(195 days)
Not Found
No
The document describes a standard blood pressure monitor with basic functions and display, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a blood pressure monitor intended for measurement and monitoring, not for treating a disease or condition.
Yes
Explanation: The device is intended to "measure non-invasively the systolic and diastolic blood pressure and pulse rate," which are physiological parameters used in diagnosing medical conditions.
No
The device description explicitly states that the device includes hardware components such as setting buttons, an LCD display, and an arm cuff, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to measure blood pressure and pulse rate non-invasively by wrapping a cuff on the upper arm. This is a physical measurement taken directly from the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Sample Analysis: The description and intended use do not mention the analysis of any biological samples.
Therefore, based on the provided information, the FORA P20 Blood Pressure Monitor / U-RIGHT TD-3132 Blood Pressure Monitor is a non-invasive medical device for measuring vital signs, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of TD-3132 is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the upper arm of the subject. This system should only be used for the testing on people over 18 years of age and over.
The FORA P20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
Product codes
DXN
Device Description
The TD-3132 is an arm type blood pressure monitor. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols displayed on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, and memory record.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
over 18 years of age and over
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)
Non-clinical Performance: The results for non-clinical trials as presented in this document demonstrated the conformance to the SP10 standard that is also the reference standard for the predicate device. Therefore, the substantial equivalence between the devices is determined.
Clinical Performance: The clinical test results of the TD-3132 showed the functions of the device met the criteria in the SP10 standard. Hence, it is reasonable to conclude the substantial equivalence between the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
JAN 2 5 2010
12106
+1/2
Attachment 2
510(k) Summary
1. Submitter's Information
Name: TaiDoc Technology Corporation Address: 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, Taiwan Phone: 886-2-6625-8188 Fax: 886-2-6625-0288 Contact Person: Erica Li Prepared Date: 06/22/2009
2. Name of Device
Trade Name: FORA P 20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor
Common Name: blood pressure monitor
Classification Name: Noninvasive Blood Pressure Measurement System (per 21 CFR 870.1130)
3. Predicate Device
Trade/Proprietary Name:A&D Medical UA-851 THW Digital Blood Pressure Monitor
Common/Usual Name: blood pressure monitor
Manufacturer: A&D Engineering, Inc.
510 (k) Number: K082734
4. Device Description
The TD-3132 is an arm type blood pressure monitor. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols displayed on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, and memory record.
1
5. Intended Use
The intended use of TD-3132 is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the upper arm of the subject. This system should only be used for the testing on people over 18 years of age and over.
6. Comparison to Predicate Device
Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.
7. Non-clinical Performance
The results for non-clinical trials as presented in this document demonstrated the conformance to the SP10 standard that is also the reference standard for the predicate device. Therefore, the substantial equivalence between the devices is determined.
8. Clinical Performance
The clinical test results of the TD-3132 showed the functions of the device met the criteria in the SP10 standard. Hence, it is reasonable to conclude the substantial equivalence between the devices.
9. Conclusions
TD-3132 demonstrates satisfactory performance (safety and effectiveness) and is suitable for its intended use.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 5 2010
Taidoc Technology Corporation c/o Ms. Erica Li Management Representative 6F, No. 127, Wugong 2nd Rd Wugu Township Taipei County China (Taiwan) 24888
Re. K092106
Trade/Device Name: FOR A P20 Blood Pressure Monitor/U-RIGHT TD-3132 Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: January 3, 2010 Received: January 8, 2010
Dear Ms. Li:
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.
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.
3
Page 2 - Ms. Erica Li
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 (reporting of medical device-rclated 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 dcsire 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 1
Indications for Use Statement
Applicant: TaiDoc Technology Corporation
510(k) Number (if known): K092106
Device Name: FORA P20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor
Indications for Use:
The FORA P20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number
AND/OR
Over-The-Counter Use X
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Olvision Sign-Off)
ivision of Cardiovascular Devices