ACON ON CALL DIABETES MANAGEMENT SOFTWARE

K131469 · ACON Laboratories, Inc. · NBW · Jan 6, 2014 · Clinical Chemistry

Device Facts

• Record ID: K131469
• Device Name: ACON ON CALL DIABETES MANAGEMENT SOFTWARE
• Applicant: ACON Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 6, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The On Call® Diabetes Management Software is an optional software accessory to be used with the compatible On Call Glucose Meters, such as On-Call Plus glucose meter, On-Call Chosen glucose meter, On-Call Vivid glucose meter and On-Call Express glucose meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.

Device Story

On Call® Diabetes Management Software (formerly ACON On Call® Plus Diabetes Monitoring Software) is a PC-based application for managing blood glucose data. It receives data via USB cable from compatible glucose meters (On-Call Plus, Chosen, Vivid, Express). The software processes, stores, and displays glucose readings, allowing users to filter data by meal markers (Before Meal, After Meal, Night). It is intended for use by patients or healthcare providers to track glycemic trends. Modifications include migration from Visual Basic to Delphi, automated data port searching, integrated USB driver installation, and flexible data set display options. The device facilitates clinical decision-making by providing organized glucose history and trend analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based data management system; operates on personal computers; connects to glucose meters via data cable; provides data visualization (tables/graphs); does not perform diagnostic analysis or treatment recommendations.

Indications for Use

Indicated for use by patients and healthcare professionals to transfer, organize, and display glucose data from compatible On Call glucose meters in tables and graphs. No specific age or disease state restrictions; not for medical treatment or dosage recommendations.

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

• On Call Diabetes Management Software (K113566)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k131469

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.) ACON On Call® Plus Diabetes Monitoring Software (k101371).

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. The name of the device has changed from ACON On Call® Plus Diabetes Monitoring Software to On Call® Diabetes Management Software

B. Ability to add future glucose meters with this database. Data Transfer from "On-Call Plus" meter (k090057), "On-Call Chosen" meter (k111371), "On-Call Vivid" meter (k112653) and "On-Call Express" meter (k132086) was validated in this submission.

C. The Windows Platform Programming Language has changed from "Visual Basic" to "Delphi"

D. Data Port search (from user interface setting to automatic)

E. USB Cable Driver (from version v5.4 to version v6.5)

F. USB Driver installation (from manual separate installation to no installation-built-in/part of software installation file)

G. Displaying "Before Meal, " After Meal," and "Night" data sets (from fixed format - all three sets together to either individual or combination of these data sets)*

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.

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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.