(247 days)
No
The summary explicitly states that the software algorithms are identical to the predicate device cleared in 1991 (K911124), which predates the widespread use of AI/ML in medical devices. There is no mention of AI, ML, or related concepts like DNNs or training/test sets for complex models.
No.
The device is indicated for measuring and displaying physiological parameters (SpO2 and pulse rate), not for treatment or therapy.
No
Explanation: While the device measures physiological parameters (SpO2 and pulse rate), its intended use is for "measuring and displaying," which aligns with monitoring or measurement devices rather than diagnostic devices that typically interpret data to determine the nature of a disease or condition. The text also lacks any description of the device interpreting the measured data to diagnose a condition.
No
The device description explicitly states it is a "Handheld Pulse Oximeter" and mentions a "reusable SpO2 sensor accessory" which is an electro-optical sensor. This indicates the device includes hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The V-TRUST Handheld Pulse Oximeter measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by using a sensor placed on the finger. This is a non-invasive measurement taken directly from the patient's body, not from a specimen taken from the body.
Therefore, based on the provided information and the definition of an IVD, the V-TRUST Handheld Pulse Oximeter is not an In Vitro Diagnostic device. It is a non-invasive physiological monitoring device.
N/A
Intended Use / Indications for Use
The V-TRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults. This device with reusable SpO2 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.
Product codes
DQA
Device Description
The V-TRUST Handheld Pulse Oximeter is a light weight, portable and non-invasive pulse oximeter designed for use in measuring and displaying functional arterial oxygen saturation and pulse rate for adults during no motion based on the principle of spectrophotometry. The V-TRUST Handheld Pulse Oximeter uses the same fundamental technology with the predicate device, 503 Pulse Oximeter. The SpO₂ and pulse rate software algorithms, interference-filtering software, and alarming system are identical to the software in the legally marketed predicate device cleared under K911124, with minor changes that do not raise new questions of safety or efficacy. The V-TRUST Handheld Pulse Oximeter is allowed to link individual Solaris Compatible Reusable Adult SpO2 Finger Sensor (K061931) only. Solaris finger sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adult
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
The clinical test included 10 healthy subjects (5 males and 5 females) aged 25-44 years old for the hypoxia study. SpO2 and heart rate accuracy were determined by testing on subjects during no motion over the range of 70% to 100% SpO2 against the artery blood gas (ABG) analyzer in hospital and the predicate device 503 Pulse Oximeter.
The study was performed in accordance with ISO 9919:2005. The SpO2 Arms of the study was equal to or less than the performance test criteria of 2% and the heart rate variation was within +/- 1 bpm as the specifications. The comparison between V-TRUST Handheld Pulse Oximeter and the predicate also showed 2% error limit for adults in the SpO2 range of 70% to 100%. Based on the results, V-TRUST pulse oximeter is substantial equivalent to the predicate device.
The consumer study was performed in both clinical and home environments and the device was used by healthcare professionals and lay users.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical test and consumer study.
Sample Size: 10 healthy subjects (5 males and 5 females) aged 25-44 years old for the hypoxia study.
Key Results: The SpO2 Arms of the clinical study was equal to or less than the performance test criteria of 2% and the heart rate variation was within +/- 1 bpm as the specifications. The comparison between V-TRUST Handheld Pulse Oximeter and the predicate also showed 2% error limit for adults in the SpO2 range of 70% to 100%. The consumer study results demonstrated that the oximeter is suitable for use as intended for SpO2 and heart rate accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SpO2 accuracy: 70% to 100%: within $\pm$ 2%
- Pulse rate accuracy: $\pm$ 1bpm
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 5 2010
Attachment C4
510(k) Summary
- Submitter Information Company name Contact person Address
Phone FAX E-mail Date Prepared
พละ แมร่เป็นตอนตรี และ เกม
- Name of Device .Trade Names Common Names Product Code Classification Panel Regulations
TaiDoc Technology Corporation Teling Hsu 3F, 5F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County, 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw April 2nd, 2010
V-TRUST Handheld Pulse Oximeter Oximeter DQA Anesthesiology Class II 21 CFR 870.2700
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
503 PULSE OXIMETER Oximeter CRITICARE SYSTEMS, INC. K911124
- Device Description
The V-TRUST Handheld Pulse Oximeter is a light weight, portable and non-invasive pulse oximeter designed for use in measuring and displaying functional arterial oxygen saturation and pulse rate for adults during no motion based on the principle of spectrophotometry.
The V-TRUST Handheld Pulse Oximeter uses the same fundamental technology with the predicate device, 503 Pulse Oximeter. The SpO₂ and pulse rate software algorithms,
1
interference-filtering software, and alarming system are identical to the software in the legally marketed predicate device cleared under K911124, with minor changes that do not raise new questions of safety or efficacy.
The V-TRUST Handheld Pulse Oximeter is allowed to link individual Solaris Compatible Reusable Adult SpO2 Finger Sensor (K061931) only. Solaris finger sensors are electro-optical sensors which function without skin penetration, electrical contact, or heat transfer. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter device.
5. Intended Use
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
い・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The V-TRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate for adults.
This device with reusable SpO2 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.
6. Comparisons to the Predicate Device
The V-TRUST Handheld Pulse Oximeter has the following technological characteristics compared with the predicate device, 503 Pulse Oximeter (K911124):
| Description | Proposed Device | Predicate Device |
|---|---|---|
| V-TRUST Handheld Pulse Oximeter | 503 Pulse Oximeter | |
| Intended patient | ||
| population | Adult | Adult |
| Intended application site | Finger | Finger |
| Performance | ||
| specifications | Subject who are well perfused | |
| during no motion | Subject who are well | |
| perfused during no motion | ||
| Detection mode | Continuous monitoring or spot | |
| checking | Continuous monitoring or | |
| spot checking | ||
| Display | LED (light-emitting diode) | LED (light-emitting diode) |
| SpO2 measurement | ||
| range | 0% to 100% | 1% to 99% |
| SpO2 accuracy | 70% to 100%: within $\pm$ 2% | 70% to 99%: within $\pm$ 2% |
| Pulse rate measurement | ||
| range | 30 to 250 BPM | 20 to 300 BPM |
2
| Pulse rate accuracy | $\pm$ 1bpm | $\pm$ 1bpm or $\pm$ 1%, whichever
is greater |
|---------------------------|-------------------------------------------------------------|-------------------------------------------------------------------|
| Power button | Yes | Yes |
| SpO2 % display | Yes | Yes |
| Pulse amplitude indicator | Yes | Yes |
| Pulse rate display | Yes | Yes |
| Low battery indicator | Yes | Yes |
| Sensor error indicator | Yes | Yes |
| Sensor connector port | Yes | Yes |
| Alarm | Yes | Yes |
| Storage condition | -4°F to 122°F (-20°C to 50°C),
below 95%, non-condensing | -4 °F to 131 °F (-20°C to 55
°C), below 95%,
non-condensing |
| Operating condition | 32 °F to 113 °F
(0 °C to 45 °C) | 50 °F to 104 °F
(10 °C to 40 °C) |
7. Performance Studies
ນ: ກິດສ່ວນພຣະເທດໄທແລນ ແລະ ບາງປີຕໍ່ໄດ້ຮັບສະໜາດການ, ການປະຊາທິປະເທດລາວ ແລະ ແລະ ແລະ ເພີ່ມເຕີຣ໌ວໄທແລນ ແລະ
היינגעינית י רטי יותר מומר מומרת מערכת מ
The clinical test included 10 healthy subjects (5 males and 5 females) aged 25-44 years old for the hypoxia study.SpO2 and heart rate accuracy were determined by testing on subjects during no motion over the range of 70% to 100% SpO2 against the artery blood gas (ABG) analyzer in hospital and the predicate device 503 Pulse Oximeter.
The study was performed in accordance with ISO 9919:2005. The SpO2 Arms of the study was equal to or less than the performance test criteria of 2% and the heart rate variation was within +/- 1 bpm as the specifications. The comparison between V-TRUST Handheld Pulse Oximeter and the predicate also showed 2% error limit for adults in the SpO2 range of 70% to 100%. Based on the results, V-TRUST pulse oximeter is substantial equivalent to the predicate device.
The consumer study was performed in both clinical and home environments and the device was used by healthcare professionals and lay users. The results demonstrate that the oximeter is suitable for use as intended SpO2 and heart rate accuracy.
The V-TRUST Handheld Pulse Oximeter meets the requirements of IEC/EN 60601-1:1995, IEC/EN 60601-1-2:2001, ISO 9919: 2005,ISO 10993-5: 1999 and ISO
3
10993-10: 2002. Software of the proposed device is validated.
The quality system for the Handheld Pulse Oximeter is well documented in the ` manufacturer's quality management system and conforms to ISO 13485 and ISO 9001.
- Conclusion
のお気になると、おすすめのお気になる。 このため、アイデントです。 このことです。 ここでは気になると、 ここでとても、 ここでとても、 ここでとても、 ここで
ﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
ディコスターになってる。
The V-TRUST Handheld Pulse Oximeter demonstrates satisfactory performance and is suitable for its intended use. The V-TRUST Handheld Pulse Oximeter is substantially equivalent to the predicate device 503 Pulse Oximeter.
4
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Teling Hsu Regulatory Affairs Specialist TaiDoc Technology Corporation 3F, 5F, No. 127, Wugong 2nd Road Wugu Township, Taipei County Taiwan 24888
DEC 1 5 2010
Re: K101012
K101012
Trade/Device Name: V-TRUST Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: December 7, 2010 Received: December 10, 2010
Dear Mr. Hsu:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 310(x) promoted is substanially equivalent (for the referenced above and nave ucterimined the to her marketed predicate devices marketed in
indications for use stated in the enclosure and as a the Medical Device indications for use stated in the circlessity to the enactment date of the Medical Device interstate commerce prior to way 20, 1770, the sidential in accordance with the provisions of
Amendments, or to devices that have been received in accordance approval of a pr Amendments, or to devices that have been routes that do not require approval of a prematice of the Federal Food, Drug, and Cosment Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the gene approval application (PMA). Tou may, more of the Act include controls provisions of the Act. The general of devices, good manufacturing practice, requirements for annual registration, institution and adulteration. Please note: CDRH does
labeling, and prohibitions against mistrant libelity wereanies We remind you, h labeling, and prohibitions against institution of the remind you, however,
not evaluate information related to contract liability warranties. We remind you, however,
of the 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
ng your device is a the same a trala - Evisting major regulations affecting you If your device is classified (See above) into this. Existing major regulations affecting your
(PMA), it may be subject to additional Controls. Tile 21, Parts 800 to 898, (PMA), it may be subject to adultions: Littlers, Title 21, Parts 800 to 898. In
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In the device can be found in the Code of Federal Regulations, TMS = 7
addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2- Mr. Hsu
Please be advised that FDA's issuance of a substantial equivalence determination does not
ements of Please be advised that FDA's issuance of a substantials with other requirements
mean that FDA has made a determination that your devices with other requires, mean that FDA has made a determination interest by other Federal agencies.
of the Act or any Federal statutes and regulations and not timited to: registration of the Act or any Federal statutes and regulations administered of onlimited to: registration
You must comply with all the Act s requirements, including, but not limited to r You must comply with all the Act STequilements; mostumby one includes reporting
and listing (21 CFR Part 807); labeling (21 CFR Part) (21 CFR Party (21 CFF) Party (21 and listing (21 CFR Part 807); labeling (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of medical device-related adverse events) (2) ceplation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 8 practice requirements as set forth in the quality systems (2) vegan of (1)
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
please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm113809.html for http://www.fda.gov/AboutFDA/CentersOffices CDTFre of Compliance. Also,
the Center for Devices and Radiological Health's (CDRH's) of comerses notification" the Center for Devices and Radiological Treating by reference to premarket notification"
please note the regulation entitled, "Misbranding of environes events under the please note the regulation entitled, "Misolanding of reference of adverse events under the MDR regulation (21 CFR Part 803), please go to
MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Report/Problem/default.htmlfor the CDRH's
http://www.fda.gov/MedicalDevices/Safety/Rep http://www.ida.gov/MedicalDevieos/Division of Postmarket Surveillance.
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general Intornitures and Consumer Assistance at its toll-free
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Small Manufacturers, International its Internet address
number (800) 638-2041 or (301) 796-7100 or at its Internet school number (800) 038-2041 01 (301) 770 7100 et and 12 - 12 08 et and 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
Sincerely yours,
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
6
KI010/2
Indications for Use
510(k) Number:
DEC 1 5 2010
Device Name:
V-TRUST Handheld Pulse Oximeter
Indications for Use:
The V-TRUST Handheld Pulse Oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adults.
This device with reusable SpO2 sensor accessories is indicated for non-invasive spot checking or continuous monitoring.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use _ (21 CFR Part 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)
L. Shultheis
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K10/012
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ancount of Antal Devices
Page 1 of -- 1-510(k) Number: _______________________________________________________________________________________________________________________________________________________________