(345 days)
Not Found
No
The document describes a standard electrochemical blood glucose monitoring system and a gateway application for data transmission and review. There is no mention of AI or ML in the intended use, device description, or performance studies. The gateway application explicitly states it makes "no interpretation, evaluation, medical iudgment or recommendations for treatment," which is contrary to typical AI/ML applications in this space.
No.
The device is described as a "Blood Glucose Monitoring System" and is intended for "quantitative measurement of glucose" and as an "aid to monitor the effectiveness of diabetes control." It explicitly states, "This device is not intended as a substitute for medical care" and "The system is not to be used for the diagnosis of or screening for diabetes." These functions are diagnostic/monitoring, not therapeutic.
No
The device is intended for self-testing by people with diabetes to monitor the effectiveness of diabetes control. The text explicitly states, "The system is not to be used for the diagnosis of or screening for diabetes."
No
The device description explicitly states that the system consists of a blood glucose meter, single use test strips, and control solution, which are hardware components. While there is a software component (the Gateway Application), the core medical device is a physical blood glucose monitoring system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 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."
- Function: The device measures glucose in blood samples, which is a classic example of an in vitro diagnostic test.
- Standards: The device conforms to ISO 15197, which is a standard specifically for "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus." It also conforms to IEC 61010-2-101, which are "Particular requirements for in vitro diagnostic (IVD) medical equipment."
N/A
Intended Use / Indications for Use
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of qlucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 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 system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.
The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh.
The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the qlucose meter and test strips are working properly and that the measurement is accurate.
The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.
The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical iudgment or recommendations for treatment. This device is not intended as a substitute for medical care.
Product codes
NBW, CGA, JQP, JJX
Device Description
The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucose meter, single use test strips and control solution.
The new device IDEAL LIFE Gluco-Manager™, Model GMM0002 is 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 IDEAL LIFE Gluco-Manager™ can be used alone to measure your blood glucose. If the user would like to transmit blood glucose information for display on a personal computer, the IDEAL LIFE Gluco-Manager™ can wirelessly communicate with a communication gateway (the optional IDEAL LIFE Pod™) or by using the Gateway Application, a mobile medical application.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Fingertip, palm, forearm, upper arm, calf, and thigh.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
people with diabetes at home, health care professionals (for reviewing results)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
IDEAL LIFE Gluco-Manager™ GMM0002 Blood Glucose Monitoring System conforms to the following standards:
- . ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- . IEC 61010-1: 2001, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements.
- . IEC 61010-2-101: 2002,Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.
- . EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use - EMC requirements part 1: General requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
JUN 2 5 2014
510(k) Summary
. .
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of the SMDA and 21 CFR 807.92.
1. Submitter's information
ldeal Life Inc. Name: 2200 Yonge Street, Suite 1300 Address: Toronto ON M4S 2C6
.
| Phone number: | (416) 489-1494 |
|---|---|
| Fax number: | (416) 489-3009 |
| Contact: | Jason Goldberg |
| Date of Summary: | May 16, 2014 |
2. Device Information
| Trade name: | IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, |
|---|---|
| Model GMM0002 | |
| Common name: | Blood Glucose Monitoring System |
| Classification name: | Blood Glucose Monitoring System |
3. Classification
| Product code: | NBW, Blood Glucose Monitoring System
CGA, Glucose Test System
JQP, Calculator/data processing module for clinical use
JJX, Quality Control Material (assayed and unassayed) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation number: | 862.1345 |
| Class: | 2 |
| Panel: | Clinical Chemistry |
4. Predicate Device Information
| Manufacturer: | Andon Medical Co., Ltd. |
|---|---|
| Device: | AG-608N Single Blood Glucose Monitoring System |
| 510(k) Number: | K110017 |
5. Device Description
The IDEAL LIFE Gluco-Manager™ Blood Glucose Monitoring System, Model GMM0002 consists of a blood glucose meter, single use test strips and control solution.
1
The new device IDEAL LIFE Gluco-Manager™, Model GMM0002 is 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 IDEAL LIFE Gluco-Manager™ can be used alone to measure your blood glucose. If the user would like to transmit blood glucose information for display on a personal computer, the IDEAL LIFE Gluco-Manager™ can wirelessly communicate with a communication gateway (the optional IDEAL LIFE Pod™) or by using the Gateway Application, a mobile medical application.
6. Intended Use
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended to be used for the quantitative measurement of qlucose in fresh capillary whole blood samples drawn from the fingertip or alternative sites (palm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 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 system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.
The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, forearm, upper arm, calf, and thigh.
The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the qlucose meter and test strips are working properly and that the measurement is accurate.
The IDEAL LIFE GlucoManager™ can wirelessly communicate with a communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid people at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.
The IDEAL LIFE Gateway Application™ makes no interpretation, evaluation, medical iudgment or recommendations for treatment. This device is not intended as a substitute for medical care.
2
| CHARACTERISTIC | NEW DEVICE: IDEAL LIFE
Gluco-Manager™ Model
GMM0002 | PREDICATE DEVICE: AG-
608N Single GBMS
(K110017) |
|-----------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Detection Method | Amperometry | Amperometry |
| Enzyme | Glucose Oxidase | Glucose Oxidase |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Sample Source | Capillary whole blood from
AST (Alternative site testing)
and finger | Capillary whole blood from
AST (Alternative site testing)
and finger |
| Sample Application | Blood sample is placed
directly to the test strip after
finger or AST is lanced | Blood sample is placed
directly to the test strip after
finger or AST is lanced |
| Hematocrit Range | 20-60% | 20-60% |
| Operating Temperature Range | 10°C to 40°C (50°-104°F) | 10°C to 40°C (50°-104°F) |
| Dimensions | 77.3mm × 60.2mm ×25mm | 87mmx 53mmx 9.9mm |
| Display | LCD | LCD |
| Result Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | 575 times with time and date
display | 500 times with time and date
display |
| Test Start | Automatic | Automatic |
| Test Time | 5 seconds | 5 seconds |
| Power Source | DC 3V (2*AAA batteries) | DC 3V (CR2032) |
| Battery Life | Over 200 determinants | Approx. 500 normal tests |
| Measurement Range | 20mg/dL-600mg/dL | 20mg/dL-600mg/dL |
| | (1.1mmol/L33.3mmol/L) | (1.1mmol/L33.3mmol/L) |
| Qualified Test Strip | AGS-1112 Test Strip | AGS-1000N Test Strip |
| Sample Volume | Minimum 0.7 micro liter | Minimum 0.7 micro liter |
| Other functionality | Bluetooth function to upload
data to IDEAL LIFE website | USB function |
7. Comparison of Technological Characteristics with Predicate Device
8. Performance Summary
IDEAL LIFE Gluco-Manager™ GMM0002 Blood Glucose Monitoring System conforms to the following standards:
- . ISO 15197: In vitro diagnostic test systems- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
- . IEC 61010-1: 2001, Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements.
- . IEC 61010-2-101: 2002,Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.
- . EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use - EMC requirements part 1: General requirements.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, or a symbol representing care and support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
IDEAL LIFE INC. C/O DIANE HORWITZ MANDELL HORWITZ CONSULTANTS LLC 2995 STEVEN MARTIN DRIVE FAIRFAX VA 22031
June 25, 2014
Re: K132180
Trade/Device Name: IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP, JJX Dated: June 16, 2014 Received: June 16, 2014
Dear Ms. Diane Horwitz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations; Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Mr. Horwitz
If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Katherine Serrano -S
For : Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132180
Device Name
IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002
Indications for Use (Describe)
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System. Model GMM0002 is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the sites (nalm, forearm, upper arm, calf, and thigh). The system is intended to be used by a single patient and should not be shared.
The IDEAL LIFE GlucoManager™ Blood Glucose Monitoring System, Model GMM0002 is intended for self-itsting outside the body (in vitro diagnostic use) by people with diabetes an aid to monitor the effectiveness of diabetes control. The system is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should only be done during steady state times when blood glucose is not changing rapidly.
The IDEAL LIFE Blood Glucose Test Strips, Model AGS-1 1 12 are for use with the IDEAL LIFE GlucoManager™ to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips, palm, calf, and thigh.
The IDEAL LIFE Control Solution, Model GCS-0104 is intended for use with IDEAL LIFE GlucoManager™ and IDEAL LIFE Blood Glucose Test Strips, Model AGS-1112. The control solution can be used to check that the glucose meter and test strips are working properly and that the measurement is accurate.
The IDEAL LIFE GlucoManager™ can wirelessly communication gateway such as the IDEAL LIFE Pod™ or the IDEAL LIFE Gateway Application™. The IDEAL LIFE Gateway Application receives data wirelessly from IDEAL LIFE devices to transmit over the Internet from the user's mobile device. The Gateway Application is intended to aid beople at home and health care professionals to review and evaluate historical blood glucose results, to support effective health care management.
The IDEAL LIFE Gateway Application makes no interpretation, medical judement or recommendations for treatment. This device is not intended as a substitute for medical care.
Type of Use (Select one or both, as applicable).
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck -S
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.