The FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System are 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 V30 Blood Glucose Monitoring System /TD-4242 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.

Device Description

The kit of FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available lancing device and sterile Lancets, User Manual, and Storage Pack.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System, nor does it describe a specific study proving the device meets those criteria with the requested level of detail.

The document is a 510(k) summary for a medical device, primarily focusing on demonstrating substantial equivalence to a predicate device (FORA G30/TD-4241 Blood Glucose Monitoring System).

Here's what can be inferred from the text regarding performance and testing, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "A comparison of system accuracy performance demonstrated that the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent."

It also mentions: "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems are equivalent to the predicate device."

Acceptance Criteria: Not explicitly stated in terms of specific thresholds for accuracy, precision, or other metrics. The implied acceptance criterion is "substantial equivalence" to the predicate device in terms of performance.
Reported Device Performance: No specific numerical performance metrics (e.g., mean absolute relative difference, percentage within specific error zones) are provided for either the new device or the predicate. The performance is reported as being "substantially equivalent."

Acceptance Criteria	Reported Device Performance
Substantial equivalence in system accuracy performance to predicate device (FORA G30/TD-4241)	Demonstrated substantial equivalence
Performance, safety, and effectiveness equivalent to predicate device	Software verification and validation confirmed equivalence

Missing Information for a comprehensive table: Specific numerical targets for accuracy, precision, linearity, or other relevant performance characteristics as defined in recognized standards (e.g., ISO 15197) or internal specifications.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 is described as a "system accuracy performance" comparison, implying a comparison against a reference method (often a laboratory analyzer), not necessarily ground truth established by experts in a diagnostic imaging or pathology context.

4. Adjudication method for the test set:

Not applicable or not specified, as the study appears to be a direct comparison of glucose measurements, not an interpretation task requiring adjudication.

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 device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers.

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

The device itself is a standalone system for measuring blood glucose. The "performance characteristics" mentioned refer to the device's accuracy in measuring glucose. This would inherently be a standalone evaluation of the device's measurement capabilities.

7. The type of ground truth used:

The text refers to "system accuracy performance." For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings to those obtained from a laboratory reference method (e.g., hexokinase method on a central laboratory analyzer) known for its high accuracy and precision. The document does not explicitly state the reference method used.

8. The sample size for the training set:

Not applicable. This device is an electrochemical biosensor system, not a machine learning model that requires a training set in the conventional sense. The "software modification" mentioned would have undergone software verification and validation, not model training.

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

Not applicable, as there is no "training set" for an electrochemical biosensor.

Summary

{0}------------------------------------------------

Attachment 6. 510(k) Summary

FEB 1 8 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: K093635

1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Debra Liang Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1198 Fax: +886-2-6625-0288 Email: debra.liang@taidoc.com.tw

Date of submission: 11.20.2009

1. Device name:
  Proprietary name: FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System

Regulatory information:

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

{1}------------------------------------------------

3. İntended Use:

The alternative site testing in the FORA V30 Blood Glucose Monitoring System /TD-4242 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 kit of FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available lancing device and sterile Lancets, User Manual, and Storage Pack.
1. Substantial Equivalence Information:
  Predicate device name: A.

FORA G30/TD-4241 Blood Glucose Monitoring System

B. Predicate K number: K090187
C. Comparison with predicate:

The modified FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems have the following similarities to the predicate device:

same operating principle,
same fundamental scientific technology, ■
incorporate the same basic circuit design, .
. incorporate the same materials,

{2}------------------------------------------------

same shelf life
packaged using the same materials, and
Manufactured by the same process. I

The modifications encompass:

A modification in the software of the glucose meter 배
일 Speaking function
Modification in the physical appearance ■
Addition of components: voice chip and speaker
1 Labeling change due to the software modification
1. Test Principle:

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

1. Performance Characteristics:
  FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System have the same performance characteristics as the predicate device.

A comparison of system accuracy performance demonstrated that the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System are substantially equivalent to the predicate FORA G30/TD-4241 Blood Glucose Monitoring System.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a series of three curved lines that resemble a stylized staff with intertwined snakes, a symbol often associated with medicine and healthcare.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB 1 8 2010

TaiDoc Technology Corporation c/o Ms. Debra Liang Specialist, Regulatory Affairs 6F, No.127, Wugong 2nd Rd. Wugu Township, Taipei County China (Taiwan) 24888

Re: K093635

Trade/Device Name: FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: December 23, 2009 Received: January 20, 2010

Dear Ms. Debra Liang:

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 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).

{4}------------------------------------------------

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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

{5}------------------------------------------------

Attachment 12. Indications for Use

Indications for Use

510(k) Number: K093635

Device Name: FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System

Indications for Use:

The alternative site testing in the FORA V30 Blood Glucose Monitoring System /TD-4242 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.

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 Safety

K 093635 510(k) =

Page 1 of

A12-1 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.