GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE

K082486 · Bayer Healthcare, LLC · NBW · Oct 8, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082486
• Device Name: GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 8, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

GLUCOFACTS® Express Diabetes Management Software is an over-the-counter software program for use by health care professionals and patients with diabetes for transferring blood glucose data from a blood glucose meter to a personal computer for the purpose of viewing and printing reports that display blood glucose readings from Bayer's CONTOUR®, CONTOUR® TS, BREEZE®, and BREEZE®2 blood glucose meters.

Device Story

Software application transfers blood glucose results, time, date, and markers from Bayer blood glucose meters (CONTOUR, CONTOUR TS, BREEZE, BREEZE2) to a personal computer via serial or USB cable. Used by patients at home or healthcare professionals in clinics. Transforms raw meter data into five visual formats: electronic logbook, glucose trend by date, daily trend (standard day), weekly trend (standard week), and summary charts (histogram/pie chart). Enables printing of reports. Assists users in visualizing glucose patterns to support diabetes management decisions.

Clinical Evidence

Performance assessed in a study with 51 participants (43 lay users, 8 healthcare professionals). Study demonstrated ease of use and understandability of results.

Technological Characteristics

Software-based diabetes management system. Architecture: Java-based. Connectivity: PC-based with automatic meter detection and web-based update capability. Features: glucose range/alarm configuration, automated report generation, simplified UI/UX.

Indications for Use

Indicated for patients with diabetes and healthcare professionals to transfer, review, and analyze blood glucose data from specific Bayer meters to support diabetes management. Suitable for home and clinical use.

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

• Ascensia® Glucofacts® Data Management System (k024234)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k082486

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 Glucofacts Express Diabetes Management Software:

1. The name and 510(k) number of Bayer Healthcare's Previously Cleared Device, Ascensia Glucofacts Data Management System, cleared under k024234. (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 removal of PC database; written in Java; ability to set newer meter alarm clock and glucose range features; web based software updates; automatic report generation upon meter connection; auto-detect meter on any port; simpler lay user terminology; use of the same icons used on compatible meters; date range button, new user interactive features and a quick reference guide.

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 – Software and Human Factors Validation Protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA)