ELEMENT BLOOD GLUCOSE MONITORING SYSTEM

K113670 · Infopia Co, Ltd. · CGA · May 8, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113670
• Device Name: ELEMENT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Element™ Blood Glucose Monitoring System is for the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element The Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element ™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Element ™ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in the management of diabetes. Alternative site Testing (ventral palm, dorsal hand, upper arm, calf and/or thigh) should be done during steady- state times when glucose is not changing rapidly. The Element ™ Test Strips are for use with the Element™ Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh, The Element TM control solutions are for use with the Element ™ Blood Glucose Monitoring system to check that the meter and the test strips are working together properly and the test is performing correctly.

Device Story

System measures glucose concentration in capillary whole blood via electrical current generated in test strips; meter processes current to provide quantitative glucose reading. Used at home by patients with diabetes for self-monitoring; aids in diabetes management. Includes meter, test strips, and control solutions for system verification. Patient applies blood sample to strip; meter displays result. Supports alternative site testing during steady-state glucose levels. Device modifications from predicate include battery type, display icon location, LCD material, meter dimensions, and removal of voice function.

Clinical Evidence

Clinical performance evaluation conducted to validate consumer use and professional accuracy. Results demonstrated substantial equivalence to the predicate device. Non-clinical testing included verification, validation, and reliability testing, all meeting pre-determined pass/fail criteria. Disinfection study validated CaviWipes (EPA 46781-8) for 1,095 cycles (simulating 3 years) with no performance degradation.

Technological Characteristics

In vitro diagnostic glucose test system. Uses electrochemical sensing principle. Components: meter, test strips, control solutions. Modifications include updated battery, LCD material, and physical dimensions. Disinfection validated for 1,095 cycles. No specific software algorithm class or connectivity details provided.

Indications for Use

Indicated for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, 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 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.

Predicate Devices

• Element Plus Blood Glucose Monitoring System (k103021)

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: k113670

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) for the Element Blood Glucose Monitoring System:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: Infopia Co., LTD, Element Plus Blood Glucose Monitoring System, cleared under k103021.

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:
- Change the battery type from Alkaline AAA batteries to 3.0 V lithium DR2032 batteries
- Design of the bottom cover of the meter has changed slightly due to the change in battery
- Removal of the voice function
- Location of the display icons were changed
- Change in physical dimensions of the meter from 82Lx54Wx24H to 82Lx54Wx18H
- Change in weight of the meter from 69 g to 48 g (battery included)
- Change in the name from "Element plus Blood Glucose Monitoring System" to "Element Blood Glucose Monitoring System"

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: 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
i) 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 demonstrates 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 pre amendment) device.

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The device is intended for single-patient use only. CaviWipes (EPA registration #46781-8) were validated demonstrating complete inactivation of live virus for use with the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in the external materials of the modified meter and lancing device after 1,095 cleaning and disinfection cycles designed to simulate one cycle a day, over 3 years of single-patient use. The labeling has been revised for adequate instructions on the validated cleaning and disinfection procedures.