ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION

K103278 · I-Sens, Inc. · CGA · Oct 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103278
• Device Name: ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
• Applicant: I-Sens, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for single patient use only.

Device Story

ACURA Plus Blood Glucose Monitoring System; modified version of CareSens N system. Modifications include: meter shell redesign, strip port repositioning, added strip ejector, backlight, increased memory capacity, extended average day calculations, additional alarm functions, and updated temperature error messaging. Device measures blood glucose levels; intended for single patient use. Validated for cleaning/disinfection using Clorox Germicidal Wipes (EPA 67619-12) for 260 cycles, simulating 5 years of use without performance degradation or material damage. Operates as a point-of-care diagnostic tool for patient self-monitoring.

Clinical Evidence

Bench testing only. Validation study conducted to verify correct operation of modified features (casing and memory display). Results confirmed modified features operated properly.

Technological Characteristics

Amperometric glucose oxidase (Aspergillus sp.) sensing. Quantitative measurement. Meter (Model GM505RA) with test strips and control solutions. Software-based memory storage and averaging.

Indications for Use

Indicated for people with diabetes for self-monitoring of blood glucose levels using capillary whole blood from fingertips or alternate sites (forearm, palm, thigh, calf). Not for neonates, not for diagnosis or screening of diabetes. Alternate site testing restricted to steady-state glucose conditions.

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: k103278

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 ACURA Plus Blood Glucose Monitoring System:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: i-Sens Inc., 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:

Meter shell and strip port position, temperature error message, increased memory, more average days, additional alarm function, strip ejector, and backlight.

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 device.

The device is intended for single patient use only. Clorox® Germicidal Wipes cleaner disinfectant towels with EPA registration 67619-12 was 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 260 cleaning and disinfection cycles designed to simulate 5 years of device use.