CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM

K102049 · Taidoc Technology Corporation · NBW · May 27, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102049
• Device Name: CLEVER CHOICE VOICE+ BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Clever Choice Voice + Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in this system can be used only during steady-state blood glucose conditions. The Clever Choice Voice + Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor (glucose oxidase). User applies blood sample to test strip; meter processes signal to display glucose concentration. Designed for home use by single patient; includes speaking functionality for visually impaired. Modifications from predicate include updated outer casing, English-language audio output, and selectable measurement units (mg/dL or mmol/L). Output aids patient in monitoring diabetes control effectiveness.

Clinical Evidence

Bench testing only. Validation included cleaning/disinfection efficacy testing using Micro-Kill+ towels (EPA #59894-10-37549) demonstrating complete inactivation of live virus. Durability testing confirmed no change in performance or external materials after 5000 cleaning/disinfection cycles.

Technological Characteristics

Electrochemical biosensor using glucose oxidase. System includes meter, test strips, and control solutions. Features audio output for visually impaired. Supports mg/dL and mmol/L units. Software-controlled measurement and voice guidance.

Indications for Use

Indicated for single patient use for blood glucose monitoring.

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

• FORA V20 Blood Glucose Monitoring System (k100406)

Submission Summary (Full Text)

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k102049- Page 1 of 2

SPECIAL 510(k): Device Modification
OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k102049

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. FORA V20 Blood Glucose Monitoring System – k100406
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 change in the device name from FORA V20 to Clever Choice Voice+
- A change to the meter's dimensions and button locations
- A change in software to allow for changes in units of measurement (mg/dL-default and mmol/l)
- A change in software to set English as the only spoken language

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 – based on ISO 14971.
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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Reviewer Comments:

The device is intended for single patient use only. Micro-Kill+ cleaner disinfectant towels with EPA registration # 59894-10-37549 was validated demonstrating complete inactivation of live virus for use with the meter. The sponsor does not market a lancing device for use with the device. The sponsor also demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 5000 cleaning and disinfection cycles designed to simulate 5 years of device use. In addition, the sponsor provided a risk analysis specific to the potential harm due to infection. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures.