The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.25" – 7.75".

Device Description

FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

AI/ML Overview

The FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01, is a non-invasive device designed to measure systolic and diastolic blood pressure and pulse rate in adults over 18 years old. It utilizes the oscillometric method with an inflatable wrist cuff.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria in the typical format of a table with specific targets for accuracy (e.g., mean difference and standard deviation within specific limits). However, it references the ANSI/AAMI SP10-1992 standard for "Electronic or Automated Sphygmomanometers" as the performance testing guideline. This standard defines accuracy requirements for blood pressure monitors.

While the document doesn't provide specific numerical results from the ANSI/AAMI SP10-1992 test, the fact that the device was deemed "substantially equivalent" implies that it met the performance requirements outlined in this standard.

Assumed Acceptance Criteria (based on ANSI/AAMI SP10-1992, typical for Blood Pressure Monitors):

Acceptance Criteria Category	Typical Requirement (based on ANSI/AAMI SP10-1992, for oscillometric devices)	Reported Device Performance (Implied)
Blood Pressure Accuracy	Mean difference ± standard deviation between device and reference measurement for systolic and diastolic pressure within ±5 mmHg for the mean, and 8mmHg for standard deviation.	Met (implied by "substantially equivalent" determination to a predicate device and adherence to ANSI/AAMI SP10-1992)
Pulse Rate Accuracy	Specific criteria for pulse rate accuracy (e.g., within ±5% or ±5 beats/min of reference).	Met (implied by "substantially equivalent" determination)
Electric Safety	Compliance with EN 60601-1:1990 & EN 1060-1/ EN1060-3	Compliant (Stated in "Performance Testing")
EMC (Electromagnetic Compatibility)	Compliance with EN 60601-1-2 (EN 55011:1991 and EN 61000-4-2:1995)	Compliant (Stated in "Performance Testing")

Note: The document only states which standards were applied, not the numerical results of those tests. The "Reported Device Performance" is inferred from the FDA's substantial equivalence determination, which means the device performed comparably to safety and effectiveness to the predicate device and met the referenced standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance testing conducted according to ANSI/AAMI SP10-1992.
The data provenance is not explicitly stated, but since the testing was done by FORTIFIER INTERNATIONAL CO., LTD. in Taiwan, it is likely that the testing was conducted prospectively (as part of the device's development and regulatory submission) and the data originated from Taiwan or other regions where the testing laboratory operates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the ANSI/AAMI SP10-1992 testing.

For blood pressure monitor validation, ground truth is typically established by trained observers (e.g., physicians or nurses) using a auscultatory method with a mercury sphygmomanometer (or an appropriately calibrated non-mercury reference device) according to a standardized protocol, often involving independent readings.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

In the context of blood pressure monitor validation, "adjudication" usually refers to a process where multiple independent readings are compared, and if discrepancies exceed a certain threshold, further review or re-measurement might be performed. The ANSI/AAMI SP10 standard outlines detailed procedures for obtaining reference brachial auscultatory measurements, which implicitly includes methods to ensure data quality, but explicit adjudication beyond those standard practices is not detailed in this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is a critical component to assess improvements in diagnostic accuracy with AI assistance. This device is a standalone measurement device; therefore, an MRMC study is not applicable.

6. If a Standalone Study Was Done

Yes, a standalone study was done. The "Performance Testing" section states that the device was tested against "ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers," along with electrical safety and EMC reports. This implies that the device's performance was evaluated inherently as a standalone unit to meet these standards' requirements for accuracy and safety. The entire 510(k) submission itself is based on the standalone performance of the device and its substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

For the ANSI/AAMI SP10-1992 standard, the ground truth for blood pressure measurements is typically established through auscultatory measurements performed by trained human observers using a standardized reference method (e.g., mercury sphygmomanometer or an equivalent validated device). This is considered the "expert consensus" or "clinical standard" for non-invasive blood pressure measurement devices.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant to machine learning or AI models. This device is a traditional oscillometric blood pressure monitor, not an AI-driven device. Therefore, there is no "training set" in the context of an AI algorithm. The device's internal algorithms are based on established oscillometric principles and calibration, not on a machine learning training process.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no training set for this type of device in the AI sense. The device's oscillometric algorithms are designed based on blood pressure physiology and empirically derived models that correlate oscillation amplitude with systolic and diastolic pressures, calibrated against established reference methods. While extensive data would have been used in the development of the oscillometric method itself historically, it's not a "training set" in the context of this specific device's regulatory submission.

Summary

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KO41400 FORTIFIER INTERNATIONAL CO., LTD.

No. 45, Jung Shan 1st Road, Jung Shan Chiu, 203, Keelung, Taiwan, ROC Tel: 886-2-24231179 Fax: 886-2-24269170 E-mail: ficl(@ms8.hinet.net

દ્ધ 510(k) SUMMARY "

FORTIFIER International Co., Ltd. Submitter's Name: No. 45, Jung Shan 1st Road, Jung Shan Chiu, 203, Keelung, Taiwan, ROC Tel: 886-2-24231179 Fax: 886-2-24269170 E-mail: ficl(@ms8.hinet.net

Date summary prepared:

Device Name:

AUG 2 4 2004

FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01 Proprietary Name: Common or Usual Name: NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM Classification Name: Blood Pressure Monitor, Class II, 21 CFR 870.1130

May 15, 2004

Indications for Use:

Description of the device:

FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcor.puter to automatically sense the characteristics of the pulse signal. Through simple calculation, clinically proven, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

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Kovács

FORTIFIER INTERNATIONAL CO., LTD.

No. 45, Jung Shan 156 Road, Jung Shan Chiu, 203, Keelung, Taiwan, ROC Tel: 886-2-24231179 Fax: 886-2-24269170 E-mail: ficl(@ms8.hinet.net

Performance Testing:

Electric Safety Requirement Test Report of EN 60601-1:1990 & EN 1060-1/ EN1060-3, and EMC test report of EN 60601-1-2 ( EN 55011:1991 and EN 61000-4-2:1995)

ANSI/AAMI SP10-1992 Electronic or Automated Sphygmomanometers

Legally marketed device for substantial equivalence comparison:

Eikon Automatic Digital Blood Pressure Monitor, HD-400M (K021239)

Summary for substantial equivalence comparison:

Same characteristics: intended use, technological characteristics, power supply, display, measuring range, accuracy, operating and storage environments.

Different characteristics: memory, dimensions, and weight.

As we can understand, the memory feature is to memorize the measurement data 1. taken previously and is related to the usage convenience, not to raise any safety or effectiveness hazard.

1. The differences between dimensions and weight are related to the designing aspects. These differences are not to raise any safety or effectiveness aspect.
  They are decided to be substantially equivalent.

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Image /page/2/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 bars extending from its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Dr. Jen Ke-Min. Fortifier International, Co., Ltd. c/o ROC Chinese-European Industrial No. 58, Fu-Chiun St. Hsin-Chu City CHINA (Taiwan) 300

Re: K041400

Trade Name: FORTIFIER Digital Wrist Blood Pressure Monitor, LF-01 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 15, 2004 Received: May 26, 2004

Dear Dr. Ke-Min:

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 such 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.

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Page 2 - Dr. Jen Ke-Min

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Neil KP S

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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FORTIFIER INTERNATIONAL CO., LTD.

No. 45, Jung Shan 1st Road, Jung Shan Chiu, 203, Keelung, Taiwan, ROC Fax: 886-2-24269170 Tel: 886-2-24231179 E-mail: ficl@ms8.hinet.net

Applicant: _ FORTIFIER International Co., Ltd..

510(k) Number ( if known):

Device Name: Digital Wrist Blood Pressure Monitor, LF-01

● Indications for use:

Prescription Use AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil HP Style
Fir BD2

(Division Sign-Off) Division of Cardiovascular Device

510(k) Number

Regulation Number and Section

§ 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).