ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE

K112738 · Andon Medical Co., Ltd. · NBW · Sep 30, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112738
• Device Name: ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
• Applicant: Andon Medical Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Andon Health Care Management System Software is an optional software accessory for use with the Andon blood glucose meters with data management capacities, When used with one of these meters, Andon Health Care Management System Software transfers data from the device's memory into a computer for enhanced data management. Andon Health Care Management System Software is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating historical blood glucose test results and other biological statistics to support diabetes management. Andon Heath Care System Software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Device Story

Andon Health Care Management System Software; manages data from blood glucose meters; modification adds compatibility with AG-6081 and AG-6951 blood glucose meters (k101307); software collects/processes glucose data; used by patients/clinicians for health management; fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements; risk analysis conducted to assess modification impact; results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

Software-based health management system; interfaces with blood glucose meters (AG-6081, AG-6951); data management functionality; design control procedures per 21 CFR 820.30.

Indications for Use

Indicated for people with diabetes and their healthcare professionals in home and clinical settings to upload, store, analyze, and communicate historical blood glucose test results and biological statistics to support diabetes management.

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

• Andon Health Care Management System Software (K102678)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k112738

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 ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE:

1. The name and 510(k) number of ANDON MEDICAL CO., LTD.'s previously cleared device, ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, cleared under k102678. (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 the addition of the cleared AG-6081 Single and Multi blood glucose meters and the AG-6951 Single and Multi blood glucose meters (k101307).

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

revised: 8/1/03