ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528

K062434 · Agamatrix · NBW · Nov 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062434
• Device Name: ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The Zero-Click™ Data Management System is intended for use in the home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the AgaMatrix's Liberty™ Blood Glucose Monitoring System. The Zero-Click™ Data Management System allows users to download Blood glucose reading automatically from the meter to the PC without clicking a button.

Device Story

Zero-Click™ Data Management System is an optional software accessory for AgaMatrix Liberty™ Blood Glucose Monitoring System; facilitates data transfer from meter to PC. Input: blood glucose test results, date, and time from meter memory via proprietary USB cable. Operation: automatic data upload without user button-press; software runs on Microsoft Windows. Output: reports, graphs, and statistics based on user-selectable date intervals and target ranges. Used in home and professional settings by patients and healthcare professionals. Benefit: eliminates manual data logs; provides enhanced glucose reading trends and statistics to support diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of software modification.

Technological Characteristics

Software-based data management accessory; operates on Microsoft Windows platform. Connectivity via proprietary USB cable for data transfer from blood glucose meter. No specific materials or sterilization required as it is a software-only accessory.

Indications for Use

Indicated for use by persons with diabetes (home/OTC) or healthcare professionals (clinical setting) to review, analyze, and evaluate glucose test results to support diabetes management programs.

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

• FreeStyle™ Connect Data Management System (k9944333)

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 k062434

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. AgaMatrix Liberty Blood Glucose Monitoring System, k052762
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 the addition of an optional accessory called the Zero-Click Data Management System software, which uploads the meter readings into various reports as an aid to the management of diabetes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, user interface, hardware, software and electrical safety.
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.