(182 days)
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.
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.
The FORA P30 Plus Multi-Mode Blood Pressure Monitoring System was validated against the ANSI/AAMI SP10 standard for non-invasive blood pressure (NIBP) devices.
Here's a breakdown of the available information regarding its acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states that the device "met the requirements of ANSI/AAMI SP10" but does not explicitly list the specific numerical acceptance criteria or the precise reported device performance metrics (e.g., mean difference, standard deviation, percentage within 5 mmHg) from the ANSI/AAMI SP10 test.
| Acceptance Criteria (ANSI/AAMI SP10) | Reported Device Performance |
|---|---|
| Accuracy Requirements: | |
| - Mean difference: | Met requirements |
| - Standard deviation: | Met requirements |
| Other Requirements: | |
| - Software validation: | Performed, works functionally |
| - Electrical safety (IEC/EN 60601-1): | Met requirements |
| - EMC (IEC/EN 60601-1-2): | Met requirements |
| - Biocompatibility (ISO 10993-5, -10): | Met requirements |
2. Sample Size and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). To meet ANSI/AAMI SP10, a clinical study on a human subject population typically involves a minimum number of subjects (usually at least 85 subjects with a well-defined distribution of blood pressures).
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as an expert consensus method is not explicitly mentioned for the blood pressure measurements. For clinical validation under ANSI/AAMI SP10, the ground truth is typically established by trained human observers using auscultation with a stethoscope, not through a panel of experts.
4. Adjudication Method
The document does not mention an adjudication method for the test set. In the context of ANSI/AAMI SP10, blood pressure measurements from the test device are compared against simultaneous auscultatory measurements obtained by trained observers. Discrepancies are handled within the statistical analysis prescribed by the standard, rather than through a separate adjudication process as might be seen for visual interpretation tasks.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size for human readers improving with or without AI assistance. This type of study is not typically applicable to a blood pressure monitoring device validated by the ANSI/AAMI SP10 standard.
6. Standalone Performance Study
Yes, a standalone performance study was done. The validation against ANSI/AAMI SP10 assesses the algorithm's (device's) ability to accurately measure blood pressure against a reference method (auscultation), without human-in-the-loop assistance for the measurement itself.
7. Type of Ground Truth Used
The ground truth for blood pressure measurements under ANSI/AAMI SP10 is typically established by auscultation, performed by trained observers using a stethoscope and sphygmomanometer. This is considered the reference method for non-invasive blood pressure measurement.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. For medical devices, particularly those using traditional algorithms (as stated for this device), the development often involves engineering and physiological modeling, with validation on a test set (clinical study). If any machine learning or AI components were involved in the algorithm's development, a dedicated training set would be common, but the document describes the algorithm as "traditional."
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is mentioned in the provided text, information on how its ground truth was established is not available.
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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
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K 11 00247
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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.
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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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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
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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)
Page 1 of _ 1 _
§ 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).