EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K121207 · Eps Bio Technology Corp. · LFR · May 18, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121207
• Device Name: EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: May 18, 2012
• 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 (EASYMAX MU Self-monitoring Blood Glucose System) and multiple patient use in a professional healthcare setting (EASYMAX MU Pro Self-monitoring Blood Glucose System).

Device Story

EasyMax MU/MU Pro systems measure glucose in whole blood samples; electrochemical biosensor technology; test strips inserted into handheld meter; meter displays quantitative glucose concentration; used by patients (home) or healthcare professionals (clinical); aids diabetes management; results inform glycemic control decisions; control solution verifies accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrochemical glucose biosensor; handheld meter with disposable test strips; quantitative measurement; battery-powered; non-sterile.

Indications for Use

Indicated for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, or forearm by people with diabetes at home or by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k121207

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.) k112901 EME Self Monitoring Blood Glucose System, EME Pro Self Monitoring Blood Glucose 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:

A. The trade name of the device has changed from EME Self-monitoring Blood Glucose System to EASYMAX MU Self-monitoring Blood Glucose System and EME Pro Self-monitoring Blood Glucose System to EASYMAX MU Pro Self-monitoring Blood Glucose System respectively.

B. Relocation of strip ejector from side to the top of the meter.

C. Addition of the power button.

D. Size and weight changes from 98 x 57 x 22 mm to 95 x 50 x 15 mm (HxWxD) and from 43.2g to 39.1g respectively.

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

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

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.

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2

The device is intended for single patient home use (EASYMAX MU Self-monitoring Blood Glucose System) and multiple patient use in a professional healthcare setting (EASYMAX MU Pro Self-monitoring Blood Glucose System). 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 and cleaning and disinfecting after every use by healthcare professionals over 3 years. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.