ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

K081318 · Lifescan, Inc. · NBW · Jun 9, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081318
• Device Name: ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The OneTouch Zoom Diabetes Management Program is intended for use by patients with diabetes to track and manage their blood glucose data.

Device Story

Web-based diabetes management application; retrieves blood glucose data from Microsoft HealthVault; provides trending and reports for diabetes management. Includes stand-alone software driver (OneTouch Meter Drivers) to download data from LifeScan blood glucose meters to Microsoft HealthVault Connection Center. Used in home and clinical settings by patients and healthcare professionals. Healthcare providers review generated reports to evaluate historical glucose data, supporting clinical decision-making and diabetes management. System architecture is .NET-based client/server; runs on Windows 2003 server; client supports Internet Explorer 6.0+. Drivers support Windows XP SP2 and Windows Vista.

Clinical Evidence

No clinical data; bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) and ISO-14971 risk analysis.

Technological Characteristics

Web-based .NET client/server application. Connectivity via Internet to Microsoft HealthVault. Software-based data management and reporting. No change to fundamental scientific technology or material composition.

Indications for Use

Indicated for people with diabetes and healthcare professionals in home and clinical settings to review, analyze, and evaluate historical blood glucose test results to support diabetes management. Used as an accessory to LifeScan blood glucose monitoring systems.

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® Diabetes Management Software

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k081318

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the OneTouch Zoom Diabetes Management Program:

1. The name and 510(k) number of Lifescan, Inc.'s previously cleared device, In Touch Diabetes Management Software (renamed OneTouch Diabetes Management Software), cleared under k984527. (For a preamendments device, a statement to this effect has been provided.)

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 reduction in the number of reports from eleven to two and a change in data storage on a local database stored on the user's PC to a remote database hosted by Microsoft Corporation, connected via the Internet.

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.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis based on ISO-14971

revised: 8/1/03