ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM

K141867 · Roche Diagnostics · NBW · Mar 3, 2015 · Clinical Chemistry

Device Facts

• Record ID: K141867
• Device Name: ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Roche Diagnostics
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 3, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ACCU-CHEK Aviva Connect System is intended for single patient use.

Device Story

System measures blood glucose via amperometric detection using Mut. Q-GDH enzyme on capillary whole blood samples (0.6 µL). Device consists of meter, test strips, and control solutions. User applies blood to strip; meter calculates glucose concentration (20-600 mg/dL) in 5 seconds. Designed for single-patient home use. Modification from predicate includes USB port and BLE (Bluetooth Low Energy) for data transmission to personal computers/mobile devices. Meter features modified housing and button functionality. Provides quantitative results to aid diabetes management. No clinical decision-making automation described; output used by patient/physician for monitoring.

Clinical Evidence

Bench testing only. Performance data demonstrates the system meets requirements for intended use, including precision (SD ≤ 5.0 mg/dL for < 75 mg/dL; CV ≤ 5.0% for ≥ 75 mg/dL), hematocrit range (10-65%), and environmental operating conditions (57-100°F, 10-80% RH).

Technological Characteristics

Electrochemical glucose meter; BLE and USB connectivity; 3-button interface. Materials validated for 260 cleaning/disinfection cycles. Software includes embedded reporting features. Single-patient use design.

Indications for Use

Indicated for single patient use for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, or upper arm as an aid in monitoring 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

• ACCU-CHEK Aviva Plus System (K133862)

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 K141867

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 for the ACCU-CHEK Aviva Connect System:

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 System (k133862).

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. Changes to the meter housing including:
i. Button functionality from 2 to 3 buttons
ii. Addition of USB port
b. Addition of Bluetooth Low Energy (BLE) communications,
c. Removal of Alternate Site Testing (AST) claims for palm, upper arm, and forearm
d. Name change: ACCU-CHEK Aviva Plus System to ACCU-CHEK Aviva Connect System
e. Embedded reports available for transmission to a Personal Computer

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

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

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 ACCU-CHEK Aviva Connect System is intended for single patient use. Disinfection efficacy studies were performed by an outside commercial testing laboratory demonstrated complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Super Sani-Cloth (EPA Registration #9480-4). Robustness studies demonstrated that there was no change in performance, functionality or external materials after 260 cleaning and 260 disinfection cycles designed to simulate a 5 year use life of the device. Adequate instructions for the validated cleaning and disinfection procedures are provided in the labeling of the device.