Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

K150396 · Apex BioTechnology Corp. · NBW · Oct 14, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150396
• Device Name: Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 14, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Device Story

The AutoSure Voice II and AutoSure Voice II Pro are blood glucose monitoring systems. The device measures glucose levels in capillary whole blood samples. The system provides audible and visual results to assist users in managing diabetes. The modification involves updating the trade names and adding validated cleaning and disinfection instructions for both self-testing and multiple-patient use environments. The device is used by patients for self-testing or by healthcare professionals in clinical settings. The output is a blood glucose concentration value, which informs clinical decision-making regarding insulin dosing or dietary adjustments. The device materials were tested for robustness against specific EPA-registered disinfectant wipes to ensure performance is maintained over the device's intended lifespan.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence supported by non-clinical bench testing, specifically disinfection/viral inactivation and robustness testing.

Technological Characteristics

Glucose test system; electrochemical sensing principle. Includes voice functionality. Supports capillary whole blood testing. Identical to predicate except for updated disinfection protocols.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood from the finger, palm, or forearm for self-testing by people with diabetes or for multiple-patient use in professional healthcare settings to monitor glucose levels.

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 Blood Glucose Monitoring System and AutoSure Blood Glucose Test Strips (k102037)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Summary

To: THE FILE

RE: DOCUMENT NUMBER K150396

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.) K102037, AutoSure Voice II 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 the following items:

a. The trade name of the meter has changed from AutoSure Voice II Blood Glucose Monitoring System to the AutoSure Voice II Blood Glucose Monitoring System (for self-testing) and AutoSure Voice II Pro Blood Glucose Monitoring System (for multiple-patient use)

b. Addition of validated cleaning and disinfection instructions to the labeling for both the AutoSure Voice II and AutoSure Voice II Pro Blood Glucose Monitoring Systems

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

5. 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

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 sponsor has added validated cleaning and disinfection instructions to the labeling for the self-testing system, the AutoSure Voice II Blood Glucose Monitoring System. Disinfection efficacy studies were performed on the materials comprising the meter by outside commercial testing laboratories demonstrating complete inactivation of hepatitis B virus (HBV) or removal of HBsAg with the following disinfectants: Clorox Healthcare Bleach Germicidal and Disinfectant Wipes (EPA Registration Number: 67619-12), Dispatch Hospital Cleaner Disinfectant Towels with Bleach (EPA Registration Number: 56392-8), Medline Micro-Kill+ Disinfecting, Deodorizing, Cleaning Wipes with Alcohol (EPA Registration

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Number: 59894-10), and Medline Micro-Kill Bleach Germicidal Bleach Wipes (EPA Registration Number: 69687-1-37549). Each of these disinfectants was validated separately for use with the meter.

Robustness studies were also performed separately for the four disinfectants listed above, demonstrating that there was no change in performance or external materials of the meter following 1825 cleaning and disinfection cycles. The robustness studies were designed to simulate five years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

The sponsor has also added validated cleaning and disinfection instructions to the labeling for the multiple-patient use system, the AutoSure Voice II Pro Blood Glucose Monitoring System. Disinfection efficacy studies were performed on the materials comprising the meter by outside commercial testing laboratories demonstrating complete inactivation of hepatitis B virus (HBV) or removal of HBsAg with the same four disinfectants listed above. Each of these disinfectants was validated separately for use with the meter. Robustness studies were also performed separately for the four disinfectants listed above, demonstrating that there was no change in performance or external materials of the meter following 10,950 cleaning and disinfection cycles. The robustness studies were designed to simulate three years of multiple-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.