(352 days)
GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The GlucoSure HT Plus blood glucose monitoring system consists of the GlucoSure HT Plus meter and GlucoSure HT Test Strips. It is used for testing of blood glucose by self-testers at home.
The provided text describes the 510(k) premarket notification for the GlucoSure HT Plus Blood Glucose Monitoring System, which is a medical device for measuring blood glucose. The information necessary to fully answer your request regarding acceptance criteria and study proving device meets criteria (especially as it pertains to AI/algorithm performance) is not fully detailed in this document, as it focuses on the substantial equivalence to a predicate device for a glucose monitoring system, and not an AI-assisted diagnostic tool in the typical sense this question implies.
However, based on the provided text, I can infer and extract some relevant information as best as possible, particularly regarding the clinical testing and the overall performance evaluation for this type of device.
Key takeaway for AI-related questions: This document describes a blood glucose monitoring system, not an AI-based diagnostic device where radiologists or extensive adjudication methods for image analysis would typically apply. The "algorithm" mentioned refers to the measurement algorithm within the glucose meter, not necessarily a complex AI/ML algorithm for image interpretation.
Here's a breakdown based on the available text:
Acceptance Criteria and Device Performance (Inferred from device type and general FDA requirements for glucose meters):
For a blood glucose monitoring system, the primary acceptance criteria revolve around the accuracy of glucose measurements compared to a reference method. While specific numerical acceptance criteria (e.g., % within 15% range) are not explicitly stated in the provided summary, these are standard for blood glucose meters. The summary states:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred for Blood Glucose Meters) | Reported Device Performance (as stated in summary) |
|---|---|
| Accuracy of Glucose Measurement: (Typically assessed against a laboratory reference method, with specific percentages of measurements falling within predefined error margins, e.g., >95% within ±15 mg/dL for <100 mg/dL and ±15% for ≥100 mg/dL) | "Clinical and analytical testing demonstrated that the GlucoSure HT Plus Blood Glucose Monitoring System perform in a substantially equivalent manner to that of the predicate." |
| Ease of Use for Home Users: (User comprehension, ability to perform test correctly, no significant errors due to device complexity) | "User studies for glucose was conducted with home users, including evaluation of ease of use and ease of understanding of the user manual. Results demonstrate substantial equivalence to the predicate system." |
| Stability (e.g., aluminum foil, battery life): (Maintain performance over time and under expected conditions) | "Battery life test, aluminum foil stability test were also done, and results demonstrate substantial equivalence to the predicate system." |
| Software Verification and Validation: (Software functions as intended, no critical errors) | "Software verification and validation were done." |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of participants or samples used in the "user studies for glucose" (clinical testing) or "analytical testing."
- Data Provenance: The studies were conducted by Apex BioTechnology Corp. No specific country of origin for the data (beyond the applicant's location in Taiwan) is mentioned. The studies appear to be for regulatory submission, implying they are prospective in nature, designed specifically to validate the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is more applicable to diagnostic devices interpreted by human experts (like radiologists for imaging). For a blood glucose monitoring system, the "ground truth" for glucose levels is typically established by laboratory reference methods (e.g., hexokinase method on a clinical chemistry analyzer), not by human experts interpreting data. The text does not mention human experts establishing ground truth for glucose values.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable in the context of a blood glucose monitoring system where ground truth is established by objective laboratory methods. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective interpretations (e.g., reviewing medical images).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a standalone blood glucose meter, not an AI-assisted diagnostic tool that humans (readers) would use to interpret medical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a "standalone" measurement system. The "algorithm" mentioned (likely the embedded algorithm within the meter that processes the chemical reaction on the test strip to produce a glucose reading) performs without human interpretation in the loop beyond the user performing the test. The "analytical testing" would assess this standalone performance against a reference method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Based on common practices for blood glucose meters, the ground truth would typically be laboratory reference standard glucose measurements obtained from clinical chemistry analyzers (e.g., YSI analyzer, hexokinase method). The document implicitly refers to "analytical testing" which would involve this comparison.
8. The sample size for the training set:
The document does not provide details about a "training set" for an AI model. For traditional medical devices like blood glucose meters, there isn't a "training set" in the machine learning sense. The device's internal algorithm is developed and calibrated, and then its performance is validated through analytical and clinical studies.
9. How the ground truth for the training set was established:
Not applicable, as there's no mention of an AI/ML training set in the document. The device's measurement algorithm is likely based on electrochemical principles and calibration data rather than a machine learning training process from labeled data.
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September 15, 2021
Apex BioTechnology Corp. Lisa Liu Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 Taiwan
Re: K202885
Trade/Device Name: GlucoSure HT Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: November 9, 2020 Received: November 12, 2020
Dear Lisa Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K202885
Device Name
GlucoSure HT Plus Blood Glucose Monitoring System
Indications for Use (Describe)
GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
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)
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| 510(k) Summary | |
|---|---|
| 510(k) number | K202885 |
| Submitter | Apex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN) |
| Contact Person | Lisa LiuManager of Quality Assurance DivisionApex Biotechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: lisaliu@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678021 |
| Date Prepared | November 10, 2020 |
| Trade Names | GlucoSure HT Plus Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | NBW |
| PredicateDevices | BGM009 Plus Blood Glucose System (K170267) |
| DeviceDescription | The GlucoSure HT Plus blood glucose monitoring system consists of theGlucoSure HT Plus meter and GlucoSure HT Test Strips. It is used fortesting of blood glucose by self-testers at home. |
| Intended Use | GlucoSure HT Plus Blood Glucose Monitoring System is intended toquantitatively measure blood glucose in fresh capillary whole blooddrawn from fingertips, palm, or forearm. Alternative site testing forglucose test should be performed only during steady-state (when glucoseis not changing rapidly). It is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes mellitus at home as anaid in monitoring the effectiveness of diabetes control and should onlybe used by a single patient and it should not be shared. It is not intendedfor diagnosis or screening of diabetes or for neonatal use.The GlucoSure HT Blood Glucose Test Strips are to be used with theGlucoSure HT Plus Blood Glucose Meter to quantitatively measureglucose in capillary whole blood taken from fingertips, palm, or forearm. |
| Comparison ofTechnologicalCharacteristics | The GlucoSure HT Plus Blood Glucose meter uses the same test stripand test algorithm as the predicate. The changes were for Dimensions of the meter were changed from 93x58x20.5 (mm)to 96x58x16 (mm) Meter was changed to add the strip ejection button. Power source was changed from two AAA 1.5V battery to two3.0 V lithium battery (CR2032) LCD change: size change, add new icons and add back light PCB circuit change according to changed LCD and batteryrequirement. Increase glucose memory capacity from 300 to 500 memoriesand add 1, 60, 90 days' average reading. The user interface was added reading tag (before meal, aftermeal, excise, and event) and hypo/hyper setting for glucosereading. Error code change: Remove error code “Premature sample application" Used Test Strip Warning change from Error 3 to Error 2 Not Enough Sample Warning change from Error 4 to Error 3 Changing the meaning of Error 4 from “Not Enough SampleWarning" to "Remove test strip during count down" Change in name from BGM009 Plus Blood Glucose MonitoringSystem to GlucoSure HT Plus Blood Glucose MonitoringSystem The GlucoSure HT Plus Blood Glucose Monitoring Systemshares identical glucose test strips with BGM009 Plus BloodGlucose Monitoring System, but only change in brand namefrom BGM009 Blood Glucose Test Strips to GlucoSure HTBlood Glucose Test Strips. Besides, the GlucoSure HT BloodGlucose test strip add single aluminum foil package. |
| Non-ClinicalTesting | Software verification and validation were done. Battery life test,aluminum foil stability test were also done, and results demonstratesubstantial equivalence to the predicate system. |
| Clinical Testing | User studies for glucose was conducted with home users, includingevaluation of ease of use and ease of understanding of the user manual.Results demonstrate substantial equivalence to the predicate system. |
| Conclusion | Clinical and analytical testing demonstrated that the GlucoSure HT PlusBlood Glucose Monitoring System perform in a substantially equivalentmanner to that of the predicate. We conclude that the GlucoSure HT PlusBlood Glucose Monitoring System is substantially equivalent to thepredicate system |
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510(k) Summary (Continued)
§ 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.