(41 days)
The BGM009 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing 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 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 indicated for the diagnosis or screening of diabetes or for neonatal use.
The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The BGM009 Plus blood glucose monitoring system consists of the BGM009 Plus meter and BGM009 Test Strips. It is used for testing of blood glucose by self-testers at home.
The provided document does not contain the detailed information necessary to answer all parts of your request. It is a 510(k) summary for a Blood Glucose Monitoring System where the applicant is asserting substantial equivalence to a predicate device.
Here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or provide a detailed table of device performance against specific metrics for the BGM009 Plus Blood Glucose Monitoring System. It only states that "Non-clinical testing show that the BGM009 Plus meter with the BGM009 Strips perform in a substantially equivalent manner to that of the predicate device."
2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The document mentions "Software verification and validation were done" and "Non-clinical testing," but no details on sample size or data provenance (e.g., country of origin, retrospective/prospective) are given for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As this is a blood glucose monitoring system, the ground truth would likely refer to a laboratory reference method, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is typically relevant for interpretative devices where human readers (e.g., radiologists) interact with AI. This document pertains to a blood glucose monitoring system, which is a quantitative measurement device. Therefore, an MRMC study as described would not be applicable and is not mentioned. The device does not involve human "readers" or AI assistance in the way described for an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document states "Clinical Testing: N/A". This suggests that no standalone clinical performance study was conducted specifically for the BGM009 Plus device in the context of this 510(k). The focus is on non-clinical testing demonstrating equivalence to the predicate. The "algorithm" here is the blood glucose measurement technology, and its standalone performance would typically be confirmed through accuracy studies against a reference method, which are usually considered "clinical testing" in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated for the BGM009 Plus, for blood glucose monitoring systems, the ground truth for accuracy studies is typically established using a laboratory reference method (e.g., YSI analyzer) to measure glucose concentration in blood samples. This is implied by the nature of the device.
8. The sample size for the training set
This information is not provided in the document. While the device utilizes an "algorithm," the document does not discuss machine learning or AI training sets. The "algorithm" likely refers to the electrochemical principles and calculations used to determine glucose concentration.
9. How the ground truth for the training set was established
This information is not provided in the document, as the concept of "training set" in the context of machine learning/AI is likely not applicable or discussed for this type of medical device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2017
APEX BIO TECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK HSINCHU 30078 TAIWAN
Re: K170267
Trade/Device Name: BGM009 Plus Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: February 6, 2017 Received: February 8, 2017
Dear Hsue-Mei Lee:
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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Kellie B. Kelm -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 SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below. |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
Indications for Use
| 510(k) Number (if known) | K170267 |
|---|---|
| Device Name | BGM009 Plus Blood Glucose Monitoring System |
| Indications for Use (Describe) | The BGM009 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing 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 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 indicated for the diagnosis or screening of diabetes or for neonatal use. |
| The BGM009 Blood Glucose Test Strips are to be used with the BGM009 and BGM009 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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| FORM FDA 3881 (8/14) | Page 1 of 1 |
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510(k) Summary 6
| Submitter | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
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| Contact Person | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science ParkHsinchu, 30078CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
| Date Prepared | January 25, 2017 |
| Trade Names | BGM009 Plus Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Devices | BGM009 (K141036) Blood Glucose Monitoring Systems |
| Device Description | The BGM009 Plus blood glucose monitoring system consists of the BGM009Plus meter and BGM009 Test Strips. It is used for testing of blood glucose byself-testers at home. |
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510(k) Summary (Continued)
| Intended Use | The BGM009 Plus Blood Glucose Monitoring System is intended for the quantitativemeasurement of glucose in fresh capillary whole blood samples drawn from thefingertips, forearm, or palm. Alternative site testing should be performed only duringsteady-state (when glucose is not changing rapidly). It is intended for self testingoutside the body (in vitro diagnostic use) by people with diabetes at home as an aid inmonitoring the effectiveness of diabetes control and should only be used by a singlepatient and it should not be shared. It is not indicated for the diagnosis or screening ofdiabetes or for neonatal use.The BGM009 Blood Glucose Test Strips are to be used with the BGM009 andBGM009 Plus Blood Glucose Meter to quantitatively measure glucose in capillarywhole blood taken from fingertips, palm, or forearm. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The BGM009 Plus meter uses the same test strip and test algorithm as the predicate.The only difference is that the voice feature has been removed from the meter. |
| Non-ClinicalTesting | Software verification and validation were done. |
| Clinical Testing | N/A |
| Conclusion | Non-clinical testing show that the BGM009 Plus meter with the BGM009 Stripsperform in a substantially equivalent manner to that of the predicate device. Weconclude that the BGM009 Plus system is substantially equivalent to the predicate. |
§ 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.