EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

K111728 · Eps Bio Technology Corp. · CGA · Sep 16, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111728
• Device Name: EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 16, 2011
• 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 (EMV3 Self Monitoring Blood Glucose Test System) and multiple patient use in a professional healthcare setting (EMV3 Pro Self Monitoring Blood Glucose System).

Device Story

The EMV3 and EMV3 Pro are blood glucose monitoring systems used for quantitative glucose measurement in capillary whole blood. These devices are modifications of the EasyMax V system (k092894), featuring updated physical appearance, modified power button, and new trade names. The systems are intended for home use by patients or professional use in healthcare settings. The device utilizes disinfection protocols validated with PDI Super SANI-CLOTH Germicidal wipes to prevent bloodborne pathogen transmission, specifically HBV. Robustness testing confirmed performance stability after 10,000 cleaning and disinfection cycles, simulating over 4 years of home use or 3 years of professional use. The output is a blood glucose concentration value, which assists healthcare providers and patients in monitoring diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance verification of the glucose measurement system.

Technological Characteristics

Electrochemical glucose test system; consists of meter and test strips. Measures glucose in capillary whole blood. Includes quality control solution. Professional version (EMV3 Pro) restricted to fingertip; home version (EMV3) supports fingertip and forearm (alternative site testing).

Indications for Use

Indicated for quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

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: k111728

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.) EasyMax V Self Monitoring Blood Glucose Test System k092894

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 Physical Appearance of the meter has changed.
B. Modification to the power button.
C. The trade name of the meter has changed from EasyMax V (EMV) to EMV3 Self Monitoring and EMV3 Pro Self Monitoring Blood Glucose Systems.

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

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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The device is intended for single patient home use (EMV3 Self Monitoring Blood Glucose Test System) and multiple patient use in a professional healthcare setting (EMV3 Pro Self Monitoring Blood Glucose System). Disinfection studies were performed on the EMV3 Self Monitoring Blood Glucose Test System, the EMV3 Pro Self Monitoring Blood Glucose System and lancet device by outside commercial laboratory testing services to determine the disinfection efficacy of the meter and lancing device to the recommended cleaning and disinfection protocol, and its effectiveness in preventing the spread of bloodborne pathogens, particularly hepatitis B Virus (HBV). PDI® Super SANI-CLOTH® Germicidal disposable wipes (EPA Reg. No: 9480-4) were validated demonstrating complete inactivation of live virus for use with the meter and lancing device. 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 10,000 disinfecting cycles which represents > 4 years of cleaning after each use and disinfection once a week by lay-users and to simulate 3 years of use by healthcare professionals. Each robustness cycle tested consisted of one pre-clean wipe and one disinfecting wipe.