ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM

K082513 · Lifescan, Inc. · NBW · Oct 22, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082513
• Device Name: ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing 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 Vita™ 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 test strips and meter. User applies blood sample to test strip; meter performs electrochemical analysis; displays quantitative glucose result. Used by patients at home or healthcare professionals in clinical settings. Modifications from predicate include ergonomic design, removal of user coding step, and updated test strip electrode layout. Provides immediate feedback for diabetes management; aids in monitoring glycemic control.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of the modified features.

Technological Characteristics

Electrochemical glucose monitoring system. Components: meter, test strips, control solutions, lancing device, sterile lancets. Features modified electrode layout on test strips. Software/firmware updated to remove user coding requirement. Operates via capillary blood sample.

Indications for Use

Indicated for use by patients for the quantitative measurement of glucose in capillary whole blood.

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

• OneTouch® Select™ Blood Glucose Monitoring System (K072543)
• OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K082513

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.) k072543
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. No coding meter (compared to a manual code entry in the predicate)
B. Ergonomic/physical design and software/firmware changes including removal of user coding step and addition of ability to mark glucose results with 'post meal' flag.

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