COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION

K103396 · I-Sens, Inc. · NBW · Sep 27, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103396
• Device Name: COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION
• Applicant: I-Sens, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The iSens COOL Blood Glucose Monitoring System is intended for single patient home use.

Device Story

iSens COOL Blood Glucose Monitoring System; modified version of CareSens N (K083468). Modifications include meter outer casing design and test strip connector pattern. Device used for home blood glucose monitoring by patients. Validated for use with Clorox Germicidal Wipes (EPA Reg. No: 67619-12); testing confirmed no performance degradation or material damage after 520 cleaning/disinfection cycles, simulating 5 years of use. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only. Validation performed on cleaning/disinfection durability using Clorox Germicidal Wipes over 520 cycles to simulate 5 years of use; results demonstrated no change in device performance or external materials.

Technological Characteristics

Blood glucose monitoring system; modified outer casing and test strip connector pattern. Validated for chemical compatibility with Clorox Germicidal Wipes (EPA Reg. No: 67619-12).

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 (k)103396

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.) k083468, CareSens N Blood Glucose Monitoring System

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.

The changes were for a design change of the meter outer casing and the connector pattern of the test strip.

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

Reviewer Comments:

The iSens COOL Blood Glucose Monitoring System is intended for single patient home use. Clorox® Germicidal Wipes (EPA Reg. No: 67619-12) were 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 520 cleaning/disinfection cycles (each cleaning/disinfection cycle includes 260 pre-cleaning and 260 disinfection wipes adding up to a total of 520 wipes) designed to simulate 5 years of device use. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures.