(317 days)
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No
The document describes a standard vital signs monitor and does not mention any AI or ML capabilities.
No
The device is a monitor that measures physiological parameters. It does not provide treatment or therapy.
No.
The "Intended Use / Indications for Use" states that the device is "intended for the monitoring of parameters," which implies measuring and displaying physiological data, not diagnosing conditions based on that data. While some of the parameters monitored might be used by a clinician for diagnostic purposes, the device itself is described as a monitor.
No
The device description explicitly mentions monitoring parameters like ECG, non-invasive blood pressure, pulse rate, body temperature, blood glucose, and SpO2. These measurements typically require physical sensors and hardware components to acquire the physiological data, indicating it is not solely software. The predicate devices also include hardware monitors.
Based on the provided information, this device is partially an IVD (In Vitro Diagnostic).
Here's why:
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Blood Glucose Measurement: The description explicitly states that the blood glucose measurement is cleared by the FDA under K120042, which is a K number for a "Blood Glucose Monitoring System". Blood glucose monitoring is a classic example of an in vitro diagnostic test, as it involves analyzing a sample (blood) outside of the body to obtain diagnostic information.
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Other Parameters: The other parameters monitored (ECG, blood pressure, pulse rate, SpO2, body temperature) are generally considered in vivo measurements, meaning they are taken directly from the patient's body without analyzing a sample outside the body.
Therefore, the Vital Signs Monitor is a multi-parameter device that includes both in vivo and in vitro diagnostic functions.
It's important to note that while the device as a whole is a "Vital Signs Monitor," the blood glucose component specifically falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN, FLL, NBW, LFR, DPS
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patient
Intended User / Care Setting
clinicians and medically qualified personnel and trained users.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The evaluation of safety, electromagnetic compatibility, biocompatibility, and software validation of the Vital Signs Monitor were conducted based on standards.
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.
Test Objectives:
ECG performance testing: To ensure the ECG performance meets the specification cleared under K101569.
SpO2 performance testing: To ensure the SpO2 performance meets the specification cleared under K101259.
NIBP performance testing: To ensure the NIBP performance meets the specification cleared under K101259.
Blood Glucose performance testing: To ensure the blood glucose performance meets the specification cleared under K120042.
Thermometer performance testing: To ensure the thermometer performance meets the specification cleared under K101259.
Clinical Evaluation: To ensure the device performance complies with the designed specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
V-TRUST Model TD-8002 Multi-Parameter Spot Check Monitor K101259, V-TRUST TD-2202 Portable ECG Recorder K101569, TD-4268 Blood Glucose Monitoring System K120042
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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)
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.
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in a gray sans-serif font, followed by three red hearts. Below the hearts is a gray rectangle with the text "www.taidoc.com" in white.
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-2300
FORA 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 Product
Codes: | 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. | | 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 |
|----------------------------------|---------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------|
| | www.taidoc.com | | | |
| Subsequent Regulation
Number: | 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:
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.
4. 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.
| Primary predicate device | V-TRUST Model TD-8002 Multi-Parameter Spot Check Monitor
K101259 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Subsequent Predicate Device
(ECG) | V-TRUST TD-2202 Portable ECG Recorder
K101569 |
| Subsequent Predicate Device
(Blood Glucose) | TD-4268 Blood Glucose Monitoring System
TD-4268 Multi Blood Glucose Monitoring System
K120042 |
| 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 : +886-2-6625-8188
Fax : +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 and |
| essential performance | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety |
| and essential performance - Collateral standard: Electromagnetic compatibility - | |
| Requirements and tests | |
| IEC 60601-1-8 | Medical electrical equipment - Part 1-8: General requirements for basic safety |
| and essential performance - Collateral Standard: General requirements, tests and | |
| guidance for alarm systems in medical electrical equipment and medical | |
| electrical systems | |
| IEC 60601-2-27 | Medical electrical equipment - Part 2-27: Particular requirements for the basic |
| safety and essential performance of electrocardiographic monitoring equipment | |
| IEC 60601-2-49 | Medical electrical equipment - Part 2-49: Particular requirements for the basic |
| safety 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 basic |
| safety and essential performance of automated non-invasive | |
| sphygmomanometers |
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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 basic
safety 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 specification |
| cleared under K101569. | |
| SpO2 performance testing | To ensure the SpO2 performance meets the specification |
| cleared under K101259. | |
| NIBP performance testing | To ensure the NIBP performance meets the specification |
| cleared under K101259. | |
| Blood Glucose performance testing | To ensure the blood glucose performance meets the |
| specification cleared under K120042. | |
| Thermometer performance testing | To ensure the thermometer performance meets the |
| specification cleared under K101259. | |
| Clinical Evaluation | To ensure the device performance complies with the designed |
| specification. |
9. Conclusion:
Based on the information provided in this submission, the Vital Signs Monitor is believed to be substantially equivalent with the predicate devices.