EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM

K133389 · Eps Bio Technology Corp. · NBW · Apr 15, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133389
• Device Name: EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 15, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The EM40 Pro Blood Glucose System is intended for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from fingertip. Testing is done outside use). It is intended for multiple-patient use in professional healthcare schings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of or screening for diabetes mellitus. The system consists of the EM40 Pro meter and the EM40 Pro meter only is used with the EM40 Pro test strips to quantitatively measure glucose in venous whole blood or fresh capillary whole blood from fingertip. The EM40 Glucose Control Solution For use with the EM40 Pro Blood Glucose System as a quality control check to verify the accuracy of blood glucose test results. The EM40 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forcarn. Testing is done outside the body (In Vitro diagnosic use), It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions. The system consists of the EM40 meter and the EM40 meter only is used with the EM40 meter only is used with the EM40 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm, The EM40 Glucose Control Solution is for use with EM40 Blood Glucose Self Monitoring System as a quality control check to verify the accuracy of blood glucose test results.

Device Story

System measures glucose in venous or capillary whole blood; utilizes test strips and meter. EM40 Pro intended for professional healthcare settings; EM40 Self-Monitoring intended for home use. Input: blood sample applied to test strip. Transformation: electrochemical reaction measured by meter. Output: quantitative glucose concentration displayed to user. Healthcare providers/patients use results to monitor diabetes control effectiveness. Quality control solution verifies accuracy. System requires single-use lancing devices.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Materials: Polycarbonate (PC). User interface: One front button, one side up/down button. Connectivity: Not specified. Sterilization: Not specified (disinfection validated for multi-patient use). Software: Modified to support new button interface.

Indications for Use

Indicated for single-patient (EM40) or multiple-patient (EM40 Pro) use for self-monitoring of blood glucose.

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

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER

k133389

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.

EG V1 (BL) Self-Monitoring Glucose Test System, EG V1 Pro Self-Monitoring Glucose Test System cleared under k101037

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:

- To add two additional names to the cleared system: EM40 Self-Monitoring Blood Glucose System, EM40 Pro Self-Monitoring Blood Glucose System
- The predicate device has two front buttons while the modified device has one front button and one up/down side button
- The predicate device is composed of ABS (Acrylonitrile Butadiene Styrene), PC (polycarbonate), and Rubber/TPE (Thermoplastic Elastomer) while the modified device is composed of PC only
- The software was modified to accommodate the new buttons
- The printed circuit board was modified to accommodate the new buttons

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

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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 sponsor's previously cleared device.

The devices are intended for single-patient (EM40) or multiple-patient (EM40 Pro) use. PDI SANI-CLOTH Germicidal disposable wipes (EPA Reg. No: 9480-4) were validated through disinfection efficacy studies demonstrating complete inactivation of hepatitis B (HBV) virus using materials comprising the meter. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate three years of multiple-patient use. This testing was also adequate to simulate 4 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.