AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM

K120649 · Apex BioTechnology Corp. · NBW · Jul 6, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120649
• Device Name: AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 6, 2012
• 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 use.

Device Story

AutoSure Voice 3 Plus is a blood glucose monitoring system for home use by patients with diabetes; includes voice functionality for visually impaired users. System uses capillary whole blood samples from fingertips, forearm, or palm. Device consists of a glucose meter and test strips; Contrex Plus III control solutions used for quality control. Operation involves applying blood to test strip; meter performs quantitative glucose measurement. Healthcare providers use output to monitor patient diabetes management. Relocation of operating buttons from front to side of meter is the primary design change from predicate.

Clinical Evidence

No clinical data. A user survey was conducted to demonstrate substantial equivalence in ease-of-use following the relocation of the operation buttons.

Technological Characteristics

Glucose monitoring system; handheld meter with lancing device. Modifications include relocated buttons and circuit board update. Validated for chemical resistance to Dispatch Hospital Cleaner Disinfectant Towels with Bleach. Fundamental sensing technology unchanged from predicate.

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

• AutoSure Voice II Plus Blood Glucose Monitoring System (k113098)

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 k120649

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.) k113098 AutoSure Voice II Plus Blood Glucose Monitoring System.

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 slightly changed

a. The three operating buttons are relocated from the front of the glucose meter to the left side of the glucose meter. The relocation of the operating buttons required a circuit board change and a labeling change

b. Weight: from 79g to 75g±1 with batteries

B. The name of the device has changed from "AutoSure Voice II Blood Glucose Monitoring System" to "AutoSure Voice 3 Plus Blood Glucose Monitoring System"

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

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.

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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.

The device is intended for single-patient use. Disinfection efficacy studies were performed on materials from the AutoSure Voice II Plus meter and lancing device (k113098) by an outside commercial laboratory to demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant Dispatch Hospital Cleaner Disinfectant Towels with Bleach disposable wipes (EPA Reg. No: 56392-8). Robustness studies were performed on the AutoSure Voice 3 Plus glucose meter to show that there was no change in performance or in the external materials of the meter and lancing device after 1825 of cleaning and disinfection cycles designed to simulate one cycle a day, over at least 5 years of single-patient use. Each robustness cycle consisted of one pre-clean wipe and one disinfection wipe. The labeling has been revised for adequate instructions on the validated cleaning and disinfection procedures.