CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM

K121133 · I-Sens, Inc. · NBW · Jul 10, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121133
• Device Name: CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CareSens N Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm. thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N Voice 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 CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Voice Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites. The CareSens Control Solutions are for use with the CareSens N Voice Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.

Device Story

CareSens N Voice Blood Glucose Monitoring System measures glucose in capillary whole blood via amperometric electrochemical reaction on test strips. User inserts strip into meter; applies blood sample (min 0.5 µL). Meter generates small electrical current proportional to glucose concentration; converts current to glucose value using internal standard curve. Device features voice guidance, test strip ejector, hypoglycemia indicator, and memory for 500 results. Used by patients at home for diabetes management. Healthcare providers review stored results to assess glycemic control. System includes meter, test strips, control solutions, lancing device, and lancets. Designed for single-patient use; not for neonates or diagnostic screening.

Clinical Evidence

Bench testing only. Validation included risk analysis (FMEA) and verification of modified features. Cleaning and disinfection validation performed using Clorox Germicidal Wipes over 260 cycles to simulate 5 years of use, confirming no degradation in performance or materials.

Technological Characteristics

Amperometric glucose oxidase (Aspergillus sp.) biosensor. Measures electrical current proportional to glucose. Battery-powered (2x 1.5V AAA). Features: voice guidance, test strip ejector, 500-result memory, hypoglycemia indicator. Operating range: 20-600 mg/dL; 50-104°F; 10-90% humidity. Connectivity: None specified. Sterilization: Not applicable (test strips/meter).

Indications for Use

Indicated for single-patient, home-use by individuals with diabetes to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm as an aid in monitoring diabetes control. Not for neonatal use or diabetes screening/diagnosis.

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 N Blood Glucose Monitoring System (k083468)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K121133

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 for the CareSens N Voice Blood Glucose Monitoring System:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. CareSens N Blood Glucose Monitoring System k083468

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
- Addition of voice feature for user convenience
- Addition of user specified hypoglycemia indicator
- Changes to meter shell
- Change in battery type from two 3.0V lithium batteries to two 1.5V alkaline batteries
- Addition of test strip ejector
- Change in memory capacity from 250 measurements to 500 measurements
- Change in average days from 14 days to (1, 7, 14, 30, and 90 days; pre-meal and post-meal)
- Addition of temperature display
- Change in display of temperature error to Lo or Hi if operating outside of range

4. Comparison Information (similarities and differences) to applicant'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. (Failure Mode and Effect 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
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

{1}

2

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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 device.

The device is intended for single patient use only. Clorox® Germicidal Wipes cleaner disinfectant towels with EPA registration 67619-12 was validated demonstrating complete inactivation of live virus for use with the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 260 cleaning and disinfection cycles designed to simulate 5 years of device use. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures.