CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA

K120351 · I-Sens, Inc. · NBW · May 3, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120351
• Device Name: CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 3, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is intended for single patient home use (CareSens N POP BGMS).

Device Story

CareSens N Pop Blood Glucose Monitoring System (BGMS) is a modified version of CareSens N BGMS; used for home blood glucose monitoring. Device inputs include blood samples via test strips; processes electrochemical signals to determine glucose concentration. Modifications include ergonomic meter design; increased memory capacity (500 values); expanded averaging intervals (1, 7, 14, 30, 90 days); ambient temperature display; improved error messaging; test strip expiration indicator; and programmable hypoglycemic indicator. Device operated by patient at home. Output displayed on meter screen; informs patient of glucose levels for self-management. Validated for 260 cleaning/disinfection cycles using Clorox Germicidal Wipes to ensure material integrity and HBV inactivation.

Clinical Evidence

Bench testing only. Validation performed on new features (user interface, memory, averaging) to ensure proper operation. Disinfection studies conducted using Clorox Germicidal Wipes (EPA Reg. No: 67619-12) to confirm robustness against HBV and simulate 5 years of use (260 cycles) without performance degradation.

Technological Characteristics

Electrochemical blood glucose monitoring system. Ergonomic plastic meter housing. Features include memory storage for 500 values, multi-day averaging (1-90 days), ambient temperature sensor, and visual indicators for hypoglycemia and test strip expiration. Operates within 50–104 °F. Disinfection validated for use with Clorox Germicidal Wipes.

Indications for Use

Indicated for single patient home use for blood glucose monitoring.

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)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k120351

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.) CareSens N BGMS (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:

A. The trade name of the device has changed from CareSens N BGMS to CareSens N Pop Blood Glucose Monitoring System.

B. The physical appearance of the meter has changed to more ergonomic shape.

C. Increased memory with multiple dates averaging. Memory increased from 250 blood glucose values to 500 blood glucose values. Dates averaging were modified from 14 days averaging to 1, 7, 14, 30 or 90 days averaging (pre-meal, post-meal and total).

D. Ambient temperature display in Celsius and Fahrenheit.

E. Improved error messages: Er. 3 was modified to a more detailed error message relating to temperature "below 50°F / above 104°F" (the meters operating temperature is 50 – 104 °F).

F. The addition of a test strip expiration date indicator.

G. The addition of a hypoglycemic (HYPo) indicator which can be set as directed by healthcare professional.

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

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

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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.

The device is intended for single patient home use (CareSens N POP BGMS). Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial laboratory testing services demonstrating complete inactivation of hepatitis B Virus (HBV) with Clorox Germicidal Wipe (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies and 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 representing 5 years of single patient use. Each robustness cycle tested consisted of one pre-clean wipe and one disinfecting wipe. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.