BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

K160365 · Infopia Co, Ltd. · NBW · Sep 28, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160365
• Device Name: BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 28, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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. 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.

Device Story

System measures glucose concentration in capillary or venous whole blood via electrical current generated in test strips; meter processes current to calculate glucose level. Used in home (single-patient) or professional healthcare settings (multi-patient). Features Bluetooth wireless connectivity for data transmission to smart devices (phone/tablet) via MyHealthPoint Listener App; data uploads to MyHealthPoint Portal. Replaces previous USB-based data transfer. Healthcare providers/patients view results on meter display or app to monitor diabetes control effectiveness. Benefits include convenient data tracking and management.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance, functionality, and reliability against pre-determined pass/fail criteria. Disinfection study validated CaviWipes (EPA Reg No. 46781-8) for effective inactivation of live virus on meter surfaces.

Technological Characteristics

Electrochemical glucose biosensor. Features integrated Bluetooth module for wireless data transmission. Housing materials updated for durability/disinfection compatibility. Powered by internal battery. Software-controlled data processing. Disinfection validated for multi-patient use via CaviWipes (EPA Reg No: 46781-8).

Indications for Use

Indicated for quantitative measurement of glucose in capillary whole blood from the finger, palm, or forearm. Intended for use by people with diabetes at home (single-patient version) or by healthcare professionals in clinical settings (professional version) to monitor glucose levels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• GluNEO™ Blood Glucose Monitoring System & GluNEO™ Professional Blood Glucose Monitoring System (K130181)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K160365

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) K130181, GluNEO Blood Glucose Monitoring System, GluNEO Professional Blood Glucose Monitoring System

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the following items:

a. Addition of Bluetooth module to the meter for wireless data transfer to mobile devices.
b. Change in material, color and texture of BLE Smart and BLE Smart Professional meter housing and LCD screen.
c. The trade name of the system has changed from GluNEO Blood Glucose Monitoring System and GluNEO Professional Blood Glucose Monitoring System to the BLE Smart Blood Glucose Monitoring System and BLE Smart Professional Blood Glucose Monitoring System.
d. The trade name of the glucose control solution has changed from GluNEO Glucose Control Solution and GluNEO Glucose Control Solution to the BLE Smart Blood Glucose Control Solutions and BLE Smart Professional Blood Glucose Control Solutions.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and device performance and specifications.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The BLE Smart Blood Glucose Monitoring Meter is intended for single patient use only. The BLE Smart Professional Blood Glucose Monitoring Meter is intended for multiple-patient use in professional healthcare settings. Disinfection efficacy studies were performed on the material comprising the meter by an outside commercial testing laboratory demonstrating complete

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inactivation of duck hepatitis B virus (surrogate virus for human hepatitis B virus) with CaviWipes (EPA Registration Number: 46781-8). Robustness studies were also performed separately for the CaviWipes demonstrating that there was no change in performance or external materials of the meter following 10,950 cleaning and disinfection cycles. The robustness studies were designed to simulate three years of multiple-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.