(85 days)
The FORA V10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the FORA V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA V10 Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control Solution, commercially available Lancing Device and Sterile Lancets, User Manual, and Storage Pack.
The FORA V10 Blood Glucose Monitoring System (Model TD-4244) met the acceptance criteria by demonstrating substantial equivalence to its predicate device through performance characteristics, specifically by meeting the requirements of ISO 15197.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 15197 Requirements | "the device met the requirements of ISO 15197." |
| Precision | Demonstrated to be "substantially equivalent" to the predicate device. |
| System Accuracy | Demonstrated to be "substantially equivalent" to the predicate device. |
2. Sample size used for the test set and the data provenance:
The document mentions "laboratory tests" and "software verification and validation testing," but does not specify the sample size used for the test set. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication method for the test set:
The document does not specify any adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it relevant for a glucose monitoring system. The study focused on the device's accuracy against a known standard (ISO 15197) and comparison to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance evaluation of the FORA V10 Blood Glucose Monitoring System appears to be a standalone assessment of the device's accuracy and precision, without human interpretation in the loop. The "laboratory tests" and "software verification and validation testing" confirm the device's inherent performance.
7. The type of ground truth used:
The ground truth used for performance comparison was likely based on reference glucose measurements obtained from a laboratory standard method against which the device's readings were compared to assess compliance with ISO 15197. This would involve a highly accurate and precise laboratory instrument with an established accuracy profile.
8. The sample size for the training set:
The document does not provide information regarding a training set sample size. This type of device (blood glucose monitor) typically undergoes calibration during manufacturing rather than a machine learning "training" phase.
9. How the ground truth for the training set was established:
As above, the concept of a "training set" and its associated ground truth establishment is not applicable in the context of this device's reported evaluation. The device would be calibrated against known glucose concentrations.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is:
-
DEC 2 4 2009 1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondence: Debra Liang Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw -
- Device name:
Proprietary name: FORA V10 Blood Glucose Monitoring System, model TD-4244
- Device name:
Regulatory information:
- Regulation section: 21 CFR 862.1345 Glucose Test Systems A.
- Classification: B. Class II
- CGA, Glucose Oxidase, Glucose Product Code: . C. NBW, System, Test, Blood Glucose, Over the Counter D. Panel: Chemistry (75)
-
- Intended Use:
The FORA V10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program.
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It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the FORA V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
-
- Device Description: ·
The FORA V10 Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control Solution, commercially available Lancing Device and Sterile Lancets, User Manual, and Storage Pack.
- Device Description: ·
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- Substantial Equivalance Information:
Predicate device name: A. Fora V10 Blood Glucose Monitoring System, Model TD-4244
- Substantial Equivalance Information:
B. Predicate K number: K090404
C. Comparison with predicate:
The modified FORA V10 Blood Glucose Monitoring System has the following similarities to the predicate device:
- Same intended use
- Same operating principle,
- l Same fundamental scientific technology,
- I Incorporate the same basic circuit design,
- I Incorporate the same materials,
- Same shelf life
- . Same physical appearance
- I Packaged using the same materials, and
- 1 Manufactured by the same process.
The modifications encompass:
- . Remove strip coding and
- Labeling change due to the modification .
6. Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor
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technology using glucose oxidase.
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- Performance Characteristics:
The FORA V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
- Performance Characteristics:
A comparison of precision and system accuracy performance demonstrated that the FORA V10 Blood Glucose Monitoring System and the currently marketed FORA V10 Blood Glucose Monitoring System are substantially equivalent, the laboratory tests showed that the device met the requirements of ISO 15197.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V10 Blood Glucose Monitoring System are equivalent to the predicate device.
-
- Conclusion:
Based on the information provided in this submission, the FORA V10 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA V10 Blood Glucose Monitoring System.
- Conclusion:
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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
TaiDoc Technology Corporation c/o Ms. Debra Liang Specialist. Regulatory Affairs 6F, No.127, Wugong 2nd Rd. Wugu Township, Taipei County China (Taiwan) 24888
DEC 2 4 2009
Re: K093035
Trade/Device Name: FORA V10 Blood Glucose Monitoring System, Model TD-4244 Regulation Number: 21 CFR $862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: November 24, 2009 Received: December 2, 2009
Dear Ms. Debra Liang:
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 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (2) 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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093035
Device Name: FORA V10 Blood Glucose Monitoring System, Model TD-4244
Indications For Use:
The FORA V10 Blood Glucose Monitoring System, Model TD-4244 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: palm, forearm, upper-arm, calf and thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the FORA V10 Blood Glucose Monitoring System, Model TD-4244 can be used only during steady-state blood glucose conditions.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety:
510(k) K093035
Page 1 of 1
§ 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.