IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION

K130535 · Agamatrix, Inc. · NBW · Apr 17, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130535
• Device Name: IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
• Applicant: Agamatrix, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Indications for Use

The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ Blood Glucose Monitoring System is intended for 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 iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional 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 iBGStar Blood Glucose Monitoring System.

Device Story

iBGStar Blood Glucose Monitoring System (BGMS) measures blood glucose via glucose oxidase test strips; provides quantitative results for home diabetes management. System includes meter, test strips, and control solution. iBGStar Diabetes Manager Application (DMA) is an optional software accessory for iPhone/iPod touch; functions as a digital logbook/tool. Users manually enter or download readings from the meter to the DMA. DMA enables emailing glucose data to healthcare professionals for review/analysis. Subject device adds compatibility with iPhone 5 and iPod touch 5th generation via Apple Lightning to 30-pin adapter. Device used by patients at home; data supports clinical decision-making by healthcare providers. Benefits include improved diabetes monitoring and data sharing.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including disinfection and robustness testing of the iPhone 5, iPod touch 5, and Lightning adapters using PDI Super Sani-Cloth wipes (260 cycles simulating 5 years of use), and a human factors study evaluating the ability of users to connect and transfer readings using the new adapters.

Technological Characteristics

Glucose oxidase electrochemical sensing; no coding required. Power: polymer lithium-ion rechargeable batteries. Connectivity: direct connection to iPhone/iPod touch via 30-pin connector or Lightning to 30-pin adapter. Software: digital logbook/data management application. No changes to fundamental scientific technology from predicate.

Indications for Use

Indicated for single-patient, in vitro quantitative measurement of glucose in fresh capillary whole blood from the fingertip to monitor diabetes control. Not for diagnosis, screening, or neonatal use.

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

• iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application (K103544)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K130535

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 iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application:

1. The name and 510(k) number of Agamatrix Inc.'s previously cleared device, iBGStar Blood Glucose Monitoring System, iBGStar Diabetes Manager Application, cleared under k103544.
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 inclusion of the iPhone 5 and iPod touch 5 as products that can be used with the iBGStar Diabetes Manager Application, which is an optional accessory to the iBGStar Blood Glucose Monitoring System.

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 validation protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA). The device system is intended for single-patient use only. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, PDI® Super Sani-Cloth® Germicidal Disposable Wipes with (EPA Registration # 9480-4). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter and lancing device after 260 cleanings and 260 disinfection steps with the PDI® Super Sani-Cloth® Germicidal Disposable Wipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.