CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION

K120759 · I-Sens, Inc. · CGA · Jun 5, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120759
• Device Name: CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
• Applicant: I-Sens, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jun 5, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device system is intended for single-patient use only.

Device Story

CareSens N Mini Blood Glucose Monitoring System; modified version of CareSens N Blood Glucose Monitoring System (k083468). Modifications include reduced meter dimensions (88Lx30Wx14.5H mm), reduction from two to one lithium battery, and removal of data transmission capability. Device intended for single-patient use; validated for cleaning and disinfection using Clorox Germicidal wipes (EPA #67619-12) to ensure inactivation of HBV. Robustness testing simulated 5 years of use (260 cleaning/disinfection cycles).

Clinical Evidence

Bench testing only. Validation included meter function tests, system accuracy tests, and human factor studies to confirm usability and performance equivalence to the predicate device. Disinfection studies validated robustness and effectiveness against HBV using CLOROX GERMICIDAL Wipes, simulating 5 years of use.

Technological Characteristics

Blood glucose monitoring system; battery-powered (single lithium battery). Dimensions: 88Lx30Wx14.5H mm. Materials validated for chemical resistance to Clorox Germicidal wipes. No data transmission capability.

Indications for Use

Indicated for single-patient 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: k120759

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) for the CareSens N Mini Blood Glucose Monitoring System:

1. The name and 510(k) number of 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:
- Reduced meter size, changed from 93Lx47Wx15H (mm) to 88Lx30Wx14.5H (mm).
- Reduced number of batteries from two lithium batteries to one lithium battery.
- Removed data transmission capability.

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.
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.

The device system is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen

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disinfectant, Clorox Germicidal wipes (EPA Registration #67619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter and lancing device after 260 cleanings and 260 disinfection steps with the Germicidal wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.