(155 days)
K11216, K112216
K11216
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard blood pressure measurement and data tracking via an app, without mentioning any AI/ML capabilities.
No
The device is intended for measuring blood pressure and pulse rate, which is a diagnostic/monitoring function, not a therapeutic one. It explicitly states it is "not to be used for the diagnosis of hypertension."
No
The "Intended Use / Indications for Use" states that "The device is not to be used for the diagnosis of hypertension." It is designed to measure blood pressure, but explicitly states it is not for diagnostic purposes.
No
The device description explicitly states it is a "Blood Pressure Monitoring System (Model: P80)" which can be operated by the device itself or with an app. The performance studies also mention testing for electrical safety, EMC, shock and vibration, and biocompatibility of the cuff materials, all of which are associated with hardware components, not software-only devices.
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 Fora Care Blood Pressure Monitoring System measures blood pressure and pulse rate using a non-invasive technique (a cuff on the upper arm). It does not analyze samples taken from the body.
- Intended Use: The intended use is for measuring blood pressure and pulse rate, not for analyzing biological samples.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DXN
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.
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
age 18 and above
Intended User / Care Setting
Home and in clinical settings
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)
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.
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.
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
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:
2
| 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.
3
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.
4
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
5
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
6
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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