(140 days)
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples 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.
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System cannot be used on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in whole blood and control solutions.
This 510(k) summary provides very limited information regarding the performance studies of the CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System. It states that the device has the "same performance characteristics as the predicate device" and that "studies of software verification and validation testing, method comparison, and meter reliability test demonstrated that the performance of systems meets the intended use." However, it does not provide any specific acceptance criteria or detailed results of these studies.
Therefore, for almost all of your requested information, the document explicitly states that the device has the 'same performance characteristics as' the predicate, but does not identify these characteristics, or describe tests that establish them. As a result, I must indicate that most of the criteria cannot be met based on the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (The document claims "CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System has the same performance characteristics as the predicate device," but does not specify what those characteristics or their acceptance criteria are. It also mentions "studies of software verification and validation testing, method comparison, and meter reliability test demonstrated that the performance of systems meets the intended use" without providing actual performance data or specific criteria for "meets the intended use".) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not provided.
- Data provenance: Not provided (e.g., country of origin, retrospective/prospective).
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)
- Not applicable as no information on ground truth establishment by experts is provided for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no details of a test set with expert adjudication are provided.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The device is a Blood Glucose Monitoring System, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The document implies standalone performance of the blood glucose monitor through "method comparison, and meter reliability test," but it does not explicitly detail these studies or provide specific data regarding standalone performance. Without specific details on the "method comparison" test, it's impossible to confirm the algorithmic performance in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated for the "method comparison" studies. For blood glucose monitoring systems, ground truth is typically established by comparing results from the device to a laboratory reference method (e.g., a YSI analyzer), rather than expert consensus, pathology, or outcomes data. However, the document does not specify the ground truth method.
8. The sample size for the training set
- Not provided. The document does not mention a "training set" in the context of machine learning, as this is a traditional medical device, not an AI/ML product. The studies mentioned ("software verification and validation testing, method comparison, and meter reliability test") are standard performance evaluations for such devices.
9. How the ground truth for the training set was established
- Not applicable, as no training set (in the ML sense) is mentioned or implied.
Summary of the Study Information Provided in the Document:
The 510(k) submission for the CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System relies heavily on its substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187). It states that the proposed device has the "same performance characteristics" as the predicate and that the "intended use, test principle, and operating technology" are the same. The only difference is an "engineering modification."
The performance studies mentioned are:
- Software verification and validation testing
- Method comparison
- Meter reliability test
The document concludes that these studies "demonstrated that the performance of systems meets the intended use." However, no specific details, data, acceptance criteria, or methodologies for these studies are provided within the given text. This level of detail is typically found in the full 510(k) submission and supporting documentation, which is not included here.
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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.
ко93506 The Assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
| 1. Submitter Information | |
|---|---|
| Company name | TaiDoc Technology Corporation |
| Contact person | Teling Hsu |
| Address | 6F, No. 127, Wugong 2nd Rd, |
| Wugu Township, Taipei County, | |
| 24888, Taiwan | |
| Phone | (+886-2) 6625-8188 #1176 |
| FAX | (+886-2) 6625-0288 |
| teling.hsu@taidoc.com.tw | |
| Date Prepared | November 6th, 2009 |
- Name of Device Proprietary Names
Common Name
Product Code
Classification Name
CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System Blood Glucose Test System Class II devices (21 CFR Section 862.1345) NBW / CGA
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Manufacturer 510 (k) Number
FORA G30 Blood Glucose Monitoring System Blood Glucose Test System TaiDoc Technology Corporation K090187
4. Device Description
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in whole blood and control solutions.
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5. Intended Use
The CLEVER CHO!CE Auto-Code Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples 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.
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System cannot be used on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
6. Comparison to Predicate Device
The intended use, test principle, and operating technology of CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System are all the same as the predicate device. The only difference between the predicate and proposed devices is in engineering modification.
This system uses amperometry for blood glucose measurement. The test is based on the measurement of electrical current generated by the reaction of glucose with reagents of the test strip.
•
7. Performance Studies
CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
The studies of software verification and validation testing, method comparison, and meter reliability test demonstrated that the performance of systems meets the intended use.
8. Conclusion
CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for the intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a simple, official representation of the department.
DEPARTMENT OF HEALTH & HUMAN SERVICES
TaiDoc Technology Corporation c/o Teling Hsu Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Road, Wugu Township Taipei County, China (Taiwan) 248
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
APR 0 1 2010
Re: K093506
Trade/Device Name: CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: February 26, 2010 Received: March 5, 2010
Dear Teling Hsu:
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 vour device is classified (see above) into class II (Special Controls), 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 (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).
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.
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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/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.
Signature
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): K093506
Device Name:
CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System
Indications for Use:
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples 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.
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System cannot be used on neonates.
The alternative site testing in above systems 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 801 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)
Carol Benson
Division Sign-off Office of in Vitro Diagnostic Devices Evaluation and Safety 510(k)
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.