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K Number
K123935
Device Name
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Manufacturer
ANDON MEDICAL CO., LTD.
Date Cleared
2013-04-12

(113 days)

Product Code
NBW,CGA,JJX,JQP
Regulation Number
862.1345
Type
Traditional
Panel
CH
Reference & Predicate Devices
k120813,k110017
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

iHealth BG5 and BG5L wireless Smart Gluco-Monitoring System 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
    iHealth BG5 and BG5L wireless Smart Gluco-Monitoring 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.
    The AGS1000I test strips are intended for use with the iHealth BG5 and BG5L meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, upper arm, calf or thigh using the iHealth BG5 and BG5L meter.
    The iHealth control solutions are intended for use with the iHealth BG5/BG5L Blood Glucose Monitoring System, to check that the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
    The iHealth Gluco-Smart App is an iOS app for iPhone, iTouch, and iPad and is used for data extraction and analysis in iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System.
Device Description

iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System consist of blood glucose meter, single use test strips, sterile lancets, lancing device and the control solutions.
The new device iHealth BG5 and BG5L Wireless Smart Glucose meters are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 5 seconds. The control solution available is used to test the performance of the device. It uses the same technological characteristics for testing with its predicate device.
The new device iHealth BG5 and BG5L meters can display the test results itself, it can also transmit the test results to the an iPhone, iPod touch or iPad through blue tooth.

AI/ML Overview

Here's an analysis of the provided text regarding the iHealth BG5 and BG5L Wireless Smart Gluco-Monitoring System, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iHealth BG5 and BG5L systems are based on the international standard ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. The document explicitly states that the system "conforms to... ISO 15197."

While the document mentions adherence to ISO 15197, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy percentages, bias limits) from that standard, nor does it present a detailed table of reported device performance against those specific criteria. It states that "Non-clinical test and the clinical test are done according to the above standard."

Therefore, based only on the provided text, we can infer the acceptance criteria are those outlined in ISO 15197, but the numerical targets and direct performance comparison are not presented.

Summary of the Study Information from the Provided Text

  1. Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Based on ISO 15197)Reported Device Performance
    Not explicitly detailed in the document, but is implicitly the requirements of ISO 15197 for blood glucose monitoring systems."Non-clinical test and the clinical test are done according to the above standard (ISO 15197)." (Specific performance metrics against ISO 15197 are not numerically provided in this summary.)

    Note: The document states the device "conforms to... ISO 15197," implying that it meets the standard's performance requirements, but the specific numerical accuracy data is not presented in this 510(k) summary.

  2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: Not specified in the provided text.
    • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). While it mentions "clinical test," it doesn't elaborate on the study design or patient demographics.

  3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    • Not specified in the provided text.

  4. Adjudication Method for the Test Set:

    • Not specified in the provided text.

  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned or performed. This device is a blood glucose monitoring system, not an imaging device typically subject to MRMC studies. The primary evaluation is device accuracy against a reference method.

  6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

    • Yes, a standalone performance evaluation was done. The document describes "Non-clinical test and the clinical test" performed to demonstrate conformity to ISO 15197. This includes evaluating the accuracy of the device itself (the meter and test strips) in measuring glucose levels against a reference method. The device is intended for "self-testing" and "in vitro diagnostic use," implying its accuracy is evaluated independently of a healthcare professional's interpretation where the result itself is the "output."

  7. Type of Ground Truth Used:

    • Not explicitly stated, but for blood glucose monitoring systems conforming to ISO 15197, the ground truth is typically a laboratory reference method (e.g., a YSI analyzer or similar). This is inferred from the standard's requirements for accuracy studies.

  8. Sample Size for the Training Set:

    • Not applicable/Not specified. Blood glucose meters do not typically use "training sets" in the same way machine learning algorithms do. Their performance is established through analytical and clinical accuracy studies where the device's measurements are compared to a reference method on a set of clinical samples.

  9. How the Ground Truth for the Training Set Was Established:

    • Not applicable/Not specified, as "training sets" are not typically used for this type of device. The accuracy of the device (meter and strips) would be assessed against a laboratory reference method during its development and validation.

§ 862.1345 Glucose test system.

(a)
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.(b)
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.