(98 days)
The U-RIGHT TD-4249/ U-RIGHT TD-4250 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 U-RIGHT TD-4249/ U-RIGHT TD-4250 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
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The provided text is a 510(k) premarket notification letter from the FDA regarding a blood glucose monitoring system. This type of document primarily confirms the substantial equivalence of a medical device to a legally marketed predicate device. It does not typically contain detailed descriptions of acceptance criteria, study methodologies, or specific performance data from clinical trials or standalone algorithm evaluations in the format requested.
Therefore, many of the requested items cannot be extracted from this document, as they are not present. However, I can provide information based on what is available in the letter and general knowledge of FDA submissions for such devices.
Here's an attempt to answer your questions based on the provided text and general context where information is missing:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance for blood glucose accuracy. For blood glucose monitoring systems, acceptance criteria typically involve comparisons to a laboratory reference method (e.g., YSI analyzer) and are often expressed as percentages of readings within certain error margins (e.g., ISO 15197 standard criteria). These specific performance metrics are usually found in the detailed submission data, not in the FDA's decision letter.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document does not specify the sample size for the test set or the data provenance. These details would be part of the clinical study report submitted with the 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to a blood glucose monitoring system. The "ground truth" for blood glucose measurements is established by a highly accurate laboratory reference method (e.g., a YSI STAT Plus Glucose & Lactate Analyzer), not by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to a blood glucose monitoring system. Adjudication methods like 2+1 are typically used in imaging studies where multiple readers interpret images, and discrepancies are resolved by an adjudicator.
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
This is not applicable to a blood glucose monitoring system. MRMC studies are used for diagnostic imaging devices involving interpretation by multiple readers. Blood glucose monitors primarily provide quantitative measurements.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A blood glucose monitoring system itself is a "standalone" device in that it provides a direct measurement without human interpretation of complex visual data. The performance study would evaluate the accuracy of the device's measurement algorithm against a reference standard. The document confirms the FDA has reviewed the "premarket notification of intent to market the device," which would include such performance data. However, the specific results or methodology details are not in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for a blood glucose monitoring system's performance evaluation is almost always a highly accurate laboratory reference method for blood glucose measurement, such as a YSI STAT Plus Glucose & Lactate Analyzer. This is considered the accepted standard for comparison.
8. The sample size for the training set
This document does not specify the sample size for any training set. For blood glucose meters, "training set" is not a typical term in the way it is used for AI/ML algorithms. The device is calibrated and validated using a series of known glucose concentrations and patient samples, but these are generally referred to as calibration and validation samples rather than a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
As with the test set, the "ground truth" for calibration/validation samples would be established by a highly accurate laboratory reference method for blood glucose measurement. The device is designed to measure glucose, and its internal algorithms are developed to accurately translate electrochemical signals into glucose concentrations that correlate with these reference values.
Summary of what can be gleaned from the document regarding the device and its regulatory status:
- Device Name: U-RIGHT TD-4249/U-RIGHT TD-4250 Blood Glucose Monitoring System
- Manufacturer: TaiDoc Technology Corporation
- Regulatory Class: Class II
- Regulation Number/Name: 21 CFR 862.1345, Glucose Test System
- Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh). Intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control. Not for diagnosis/screening for diabetes or use on neonates. Alternative site testing only during steady-state blood glucose conditions.
- Regulatory Outcome: Found substantially equivalent (SE) to a legally marketed predicate device, allowing it to proceed to market.
The FDA letter confirms the regulatory clearance for the device based on the substantial equivalence determination, which implicitly means the submitted data (including performance studies, which are not detailed here) met the criteria for this determination.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is facing to the right and its wings are curved upwards. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2 2009 UUN
TaiDoc Technology Corporation c/o Sophie Lin Regulatory Affairs Specialist 6F, No. 127 Wugong 2nd Rd. Wugu Township Taipei County China (Taiwan) 241
Re: K083570
Trade/Device Name: U-Right TD-4249/U-Right TD-4250 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: February 9, 2009 Received: February 9, 2009
Dear Ms. Lin:
This letter corrects our substantially equivalent letter of March 11, 2009.
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting 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: K083570
Device Name: U-RIGHT TD-4249/ U-RIGHT TD-4250 Blood Glucose Monitoring System
Indications for Use:
The U-RIGHT TD-4249/ U-RIGHT TD-4250 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 U-RIGHT TD-4249/ U-RIGHT TD-4250 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ And/Or Over the Counter Use _ X (21 CFR Part 801 Subpart D) (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 (OVD)
Rute Charles
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k) ko8357 0
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§ 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.