FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM by TaiDoc Technology Corporation

The FORA Premium 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. 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 Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA Premium V10 Test Strips are for use with the FORA Premium V10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, upper-arm, calf and thigh.

This meter has some speaking functions but is not intended for use by the visually impaired.

Device Description

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA test strips and FORA control solutions (cleared under K093724) with the FORA Premium V10 Blood Glucose Monitoring System.

AI/ML Overview

The provided 510(k) summary for the FORA Premium V10 Blood Glucose Monitoring System does not contain detailed information about the acceptance criteria and the study that proves the device meets them in the format requested.

Specifically, it states: "FORA Premium V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device. A comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent." And also, "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Premium V10 Blood Glucose Monitoring System are equivalent to the predicate device."

This indicates that the device's performance was established by demonstrating substantial equivalence to a predicate device (FORA V30 Blood Glucose Monitoring System, K093635), rather than through a detailed, standalone study with specific acceptance criteria and performance metrics presented in this document.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone study details, and training set information) is not available in the provided text.

However, based on the information that is present, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document for the FORA Premium V10, but implied to be "same performance characteristics as the predicate device" (FORA V30 Blood Glucose Monitoring System). For blood glucose monitors, typical acceptance criteria would involve accuracy standards such as ISO 15197 (which often specifies limits like ±15% or ±20% agreement with a reference method within certain glucose ranges), but these are not cited here.
Reported Device Performance: The document states that the system "has the same performance characteristics as the predicate device" and that a "comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent." No specific numerical performance metrics are provided for the FORA Premium V10 in this summary.

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The study appears to be a bench-level comparison to a predicate device, rather than a clinical study requiring expert ground truth establishment for a test set.

4. Adjudication method

Not applicable/not specified in the provided text.

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

Not applicable. This is a blood glucose monitoring system, not an imaging device typically evaluated with MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

"Standalone" performance, in the context of a blood glucose meter, refers to the accuracy of the device itself compared to a reference method. The document indicates that "system accuracy performance" was compared to the predicate device. However, no specific data from such a standalone study (if one was performed) is included in this summary.

7. The type of ground truth used

Not explicitly stated. For blood glucose meters, the "ground truth" (or reference standard) is typically established using a laboratory-grade, highly accurate glucose measurement method (e.g., YSI analyzer) on venous blood samples. The document doesn't detail the method used to compare against the predicate.

8. The sample size for the training set

Not applicable/not specified in the provided text. As this relies on substantial equivalence to an existing device and a well-established measurement principle (electrochemical biosensor using glucose oxidase), there isn't a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

Not applicable/not specified in the provided text.

Summary

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DEC 1 5 2011

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: K112275

1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 248, Taiwan
  Correspondent: Teling Hsu Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0288 Email: teling.hsu(@taidoc.com.tw

Prepared date: Aug 03, 2011

1. Device name:
  Proprietary name: FORA Premium V10 Blood Glucose Monitoring System

Regulatory information:

A. Regulation section: 21 CFR 862.1345 Glucose Test System
Classification: Class II B.
Product Code: CGA, Glucose Oxidase, Glucose C.
- NBW, System, Test, Blood Glucose, Over The Counter
D. Panel: Clinical Chemistry (75)

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1. Intended Use:
  The FORA Premium 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. 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 Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

This meter has some speaking functions but is not intended for use by the visually impaired.

1. Device Description:
  The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA test strips and FORA control solutions (cleared under K093724) with the FORA Premium V10 Blood Glucose Monitoring System.
1. Substantial Equivalence Information:
- A. Predicate device name: FORA V30 blood glucose monitoring system
- B. Predicate K number: K093635
- C. Comparison with predicate:

The modified FORA Premium V10 Blood Glucose Monitoring System has the following similarities to the predicate device:

1 same operating principle,
I same fundamental scientific technology,
트 incorporate the same basic circuit design,
incorporate the same materials,
. same shelf life

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packaged using the same materials, and
manufactured by the same process.

The modifications encompass:

Modification in the physical appearance
. Minor software modifications of the glucose meter
Change of the data transmission method from RS-232 to USB
그 Labeling change due to the above modifications
1. Test Principle:

The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.

1. Performance Characteristics:
  FORA Premium V10 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA Premium V10 Blood Glucose Monitoring System and the FORA V30 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA Premium V10 Blood Glucose Monitoring System are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the FORA Premium V10 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA V30 blood glucose monitoring system.

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Image /page/3/Picture/13 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

10903 New Hampshire Avenue Silver Spring, MD 20993

TAIDOC TECHNOLOGY CORPORATION C/O TELING HSU 3F-5F NO. 127 WUGONG 2ª0 RD. WUGU DISTRICT NEW TAIPEI CITY CHINA (TAIWAN) 24888

DEC 1 5 2011

Re: K112275

Trade Name: FORA Premium V10 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA Dated: November 16, 2011 Received: November 22, 2011

Dear Ms. 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 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 (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 (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,

Signature

Couriney 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

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Indications for Use

51.0(k) Number (if known): K112275

Device Name: FORA Premium V10 Blood Glucose Monitoring System, model TD-4124 Indications for Use:

The alternative site testing in the FORA Premium V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

This meter has some speaking functions but is not intended for use by the visually impaired.

AND/OR

Prescription Use _______ (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 Device (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K 1122 )

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Regulation Number and Section

§ 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.