(232 days)
The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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).
The BLE Smart Blood Glucose Test Strips are for use with the BLE Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly.
The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System 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). The BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.
BLE Smart Blood Glucose Monitoring System / BLE Smart Professional Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BLE Smart Blood Glucose Monitoring System, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary (K160365) does not explicitly list quantitative acceptance criteria in a table format. However, it states that:
- "The device passed all of the tests based on pre-determined Pass/Fail criteria."
- "The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated [sic] device."
This implies that some performance metrics, likely related to glucose measurement accuracy, precision, and safety, were evaluated and met the pre-defined criteria. The predicate device (K130181, GluNEO™ Blood Glucose Monitoring System) would have had its own set of performance criteria, and the new device is deemed substantially equivalent.
For a blood glucose monitoring system, common performance metrics and their typical acceptance criteria (based on ISO 15197 or similar standards) would include:
| Acceptance Criteria Category | Typical Acceptance Criteria (e.g., ISO 15197) | Reported Device Performance (Implied) |
|---|---|---|
| Accuracy (System Accuracy) | For glucose concentrations < 100 mg/dL: ≥95% of results within ±15 mg/dL of lab ref.For glucose concentrations ≥ 100 mg/dL: ≥95% of results within ±15% of lab ref. | Met pre-determined Pass/Fail criteria (implied to be equivalent to predicate) |
| Precision (Repeatability) | Coefficient of Variation (CV) < 5% (typically for higher glucose concentrations) | Met pre-determined Pass/Fail criteria (implied to be equivalent to predicate) |
| User Performance | Lay-user accuracy meeting similar criteria to system accuracy using simulated or real-user testing. | Met pre-determined Pass/Fail criteria (implied to be equivalent to predicate) |
| Interfering Substances | No significant interference from common exogenous and endogenous substances. | Met pre-determined Pass/Fail criteria (implied to be equivalent to predicate) |
| Hematocrit Range | Accurate measurements across specified hematocrit range. | Met pre-determined Pass/Fail criteria (implied to be equivalent to predicate) |
| Environmental Conditions | Performance maintained within specified temperature, humidity, altitude. | Met pre-determined Pass/Fail criteria (implied to be equivalent to predicate) |
| Disinfection Efficacy | Complete inactivation of specified pathogens after disinfection. | Disinfectant CaviWipes demonstrated complete inactivation of live virus of use with the meter. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the performance testing (often referred to as verification/validation activities). It broadly states that "Verification, validation and testing activities were conducted."
The data provenance is not explicitly mentioned but typically for medical device submissions, it would be prospective data collected specifically for the regulatory submission. The applicant, Infopia Co., Ltd., is based in the Republic of Korea. Therefore, the data would likely originate from studies conducted in the Republic of Korea or other regions where they have conducted clinical testing. The text does not indicate whether the data was retrospective or prospective, but for performance validation, it would strongly be implied to be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood glucose monitoring systems, ground truth (reference values) is typically established using a highly accurate laboratory reference method (e.g., hexokinase method on a central laboratory analyzer) rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. For blood glucose measurements, adjudication methods as typically understood in image analysis (e.g., 2+1, 3+1) are not generally applicable. Instead, the focus is on the agreement between the device's reading and the laboratory reference method. Discrepancies would be investigated, but not "adjudicated" in the same sense as expert reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human interpretation is a critical component. For a blood glucose meter, the measurement is largely automated, reducing the role of human "readers" in the primary measurement task. Therefore, the concept of improving human readers with AI assistance does not directly apply here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance testing for the blood glucose monitoring system is inherently standalone. The device (meter and test strips) measures glucose concentrations directly. The listed "Verification, validation and testing activities" would refer to the performance of the algorithm and hardware without human intervention, compared against a laboratory reference.
7. The Type of Ground Truth Used
While not explicitly stated, for blood glucose monitoring systems, the ground truth is established using a laboratory reference method (e.g., a YSI analyzer or similar highly accurate enzymatic assay, typically the hexokinase method). This is considered the gold standard for glucose measurement in blood samples.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or its size. For a glucose meter, the device is designed based on electrochemical principles and calibration protocols. While there is development and optimization, it's not typically described in terms of a "training set" like a machine learning algorithm. The "verification, validation and testing activities" refer to the final performance evaluation rather than a training phase.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and associated ground truth establishment, as typically understood in AI/ML, is not directly applicable or described for this type of medical device in the provided text. The calibration and development would be based on established chemical and electrical engineering principles, with reference to highly accurate laboratory methods for accuracy and linearity.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2016
INFOPIA CO., LTD. C/O PRISCILLA CHUNG LK CONSULTING GROUP 800 ROOSEVELT STE 417 IRVINE CA 92620
Re: K160365
Trade/Device Name: BLE Smart Blood Glucose Monitoring System. BLE Smart Professional Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: August 31, 2016 Received: September 2, 2016
Dear Priscilla Chung:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Katherine Serrano -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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Indications for Use
510(k) Number (if known) K160365
Device Name
BLE Smart Professional Blood Glucose Monitoring System
Indications for Use (Describe)
The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, calf and thigh and in venous whole blood.
The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System 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).
The BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K160365
Device Name
BLE Smart Blood Glucose Monitoring System
Indications for Use (Describe)
The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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).
The BLE Smart Blood Glucose Test Strips are for use with the BLE Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
(K160365)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 08/31/2016
1. Applicant / Submitter:
Infopia Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu, Anyang, Gyeonggi-do, Republic of Korea 14040 Tel : +82-31-460-0415 Fax : +82-31-460-0401
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine, CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
- Trade Name: BLE Smart Blood Glucose Monitoring System BLE Smart Professional Blood Glucose Monitoring System
- · Classification Name: Blood Glucose Test System
- Classification regulation: 21 CFR Part 862.1345, 21 CFR Part 862.1660 ▪ Product Code:
- NBW, LFR, JJX
4. Predicate Device:
K130181, GluNEO™ Blood Glucose Monitoring System & GluNEO™ Professional Blood Glucose Monitoring System by Infopia Co., Ltd.
5. Description:
BLE Smart Blood Glucose Monitoring System / BLE Smart Professional Blood Glucose Monitoring System consist of a meter, test strips, and control solutions (Level 1, Level 2 and level 3). These blood glucose test systems are an in vitro diagnostic device designed for measuring the concentration of glucose in blood by means of an electrical current produced in the test strip and sent to the meter for measurement.
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6. Indications for use:
BLE Smart Blood Glucose Monitoring System
The BLE Smart Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The BLE Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The BLE Smart Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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).
The BLE Smart Blood Glucose Test Strips are for use with the BLE Smart Meter to quantitatively measure glucose in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The BLE Smart Blood Glucose Control Solutions are for use with the BLE Smart Blood Glucose Monitoring System to check that the meter and test strips are working together properly and the test is performing correctly.
BLE Smart Professional Blood Glucose Monitoring System
The BLE Smart Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The BLE Smart Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The BLE Smart Professional Blood Glucose Monitoring System 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). The BLE Smart Professional Blood Glucose Test Strips are for use with the BLE Smart Professional Meter to quantitatively measure glucose in venous whole blood samples and
fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The BLE Smart Professional Blood Glucose Control Solutions are for use with the BLE Smart Professional Blood Glucose Monitoring System to check that the meter and test strips are working together properly and that the test is performing correctly.
7. Comparison to the Cleared Device
The modifications are as below.
י Adding Bluetooth Function
Bluetooth wireless technology is added to the BLE SmartMeter. The meter can communicate with smart devices such as a smart phone or a tablet via MyHealthPoint Listener App. The app directly allows the data to upload readings on MyHealthPoint Portal (K132930). The unmodified device (K130181) already had the data transfer function of transmitting the stored information (data) to PC via a USB cable.
The following modifications occurred due to adding Bluetooth module.
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- · Adding Bluetooth module chip
- · Modifications to hardware components and re-layout of PCB
- · Changes to Firmware
. Appearance of the BLE Smart Meter
- · The color and the texture of the meter housings have been changed.
- · The raw material of LCD Screen has been changed from PMMA to PET FLIM.
- · The texture of some parts (LCD Screen, Power button, Up/Down button, Back Case, Bottom Case, Battery cover) has been changed to Non-Etched (Gloss).
- · The color of deco also has been changed from orange to bluish-green per buyer (distributor)'s request.
. Device Name Change
The device name has changed from GluNEO™ Blood Glucose Monitoring System and GluNEO™ Professional Blood Glucose Monitoring System to BLE Smart Blood Glucose Monitoring System and BLE Smart Professional Blood Glucose Monitoring System.
Other than these modifications, the modified meter has the following similarities to the cleared device:
- · has the same intended use.
- · uses the same operating principle,
- · adopts the same use environment and calibration method.
8. Performance Data
Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter.
9. Conclusion
The conclusion drawn from the verification/validation activities is that the subject devices is substantially equivalent to the predicated device.
§ 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.