Counter Use J イ (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)
Yung Wilehan -S
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)_k123935
§ 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.