This blood pressure monitor is designed to measure blood pressure (diastolic and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

Device Description

The KOROT P3 Accurate is a digital monitor intended for use in measuring blood pressure and pulse rate in adults with upper arm circumference ranging from 22cm (9-inch to 20-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The KOROT P3 Accurate may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension.

Blood pressure is the measurement of pressure of blood vessels. Blood vessels. Blood pressure can be measured by direct or indirect measurement supports indirect measurement using cuff. This equipment tracks and analyzes the blood flow oscillations under the pressure using the highest to the lowest pressure as shown by the figure below when the minute pressure speed is determined by the heartbeat. This equipment adopts Oscillometric method and automated auscultation method using a cuff for blood pressure measurement. In case of Oscilometric method, the device determines the systolic, diastolic and pulse rate on the blood flow oscillations measured through the cuff. On the other hands, in case of Auto auscultation method that combines the accuracy of auscultation, which is regarded as the gold standard for blood pressure measurement. To measure the blood pressure, wap the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the Korotkoff sound signal and the pressure sensor signal, which you can catch with the sensor attached to the cuff, to measure the systolic blood pressure. The Automated Auscultation applied to KOROT P3 Accurate combines the accuracy of the auscultation method staffs hear directly with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and study information for the KOROT Blood Pressure Monitor (KOROT P3 Accurate), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KOROT P3 Accurate are aligned with the ISO 81060-2:2018 standard for non-invasive sphygmomanometers. The study aims to demonstrate that the device's measurements are within specified limits compared to a reference measurement.

Acceptance Criteria (ISO 81060-2:2018)	Reported Device Performance (KOROT P3 Accurate)	Met?
Statistical Analysis of Device vs. Reference sphygmomanometer:
Criterion 1 (Mean Difference): Mean of the differences between the device and reference measurements must be ≤ ±5 mmHg.	Not explicitly stated as a single value for mean difference across all subjects/measurements, but the overall conclusion of the clinical data (22-52 cm) supported the device's claim to be applicable. This implies that the mean difference fell within the acceptable range.	Yes (Implied)
Criterion 2 (Standard Deviation): Standard deviation of the differences must be ≤ 8 mmHg.	Not explicitly stated as a single value for standard deviation across all subjects/measurements, but the overall conclusion of the clinical data (22-52 cm) supported the device's claim to be applicable. This implies that the standard deviation fell within the acceptable range.	Yes (Implied)
Criterion 3 (Individual Differences): Cumulative percentage of differences. This criterion often requires a certain percentage of readings to be within specific error bands (e.g., 60% within ±5 mmHg, 85% within ±10 mmHg, 95% within ±15 mmHg).	The document states "the totality of the clinical data from 22 to 52 cm supported the device's claim of being applicable". This suggests that the device met the individual difference criteria as well.	Yes (Implied)

Note on "Implied": The provided document is a 510(k) clearance letter and a summary. It confirms that "the totality of the clinical data...supported the device's claim of being applicable," indicating that the device met the performance requirements of ISO 81060-2:2018. However, the exact numerical performance values (e.g., mean difference and standard deviation) are not explicitly stated in this high-level summary. These details would typically be found in the full clinical study report submitted to the FDA.

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

Sample Size:
- The document mentions "additional clinical data were collected for the extra range of the upper arm circumference," specifically for the range of 42 to 52 cm.
- It also states that "the totality of the clinical data from 22 to 52 cm supported the device's claim." This implies the original clinical data for 22-42 cm was combined with the new data.
- The exact number of subjects for the additional test set (42-52 cm) is not specified.
- The exact total number of subjects across the entire 22-52 cm range is not specified.
Data Provenance: Not explicitly stated (e.g., country of origin).
Retrospective or Prospective: Not explicitly stated, but clinical validation studies for medical devices are typically prospective to gather new data under controlled settings.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. For blood pressure monitor validation studies (like ISO 81060-2), ground truth is typically established by two trained observers using a reference sphygmomanometer (mercury sphygmomanometer or an equivalent standard) simultaneously, following very strict protocols for auscultation. While not explicitly stated here, it is standard practice for such studies.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method. However, in studies validating blood pressure devices against a reference method (auscultation), the widely accepted standard involves:

Two trained observers providing independent readings.
If there's a significant discrepancy between the two observers' readings (e.g., > 4 mmHg), a third trained observer may be invoked, or the measurement might be discarded and re-taken. This is often referred to as a "2+1" or similar method, ensuring high accuracy for the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- MRMC studies are typically for diagnostic imaging interpretation (e.g., radiologists interpreting images with and without AI assistance).
- This device is a blood pressure monitor, and its validation involves comparing its numerical output to a reference standard (auscultation), not comparing interpretations by multiple human readers of complex cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed.
- The KOROT P3 Accurate is a device that autonomously measures and reports blood pressure and pulse rate (using oscillometric and automated auscultation methods).
- The clinical validation studies comparing its readings directly against a reference standard (human auscultation) are by definition standalone performance assessments of the device itself.
- There is no "human-in-the-loop" AI interpretation component for this type of device.

7. Type of Ground Truth Used

The ground truth used for this device's validation is likely expert auscultatory measurements using a reference sphygmomanometer (e.g., mercury sphygmomanometer or a validated electronic reference device) according to the ISO 81060-2 standard. This is the gold standard for non-invasive blood pressure measurement validation.

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" sample size. Blood pressure monitors often rely on established algorithms for oscillometric measurement, which might be developed using extensive physiological data, but this is distinct from "training data" in the machine learning sense for tasks like image classification. If the device uses adaptive algorithms that learn from patient data over time (unlikely for a basic BP monitor), that information is not disclosed here.

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

As no specific training set and its size are mentioned, the method for establishing its ground truth is also not provided. Given the nature of a blood pressure monitor, the core algorithms are likely based on well-established physiological models and signal processing, rather than a machine learning "training set" with ground truth in the typical AI context.

Summary

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March 14, 2025

Korot Co. Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K250091

Trade/Device Name: KOROT Blood Pressure Monitor (KOROT P3 Accurate) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 13, 2025 Received: March 13, 2025

Dear Dave Yungvirt:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K250091

Device Name Blood Pressure Monitor (KOROT P3 Accurate)

Indications for Use (Describe)

This blood pressure monitor is designed to measure blood pressure (diastolic and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Prepared on: 2025-03-12
510(k)#: K250091
Contact Details
Applicant Name	KOROT Co., Ltd.
Applicant Address	1-102, 330, Yeongok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do,
	31026 Korea, South
Applicant Contact telephone	827040166745
Applicant Contact	Mr. Muyeol Lee
Applicant Contact Email	jimmy@inbody.com
Device Name
Device Trade Name	KOROT Blood Pressure Monitor (KOROT P3 Accurate)
Common Name	Noninvasive blood pressure measurement system
Classification Name	System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number	870.1130
Product Code(s)	DXN
Legally Marketed Predicate Devices
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K221764	Blood Pressure Monitor	DXN

Device Description Summary

*Cuffs: KR-CGM01, KR-CGL01, KR-CGML1, KR-CGXL1, KR-CDM01, KR-CDL01, KR-CDML1

Bluetooth is only used to transmit data from the device to KOROT program and not used for active patient monitoring

Intended Use/Indications for Use

This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 52 cm.

Indications for Use Comparison

The indications for use is identical except the range of arm circumference. So, we performed additional validation the range of 42 to 52cm.

Technological Comparison

All the modifications were verified with rationales and we concluded that the substantially equivalent to the predicate device in terms of intended use, safety and effectiveness. The device has the same technological characteristics with the predicate device except the modifications below;

Expansion of the arm circumference range (22cm~52cm)
Addition of Bluetooth
GUI change
Addition of functions
Component change
Improved pulse accuracy
Improved data storage
Transport/Storage condition change

Non-Clinical and/or Clinical Tests Summary & Conclusions

For non-clinical test, all necessary bench testing were conducted on the subject device to support the determination of substantial equivalence to the predicate device. Not only the same standards and methods which are used to support the predicate device, but also the additional standards and methods were used for the subject device to support the equivalence and modifications. For clinical test, the additional clinical data were collected for the extra range of the upper arm circumference and the totality of the clinical data from 22 to 52 cm supported the device's claim of being applicable to patients with upper arm circumference

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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).