(155 days)
Fora Care Blood Pressure Monitoring System is a system designed 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. It is intended for individuals age 18 and above use at home and in clinical settings. The device is not to be used for the diagnosis of hypertension or for testing on newborns.
Fora Care Blood Pressure Monitoring System (Model: P80) can be operated by the device itself or with the TDLink BP App. TDLink BP App is designed to assist in blood pressure testing, recording, tracking and monitoring in easy.
Here's a breakdown of the acceptance criteria and study information for the Fora Care Blood Pressure Monitoring System, Model P80, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance:
The 510(k) summary explicitly states that the Fora Care Blood Pressure Monitoring System (Model P80) "meets the same performance specifications as the predicate device" and that "the accuracy has been demonstrated in the predicate 510(k) submission according to the requirements of ANSI/AAMI SP10:2002."
Therefore, the acceptance criteria and reported device performance are derived from the predicate device (U-RIGHT TD-3128 Blood Pressure Monitoring System, K112216) as required by ANSI/AAMI SP10:2002. While the exact numerical acceptance criteria are not provided in this document, the standard typically requires that the device's blood pressure measurements be within a certain mean difference and standard deviation compared to reference measurements.
| Acceptance Criteria (Based on ANSI/AAMI SP10:2002 requirements as met by predicate) | Reported Device Performance (As demonstrated by predicate, and asserted for subject device) |
|---|---|
| No specific numerical criteria are provided in this document, but they would align with the requirements of ANSI/AAMI SP10:2002 for blood pressure measurement accuracy. This standard typically requires a mean difference of ≤ 5 mmHg and a standard deviation of ≤ 8 mmHg for both systolic and diastolic blood pressure compared to reference measurements. | The Fora Care Blood Pressure Monitoring System meets the same performance specifications as the predicate device, which demonstrated accuracy according to ANSI/AAMI SP10:2002. |
Study Details:
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Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for the subject device (Fora Care Blood Pressure Monitoring System). The submission leverages the performance data of the predicate device (U-RIGHT TD-3128), which would have had its own test set size to meet ANSI/AAMI SP10:2002.
- Data Provenance: Not specified for the subject device or the predicate's original study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. For blood pressure monitors tested against ANSI/AAMI SP10, ground truth is typically established using simultaneous auscultatory measurements by trained observers.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified, but for ANSI/AAMI SP10, it's common to have at least two trained observers taking simultaneous readings, with a third if there are significant discrepancies.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted, or rather, the performance of the algorithm (oscillometric method) embedded in the device was demonstrated through its substantial equivalence to a predicate device that had undergone such testing. The document states: "No clinical study was performed using the subject device since the subject device's blood pressure monitoring capability was duplicated from the predicate, K11216 submitted by TaiDoc." This means the standalone performance is inherited from the predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure monitors adhering to ANSI/AAMI SP10:2002 is typically established through auscultatory measurements performed by trained observers (experts) using a mercury sphygmomanometer or validated reference device.
-
The sample size for the training set:
- Not applicable as this is a blood pressure monitor based on a physical measurement principle (oscillometric method) rather than a machine learning algorithm requiring a separate training set. The algorithm itself
is a well-established method.
- Not applicable as this is a blood pressure monitor based on a physical measurement principle (oscillometric method) rather than a machine learning algorithm requiring a separate training set. The algorithm itself
-
How the ground truth for the training set was established:
- Not applicable for the reason stated above. The "training" for the oscillometric method's development would have historically involved extensive empirical data collection and validation against auscultatory readings.
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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 Information
| 1.1 Submitter's Identification: | |
|---|---|
| Company Name: | FORA CARE INC. |
| Contact Person: | Sophia Wu |
| Title: | CEO |
| Address: | 893 Patriot Dr., Suite D, Moorpark, CA 93021 USA |
| Phone: | (805) 498-8188 |
| Fax: | (805) 498-7188 |
| E-mail: | sophiawu@foracare.com |
1.2 Correspondence:
| Contact Person: | Sharon Peng |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Phone: | +886-2-6625-8188 #1176 |
| Fax: | +886-2-6625-0288 |
| E-mail: | sharon_peng@taidoc.com.tw |
| Prepared Date: | November 15th, 2013 |
2. Device name:
| Trade/Proprietary Name: | Fora Care Blood Pressure Monitoring System |
|---|---|
| Common Name: | Blood Pressure Monitor/Measurement |
| Model Number: | P80 |
| Product Code: | DXN |
| Classification Panel: | 74, Cardiovascular |
| Classification: | Class II |
| Regulation Section: | 21 CFR §870.1130, Non-invasive Blood Pressure Measurement System |
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K133588
3. Predicate Device
| Trade/Proprietary Name: | U-RIGHT TD-3128 Blood Pressure Monitoring System |
|---|---|
| Common/Usual Name: | Blood Pressure Test System |
| 510(k) Number: | K112216 |
4. Intended Use
Fora Care Blood Pressure Monitoring System is a system designed 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. It is intended for individuals age 18 and above use at home and in clinical settings.
The device is not to be used for the diagnosis of hypertension or for testing on newborns.
5. Device Description:
Fora Care Blood Pressure Monitoring System (Model: P80) can be operated by the device itself or with the TDLink BP App. TDLink BP App is designed to assist in blood pressure testing, recording, tracking and monitoring in easy.
6. Test Principle:
Fora Care Blood Pressure Monitoring System is measured non-invasively at the arm based on oscillometric method.
This device is not able to take measurements in the presence of common arrhythmia, such as atrial or ventricular premature beats or atrial fibrillation. It may produce reading error.
| Predicate device name: | U-RIGHT TD-3128 Blood Pressure Monitoring System |
|---|---|
| Predicate K number: | K112216 |
| Comparison with | The modified Fora Care Blood Pressure Monitoring System has |
| predicate: | the following similarities to the predicate device: |
| ■ same intended use, |
7. Substantial Equivalence Information:
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| same operating principle, same fundamental scientific technology, incorporate the same basic circuit design, incorporate the same materials, same shelf-life, packaged using the same materials, and manufactured by the same process. The modifications encompass: Linkage with TDLink BP App Remove irregular heart rate detection Without meter memory Modification of the devices physical appearance Labeling change due to the above modifications | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
The Fora Care 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 the application of TDLink BP App and physical appearance of device. The minor software change enables the device to connect with TDLink BP App in personal mobile. The memory unction of meter itself and irregular heart rate detection are removed. User may use the compatible TDLink BP App and review the test results on personal mobile.
8. Performance Characteristics:
A blood pressure accuracy testing was performed to demonstrate the Fora Care Blood Pressure Monitoring System meets the same performance specifications as the predicate device. And the accuracy has been demonstrated in the predicate 510(k) submission according to the requirements of ANSI/AAMI SP10:2002. No clinical study was performed using the subject device since the subject device's blood pressure monitoring capability was duplicated from the predicate, K11216 submitted by TaiDoc.
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K133588
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 Care 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 Care Blood Pressure Monitoring System are substantial equivalent to the predicate device.
9. Conclusion:
Based on the information provided in this submission, the Fora Care Blood Pressure Monitoring System is substantially equivalent to the predicate U-RIGHT TD-3128 Blood Pressure Monitoring System.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Fora Care Inc. c/o Ms. Sharon Peng, Regulatory Affairs Specialist TaiDoc Technology Corporation 6F, No. 127, Wugong 2nd Road, Wugu District New Taipei City 24888 TAIWAN
Re: K133588
Trade/Device Names: Fora Care Blood Pressure Monitoring System, Model P80 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: March 15, 2014 Received: March 19, 2014
Dear Ms. Peng:
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.
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
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Page 2 - Ms. Sharon Peng
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
Image /page/5/Picture/6 description: The image shows the text "Sincerely yours," followed by a logo. The logo appears to be the FDA logo, but it is heavily crossed out with a thick black line. The logo is in black and white and is somewhat pixelated.
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 Statement
510(k) Number: K133588
Device Name: Fora Care Blood Pressure Monitoring System
Indications for Use:
Fora Care Blood Pressure Monitoring System is a system designed 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. It is intended for individuals age 18 and above use at home and in clinical settings. The device is not to be used for the diagnosis of hypertension or for testing on newborns.
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 Device Evaluation (ODE) e: 2014.04.25 4:46:01 -04'00'
Division Sign-Off Office of Device Evaluation (ODE) 510(k)
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§ 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).