(182 days)
Not Found
No
The document describes standard oscillometric blood pressure measurement and basic signal processing for irregular heartbeat detection, with no mention of AI or ML terms or concepts.
No
The device is intended to measure blood pressure and pulse rate, and detect irregular heartbeats, which are diagnostic/monitoring functions, not therapeutic.
Yes
Explanation: The device measures blood pressure and pulse rate, and also detects irregular heartbeats, which are all indicators of a person's health status. This information can be used by a healthcare professional to identify or monitor medical conditions.
No
The device description explicitly mentions an "inflatable arm cuff" and describes hardware components and measurement methods that require physical interaction with the patient's arm, indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for non-invasive measurement of blood pressure and pulse rate. IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The description details how the device works by using an inflatable cuff on the arm, which is a non-invasive method.
- No mention of biological samples: There is no mention of collecting or analyzing any biological samples.
Therefore, the FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a non-invasive medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Product codes
DXN
Device Description
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System.uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with a inflatable arm cuff on adults.
The device has single measurement mode, averaging mode and auscultatory mode of blood pressure measurements. The single measurement mode functions like a regular blood pressure monitor. The averaging mode is selected for performing three consecutive measurements with a fixed resting period between each measurement and displays the averaged result on LCD. The auscultatory mode is selected for trained persons to measure with a stethoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
arm
Indicated Patient Age Range
over age of 18
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System was validated by the tests according to ANSI/AAMI SP10 and met the requirements of ANSI/AAMI SP10 for NIBP (non-invasive blood pressure).
Software validation was performed to verify and validate the system works functionally.
Testing performed also included electrical safety, EMC and biocompatibility. The proposed device met the requirements of IEC/EN 60601-1 and IEC/EN 60601-1-2. The materials of arm cuff met the requirements of ISO 10993-5 and 10993-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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Page 1-of-3
JUL - 7 2011
510(k) Summary
- Submitter Information Application Correspondent Contact person Address
Phone FAX E-mail Date Prepared
Applicant Company Name Contact person Address
Phone FAX E-mail
- Name of Device Trade/Proprietary Name
Common Names Product Code Classification Panel Requiations
- Predicate Device Trade/Proprietary Name: Common/Usual Name: Submitter 510 (k) Number
Teling Hsu 3F, 5F, 6F, No. 127, Wugong 200 Rd., Wugu Township, Taipei County, 24888, Taiwan (+886-2) 6625-8188 ext.1176 (+886-2) 6625-0288 teling.hsu@taidoc.com.tw December 31, 2010
FORA CARE Inc. Sophia Wu 810 Lawrence Drive, Suite104 Newbury Park, CA 91320 (805) 498-8188 (805) 498-7188 sophiawu@foracare.com
FORA P30 Plus Multi-Mode Blood Pressure Monitoring System Blood pressure test system DXN Cardiovascular Class II, 21 CFR 870.1130
FORA P20 Blood Pressure Monitor Blood pressure test system TaiDoc Technology Corporation K092106
1
K 11 00247
Page 2-of-3
4. Device Description
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System.uses the oscillometric method to measure the systolic, diastolic blood pressure and pulse rate with a inflatable arm cuff on adults.
The device has single measurement mode, averaging mode and auscultatory mode of blood pressure measurements. The single measurement mode functions like a regular blood pressure monitor. The averaging mode is selected for performing three consecutive measurements with a fixed resting period between each measurement and displays the averaged result on LCD. The auscultatory mode is selected for trained persons to measure with a stethoscope.
5. Intended Use
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
6. Comparison to Predicate Device
The FORA P30 Plus Multi-Mode 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 a inflatable arm cuff. They all provide the auscultatory mode to allow trained persons to measure blood pressure with a stethoscope, and show a warning signal on LCD when detecting an irregular heartbeat (IHB). They both use traditional algorithm.
The major difference between the two devices is the physical appearance of device including outer casing design, printing and buttons. Minor software change includes the addition of the averaging mode that takes three consecutive measurements and displays the averaged result on the screen.
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7. Performance Studies
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System was validated by the tests according to ANSI/AAMI SP10 and met the requirements of ANSI/AAMI SP10 for NIBP (non-invasive blood pressure).
Software validation was performed to verify and validate the system works functionally.
Testing performed also included electrical safety, EMC and biocompatibility. The proposed device met the requirements of IEC/EN 60601-1 and IEC/EN 60601-1-2. The materials of arm cuff met the requirements of ISO 10993-5 and 10993-10.
8. Conclusion
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System demonstrates the safety and effectiveness for its intended use. The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 7 2011
FORA CARE Inc. c/o Teling Hsu Regulatory Affairs Specialist, TaiDoc Technology Corporation 3F, 5F, 6F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County, 24888. Taiwan
Re: K110044
Trade/Device Name: FORA P30 Plus Multi-Mode Blood Pressure Monitoring System (TD-3129) Regulation Number: 21 CFR 870.1130 Regulation Name: Non invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 24, 2011 Received: June 28, 2011
Dear Mrs. Hsu:
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
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Page 2 – Mrs. Hsu
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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/ReportalProblem/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/Resourcesfor You/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
5
Attachment 5
Indications for Use
510(k) Number: K110044
Device Name: FORA P30 Plus Multi-Mode Blood Pressure Monitoring System
Indications for Use:
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System is a device intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual. The blood pressure is measured by using an inflatable cuff wrapped around the arm. This system should be used for the testing on people over age of 18.
The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Prescription Use _ _ _ _ _ (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use X (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)
Signature of Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
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