IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM

K133790 · Andon Health Co, Ltd. · NBW · May 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133790
• Device Name: IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM
• Applicant: Andon Health Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The iHealth Align Mini Gluco-Monitoring system(BG1) is intended to be used for: · Quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper arm, calf, or thigh · single person measurement only and should not be shared · Self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control The iHealth system should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative Site Testing (AST) should be done only during steady state times when glucose levels are not changing rapidly. iHealth Blood Glucose Test Strips(AGS-1000I) are intended for use with the iHealth Align Mini Glucose meter (BG1) to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG1 meter.

Device Story

iHealth BG1 Align Mini Gluco-Monitoring System is a portable blood glucose meter for home use by patients with diabetes. Device uses electrochemical biosensor technology and capillary action to draw blood into a test strip chamber. Input is a fresh capillary whole blood sample (min 0.7 µL) applied to an AGS-1000I test strip. Meter connects to an iOS device via the earphone jack to display results in 5 seconds. Powered by a DC 3.0V (CR1620) battery. Output is quantitative glucose concentration (mg/dL or mmol/L) displayed on the connected iOS device. Data helps patients monitor diabetes control effectiveness. Device is for single-person use only.

Clinical Evidence

Conforms to ISO 15197 standards for in vitro diagnostic blood-glucose monitoring systems. Performance validated through non-clinical and clinical testing. No specific clinical trial metrics (e.g., sensitivity, specificity) provided in the summary.

Technological Characteristics

Electrochemical glucose monitoring. Powered by internal battery. Connects to iOS devices via earphone jack. Designed for single-patient use. Validated for 11,000 cleaning/disinfection cycles.

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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

• iHealth BG3 Smart Gluco-Monitoring System (k120813)

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 k133790

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 for the iHealth Align Mini Gluco-Monitoring System (BG1):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. iHealth BG3 Smart Gluco-Monitoring System (k120813).
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:

1. Changes in the dimensions of the device,
2. Changes to the power source (from using iOS device power to using an internal battery), and
3. Changes in the method of connection (from 30 pin to earphone jack) between the device and the iOS device used for display and data management.

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.

The device is intended for single-patient use. CaviWipes Disinfecting Towelettes (EPA registration #46781-8) were validated through disinfection efficacy studies demonstrating complete inactivation of hepatitis B (HBV) virus using materials comprising the meter. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the meter after 11,000 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one

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disinfecting wipe) to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.