ACCU-CHEK AVIVA PLUS SYSTEM

K133862 · Roche Diagnostics Corporation · NBW · Apr 29, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133862
• Device Name: ACCU-CHEK AVIVA PLUS SYSTEM
• Applicant: Roche Diagnostics Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 29, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Plus 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 to monitor the effectiveness of diabetes control. The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The ACCU-CHEK Aviva Plus Test Strips are for use with the ACCU-CHEK Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Device Story

System consists of ACCU-CHEK Aviva meter and Aviva Plus test strips. Device measures glucose in capillary whole blood samples. User applies blood to test strip; meter performs quantitative measurement. Designed for single-patient home use by individuals with diabetes. Modification from predicate involves removal of code key requirement. Output displayed on meter screen to assist users in monitoring diabetes control. No remote processing or cloud connectivity described.

Clinical Evidence

Bench testing only. Studies included software validation, EMC safety, linearity, accuracy, and lay user studies. Robustness and disinfection efficacy testing performed for 260 cycles, simulating 5-year use life; validated complete inactivation of HBV.

Technological Characteristics

Glucose dehydrogenase-based blood glucose monitoring system. Consists of meter and test strips. Modification involves removal of code key functionality. Intended for in vitro diagnostic use.

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

• ACCU-CHEK Aviva Plus System (K101299)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K133862

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.) ACCU-CHEK Aviva Plus Blood Glucose Monitoring System (k101299)

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 device has a modified black outer housing
B. Change to universal code lot parameters contained within the meter and removal of code key port

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. Studies performed include software validation, electric and magnetic (EMC) safety, linearity, accuracy and lay user studies. Additionally, the sponsor performed disinfection and robustness testing on the proposed device.

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.

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. Usability studies were conducted to demonstrate that the users could still use the devices with the button modifications. 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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The ACCU-CHEK Aviva Plus Blood Glucose Monitoring System is intended for single-patient use. Disinfection efficacy of the Super Sani-cloth Germicidal Wipes (with EPA registration# 9480-4) was validated using materials from the meter demonstrating complete inactivation of hepatitis B virus (HBV).

The sponsor also performed robustness studies demonstrating that there was no change in performance or in the materials of the meters after 260 cleaning and disinfection cycles designed to simulate a 5 year use life of the device. Adequate instructions for the validated cleaning and disinfection procedures have been reflected in the labeling of the devices.