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

K201394 · I-Sens, Inc. · NBW · Oct 5, 2021 · Clinical Chemistry

Device Facts

• Record ID: K201394
• Device Name: CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 5, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device systems are intended for single-patient use only.

Device Story

CareSens N Feliz BT Blood Glucose Monitoring System measures glucose in fresh capillary whole blood samples from fingertips. System consists of CareSens N Blood Glucose Test Strips and CareSens N Feliz BT Blood Glucose Meter. Used by people with diabetes at home for self-monitoring of glycemic control. Device provides quantitative glucose concentration output to user. Intended for single-patient use; not for neonates or diabetes diagnosis/screening.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence is based on bench testing and comparison to the predicate device.

Technological Characteristics

Amperometric glucose test system. Powered by one 3.0V CR2032 lithium battery. Features micro USB data port and Bluetooth (BT model). Dimensions: 93.5 x 43.9 x 14.9 mm. Materials validated for 260 cleaning/disinfection cycles with EPA-registered bleach wipes.

Indications for Use

Indicated for single-patient use as a blood glucose monitoring system for the quantitative measurement of glucose in capillary whole blood.

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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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K201394

B Applicant

i-SENS, Inc.

C Proprietary and Established Names

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

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: NoCoding1 Plus Blood Glucose Monitoring System, k160742.
2. Submitter's statement that the INDICATIONS FOR USE/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).

A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- Change in name from NoCoding1 Plus Blood Glucose Monitoring System to CareSens N Feliz Blood Glucose Monitoring System and CareSens N Feliz BT Blood Glucose Monitoring System.
- Changes to the meter housing and appearance that included changes to button positions, addition of a test strip ejection button and a change in meter dimensions from 95 x 49 x 17.5 mm to 93.5 x 43.9 x 14.9 mm.
- Change from phone jack to micro USB data transmission capability.
- Change from two 3.0 V lithium batteries (disposable, type CR2032) to one 3.0 V lithium battery (disposable, type CR2032).
- Addition of settable indicators for hypoglycemia, hyperglycemia and normal range indicators.
- Addition of Bluetooth functionality to the CareSens N Feliz BT Blood Glucose Monitoring System only.

3. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

4. 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 device systems are intended for single-patient use only. Disinfection efficacy studies were performed using the external meter materials by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with Clorox Healthcare Bleach Germicidal Wipes (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies demonstrating that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles using the chosen wipe representing 5 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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