CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System

K170614 · I-Sens, Inc. · NBW · Oct 19, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170614
• Device Name: CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier 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 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Device Story

CareSens N Premier/BT systems are electrochemical blood glucose monitors for home use by patients with diabetes. Input: fresh capillary whole blood via test strip. Operation: electrochemical biosensor measures electrical current generated by glucose oxidase reaction; amperometric method. Output: blood glucose concentration (mg/dL) displayed on meter screen. BT model includes Bluetooth for wireless data transfer to mobile devices (SmartLog App); non-BT model uses USB. Used by patients for self-monitoring; results aid in diabetes management. Benefits: convenient, rapid (5s) glucose monitoring to track control effectiveness.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance, functionality, and reliability against pre-determined criteria. Disinfection studies using Clorox Germicidal Wipes demonstrated complete inactivation of HBV and confirmed that 260 cleaning/disinfection cycles (simulating 5 years of use) did not affect device performance or material integrity.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme. Amperometric measurement. Power: two 3.0V lithium batteries (CR2032). Materials: PC, PMMA, POM, TPE. Connectivity: Bluetooth (BT model) or USB. Form factor: handheld meter with screen and test strip port. Single-patient use.

Indications for Use

Indicated for single patient home 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

• NoCoding1 Plus Blood Glucose Monitoring System (k160742)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k170614

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:

The two meters in this submission are identical except for the name and the addition of Bluetooth to one of the meters

a. The trade name was changed from NoCoding1 Plus Blood Glucose Monitoring System to CareSens N Premier Blood Glucose Monitoring System and CareSens N Premier BT Blood Glucose Monitoring System
b. The meter shell color was changed from white to black (upper case) and light gray to black (lower case)
c. Button positioning was changed from the sides to the front of the meter
d. The material of the buttons was changed from Polycarbonate (PC) to Silicone Rubber and color changed from gray to black
e. The material of the meter screen was changed from PC to Acrylic
f. The material of the foot of the meter changed from Thermoplastic Polyurethane (TPU) to Thermoplastic elastomer (TPE)
g. Addition of a test strip ejection button
h. Addition of backlight capability to the LCD
i. Addition of a Bluetooth module to the CareSens N Premier BT Blood Glucose Monitoring System for the wireless transfer of data to mobile devices

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

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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 CareSens N Premier Blood Glucose Monitoring System and the CareSens N Premier BT Blood Glucose Monitoring System are intended for single patient home use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial laboratory testing services demonstrating complete inactivation of hepatitis B Virus (HBV) with Clorox Germicidal Wipe (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles representing 5 years of single patient use. Each robustness cycle tested consisted of one pre-clean wipe and one disinfecting wipe. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.