EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031

K101457 · Eps Bio Technology Corp. · NBW · Jul 1, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101457
• Device Name: EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyPlus mini R9N SMBG Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. This device is not intended for the diagnosis or screening of diabetes mellitus and is not intended for use in neonates. Alternate Site Testing (AST) in the EasyPlus mini R9N Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

Device Story

EasyPlus mini R9N SMBG system measures glucose in fresh capillary whole blood; samples obtained via fingerstick or forearm. System comprises meter, test strips, and control solutions. Used by patients at home or healthcare professionals in clinical settings to monitor diabetes management. Principle of operation involves electrochemical measurement of glucose concentration in blood sample applied to test strip. Meter processes electrical signal to calculate glucose level; displays result on screen. Provides quantitative data to assist in diabetes control; not for diagnostic or screening purposes. Requires steady-state conditions for alternate site testing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis (FMEA), and verification/validation testing of the modified hardware components.

Technological Characteristics

Electrochemical glucose monitoring system; consists of handheld meter, disposable test strips, and control solutions. Operates via enzymatic reaction on test strip; electrical signal measured by meter. Battery-powered. No connectivity features described.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (finger, palm, forearm, upper arm, calf, thigh) for home use by individuals with diabetes to monitor glycemic control. Not for diabetes diagnosis, screening, or neonatal use.

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: k101457

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 N Self Monitoring Blood Glucose System (k083099)

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 power source was changed from one AAA alkaline battery to two CR2032 batteries.
B. The physical appearance of the meter has changed.
C. The name of the device has changed from "EasyMax N" to "EasyPlus mini R9N".
D. The labeling was modified to reflect the changes to the device.

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

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: FMEA.
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.