CareSens S Fit BT Blood Glucose Monitoring System

K193590 · I-Sens, Inc. · NBW · Jan 17, 2020 · Clinical Chemistry

Device Facts

• Record ID: K193590
• Device Name: CareSens S Fit BT Blood Glucose Monitoring System
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 17, 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

System comprises CareSens S Fit BT meter and CareSens S test strips; measures glucose in fresh capillary whole blood from fingertips. Used by patients at home for self-monitoring of diabetes control. Device utilizes electrochemical biosensor technology; blood sample applied to test strip; meter performs quantitative analysis; displays glucose concentration. Intended for single-patient use only; not for neonates. Provides real-time glucose data to assist patients in managing diabetes.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the BLE modification. Disinfection efficacy and material robustness studies were previously established in K180866.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Modification: addition of Bluetooth Low Energy (BLE) wireless module. Materials validated for 260 cleaning/disinfection cycles (simulating 5 years of use) using Clorox Healthcare Bleach Germicidal Wipes. Fundamental sensing technology unchanged from K180866.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood 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

• CareSens S Fit Blood Glucose Monitoring System (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

K193590

B Applicant

i-SENS, Inc.

C Proprietary and Established Names

CareSens S Fit 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 Monitoring System, 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).
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

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 the addition of bluetooth low energy (BLE) wireless communication capability to the meter.

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 previously performed (k180866) on the external materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Healthcare Bleach Germicidal Wipes (EPA Registration #67619-12). A robustness study was also previously conducted (k180866) by the sponsor demonstrating that there was no change in performance or in the external materials of the meter after 260 cleaning and disinfection cycles using the Clorox Healthcare Bleach Germicidal Wipes. The robustness studies were designed to simulate 5 years of single-patient device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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