The FORA V20 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 V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

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 V20 test strips and control solutions with the FORA V20 Blood Glucose Monitoring System.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary for the FORA V20 Blood Glucose Monitoring System, focusing on demonstrating substantial equivalence to a predicate device (FORA TD-4245 Blood Glucose Monitoring System).

Here's what can be extracted and what is missing, based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in a quantitative table. The document claims "FORA V20 Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
Reported Device Performance: Not explicitly provided in a quantitative table for the FORA V20. The document states a "comparison of system accuracy performance demonstrated that the FORA V20 Blood Glucose Monitoring System and the currently marketed FORA TD-4245 Blood Glucose Monitoring System are substantially equivalent." This implies performance was measured but the actual metrics are not detailed here.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (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:

Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

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 involving human readers or AI assistance in a diagnostic capacity described by an MRMC study.

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

The device performs a quantitative measurement of glucose. The nature of its operation is inherently "standalone" in calculating the glucose level. However, explicit details about a "standalone performance study" in the context of an algorithm's output vs. human interpretation are not present, as the device primarily provides a direct numerical reading.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated. For blood glucose monitors, the ground truth is typically a reference laboratory method (e.g., YSI analyzer) for glucose measurement. The document states "The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase," but doesn't detail the reference method used for comparison during testing.

8. The sample size for the training set:

Not applicable/Not specified. This document pertains to the submission of a device for substantial equivalence, not the development of a machine learning algorithm with an explicit "training set" in the conventional sense. The "software modification to no-coding" and "software modification to use mg/dL as the preset measurement" are functional changes, not indicative of a machine learning model that undergoes training on a dataset.

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

Not applicable/Not specified (as there's no explicit mention of a training set for an AI/ML model).

Summary of what is present:

The device is a FORA V20 Blood Glucose Monitoring System.
It measures glucose in fresh capillary whole blood from the finger and alternative sites.
It's intended for use by healthcare professionals and people with diabetes mellitus at home.
It's not for diagnosis or screening of diabetes mellitus, nor for use on neonates.
It has a speaking functionality for visually impaired persons.
The principle is electrochemical biosensor technology using glucose oxidase.
The primary means of demonstrating suitability for market is through substantial equivalence to a predicate device (FORA TD-4245 Blood Glucose Monitoring System), noting similarities (operating principle, technology, circuit design, materials, shelf life, packaging, manufacturing process) and modifications (software for no-coding, Spanish speaking function, preset mg/dL).
The document implies that the performance characteristics are the same as the predicate device and that software verification and validation confirmed equivalence in performance, safety, and effectiveness.

Conclusion based on the provided text:

The document primarily focuses on establishing substantial equivalence to a predicate device, rather than detailing a specific de novo study with explicit acceptance criteria, ground truth methodology, and performance metrics as if it were a new AI/ML diagnostic tool. Therefore, much of the requested information regarding detailed study design and acceptance criteria is not present in this 510(k) summary.

Summary

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Attachment 3. 510(k) Summary

MAY 1 1 2010

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: K100406

1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Nicky Pan Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1196 Fax: +886-2-6625-0288 Email: nicky@taidoc.com.tw

Date of submission: 02/12/2010

1. Device name:
  Proprietary name: FORA V20 blood glucose monitoring system

Regulatory information:

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

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3. Intended Use:

The alternative site testing in the FORA V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

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 V20 test strips and control solutions with the FORA V20 Blood Glucose Monitoring System.
1. Substantial Equivalence Information:
  Predicate device name: A. FORA TD-4245 Blood Glucose Monitoring System

B. Predicate K number: K083664

C. Comparison with predicate:

The modified FORA V20 Blood Glucose Monitoring Systems has the following similarities to the predicate device:

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

A3-2 of 3

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

The modifications encompass:

Software modification to no-coding
I Addition of "no-coding" phrase on the labeling
Addition of speaking function in Spanish ■
... Software modification to use mg/dL as the preset measurement.
1. Test Principle:

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

1. Performance Characteristics:
  FORA V20 Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA V20 Blood Glucose Monitoring System and the currently marketed FORA TD-4245 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V20 Blood Glucose Monitoring Systems arc equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the FORA V20 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA TD-4245 Blood Glucose Monitoring System.

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Public Health Service

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

TaiDoc Technology Corporation c/o Nicky Pan Specialist of Regulatory Affairs 3F, 5F, No. 127, Wugong 2nd Rd Wugu Township Taipei County, China (Taiwan) 248

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Hay 1 1 2010

Re: k 100406

Trade name: FORA V20 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 16, 2010 Received: April 16, 2010

Dear Nicky Pan:

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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 Form

510(k) Number (if known): K100406

Device Name: FORA V20 Blood Glucose Monitoring System

Indications for Use:

The alternative site testing in the FORA V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off Office of In Vitro

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100406

Page 1 of 1

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.