(143 days)
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System.
The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable.
The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.
The system includes: 1) Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest™ PC Link Adapter Driver, 2) GP550 PC Link Adapter.
Here's an analysis of the Bionime Diabetes Management System, detailing its acceptance criteria and the study that proves it, based on the provided 510(k) summary:
Analysis of Bionime Diabetes Management System Performance
The 510(k) summary for the Bionime Diabetes Management System (BDMS) provides limited details regarding specific, quantifiable acceptance criteria and the comprehensive study results to demonstrate performance. The primary focus of the performance section is on the user experience and the functionality of the software for managing glucose data.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly related to the usability and effectiveness of the software in displaying and analyzing blood glucose data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| System allows transfer of blood glucose readings. | The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable. |
| Data analysis features enable viewing and analysis of readings. | Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots. |
| System is easy to use. | "The results of these studies demonstrate satisfactory performance of Bionime Diabetes Management System (GP 200 Diabetes Assistant Software and GP550 PC Link Adaptor), and it is easy to use and the results are understandable by the users." |
| Results are understandable by users. | "The results of these studies demonstrate satisfactory performance of Bionime Diabetes Management System (GP 200 Diabetes Assistant Software and GP550 PC Link Adaptor), and it is easy to use and the results are understandable by the users." |
| Performance is satisfactory for its intended use (aid in managing diabetes). | "The results of the verification and validation studies of the Bionime Diabetes Management System demonstrated that the product is safe and effectiveness in the hands of lay users and health care professionals." "The product performance characteristics of Bionime Diabetes Management System were assessed through internal and external performance and validation studies, include a consumer study with 29 lay users. These studies demonstrate satisfactory performance..." |
| Substantial equivalence to predicate device. | The Bionime Diabetes Management System is substantially equivalent to the predicate device Glucofacts® Deluxe Diabetes Management Software (K091820). This is the overarching "acceptance" for 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A consumer study was conducted with 29 lay users.
- Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given that the applicant is Bionime Corporation in Taiwan, it's possible the study was conducted there, but this is not confirmed. The study appears to be prospective in nature as it involved users interacting with the system, implying data was generated during the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional medical device sense (e.g., expert interpretation of medical images). The study primarily focused on user interaction, usability, and the system's ability to accurately display and analyze existing blood glucose readings. The "ground truth" in this context would be the accuracy of the glucose meter readings themselves (which is outside the scope of this software's performance validation) and the correctness of the software's data processing and display.
4. Adjudication Method for the Test Set
No adjudication method is described for the test set. Given the nature of the study (usability and display validation), an adjudication process among experts for diagnostic decisions would not be applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where multiple human readers interpret cases with and without AI assistance. The BDMS is a data management and analysis tool, not a diagnostic interpretation tool, and its evaluation focuses on its functionality and user experience.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Yes, in a sense, the core functionality of the software itself, in terms of its ability to transfer, store, and graphically represent data, would be evaluated in a "standalone" manner. The consumer study with lay users then validated the human-in-the-loop interaction from the user's perspective (usability and interpretability). The algorithm in this case is not making diagnostic decisions, but rather performing data processing and visualization. The evaluation of whether "data tables, trend charts, pie charts" are correctly generated based on the transferred data would be a standalone assessment of the algorithm's performance.
7. The Type of Ground Truth Used
The "ground truth" for the BDMS would be based on:
- Correctness of data transfer: Verifying that blood glucose readings are accurately transferred from the meter to the software.
- Accuracy of data processing and display: Ensuring that the software correctly calculates trends, averages, and generates accurate charts and tables based on the transferred data.
- User feedback on usability and understandability: Direct feedback from the 29 lay users.
This is fundamentally different from a ground truth established by pathology reports or clinical outcomes data, as the software is not making diagnostic calls.
8. The Sample Size for the Training Set
The document does not specify a training set sample size or even the use of a distinct "training set" in the context of machine learning. The BDMS, as described, appears to be a rule-based software for data management and visualization, rather than an AI/ML diagnostic algorithm that would require a vast training dataset for learning. The "internal and external performance and validation studies" (which include the consumer study) likely served as the testing/validation phase for the software's developed functions.
9. How the Ground Truth for the Training Set was Established
As no specific training set for a machine learning model is mentioned, there's no information on how the ground truth for such a set was established. The software's functionality would have been developed and tested against expected outcomes for data processing and display.
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510(k) SUMMARY Bionime Diabetes Management System
FEB 2 7 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92(C)
The Assigned 510(k) number is: K113007
Date of Summary: October 3rd, 2011
Common Name: Bionime Diabetes Software System; Bionime Diabetes Assistant Software
Regulatory Information:
| Device Name | Product Code | Classification | Regulation | Panel |
|---|---|---|---|---|
| Glucose TestSystem | NBW: Blood GlucoseTest System, Over-the-Counter | Class II | 21 CFR §862.1345 | ClinicalChemistry(75) |
| Calculator/DataProcessing Modulefor Clinical Use | JQP: Calculator/ DataProcessing Module forClinical Use | Class I | 21 CFR §862.2100 | ClinicalChemistry(75) |
Applicant:
Bionime Corporation No. 694 Renhua Road, Dali District Taichung City, Taiwan 412 Tel.: 886 - 4 - 2495-1268 Fax: 886 - 4 - 2495-2568
Contact Persons:
Primary Contact:
Mrs. Feng-Yu Lee Correspondent for this Application Bionime Corporation c/o IVDD Regulatory Consultant 27001 La Paz Road Suite 266B Mission Viejo, CA 92691 Tel: (949) 951-3046 Fax: (949) 951-2042 fengyulee@ivddreg.com
Alternate Only:
Ming-Hung Wu Bionime Corporation No. 694 Renhua Road, Dali District Taichung City, Taiwan 412 Tel.: 886 - 4 - 2495-1268 Fax: 886 - 4 - 2495-2568 Ming-Hung. Wu(@bionime.com
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510(k) SUMMARY (Cont.) Bionime Diabetes Management System
Identification / Product Name:
Bionime Diabetes Management System
Device Description:
The Bionime Diabetes Management System allows the transfer of blood glucose readings from a compatible Bionime Rightest™ Glucose Meter to a PC via USB cable.
The Data analysis features enable the user(s) to view and analyze blood glucose readings from different meal times or time periods up to 90 days. Other features including data tables, trend charts, pie charts, and printed reports are available for viewing and analyzing these readings within the different time slots.
The system includes: 1) Installation CD with setup files for Bionime GP200 Diabetes Assistant Software and Rightest™ PC Link Adapter Driver, 2) GP550 PC Link Adapter.
Intended Use:
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the blood glucose readings, as well as to backup and to recover users' profile and data. Bionime Rightest™ GM550 and GM250 meters are compatible with Bionime Diabetes Management System.
The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
Predicate Kit:
The Bionime Diabetes Management System is substantially equivalent to the predicate device noted below:
Device Name: Glucofacts® Deluxe Diabetes Management Software 510k No.: K091820 Device Company: Bayer Healthcare, LLC
Technology Characteristics:
The Bionime Diabetes Management System (GP200 Diabetes Assistant Software) is used to capture Rightest " blood glucose meter readings and graphically display the information. It utilizes the standard statistical and graphical techniques to facilitate the review of glucose readings by individual user or health care professionals.
Performance:
The product performance characteristics of Bionime Diabetes Management System were assessed through internal and external performance and validation studies, include a consumer study with 29 lay users.
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The results of these studies demonstrate satisfactory performance of Bionime Diabetes Management System (GP 200 Diabetes Assistant Software and GP550 PC Link Adaptor), and it is easy to use and the results are understandable by the users.
Conclusion:
The results of the verification and validation studies of the Bionime Diabetes Management System demonstrated that the product is safe and effectiveness in the hands of lay users and health care professionals. The product is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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10903 New Hampshire Avenue Silver Spring, MD 20993
Bionime Corporation c/o Feng-Yu Lee IVDD Regulatory Consultant 27001 La Paz Road, Suite 266B Mission Viejo. CA 92691
FEB 2 7 2012
Re: K113007
Trade Name: Bionime Diabetes Management System Software Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JQP Dated: February 13, 2012 Received: February 16, 2012
Dear Mrs. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 minted to registration or medical device-related adverse events) (21 007); medical as not reanufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
R
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): k
Device Name: Bionime Diabetes Management System (BDMS)
Indication For Use:
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightest® Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the glucose readings, as well as to backup and to recover users' profile and data.
The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 1< 113007
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§ 862.2100 Calculator/data processing module for clinical use.
(a)
Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.