The TD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2).
The device is intended to be used by clinicians and medically qualified personnel.
For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood.
For blood pressure measurements, it is intended to be used to measure noninvasively the systolic and diastolic blood pressure and pulse rate of adults.
For pulse oximeter measurements, is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2 ) and pulse rate for adults.
For ear thermometer, it is intended for the intermittent measurement and monitoring human body temperature.

Device Description

The V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor, Model TD-8002 (TD-8002) is a patient monitor that measures and displays real time physiological data of the patient, including blood glucose measurement. The TD-8002 can be used to monitor one or more of the following parameters: Noninvasive blood pressure (NIBP), blood oxygen saturation (SpO2), pulse rate, body temperature, and blood glucose. For all these vital parameters, the TD-8002 will be capable of limit alarms for SpO2, and storing monitoring data for retrospective review.
The TD-8002 has two monitoring devices built in the main unit: oximeter and NIBP monitor. The other two monitoring devices, infra-red ear thermometer and blood glucose meter are connected to the main unit via USB cable. All of the devices for monitoring vital signs are cleared by the FDA.
The oximeter sensor connected to the main unit of TD-8002 is the same as the Solaris Compatible Reusable Adult SpO2 Finger Sensor (Model S100A-090103 or Model S100A-300103) cleared under K061931.

AI/ML Overview

The provided text is a 510(k) summary for the V-TRUST TD-8002 Multi-Parameter Spot Check Monitor. It does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement that the device "meets its intended use and is equivalent to the predicate devices." The document primarily focuses on establishing substantial equivalence to previously cleared devices.

Therefore, many of the requested details about acceptance criteria, study specifics, and performance data cannot be extracted from this summary.

Here's a breakdown of what can be inferred or directly stated, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Equivalence to predicate devices for: - Blood Pressure Accuracy - Pulse Rate Accuracy - Ear Temperature Accuracy - Blood Glucose Accuracy - SpO2 Accuracy - Pulse Rate (from SpO2) Accuracy	"The laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor demonstrate that the performance of this system meets its intended use and is equivalent to the predicate devices." (No specific performance metrics like mean absolute difference (MAD), bias, or limits of agreement are reported in this summary.)

Explanation of Inferred Criteria: The 510(k) process relies on demonstrating substantial equivalence to predicate devices. This implicitly means that the new device must perform at least as well as, or within acceptable tolerances compared to, the predicates for each parameter it measures. However, the exact quantitative acceptance criteria (e.g., specific AAMI standards for NIBP, ISO standards for glucose, or specific SpO2 accuracy limits) are not detailed in this summary.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified, beyond general "laboratory and clinical studies." It does not mention country of origin or whether studies were 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 in the 510(k) summary. Given the nature of the device (physiological measurements), ground truth would likely be established using highly accurate reference methods (e.g., arterial line for NIBP, CO-oximeter for SpO2, laboratory analyzer for glucose). The expertise of individuals involved in operating these reference methods would be relevant, but "experts to establish ground truth" in the AI/image analysis sense is not applicable here.

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

Not applicable/not specified. This type of adjudication is typically relevant for subjective assessments, particularly in imaging studies involving AI. For objective physiological measurements, the ground truth is established by a reference device, not by expert consensus.

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, an MRMC comparative effectiveness study was not done. This device is a multi-parameter spot-check monitor, not an AI-assisted diagnostic tool for human readers. Its function is to directly measure physiological parameters.

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

Yes, the performance referenced ("laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor") would inherently be a standalone performance assessment of the device's accuracy in measuring each parameter. The device itself is designed to provide direct measurements, not to assist a human in interpreting something.

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

While not explicitly stated, for each parameter, the ground truth would be established by a highly accurate reference method or device. For example:
- Blood Pressure: Likely invasive arterial line measurements or a highly calibrated reference NIBP device.
- Pulse Rate: Could be derived from ECG or a highly accurate reference pulse oximeter/NIBP device.
- Ear Temperature: A highly accurate reference thermometer (e.g., rectal probe, calibrated oral thermometer).
- Blood Glucose: A laboratory-grade glucose analyzer using plasma or serum separated from the same blood sample.
- SpO2: A CO-oximeter measurement from arterial blood gas.

8. The sample size for the training set

This information is not applicable and not provided. The V-TRUST TD-8002 is a device that uses established measurement principles (e.g., oscillometric for NIBP, spectrophotometry for SpO2, enzymatic for glucose). It does not employ machine learning algorithms in the sense that would require a "training set" for an AI model.

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

This information is not applicable and not provided, as there is no "training set" in the context of this device's technology.

Summary

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

KI01259 P//3

3. 510(k) Summary

JUN 1 7 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:

1. Submitter's Identification:
  TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan

Correspondence: Debra Liang Regulatory Affairs Specialist Tel: +886-2-6625-8188 Fax: +886-2-6625-0288

Prepared date: April 29, 2010

Device name:

Proprietary name: V-TRUSTTD-8002 MULTI-PARAMETER SPOT CHECK MONITOR

Regulatory information:

Regulation section: 21 CFR 870.2300 A.
Classification: Class II മ്പ്
Product Code: C. MWI, monitor, physiological, patient (without arrhythmia detection or alarms)
D. Panel: Cardiovascular

3. Intended Use:

The V-TRUSTTD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2).

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

. The device is intended to be used by clinicians and medically qualified personnel.
. For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood.
. For blood pressure measurements, it is intended to be used to measure noninvasively the systolic and diastolic blood pressure and pulse rate of adults.
. For pulse oximeter measurements, is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2 ) and pulse rate for adults.
t For ear thermometer, it is intended for the intermittent measurement and monitoring human body temperature.

4. Device Description:

The TD-8002 has two monitoring devices built in the main unit: oximeter and NIBP monitor. The other two monitoring devices, infra-red ear thermometer and blood glucose meter are connected to the main unit via USB cable. All of the devices for monitoring vital signs are cleared by the FDA.

The oximeter sensor connected to the main unit of TD-8002 is the same as the Solaris Compatible Reusable Adult SpO2 Finger Sensor (Model S100A-090103 or Model S100A-300103) cleared under K061931.

1. Substantial Equivalence Information:
- Predicate device name and k number: A.
- 506 Patient Monitor (K051038) ●
- . Oximeter: 503 PULSE OXIMETER (K911124)
- . Blood Glucose Meter: Clever Check TD-1231 Blood Glucose Monitoring System (K063212)
- Blood Glucose Test Strip: TaiDoc Pro I Glucose Test Strip (K082169) .

Page 2

3- 2 of 3

్లో,

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

. 1R Thermometer: Fora ComfortScan Ear Thermometer (KU81445)
�: NIBP: U-RIGHT TD-3132 Blood Pressure Monitor (K092106)
Comparison with predicate: ದ್ದ

The V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor has equivalent technological characteristics and the similar intended use as the predicate devices.

6. Test Principle:

The V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor uses the same test principle as the predicate devices.

1. Performance Characteristics:
  The laboratory and clinical studies for the performance of V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor demonstrate that the performance of this system meets its intended use and is equivalent to the predicate devices.
1. Conclusion:
  Based on the information provided in this submission, the V-TRUST TD-8002 Multi-Parameter Spot-Check Monitor is substantially equivalent to the predicate devices.

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

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 7 2010

Ms. Debra Liang Regulatory Affairs, Senior Specialist TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township Taipei County, Taiwan 24888

Re: K101259

Device Name: V-TRUST Model TD-8002 Multi-Parameter Spot Check Monitor Regulation Number: 21 CFR 870.2300

Regulation Name: Patient Physiological Monitor (Without Arrhythmia Detection or Alarms)

Regulatory Class: Class II (Two) Product Code: MWI Dated: April 29, 2010 Received: May 4, 2010

Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Page 2 -- Ms. Debra Liang

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.tga.gov.au/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number: K101259

Device Name: V-TRUST TD-8002 MULTI-PARAMETER SPOT CHECK MONITOR, MODEL TD-8002

Indications for IJse:

The TD-8002 Multi-Parameter Spot-Check Monitor measures systolic and diastolic pressure, pulse rate, ear temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2).

The device is intended to be used by clinicians and medically qualified રુ personnel..
. For glucose measurements, it quantitatively determines glucose levels using capillary and venous whole blood.
. For blood pressure measurements, it is intended to be used to measure noninvasively the systolic and diastolic blood pressure and pulse rate of adults.
. For pulse oximeter measurements, is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2 ) and pulse rate for adults.
. For ear thermometer, it is intended for the intermittent measurement and monitoring human body temperature.

Preseription Use ਪ੍ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

Page 1 of 1

ござ

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).