CareSens S Clear BT Blood Glucose Monitoring System

K192859 · I-Sens, Inc. · NBW · Jan 24, 2020 · Clinical Chemistry

Device Facts

• Record ID: K192859
• Device Name: CareSens S Clear BT Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 24, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device system is intended for single-patient use only.

Device Story

CareSens S Clear BT Blood Glucose Monitoring System measures glucose in fresh capillary whole blood via test strips. Used by patients with diabetes at home for self-monitoring. Device consists of a meter and test strips; provides quantitative glucose results to aid diabetes management. Bluetooth connectivity enables data transmission. Single-patient use only.

Clinical Evidence

Bench testing only. Performance evaluated through accuracy and precision studies comparing system results to laboratory reference methods. Results demonstrate system meets established accuracy requirements for blood glucose monitoring systems.

Technological Characteristics

Electrochemical glucose measurement. Powered by two 3.0V CR2032 lithium batteries. Connectivity via Bluetooth and micro-USB. Features test strip ejector. Dimensions: 93.5 x 43.9 x 14.9 mm. Validated for cleaning/disinfection with Clorox Germicidal Wipes.

Indications for Use

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

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

• CareSens S Fit Blood Glucose Meter (K180866)

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

K192859

B Applicant

i-SENS, Inc.

C Proprietary and Established Names

CareSens S Clear 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. The CareSens S Fit Blood Glucose Meter, k180866.
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).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

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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:

- Bluetooth connectivity was added to the meter.
- Data port was changed from a SMD type connector to a micro-USB port
- Dimensions of the meter were changed from 95 x 49 x 17.5 (mm) to 93.5 x 43.9 x 14.9 (mm)
- Meter was changed to add a test strip ejector
- Power source was changed from one 3.0 V lithium battery (CR2032) to two 3.0 V lithium battery (CR2032)
- Change in name from CareSens S Fit Blood Glucose Monitoring System to CareSens S Clear BT Blood Glucose Monitoring System.

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

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 device system is intended for single-patient use only. Disinfection efficacy studies were performed on the external meter materials by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with Clorox 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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