CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER

K132288 · I-Sens, Inc. · NBW · Nov 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132288
• Device Name: CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The CareSens N Voice Multi 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 system is intended for use outside the body (in vitro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N Voice Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites. The meter has a speaking function but it is not intended for use by the visually impaired persons.

Device Story

System consists of blood glucose meter, test strips, and control solutions. Uses electrochemical biosensor technology; reagent on test strip generates small electrical current proportional to glucose concentration in whole blood sample. Meter converts current to glucose concentration value. Designed for multiple-patient use in professional healthcare settings; requires use with auto-disabling, single-use lancing device. Healthcare providers use output to monitor diabetes control effectiveness. Device includes speaking function for audio output, though not intended for visually impaired users. Disinfection protocol using Clorox Germicidal Wipes validated for 10,950 cycles to prevent blood-borne pathogen spread (e.g., HBV) in multi-patient environments.

Clinical Evidence

Bench testing only. Robustness studies performed to validate cleaning and disinfection efficacy for multiple-patient use. Testing demonstrated no change in performance or external materials after 10,950 cleaning and disinfection cycles using Clorox Germicidal Wipes (EPA #67619-12), simulating 3 years of use.

Technological Characteristics

Electrochemical glucose meter; handheld form factor; validated for multiple-patient use via specific cleaning/disinfection protocols; materials tested for chemical resistance to Clorox Germicidal Wipes.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm, thigh, calf) in professional healthcare settings for multiple-patient diabetes monitoring. Contraindicated for neonates, diabetes diagnosis, or screening. Not intended for visually impaired users despite speaking function.

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 Voice Blood Glucose Monitoring System (k121133)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k132288

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): CareSens N Voice Multi Blood Glucose Monitoring System

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.) CareSens N Voice Blood Glucose Monitoring System; k121133

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:
1. Adding an additional name to their cleared system: CareSens N Voice Multi Blood Glucose Monitoring System
2. To add validated cleaning and disinfection instructions for multiple patient use to the labeling.

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.

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

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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.

**Infection Control Studies:** The device system is intended for multiple-patient use. Disinfection efficacy was validated in k121133. Robustness studies were performed by the sponsor demonstrating that there was no change in the performance or external materials of the meter after 10,950 cleanings and 10,950 disinfection cycles with the Clorox Germicidal Wipes (EPA registration # 67619-12). The robustness studies were designed to simulate 3 years of multiple patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.