(158 days)
The Clever Chek TD-3250C Blood Glucose plus Blood pressure Monitoring System / Clever Chek TD-3250D Blood Glucose plus Blood pressure Monitoring System / Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure 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 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 alternative site testing in this system can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.
The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" - 13.8".
This system offers wireless communication function which is able to transmit the test result to other devices, such as PC,
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system consists of a monitor with arm cuff and test strips. The 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 fresh whole blood and control solutions.
The system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8" (24 ~35 cm) for am.
Above systems offer wireless communication function which is able to transfer the test result to other devices, such as PC.
Here's a breakdown of the acceptance criteria and study information for the Clever Chek TD-3250C / TD-3250D / Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure Monitoring System, extracted from the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list numerical "acceptance criteria" for the blood glucose or blood pressure measurements in a table format with corresponding "reported device performance." Instead, it generally states that "The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use" and "Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system demonstrate satisfactory performance and are suitable for their intended use."
However, for similar devices, the FDA typically requires performance standards for glucose meters to establish accuracy within certain limits compared to a reference method (e.g., ISO 15197 standards for blood glucose monitoring systems). For blood pressure monitors, accuracy is usually assessed against a reference standard or by comparison with a sphygmomanometer against established protocols (e.g., AAMI, BHS, ESH protocols).
Given the lack of specific numerical criteria and performance data in this summary, it's not possible to generate the requested table directly from the provided text. The submission relies on the general finding of "satisfactory performance" to demonstrate substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
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Blood Glucose:
- Sample Size: Not specified in the provided text. The document only mentions "clinical settings by healthcare professionals and lay users."
- Data Provenance: Not explicitly stated. The submitter is TaiDoc Technology Corporation from Taiwan, but the location of the clinical studies is not mentioned. The studies are referred to generally as being "in the laboratory and in clinical settings." It is not specified if the studies were retrospective or prospective.
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Blood Pressure:
- Sample Size: Not specified in the provided text. The document only mentions "clinical settings by healthcare professionals and lay users."
- Data Provenance: Not explicitly stated. Similar to the blood glucose analysis, the location of the studies is not specified, nor whether they were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The document does not detail how the ground truth for either glucose or blood pressure measurements was established, nor does it mention the involvement or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically done for diagnostic imaging devices where human readers interpret images, sometimes with and without AI assistance. The described device is a blood glucose and blood pressure monitoring system, which does not involve human interpretation of complex data in the same way.
- Effect Size of AI vs. absence of AI: Not applicable, as no such study was performed or described.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone measurement system (meter and strips for glucose, cuff and monitor for blood pressure). The performance studies mentioned (in laboratory and clinical settings) inherently assess the algorithm's performance in generating the readings. However, the summary does not explicitly define a "standalone study" in the context of an AI algorithm separate from the device's operational use, as the device's core function is to produce quantitative measurements directly. The studies were designed to evaluate the system's accuracy in direct measurement.
7. Type of Ground Truth Used
The specific type of ground truth used is not explicitly stated in the summary. For blood glucose monitoring systems, ground truth is typically established using laboratory reference methods (e.g., YSI glucose analyzer). For blood pressure monitors, ground truth is usually established via a validated sphygmomanometer or another accepted reference standard. Since the summary only mentions "performance studies" and "clinical settings," it's implied that some form of comparative or reference measurement was used, but the specifics are absent.
8. Sample Size for the Training Set
This information is not provided in the 510(k) summary. The document describes the device's technology but does not discuss machine learning or AI models with distinct "training sets" in the context of their development. The device relies on electrochemical and oscillometric methods, which are established physical measurement principles, not typically "trained" in the same way an AI algorithm designed for image interpretation would be.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as the concept of a "training set" in the context of an AI algorithm is not discussed for this device.
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510 (k) Summary
K0800J4
Page 1-of-3
| 1. Submitter Information | JUN - 9 2008 | ||
|---|---|---|---|
| Company name | TaiDoc Technology Corporation | ||
| Contact person | Yuhua Chen | ||
| Address | 6F, No.127, Wugong 2nd Rd.,Wugu Township, Taipei County,248, Taiwan | ||
| Phone | (886-2) 6625-8188 | ||
| FAX | (886-2) 6625-0288 | ||
| yuhua.chen@taidoc.com.tw | |||
| 2. Name of Device | |||
| Trade Names | - Clever Chek TD-3250C BloodGlucose plus Blood pressure MonitoringSystem- Clever Chek TD-3250D BloodGlucose plus Blood pressure MonitoringSystem- Fora Comfort 2 in 1 BloodGlucose plus Blood PressureMonitoring System | ||
| Common Names/Descriptions | - Blood Glucose and Blood PressureMeasurement System- Blood Glucose Test Strips | ||
| Classification Names | - Class II devices- 21 CFR Section 862.1345, Glucose TestSystem- 21 CFR Section 870.1130, Non-invasiveBlood Pressure Measurement System |
Page 2-of-3
:
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| 3. Predicate Device | |
|---|---|
| Trade/Proprietary Name: | Clever Chek TD-3250 Blood Glucose plusBlood Pressure Monitoring System |
| Common/Usual Name: | - Blood Glucose and Blood PressureMeasurement System- Blood Glucose Test Strips |
| Manufacturer | TaiDoc Technology Corporation |
| 510 (k) Number | K062800 NBW, CGA, DXN |
4. Device Description
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system consists of a monitor with arm cuff and test strips. The 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 fresh whole blood and control solutions.
The system is able to provide blood pressure measurement which adopts the "oscillometric method" as the measuring principle. It provides the systolic pressure, diastolic blood pressure and pulse rate on an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4"~13.8" (24 ~35 cm) for am.
5. Intended Use
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).
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The alternative site testing (the palm, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
The system is also intended to be used to non-invasively measure the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".
Above systems offer wireless communication function which is able to transfer the test result to other devices, such as PC.
6. Comparison to Predicate Device
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system has equivalent technological characteristics and intended use as the Clever Chek TD-3250 blood glucose plus blood pressure monitoring system (K062800).
7. Performance Studies
The performance of Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the above blood glucose plus blood pressure monitoring system is suitable for its intended use.
8. Conclusion
Clever Chek TD-3250C / Clever Chek TD-3250D / Fora Comfort 2 in 1 blood glucose plus blood pressure monitoring system demonstrate satisfactory performance and are suitable for their intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Taidoc Technology Corporation c/o Yuhua Chen 6F, No. 127, Wugong 2nd Rd. Taipei County, 241 Taiwan (ROC)
JUN = 9 2008
Re: K080014
Trade/Device Name: Clever Chek TD-3250C Blood Glucose plus Blood Pressure Monitoring System
Clever Chek TD-3250D Blood Glucose plus Blood Pressure Monitoring System
Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure Monitoring System
Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, DXN Dated: June 3, 2008 Received: June 4, 2008
Dear Mr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your or your we 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 I ou may, iteretory manns 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 It may be bable 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 I loast be advisou and I DTT 3 issuantes vour device complies with other requirements of the Act that I Driving and regulations administered by other Federal agencies. You must or any I otoral butther and regulanents, 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Téan M. Cooper, M.S., D.V.M. 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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Indication for Use
510(k) Number: (080014
Device Name:
Clever Chek TD-3250C Blood Glucose plus Blood pressure Monitoring System Clever Chek TD-3250D Blood Glucose plus Blood pressure Monitoring System Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure Monitoring System
Indication For Use:
The Clever Chek TD-3250C Blood Glucose plus Blood pressure Monitoring System / Clever Chek TD-3250D Blood Glucose plus Blood pressure Monitoring System / Fora Comfort 2 in 1 Blood Glucose plus Blood Pressure 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 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 alternative site testing in this system can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home.
The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" - 13.8".
This system offers wireless communication function which is able to transmit the test result to other devices, such as PC,
Prescription Use (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 Safe 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.