This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults, using wrist cuff and oscillometric method of measurement.

Device Description

FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 is intended to measure systolic and diastolic pressure and pulse rate of adults in a home care environment using wrist cuff and oscillometric method of measurement.
There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.
The user interface panel of FP-0217 has power button, mode button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate and date. FP-0217 has memory capacity to store the 58 most recent measurement results.
The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.

AI/ML Overview

Acceptance Criteria and Study for FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217

The provided document, K092061, is a 510(k) summary for a blood pressure monitor, not a detailed clinical study report. Therefore, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full independent study with explicit acceptance criteria and corresponding performance data.

Based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are generally derived from the established performance standards for blood pressure monitors and the performance of the predicate device. The document does not explicitly state numerical acceptance criteria but implies adherence to recognized standards.

Acceptance Criteria (Implied)	Reported Device Performance (Implied by Substantial Equivalence)
Measurement of Systolic Blood Pressure accuracy (compared to a reference method)	Equivalent to predicate device (K012054)
Measurement of Diastolic Blood Pressure accuracy (compared to a reference method)	Equivalent to predicate device (K012054)
Measurement of Pulse Rate accuracy	Equivalent to predicate device (K012054)
Safety of device operation	Equivalent to predicate device (K012054)
Effectiveness for intended use (adults, home care, wrist cuff, oscillometric method)	Equivalent to predicate device (K012054)

Note: The document does not provide specific numerical performance data (e.g., mean difference, standard deviation) for the device itself. The core argument is substantial equivalence to the predicate device, K012054, meaning its performance characteristics are considered similar enough not to raise new questions of safety and effectiveness.

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

The 510(k) summary does not explicitly state a sample size for an independent test set used to evaluate the FP-0217 directly against clinical standards. The entire premise of the submission is demonstrating substantial equivalence to a predicate device (K012054).

For blood pressure monitors, clinical validation typically involves studies adhering to standards like ANSI/AAMI/ISO 81060-2 (or its predecessors at the time of submission). While such studies would have a defined sample size, this document does not present such a study for the FP-0217. It's highly probable that the predicate device (K012054) would have undergone such validation with a specified sample size.

Data Provenance: Not explicitly stated for specific validation data for FP-0217. The submission is from a South Korean manufacturer (Genexel Medical Instrument Inc.) and indicates the device is intended for "home care environment."

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

Given that this 510(k) submission relies on substantial equivalence rather than presenting a new, full clinical validation study for the FP-0217, this information is not provided.

If a clinical validation study had been performed for the FP-0217, the ground truth for blood pressure measurements would typically be established by trained observers (often medical professionals) using a auscultatory method with a mercury sphygmomanometer (or an equivalent validated reference device), following a standardized protocol (e.g., as per ANSI/AAMI/ISO 81060-2). The number and qualifications of these observers would be detailed in such a study.

4. Adjudication Method for the Test Set

This information is not provided as no explicit test set data for the FP-0217 is presented for clinical performance evaluation. For a proper clinical validation study of a blood pressure monitor, when multiple observers establish ground truth, adjudication methods (e.g., averaging readings, resolving discrepancies) are crucial.

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, nor is it typically relevant for a standalone blood pressure monitor of this type. MRMC studies are primarily used for diagnostic imaging devices where human readers interpret medical images, and the AI's role is to assist or augment that interpretation. This device is an automated measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The device is a "Digital Blood Pressure Monitor" intended for home use, meaning it operates in a standalone fashion, providing measurements without human interpretation or intervention in the measurement process itself. The user initiates the measurement, but the device's "oscillometric method of measurement" is an automated algorithmic process to determine blood pressure and pulse rate. The safety and effectiveness claim is for this automated measurement.

7. The Type of Ground Truth Used

For blood pressure monitors, the "ground truth" for clinical accuracy studies is typically established by:

Expert Consensus / Reference Method: Simultaneously measuring blood pressure using a standardized auscultatory method (e.g., using a mercury sphygmomanometer) performed by trained observers, against which the automated device's readings are compared. This involves specific protocols for simultaneous readings, observer blinding, and statistical analysis of differences.

While not explicitly stated for this particular device's validation due to the nature of the 510(k) submission, this is the standard ground truth method for blood pressure monitors.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 is described as using an "oscillometric method of measurement." While oscillometric algorithms are developed and refined, they are typically based on established physiological principles and extensive prior research, rather than "training" an AI model in the sense of modern deep learning. Therefore, there isn't a "training set" in the context of recent machine learning-based medical devices. The algorithm's parameters might be calibrated or optimized, but this is different from a large-scale supervised learning training set.

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

As explained above, the concept of a "training set" and associated ground truth establishment for this type of device (traditional oscillometric BP monitor) is not applicable in the same way it would be for an AI/ML-driven diagnostic device. The oscillometric algorithm's development would rely on engineering principles, signal processing, and prior physiological data, rather than a specific "training set" with established ground truth labels for an AI model.

Summary

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K09 2061

510(k) Summary As Required by 21 section 807.92 ( c )

Genexel Medical Instrument Inc

1- Submitter Name: FDA Registration number 8043684 111 Yangjae-dong, Seocho-gu 2- Address: MAR 2 6 2010 Seoul, Republic of Korea (82) 2-575-1141 3- Phone: (82) 2-575-1688 4- Fax: Mr Jonathan Seo 5- Contact Person: 6- Date summary prepared: July 3, 2009 7 - Official Correspondent: Mansour Consulting LLC 845 Aronson Lake Ct. Roswell, GA 30075 USA 8- Address: 9- Phone: 678-908-8180 678-623-3765 10- Fax: Jav Mansour, President 11- Contact Person: 12- Device Trade or Proprietary Name: FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 13- Device Common or usual name: Digital Blood Pressure Monitor

14- Device Classification Name: Non Invasive blood pressure measuring system

15- Substantial Equivalency is claimed against the following device:

510K #K012054 Full Auto Wrist Digital Blood Pressure Monitor, Model SE-312. manufactured by Genexel Medical Instrument Inc. formerly Sein Electronics

16- Description of the Device:

There are no contraindications; the subject device may be employed in the care of normotensive, hypertensive, or hypotensive patents.

The user interface panel of FP-0217 has power button, mode button, memory button and liquid crystal display ("LCD") for displaying systolic pressure, diastolic pressure, pulse rate and date. FP-0217 has memory capacity to store the 58 most recent measurement results.

The device measures blood pressure through the use of an automatic inflating cuff. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically re-pressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The cuff automatically deflates with stepwise pressure drop of 5~6 mmHg per 2 pulses during blood pressure measurement.

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The patient is responsible for applying the cuff, for initiating the measurements sequence by pressuring the "Power" button, and for recording results. The patient cannot alter bleed-down rate.

All system functions are preprogrammed. The user is cautioned in the instruction manual against attempting any programming or other modification.

No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.

17- Intended use of the device: (refer to FDA form attached)

This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults, using wrist cuff and oscillometric method of measurement.

18- Safety and Effectiveness of the device:

This device is safe and effective as the predicate device cited above.

19- Summary comparing technological characteristics with predicate device:

Comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution is included within this submission. Also. Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR 2 6 2010

Genexel Medical Instrument Inc. c/o Mr. Jay Mansour Mansour Consulting LLC 845 Aronson Lake Court Roswell, GA 30075

Re: K092061

Trade Name: Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: February 24, 2010 Received: February 26, 2010

Dear Mr. Mansour:

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 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 - Mr. Jay Mansour

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/CDRH/CDRHOffices/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/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/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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Indications for Use

510(k) Number (if known):

Device Name: Forecare Advanced Sport Wrist Blood Pressure Monitor, Model FP-0217

K092061

Indications For Use:

This device is an over the counter device, and its intended use is to measure systolic and diastolic pressure and pulse rate of adults, using wrist cuff and oscillometric method of measurement.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

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

nuaccii

510(k) Number

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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).