AGAMATRIX HEALTH MANAGER

K132821 · Agamatrix, Inc. · NBW · Nov 20, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132821
• Device Name: AGAMATRIX HEALTH MANAGER
• Applicant: Agamatrix, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The AgaMatrix Health Manager is intended for use in the home to aid individuals with diabetes and their healthcare professionals in the review, analysis and evaluation of blood glucose test results to support an effective diabetes management program. The AgaMatrix Health Manager App is an optional data management software accessory that connects to AgaMatrix blood glucose meters. The AgaMatrix Health Manager is not intended to provide automated treatment guidance or decisions; nor is it to be used as a substitute for professional healthcare judgment.

Device Story

AgaMatrix Health Manager is a digital logbook/diabetes management app for iPhone/iPod touch. It functions as an accessory to AgaMatrix blood glucose meters. Input: blood glucose readings (via cable connection from meter) and manual entry of carbohydrate, insulin, and weight data. Operation: app stores data locally on the mobile device; supports optional cloud backup to a secure server. Output: trend charts, statistics, and logbook views accessible via app or web browser. Users can email data reports. Context: home-use by patients. Healthcare providers review the generated reports to support diabetes management. The device does not provide automated treatment guidance or clinical decisions.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm modification impact.

Technological Characteristics

Software-based diabetes management application; mobile platform; includes cloud-based data storage; updated user interface; fundamental scientific technology consistent with predicate.

Indications for Use

Indicated for single patient use by individuals with diabetes to assist in the review, analysis, and evaluation of blood glucose results to aid in diabetes and health management. Not intended for automated treatment guidance or as a substitute for professional healthcare advice.

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

• WaveSense Diabetes Manager application (WDM) (K101597)

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 K132821

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 Agamatrix's previously cleared device, WaveSense Diabetes Manager App, cleared under k k101597. (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 (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 name change (AgaMatrix Health Manager), updated user interface and inclusion of optional data backup to a secure cloud.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and operating system.

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 (Fault Tree)
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.