CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)

K083468 · I-Sens, Inc. · NBW · Feb 10, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083468
• Device Name: CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR)
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 10, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The CareSens N Meter is used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf. CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for selftesting outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of diabetes without the guidance of healthcare professional. Testing sites include the traditional fingertip testing along with alternate sites testing on forearm, palm, thigh and calf. CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.

Device Story

CareSens N BGMS is an in vitro diagnostic system measuring glucose concentration in capillary whole blood. Input: capillary blood sample applied to CareSens N test strip. Principle: amperometric method using glucose oxidase enzyme; meter detects current proportional to glucose concentration. Key modification: automatic code identification via infrared sensors detecting patterns on test strips, eliminating manual coding. Features: 3-button interface, time-set alarms, 2-hour post-meal alarm, post-meal flagging. Used at home or point-of-care by patients or clinicians. Output: digital glucose reading on meter display. Benefits: simplifies user workflow, reduces errors from manual coding, aids diabetes management monitoring.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm modifications met predetermined acceptance criteria.

Technological Characteristics

Blood glucose monitoring system; auto-code test strip calibration; three-button user interface; reminder alarm functionality; post-meal flagging capability. Fundamental scientific technology consistent with predicate K080923.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood to monitor diabetes management effectiveness. For use by patients (home) or clinicians (clinical settings). Testing sites include fingertip, forearm, palm, thigh, and calf. Not for diabetes diagnosis or screening.

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

• K080923

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K083468

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):

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.) k080923
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:

A. Change in calibration method implementing an auto-code test strip.
B. Addition of reminder alarms.
C. Addition of post-meal flagging.
D. Change from two buttons to three buttons

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytes.

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
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 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.