(143 days)
Not Found
No
The description focuses on data transfer, storage, and basic visualization/analysis (tables, charts) of blood glucose readings. There is no mention of algorithms that learn from data or make predictions, which are characteristic of AI/ML.
No.
The system is a software for viewing, analyzing, printing, backing up, and recovering blood glucose readings, and it explicitly states it is "not intended to provide treatment decisions, nor should it substitute professional opinion."
No
The device is an over-the-counter software system designed to view, analyze, and print blood glucose readings, and to back up and recover user profiles and data. Its intended use states it is “not intended to provide treatment decisions, nor should it substitute professional opinion.” This indicates it is for managing existing data rather than diagnosing a condition.
No
The device description explicitly states that the system includes a "GP550 PC Link Adapter," which is a hardware component used for transferring data from the glucose meter to the PC.
Based on the provided text, the Bionime Diabetes Management System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The system is used to view, analyze, and print blood glucose readings. Blood glucose readings are obtained from a glucose meter, which is an in vitro diagnostic device used to measure a substance (glucose) in a biological sample (blood).
- Connection to IVD: The software directly interacts with and processes data from an IVD (the glucose meter). While the software itself doesn't perform the diagnostic test, it is an essential component in the management and interpretation of the results generated by the IVD.
- Predicate Device: The predicate device listed, "Glucofacts® Deluxe Diabetes Management Software (K091820)", is also a diabetes management software that interacts with glucose meters. This further supports the classification of such software as related to IVDs.
Therefore, even though the software itself doesn't perform the blood glucose test, its function is directly tied to the use and interpretation of data from an IVD, making it part of the overall in vitro diagnostic system for diabetes management.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Care Professionals and Patients with diabetes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
Not Found
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).
Not Found
§ 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.
0
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 Test | ||||
| System | NBW: Blood Glucose | |||
| Test System, Over-the- | ||||
| Counter | Class II | 21 CFR § | ||
| 862.1345 | Clinical | |||
| Chemistry | ||||
| (75) | ||||
| Calculator/Data | ||||
| Processing Module | ||||
| for Clinical Use | JQP: Calculator/ Data | |||
| Processing Module for | ||||
| Clinical Use | Class I | 21 CFR § | ||
| 862.2100 | Clinical | |||
| Chemistry | ||||
| (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
1
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.
2
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract image of an eagle.
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).
4
Page 2
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
5
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