ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM

K053529 · Lifescan, Inc. · NBW · Jan 17, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053529
• Device Name: ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Ultra 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Device Story

System measures glucose in fresh capillary whole blood; utilizes meter, test strips, control solution, and blood sampler. Designed for home use by patients or clinical use by professionals to monitor diabetes control. Modifications to predicate include updated meter software/firmware, ergonomic/physical design, and hardware changes. Operates via electrochemical sensing technology consistent with predicate. Provides quantitative glucose results to assist in clinical decision-making and diabetes management.

Clinical Evidence

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

Technological Characteristics

Electrochemical glucose measurement; consistent with predicate technology. Includes meter, test strips, control solution, and adjustable blood sampler. Modifications involve ergonomic/physical design and software/firmware updates. No changes to fundamental scientific technology or material composition.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for individuals with diabetes at home or by healthcare professionals in clinical settings. Indicated for use on finger, forearm, or palm.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k 053529

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.
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.
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 name change, software/firmware changes (changed software from Assembly Language to C, increased memory capacity from 150 to 500 records, and enhanced user interface), ergonomic/physical design changes (changed from segmented to dot matrix display, added backlight and backlight battery, improved chemically resistant coating on meter lens, change In number, function, shape of buttons and icons used, changed the meter housing shape, size and color), and hardware changes (changed from 4-bit to 16-bit microprocessor, including sufficient memory for software/firmware changes and printed circuit board modifications to accommodate the 16-bit microprocessor.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and all modifications from number 3 above.

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 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.