EasyMax BT Self-Monitoring Blood Glucose System

K182057 · Eps Bio Technology Corp. · NBW · Aug 24, 2018 · Clinical Chemistry

Device Facts

• Record ID: K182057
• Device Name: EasyMax BT Self-Monitoring Blood Glucose System
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 24, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is intended for single patient home use.

Device Story

EasyMax BT is a blood glucose monitoring system consisting of a meter and test strips. It uses an electrochemical biosensor with FAD glucose dehydrogenase (FAD-GDH) to measure glucose in capillary whole blood. The meter generates a current proportional to glucose concentration, displays the result, and stores up to 480 tests. The device is intended for home use by patients with diabetes. The primary modification from the predicate (EasyMax MU) is the addition of a Bluetooth dongle and firmware updates to enable wireless data transmission to a mobile device via the GlucoManager App. The healthcare provider or patient uses the displayed glucose values to monitor diabetes control. The system includes a control solution for performance verification.

Clinical Evidence

Bench testing only. Verification and validation activities included safety (IEC 61010-1, IEC 61010-2-101), EMC (IEC 60601-1-2, 61326-1), FCC testing, human factors (IEC 62366-1), and software validation (IEC 62304). No clinical trial data was required for this modification.

Technological Characteristics

Electrochemical biosensor using FAD glucose dehydrogenase and potassium ferricyanide mediator. Powered by two alkaline batteries. Dimensions: 95 x 50 x 15 mm. Connectivity: Bluetooth wireless data transfer to mobile app. Software: Firmware for Bluetooth pairing/transmission. Sterilization: Not specified.

Indications for Use

Indicated for single-patient home use (OTC) by individuals with diabetes to monitor blood glucose control. Not for neonates, diagnosis, or screening. Suitable for fingertip, palm, or forearm capillary blood; alternative site testing restricted to steady-state conditions.

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

• EasyMax MU Self-Monitoring Blood Glucose System (K121207)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k182057

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device: k121207, EasyMax Mu Self-Monitoring Blood Glucose System (For a preamendments device, a statement to this effect has been provided.)

2. Applicant’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 changes were for:

1) The addition of a Bluetooth dongle to be used with the meter.
2) Change in the system name from EasyMax MU Self-Monitoring Blood Glucose System to Easy Max BT Self-Monitoring Blood Glucose System.

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

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The device is intended for single patient home use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial laboratory testing services demonstrating complete inactivation of hepatitis B Virus (HBV) with PDI® Super SANI-CLOTH® Germicidal disposable wipes (EPA Reg. No: 9480-4). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter and lancing device (for single patient use only) after 10,000 cleaning and disinfecting cycles to validate cleaning and disinfecting once per week for single-patient use over 4 years.

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