NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System

K171480 · I-Sens, Inc. · NBW · Dec 13, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171480
• Device Name: NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 13, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. The NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip. The VeraSens Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The VeraSens Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. The VeraSens Blood Glucose Test Strips are for use with the VeraSens Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Device Story

Blood glucose monitoring system; measures glucose levels from capillary whole blood samples; utilizes electrochemical biosensor technology; modified to include Bluetooth module for wireless data transmission to mobile devices; intended for home use by patients; firmware updated to support Bluetooth pairing and automatic data transfer; healthcare providers access data via mobile device integration; facilitates patient self-management of glucose levels.

Clinical Evidence

No clinical data provided. Bench testing included disinfection efficacy studies using Clorox Germicidal Wipes (EPA Reg. No: 67619-12) demonstrating complete inactivation of HBV, and robustness studies confirming no performance degradation after 260 cleaning/disinfection cycles (simulating 5 years of use).

Technological Characteristics

Electrochemical glucose biosensor; includes Bluetooth module for wireless connectivity; firmware-based data management; compatible with mobile devices; validated for 260 cleaning/disinfection cycles using Clorox Germicidal Wipes.

Indications for Use

Indicated for single-patient home use for the monitoring of blood 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

• NoCoding1 Plus Blood Glucose Monitoring System (K160742)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: K171480

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.)

NoCoding1 Plus Blood Glucose Monitoring System, k160742

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. Addition of a Bluetooth module for the wireless transfer of data to mobile devices.
b. Software (firmware) changes include addition of Bluetooth pairing function, Bluetooth data transfer function including automatic data transfer to ensure all data are transferred to the mobile device when Bluetooth function is on.
c. The candidate device system is introduced with a new name "VeraSens Blood Glucose Monitoring System" in addition to the original predicate name "NoCoding1 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 specifications.

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

{1}

recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The NoCoding1 Plus Blood Glucose Monitoring System and the VeraSens Blood Glucose Monitoring System are intended for single-patient home use only. Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of viral hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipes (EPA Reg. No: 67619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 260 cleaning and disinfection cycles designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

2