(237 days)
Not Found
No
The description explicitly states the device utilizes "conventional oximetry technology" and an "algorithm" based on spectrophotometry, with no mention of AI or ML terms or concepts.
No
Explanation: The device is described as a pulse oximeter for measuring and displaying oxygen saturation and pulse rate. Its intended use is for non-invasive spot checking, which is a diagnostic or monitoring function, not a therapeutic intervention.
No
Explanation: The device measures and displays physiological parameters (SpO2 and pulse rate) for spot-checking, but it does not claim to diagnose any condition or disease. It provides data for information purposes rather than directly aiding in diagnosis.
No
The device description explicitly states it is a "finger type device" and describes hardware components like "dual light source (red and infrared light-emitting diodes)" and a "photo-detector (photodiode)". It also mentions water and dust resistance levels, which are hardware specifications.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The VTRUST Finger Type Pulse Oximeter measures and displays functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by placing the device on the finger. This is a non-invasive measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use describes non-invasive spot checking of physiological parameters.
Therefore, the device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
According to those reports, it confirmed that the performance, safety and effectiveness of the proposed device are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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).
0
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:
-
- Submitter's Identification: VTRUST Medical Business Unit TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondent:
- Submitter's Identification: VTRUST Medical Business Unit TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
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
-
- Device name:
Proprietary name: VTRUST FINGER TYPE PULSE OXIMETER
- Device name:
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.
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.
- Intended Use:
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.
- Device Description:
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.
-
- 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,
2
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, and | ||
| Consumer 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.
-
- 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.
- Conclusion:
3
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.
4
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
5
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: