The Vital Signs Monitor is intended for the monitoring of parameters such as ECG, non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, blood glucose and oxygen saturation of arterial hemoglobin (SpO2) of adult patient. The monitor is intended to be used by clinicians and medically qualified personnel and trained users.

Device Description

The Vital Signs Monitor is intended for the monitoring of parameters such as ECG, non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, body temperature, blood glucose and oxygen saturation of arterial hemoglobin (SpO2) of adult patient. The monitor is intended to be used by clinicians and medically qualified personnel and trained users.

The body temperature and blood glucose measurements are cleared by FDA under K101259 and K120042 respectively.

VTRUST Vital Signs Monitor and FORA Vital Signs Monitor are exactly identical in design technical and physical appearance. The only difference is the brand name and model name.

AI/ML Overview

This document is primarily a 510(k) summary for a vital signs monitor, focusing on demonstrating substantial equivalence to predicate devices, rather than an in-depth study report with acceptance criteria and detailed performance data like those for AI/ML devices. Therefore, much of the requested information (like specific acceptance criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present.

However, I can extract the available information and indicate where the requested details are missing.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in the format of specific numerical thresholds for performance metrics. Instead, it refers to the device meeting the "specification cleared under" previous 510(k)s for the predicate devices. The "Test Objective" is to ensure performance meets these prior specifications.

Parameter	Test Objective	Reported Device Performance (as stated in the document)
ECG performance	To ensure the ECG performance meets the specification cleared under K101569.	The "Performance Bench Testing" section states: "The laboratory and clinical evaluations for the performance of Vital Signs Monitor demonstrate that the modifications do not impact on the effectiveness. The performance of this system meets its intended use and is equivalent to the predicated devices."
SpO2 performance	To ensure the SpO2 performance meets the specification cleared under K101259.	(Same as above)
NIBP (Non-Invasive Blood Pressure) performance	To ensure the NIBP performance meets the specification cleared under K101259.	(Same as above)
Blood Glucose performance	To ensure the blood glucose performance meets the specification cleared under K120042.	(Same as above)
Thermometer performance	To ensure the thermometer performance meets the specification cleared under K101259.	(Same as above)
Clinical Evaluation	To ensure the device performance complies with the designed specification.	(Same as above)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: This information is not provided in the document. The document mentions "laboratory and clinical evaluations" but does not give specific numbers of subjects or data points for these evaluations.
Data Provenance: This information is not provided in the document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable/not provided. For a vital signs monitor, ground truth is typically established by reference devices or calibrated standards, not expert readers as would be the case for image-based diagnostic AI. The document refers to meeting specifications cleared under previous 510(k)s.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in cases where interpretation is subjective (e.g., radiology reads). For a vital signs monitor, performance is assessed against objective measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is a key metric. This document describes a vital signs monitor for measuring objective physiological parameters.

6. Standalone Performance Study (Algorithm Only)

Yes, a form of standalone performance was assessed. The document states that "laboratory and clinical evaluations for the performance of Vital Signs Monitor demonstrate that the modifications do not impact on the effectiveness." This implies that the device's measurements (ECG, SpO2, NIBP, Blood Glucose, Thermometer) were directly evaluated against established performance specifications, independently of a human-in-the-loop scenario. The term "algorithm only" is less fitting here as it's a hardware device measuring physiological signals.

7. Type of Ground Truth Used

The ground truth for this type of device would typically be established through calibrated reference standards or predicate devices known to be accurate. The document repeatedly states that the device's performance is intended "To ensure ... meets the specification cleared under [previous 510(k) numbers]." This implies the prior 510(k) submissions established what constitutes acceptable performance against a gold standard for each physiological parameter.

8. Sample Size for the Training Set

This information is not applicable/not provided. This device is a vital signs monitor, not an AI/ML device that requires a training set in the conventional sense. Its function is based on established signal processing and measurement principles, not learned from a training dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons above (not an AI/ML device with a training set).

Summary

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June 6, 2018

TaiDoc Technology Corporation Anne Kuo Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, Taiwan 24888

Re: K172221

Trade/Device Name: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, FLL, NBW, LFR, DPS Dated: May 1, 2018 Received: May 4, 2018

Dear Anne Kuo:

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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

M.A. Wilhelm

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

Enclosure

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Indications for Use

510(k) Number (if known) K172221

Device Name

VTRUST Vital Signs Monitor, Model: TD-2300 FORA Vital Signs Monitor, Model: VSM100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Tel : +886-2-6625-8188 Fax : +886-2-6625-0288

510(k) Summary

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is: K172221_

1. Submitter Information

Company Name:	TaiDoc Technology Corporation
Address:	6F, No. 127, Wugong 2nd Rd., Wugu Dist., New Taipei City, Taiwan 24888
Contact Person:	Anne Kuo
Title:	Regulatory Affairs Specialist
Phone:	+886-2-6625-8188 #1195
Fax:	+886-2-6625-0608
E-mail:	Anne.Kuo@taidoc.com.tw

2. Proposed Device Information:

Trade/Device Name:	VTRUST Vital Signs Monitor, Model: TD-2300FORA Vital Signs Monitor, Model: VSM100
Regulation Name:	Monitor, physiological, patient (without arrhythmia detection or alarms)
Regulatory Class:	Class II
Regulation Number:	21 CFR §870.2300
Review Panel:	Cardiovascular
Product Code:	MWI
Subsequent ProductCodes:	DPS Electrocardiograph
	DQA Oximeter
	DXN System, measurement, blood-pressure, non-invasive
	FLL Thermometer, Electronic, Clinical
	NBW Blood Glucose Test System, Over-the-Counter
	LFR Glucose Dehydrogenase

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	泰博科技股份有限公司TaiDoc Technology Corp.
	www.taidoc.com
Subsequent RegulationNumber:	21 CFR §870.2340	Electrocardiograph
	21 CFR §870.2700	Oximeter
	21 CFR §870.1130	Noninvasive blood pressure measurement system
	21 CFR §880.2910	Clinical electronic thermometer
	21 CFR §862.1345	Glucose test system

3. Intended Use:

4. Device Description:

The body temperature and blood glucose measurements are cleared by FDA under K101259 and K120042 respectively.

VTRUST Vital Signs Monitor and FORA Vital Signs Monitor are exactly identical in design technical and physical appearance. The only difference is the brand name and model name.

Primary predicate device	V-TRUST Model TD-8002 Multi-Parameter Spot Check MonitorK101259
Subsequent Predicate Device(ECG)	V-TRUST TD-2202 Portable ECG RecorderK101569
Subsequent Predicate Device(Blood Glucose)	TD-4268 Blood Glucose Monitoring SystemTD-4268 Multi Blood Glucose Monitoring SystemK120042
Similarities	ECG technology

5. Substantial Equivalence Information:

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	泰博科技股份有限公司TaiDoc Technology Corp.	新北市24888五股區五工二路127號6樓6F., No.127, Wugong 2nd Rd., Wugu Dist.,New Taipei City 24888, Taiwan	Tel : +886-2-6625-8188Fax : +886-2-6625-0288
	www.taidoc.com
	NIBP technology
	SpO2 technology
	Blood glucose technology
	Temperature technology
	Data transmission
	Power source

6. Test Principle:

The Vital Signs Monitor applies the same test principle as those of the predicate devices. No changes were made in the peripheral blood glucose meter and thermometer.

7. Safety and Effectiveness Characteristics:

The evaluation of safety, electromagnetic compatibility, biocompatibility, and software validation of the Vital Signs Monitor were conducted based on the following standards:

Standard	Title
IEC 60601-1	Medical Electrical Equipment, Part 1: General requirements for basic safety andessential performance
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 60601-1-8	Medical electrical equipment - Part 1-8: General requirements for basic safetyand essential performance - Collateral Standard: General requirements, tests andguidance for alarm systems in medical electrical equipment and medicalelectrical systems
IEC 60601-2-27	Medical electrical equipment - Part 2-27: Particular requirements for the basicsafety and essential performance of electrocardiographic monitoring equipment
IEC 60601-2-49	Medical electrical equipment - Part 2-49: Particular requirements for the basicsafety and essential performance of multifunction patient monitoring equipment
IEC 62304	Medical device software - Software life-cycle processes
IEC 80601-2-30	Medical electrical equipment - Part 2-30: Particular requirements for the basicsafety and essential performance of automated non-invasivesphygmomanometers

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Image /page/6/Picture/0 description: The image shows the logo for TaiDoc, a company that specializes in medical devices. The logo consists of the word "TaiDoc" in gray letters, followed by three red hearts. Below the logo is the website address "www.taidoc.com".

泰博科技股份有限公司 TaiDoc Technology Corp.

新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist. New Taipei City 24888, Taiwan

Tel : +886-2-6625-8188 Fax : +886-2-6625-0288

ISO 80601-2-61	Medical electrical equipment -- Part 2-61: Particular requirements for basicsafety and essential performance of pulse oximeter equipment
ISO 10993 series	Biological evaluation of medical devices
ISO 14971	Medical device - Application of Risk Management to Medical Devices

8. Performance Bench Testing:

The laboratory and clinical evaluations for the performance of Vital Signs Monitor demonstrate that the modifications do not impact on the effectiveness. The performance of this system meets its intended use and is equivalent to the predicated devices.

Description	Test Objective
ECG performance testing	To ensure the ECG performance meets the specificationcleared under K101569.
SpO2 performance testing	To ensure the SpO2 performance meets the specificationcleared under K101259.
NIBP performance testing	To ensure the NIBP performance meets the specificationcleared under K101259.
Blood Glucose performance testing	To ensure the blood glucose performance meets thespecification cleared under K120042.
Thermometer performance testing	To ensure the thermometer performance meets thespecification cleared under K101259.
Clinical Evaluation	To ensure the device performance complies with the designedspecification.

9. Conclusion:

Based on the information provided in this submission, the Vital Signs Monitor is believed to be substantially equivalent with the predicate devices.

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).