(113 days)
The FORA P100 Blood Pressure Monitoring System is intended to measure 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. Do not use this system on babies, young children or persons who cannot express their consent.
FORA P100 Blood Pressure Monitoring System (Model: P100) can be operated by the device itself to assist in blood pressure testing, recording, tracking and monitoring in easy.
The TD-3130 in report is an internal model and FORA P100 is the marketing name for this system.
The FORA P100 Blood Pressure Monitoring System was validated by tests conducted according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009.
1. Table of Acceptance Criteria and Reported Device Performance:
| Standard/Requirement | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| IEC 80601-2-30:2009 | Met requirements | Met requirements |
| ANSI/AAMI/ISO 81060-2:2009 | Met requirements | Met requirements |
| Electrical Safety (IEC/EN 60601-1) | Met requirements | Met requirements |
| EMC (IEC/EN 60601-1-2) | Met requirements | Met requirements |
| Shock and Vibration (IEC/EN 60601-1-11) | Met requirements | Met requirements |
| Biocompatibility (ISO 10993-5, 10993-10) | Met requirements | Met requirements |
| Software Validation | Functionally works | Verified and validated |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample size used for the specific tests in the performance characteristics section, nor does it detail the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the device was validated by specific international standards.
3. Number of Experts and Qualifications:
The document does not provide information about the number of experts used to establish a ground truth or their qualifications. The validation relies on adherence to established international standards for medical devices, which typically involve standardized testing protocols rather than expert consensus on individual readings for ground truth in the context of blood pressure monitoring devices.
4. Adjudication Method:
The document does not mention an adjudication method for a test set. This type of method is usually associated with studies involving human interpretation (e.g., radiology images) rather than the direct measurement and algorithmic calculation performed by a blood pressure monitor.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The device's validation is based on its performance against recognized industry standards for accuracy and safety, rather than comparing human readers with and without AI assistance.
6. Standalone Performance:
The performance characteristics described (validation against IEC 80601-2-30:2009 and ANSI/AAMI/ISO 81060-2:2009) implicitly refer to the standalone performance of the FORA P100 Blood Pressure Monitoring System, as these standards assess the accuracy and functionality of the device itself. The device uses an oscillometric method to determine blood pressure and pulse rate.
7. Type of Ground Truth Used:
For blood pressure monitors, the "ground truth" for accuracy studies (such as those conforming to ANSI/AAMI/ISO 81060-2) typically involves direct comparison with a reference method, often auscultation by trained observers using a mercury sphygmomanometer or another validated reference device, under strictly controlled conditions. The document states validation was done "according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009," which implies this type of ground truth was used for accuracy assessment.
8. Sample Size for the Training Set:
The document does not explicitly mention a training set or its sample size. This information is typically relevant for machine learning models, and while the device uses a "software algorithm," the document doesn't provide details on an explicit training phase for that algorithm within the context of the submission. The algorithm for blood pressure measurement based on the oscillometric method is well-established.
9. How Ground Truth for the Training Set Was Established:
Since no explicit training set is mentioned in the document, there is no information on how its ground truth might have been established.
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February 12, 2019
TaiDoc Technology Corporation Sophia Wu Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 TAIWAN
Re: K182934
Trade/Device Name: FORA P100 Blood Pressure Monitoring System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 19, 2018 Received: October 22, 2018
Dear Sophia Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 mediation-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,
Stephen C. Browning -S5
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) K182934
Device Name
FORA P100 Blood Pressure Monitoring System
Indications for Use (Describe)
The FORA P100 Blood Pressure Monitoring System is intended to measure 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. Do not use this system on babies, young children or persons who cannot express their consent.
Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K182934
Image /page/3/Picture/1 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters above three red hearts. Below the hearts is the website address "www.taidoc.com" in white letters on a gray background.
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., W New Tainei City 7488
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
Section9 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: K182934
1. Submitter Information:
| Company Name | TaiDoc Technology Corporation |
|---|---|
| Address | 6F, No. 127, Wugong 2nd Rd., Wugu District, |
| New Taipei City, 24888, Taiwan | |
| Establishment Registration No. | 3004145393 |
| Date Prepared | October 19th, 2018 |
| Contact Person | Sophia Wu |
| Title | Vice President of Regulatory Affairs Department |
| Phone | +886-2-6625-8188 |
| Fax | +886-2-6625-0288 |
| sophiawu@taidoc.com.tw / ra.cert@taidoc.com.tw |
2. Proposed Device Information:
| Trade/Proprietary Name | FORA P100 Blood Pressure Monitoring System |
|---|---|
| Model Number | P100 |
| Common Name | Blood Pressure Monitoring System |
| Product Code | DXN |
| Classification Panel | 74, Cardiovascular |
| Classification | Class II |
| Regulation citation | 21 CFR §870.1130, Non-invasive Blood PressureMeasurement System |
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Image /page/4/Picture/1 description: The image shows the logo for TaiDoc. The word "TaiDoc" is written in gray letters at the top of the image. Below the word are three red hearts. At the bottom of the image, on a gray background, is the website address "www.taidoc.com".
股份有限公司
新北市24888万股幅于
Tel : +886-2-6625-8188
Fax : +886-2-6625-0288
3. Predicate Device:
| Trade/Proprietary Name | FORA CARE BLOOD PRESSURE MONITORING SYSTEM |
|---|---|
| Common Name | Blood Pressure Monitoring System |
| Submitter | TaiDoc Technology Corporation |
| 510(k) Number | K133588 |
4. Intended Use
The FORA P100 Blood Pressure Monitoring System is intended to be used to measure 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. Do not use this system on babies, young children or persons who cannot express their consent.
5. Device Description:
FORA P100 Blood Pressure Monitoring System (Model: P100) can be operated by the device itself to assist in blood pressure testing, recording, tracking and monitoring in easy.
The TD-3130 in report is an internal model and FORA P100 is the marketing name for this system.
6. Test Principle:
Blood pressure is measured non-invasively at the arm based on oscil-lometric method.
For people of common arrhythmia, such as atrial or ventricular pre-mature beats or atrial fibrillation, we recommend to use auscultatory mode. The reading obtained by single and average mode which use oscillometic method is for reference only and should be discussed with the healthcare professionals.
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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
7. Substantial Equivalence Information:
| Similarities | Modifications | |
|---|---|---|
| • | Operating principle | • Meter appearance |
| • | Detection method / scientific technology | • Power source |
| • | Employs the same test strip | • User interface |
| • | Narrower intended use | • Speaking function |
| Predicate device name | FORA CARE BLOOD PRESSURE MONITORING SYSTEM |
|---|---|
| Predicate K number | K133588 |
| Comparison withpredicate | The modified FORA P100 Blood Pressure Monitoring Systemhas the following similarities to the predicate device:same intended use, same operating principle, same fundamental scientific technology, incorporate the same basic circuit design, incorporate the same materials, manufactured by the same process.The modifications encompass:Meter memory Speaking function Modification of the devices physical appearance Labeling change due to the above modifications |
The FORA P100 Blood Pressure Monitoring System and the predicate device both use the oscillometric method within the software algorithm to determine the systolic, diastolic blood pressure and pulse rate with an inflatable arm cuff. The major difference between the two devices is physical appearance of device. The minor changes are software.
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8. Performance Characteristics:
The FORA P100 Blood Pressure Monitoring System was validated by the tests according to IEC 80601-2-30:2009 and met the requirements of ANSI/AAMI/ISO 81060-2:2009.
Software validation was performed to verify and validate the system works functionally.
Testing performed included electrical safety, EMC, and shock and vibration test. The proposed device met the requirements of IEC/EN 60601-1, IEC/EN 60601-1-2 and IEC/EN 60601-1-11.
Biocompatibility testing was also performed. The materials of cuff met the requirements of ISO 10993-5 and 10993-10.
The FORA P100 Blood Pressure Monitoring System has the same performance characteristics as the predicate device. Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the FORA P100 Blood Pressure Monitoring System are substantial equivalent to the predicate device.
9. Conclusion:
Based on the information provided in this submission, the FORA P100 Blood Pressure Monitoring System is substantially equivalent to the predicate FORA CARE BLOOD PRESSURE MONITORING SYSTEM.
§ 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).