The VTRUST Finger Type Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.

This device is indicated for non-invasive spot checking.

Device Description

The proposed device is a finger type device which is designed for non-invasive spot checking of functional arterial oxygen saturation (SpO2) and pulse rate for adults based on the principle of spectrophotometry.

The proposed device utilizes the conventional oximetry technology. The sensor contains a dual light source (red and infrared light-emitting diodes) and photo-detector (photodiode). The photo-detector senses the light signal and the sensor converts this electrical information by use of an algorithm to provide real time values of SpO2, pulse rate and pulse amplitude.

The proposed device has approved under water resistant and dust resistant level IPS6.

AI/ML Overview

The provided text describes a 510(k) submission for the VTRUST Finger Type Pulse Oximeter, but it does not contain specific acceptance criteria, detailed study results, or the other requested information for a comprehensive study description.

However, based on the information provided, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the provided text. For pulse oximeters, acceptance criteria typically involve accuracy (Root Mean Square - RMS, or bias and precision) for SpO2 and pulse rate against a co-oximeter reference, often across a range of saturations. These are usually defined based on international standards like ISO 80601-2-61.
Reported Device Performance: The text generally states that a "Clinical study" (Attachment 4.5) confirmed the "performance, safety and effectiveness of the proposed device are equivalent to the predicate device." However, no specific performance metrics (e.g., accuracy, bias, precision values for SpO2 or pulse rate) are provided in the main summary.

Metric (Inferred)	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
SpO2 Accuracy	(Likely based on ISO 80601-2-61)	Performance equivalent to predicate
Pulse Rate Accuracy	(Likely based on ISO 80601-2-61)	Performance equivalent to predicate
Safety	(Likely based on ISO 80601-2-61)	Safety equivalent to predicate
Effectiveness	(Likely based on ISO 80601-2-61)	Effectiveness equivalent to predicate

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

Sample Size for Test Set: Not specified. The document only mentions a "Clinical study" was performed.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Clinical studies for pulse oximeters are typically prospective and conducted by inducing controlled hypoxia in healthy volunteers.

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

For pulse oximetry, "ground truth" for SpO2 is typically established using a co-oximeter measurement of arterial blood samples. This does not involve human experts in the same way an imaging study would. Therefore, this question is not directly applicable in the context of pulse oximeter accuracy testing.

4. Adjudication Method for the Test Set:

Not applicable as the ground truth is established by a co-oximeter, not by expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic imaging or interpretation tasks involving human readers. For a pulse oximeter, the device directly measures physiological parameters. There's no "human reader" interpreting cases in the context of device accuracy, only the device's measurement against a reference standard.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Yes, implicitly. The "Clinical study" would evaluate the device's (algorithm's) performance in measuring SpO2 and pulse rate directly against a reference standard (co-oximeter) without human intervention in the measurement process itself, beyond operating the device.

7. The Type of Ground Truth Used:

Co-oximetry. For pulse oximeters, the gold standard for measuring arterial oxygen saturation (SaO2) is typically a laboratory co-oximeter analysis of simultaneously drawn arterial blood samples. The device's SpO2 readings are then compared to these SaO2 values.

8. The Sample Size for the Training Set:

Not applicable / Not specified. Pulse oximeters typically use established physics-based algorithms (spectrophotometry) rather than machine learning models that require distinct "training sets" and "test sets" in the same way. While the algorithm may have been developed and refined using data, it's not a "training set" in the common machine learning sense for a clinical validation study. The document focuses on the validation of the final device.

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

Not applicable. As above, the concept of a "training set" for ground truth establishment isn't directly relevant in the device's described operating principle. Algorithm development would rely on accurate physiological models and data, likely using co-oximetry as the reference, but this isn't a separate "training set" in the context of this 510(k) submission.

Summary

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NOV 222 2011

Attachment 3

K 110893 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: VTRUST Medical Business Unit TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondent:

Erica Li Sales Director Tel: +886-2-6625-8188 #1172 Fax: +886-2-6625-0288 Email:erica@taidoc.com

Date of preparation: March 22, 2011

1. Device name:
  Proprietary name: VTRUST FINGER TYPE PULSE OXIMETER

Regulatory information:

Regulation section: 21 CFR 870.2700 Oximeter A.
Classification: Class II B.
DQA C. Product Code: .
D. Panel: Anesthesiology

Image /page/0/Figure/16 description: The image shows the text "11-1 of 3". This text likely indicates a page number or a position within a sequence. The number 11-1 could be a chapter and section, and "of 3" suggests that there are a total of three pages or items in the sequence.

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1. Intended Use:
  The VTRUST Finger Type Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.

This device is indicated for non-invasive spot checking.

1. Device Description:
  The proposed device is a finger type device which is designed for non-invasive spot checking of functional arterial oxygen saturation (SpO2) and pulse rate for adults based on the principle of spectrophotometry.

The proposed device has approved under water resistant and dust resistant level IPS6.

1. Substantial Equivalence Information:
- Predicate device name: V-TRUST Handheld Pulse Oximeter A.
- Predicate K number: K101012 B.
- C. Comparison-with predicate:

The proposed device has the following similarities to the predicate device:

E same operating principle,
same oximetry measuring technology, E
i same intended use

The modifications encompass:

Device dimension including PCB layout, E
E Software,

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A comparison table that describes detailed similarities and modifications is provided in attachment 2 and it demonstrates that the proposed and the predicated devices are substantially equivalent.

Testing D.

Modification	Validation report	Attachment
Device dimension	Safety, EMC,Biocompatibility	Attachment 4.2-4.4
Software	Software validation	Attachment 4.7
Safety and effectiveness	Risk management,Clinical study, andConsumer study	Attachment 4.1, 4.5, 4.6

For testing according to the above modification, please see below table

According to those reports, it confirmed that the performance, safety and effectiveness of the proposed device are equivalent to the predicate device.

1. Conclusion:
  Based on the performance data provided in this submission, the proposed device is substantially equivalent to the predicate with the same effectiveness and safety.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the left side of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Teling Hsu Regulatory Affairs Specialist TaiDoc Technology Corporation 3F, 5F, NO 127 Wugong 2nd Road Wugu Township Taipei County CHINA (TAIWAN) 24888

NOV 222 2011

Re: K 110893

Trade/Device Name: VTRUST Finger Type Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 13, 2011 Received: July 13, 2011

Dear Ms. Hsu:

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.

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Page 2 - Ms. Hsu

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 your 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anthony V. Arnhim

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

Indications for Use

510(k) Number (if known):

Device Name: VTRUST Finger Type Pulse Oximeter

Indications for Use:

The VTRUST Finger Type Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.

This device is indicated for non-invasive spot checking.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 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 510(k)

L. Schull Other

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

8-1 of 1

510(k) Number:

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).