(461 days)
The Gmate® SMART Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Gmate® SMART should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).
The Gmate® Blood Glucose Test Strips are for use with the GMATE® SMART Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management.
The Gmate® SMART Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® SMART System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® SMART Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The small Gmate® SMART meter does not require coding or calibration, no need of batteries, and no settings are required. The Gmate® SMART meter is powered on by plugging it into the headphone iack of the Apple device. Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds count down of your test result. The Gmate™ SMART App converts the signal generated from the meter and test strip and displays the test result on the Apple device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4tt generation, iPad, and iPad2), to view glucose test results. A simple download of the Gmate® SMART App, enables use of many functions. The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider or healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management. The test principle is: This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level. Combined with the Gmate™ SMART App, it displays the test result and stores them on your Apple device.
Acceptance Criteria and Study for Gmate® SMART Blood Glucose Monitoring System
This document describes the acceptance criteria and the study performed for the Gmate® SMART Blood Glucose Monitoring System, based on the provided 510(k) summary (K131230).
1. Acceptance Criteria and Reported Device Performance
The provided document states that the performance evaluations were conducted to establish the performance, functionality, and reliability characteristics of the Gmate® SMART Blood Glucose System, and "The devices passed all of the tests based on pre-determined Pass/Fail Criteria." However, the specific quantitative acceptance criteria (e.g., specific accuracy percentages for different glucose ranges) are not explicitly detailed in the provided text. It refers to compliance with ISO15197 and other reference standards, which would define these criteria.
Based on the general requirements of ISO 15197, for a blood glucose monitoring system, the acceptance criteria typically specify the percentage of results that must fall within certain accuracy ranges when compared to a laboratory reference method. A common set of criteria from ISO 15197:2003 (which was likely relevant in 2013/2014) is:
- For glucose concentrations < 75 mg/dL (4.2 mmol/L): at least 95% of the measured glucose values shall fall within ± 15 mg/dL (± 0.83 mmol/L) of the reference method values.
- For glucose concentrations ≥ 75 mg/dL (4.2 mmol/L): at least 95% of the measured glucose values shall fall within ± 20% of the reference method values.
Since the document states the device "passed all of the tests based on pre-determined Pass/Fail Criteria" and was performed in accordance with ISO15197, we infer that the device performance met the criteria of ISO15197. Without the exact quantitative data presented in the summary, we cannot create a detailed table of reported performance against specific numerical acceptance criteria.
Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from the provided text. The document only broadly states that the device met the pre-determined Pass/Fail Criteria based on ISO15197.
2. Sample Size and Data Provenance for the Test Set
The 510(k) summary does not specify the exact sample size used for the clinical test set, nor does it explicitly state the country of origin or whether the study was retrospective or prospective. It generally refers to "Non-clinical and clinical tests."
3. Number and Qualifications of Experts for Ground Truth
The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their specific qualifications. For blood glucose monitoring systems, the "ground truth" is typically established by laboratory reference methods (e.g., using a YSI glucose analyzer) rather than expert consensus on visual interpretation.
4. Adjudication Method
The document does not mention an adjudication method, which is generally not applicable for performance studies of blood glucose meters where comparisons are made against a laboratory reference method rather than subjective expert interpretations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC study is not relevant for this type of device (blood glucose monitoring system). Blood glucose meters are assessed for their accuracy in quantifying glucose levels, not for improved human interpretation or diagnostic capabilities with AI assistance. Therefore, no information on an MRMC study or effect size of AI assistance for human readers is provided or expected.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Non-clinical and clinical tests for the Gmate® SMART Blood Glucose System" evaluated the device's performance, functionality, and reliability. This would inherently be a standalone evaluation of the algorithm and device's measurement capabilities without human-in-the-loop performance being a primary metric. The system's ability to accurately measure glucose and display results on the connected Apple device constitutes its standalone performance.
7. Type of Ground Truth Used
The ground truth for the clinical performance evaluation (specifically system accuracy) would be laboratory reference method measurements of blood glucose. While not explicitly stated, this is the standard for evaluating blood glucose monitoring systems against ISO 15197. These reference measurements are typically obtained using highly accurate laboratory instruments (e.g., a YSI analyzer).
8. Sample Size for the Training Set
The document does not mention a "training set" or "training data" in the context of device development. Blood glucose monitors primarily use a fixed algorithm and calibration rather than machine learning models that require a distinct training set. The calibration and factory settings would be established during manufacturing based on extensive testing and quality control processes.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for a machine learning model is not explicitly detailed or indicated for this device. The device's underlying "algorithm" (the conversion of the electrochemical signal to a glucose reading) is based on established electrochemical principles and calibration. The ground truth for establishing and verifying this algorithm/calibration would be through laboratory reference method measurements using standard glucose solutions and blood samples across the device's measurement range, similar to how the clinical test set's ground truth is established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2014
PHILOSYS, INC. C/O LINDA CHAN PHILOSYS, INC 304 PARK AVENUE SOUTH, SUITE 218 NEW YORK NY 10010
Re: K131230
Trade/Device Name: Gmate® SMART Blood Glucose Monitoring System, Gmate® SMART Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JQP Dated: July 28, 2014 Received: July 29, 2014
Dear Ms. Linda Chan:
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, listing 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.
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If you desire specific advice for your device on our labeling regulations (21 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 yours,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131230
Device Name
Gmate® SMART Blood Glucose Monitoring System
Indications for Use (Describe)
The Gmate® SMART Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf. The Gmate® SMART Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Gmate® SMART should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly).
The Gmate® Blood Glucose Test Strips are for use with the GMATE® SMART Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.
The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results. The user may e-mail their glucose test results to their healthcare provider to help them review, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management.
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)
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osys, Inc.
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 USA TEL: 855-GO-GMATE FAX: 800-939-8670
Seoul Office
635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423
510(k) SUMMARY
(As required by 21.CFR.807.92)
| Manufacturer Name: | Philosys Co. Ltd.827-3Sanpyeong-ri, Okgu-eup, Gunsan-riJeollabuk-do, 573-907 Republic of Korea | |
|---|---|---|
| Phone: +82-63-453-1421Fax: +82-63-453-1423Contact: Byeong-Kyu Kim (Email: bkkim@philosys.com) | ||
| Submitted By: | Linda ChanPhilosys304 Park Avenue SouthSuite 218New York, NY 10010 | |
| Contact Person: | Linda ChanPhone: 908-505-1649Fax: 646-400-5240Email: lchan@usdiagnostics.net | |
| Date Summary,Prepared: | April 29, 2013 | |
| Device Name: | Propriety Name:Gmate® SMART Blood Glucose Monitoring SystemGmate® SMART Application | |
| Model Number: PG-101Common Name: Blood Glucose Test System, Blood Glucose MonitoringSystem | ||
| Classification Name: Blood Glucose, Test, System, Glucose Oxidase, over thecounter |
| ProductCode | Classification | Regulation Section | Panel |
|---|---|---|---|
| CGA | II | 21 CFR 862.1345 | Chemistry (75) |
| NBW | II | 21 CFR 862.1345 | Chemistry (75) |
| JQP | I | 21 CFR 862.2100 | Chemistry (75) |
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ohilosus, Inc.
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 USA TEL: 855-GO-GMATE FAX: 800-939-8670
Seoul Office
635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423
510(k) SUMMARY (As required by 21.CFR.807.92)
Predicate Device: We claim substantial equivalence to: 1) K103544 - AgaMatrix, Inc. iBGStar System. Device Description: The Gmate® SMART Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood. The Gmate® SMART System is intended for self-testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of their diabetes management. The Gmate® SMART Blood Glucose Monitoring System consists of a glucose meter, test strips, and one control material (additional levels of control material are available upon request). The small Gmate® SMART meter does not require coding or calibration, no need of batteries, and no settings are required. The Gmate® SMART meter is powered on by plugging it into the headphone iack of the Apple device. Insert the test strip into the meter, apply the blood or control solution to the strip and the meter will begin the 5 seconds count down of your test result. The Gmate™ SMART App converts the signal generated from the meter and test strip and displays the test result on the Apple device. The Gmate® SMART Blood Glucose Monitoring System uses the smartphone technology, currently Apple's iOS (with use of the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPhone 5, iPod Touch 4tt generation, iPad, and iPad2), to view glucose test results. A simple download of the Gmate® SMART App, enables use of many functions. The Gmate™ SMART App is a component of the Gmate® SMART Blood Glucose Monitoring System and is intended to be used by people with diabetes at home as an aid to monitor and track the effectiveness of their diabetes management. The Gmate™ SMART App allows the user to view their glucose test results and store a lifetime of results. The user may e-mail their glucose test results to their healthcare provider or healthcare provider to help them review, analyze, and evaluate their glucose test results to support an effective diabetes management program. The user can also graph and trend their glucose test results to provide an outlook of their diabetes management. The test principle is: This device is an in vitro diagnostic only product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the glucose oxidase that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. The meter measures the current and calculates your blood glucose level. Combined with the Gmate™ SMART App, it displays the test result and stores them on your Apple device.
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hilosys, Inc.
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 USA TEL: 855-GO-GMATE FAX: 800-939-8670
Seoul Office
635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423
510(k) SUMMARY
(As required by 21.CFR.807.92)
| Intended Use: | The Gmate® SMART Blood Glucose Monitoring System is intended for thequantitative measurement of glucose (sugar) in fresh capillary whole bloodsamples drawn from the fingertips, forearm, upper arm, palm, thigh or calf.The Gmate® SMART Blood Glucose Monitoring System is intended to beused by a single person and should not be shared.The Gmate® SMART Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes athome to monitor the effectiveness of diabetes control. The Gmate® SMARTshould not be used for the diagnosis of or screening of diabetes or for neonataluse. Alternate site testing should be done only during steady state times (whenglucose is not changing rapidly).The Gmate® Blood Glucose Test Strips are for use with the GMATE®SMART meter to quantitatively measure glucose (sugar) in fresh capillarywhole blood samples drawn from the fingertips, forearm, upper arm, palm,thigh or calf.The Gmate™ SMART App is a component of the Gmate® SMART BloodGlucose Monitoring System and is intended to be used by people with diabetesat home as an aid to monitor and track the effectiveness of their diabetesmanagement. The Gmate™ SMART App allows the user to view their glucosetest results and store a lifetime of results. The user may e-mail their glucosetest results to their healthcare provider to help them review, analyze, andevaluate their glucose test results to support an effective diabetes managementprogram. The user can also graph and trend their glucose test results to providean outlook of their diabetes management. |
|---|---|
| Comparison toPredicate Device: | The indication for use and the scientific technology of the Gmate® SMARTBlood Glucose Monitoring System and the predicate device are similar. Thereare few items of the specifications such as test range, storage conditions aredifferent. The performance testing data demonstrated that those differences donot raise issues of safety and effectiveness. Therefore, based on theinformation provided in this Premarket notification, we conclude that theGmate® SMART Blood Glucose Monitoring System is safe, effective, andsubstantially equivalent to the predicate device as described herein. |
| Performance Data: | Non-clinical and clinical tests for the Gmate® SMART Blood Glucose Systemwere performed in accordance with ISO15197 and other reference standards.The clinical performance evaluation testing included system accuracy, userperformance, and alternative-site blood glucose measurement. The non-clinical performance evaluations were conducted to establish the performance,the functionality and the reliability characteristics of the Gmate® SMARTBlood Glucose System. The devices passed all of the tests based on pre-determined Pass/Fail Criteria. |
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sys, Inc.
New York Office 304 Park Avenue South, Suite 218 New York, NY 10010 USA TEL: 855-GO-GMATE FAX: 800-939-8670
Seoul Office 635-5 Yeoksam-dong, Kangnam-ku, Seoul, 135-908, Korea TEL: +82-2-553-1421 FAX: +82-2-553-1423
510(k) SUMMARY (As required by 21.CFR.807.92)
Conclusion:
The Gmate SMART Blood Glucose Monitoring System is safe and effective and substantially equivalent to K103544 – AgaMatrix, Inc. IBGStar System.
§ 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.