ArteVu is intended to noninvasively and continuously measure a patient's blood pressure and pulse rate, which are derived from the pulse pressure waveform using the scientific method of pulse waveform decomposition, for use on adult patients aged between 50 and 86 years who are resting in a supine or similarly reclined position.

ArteVu is calibrated using an ISO 81060-2 compliant sphygmomanometer. All parameters derived by ArteVu are shown on a compatible remote display monitor (RDDS) via wired transmission. The device is intended for use by clinicians or other properly trained medical personnel in professional healthcare facilities.

Device Description

ArteVu is an automatic, continuous, and non-invasive blood pressure (CNBP) monitoring system designed for adult patients at rest and intended for use by medical professionals. The device features a disposable Finger Clip containing a tactile sensor that detects pulse pressure waveforms at the fingertip. ArteVu utilizes the scientific method of pulse waveform decomposition to derive blood pressure and pulse rate, with initial calibration performed using a non-invasive upper arm cuff. These measurements are displayed on a compatible remote monitor, updated every two seconds via wired transmission. ArteVu incorporates technical and physiological alarms to enhance reliability, providing continuous and accurate monitoring while alerting users to abnormal conditions.

AI/ML Overview

The provided FDA 510(k) clearance letter for ArteVu does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets these criteria. Specifically, it lacks a table of acceptance criteria with reported device performance metrics and explicit details on how ground truth was established for training and testing sets.

However, based on the information available, here's a structured response addressing the requested points to the best of what the document provides:

Acceptance Criteria and Study for ArteVu

The document states that ArteVu's safety and effectiveness were validated through a clinical study that adhered to the acceptance criteria of ISO 81060-2 for substantial equivalence to the predicate device, CareTaker4. It also incorporated elements from IEEE 1708, ISO 81060-3, ISO 80601-2-61, and IEC 60601-2-27. While it doesn't provide a specific table of numerical acceptance criteria or reported values for ArteVu, it implicitly relies on the standards set by ISO 81060-2 for non-invasive sphygmomanometers. This standard typically defines accuracy requirements for blood pressure measurements.

1. A table of acceptance criteria and the reported device performance

The document does not provide an explicit table with numerical acceptance criteria and ArteVu's reported performance metrics against those criteria. It only states that the study design "adhered to the acceptance criteria of ISO 81060-2."

If this were a complete submission, such a table would typically include:

Metric (e.g., Mean Difference, Standard Deviation)	Acceptance Criteria (from ISO 81060-2)	ArteVu Performance	Pass/Fail
Mean Difference (Device - Reference BP)	≤ ±5 mmHg	(Not provided)	(Not provided)
Standard Deviation (of Differences)	≤ 8 mmHg	(Not provided)	(Not provided)
Percentage of measurements within X mmHg	(e.g., typically for each 5, 10, 15 mmHg accuracy)	(Not provided)	(Not provided)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 109 subjects. The document states, "ArteVu's safety and effectiveness have been validated through a clinical study conducted in Taiwan involving 109 subjects." Since this is the primary validation study mentioned, it serves as the test set for the device's performance claims.
Data Provenance: The clinical study was "conducted in Taiwan." The data is prospective, as it was collected as part of a clinical study to validate the device.
Subject Recruitment: Subjects were recruited from "operating rooms and intensive care units."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that ArteVu is calibrated using an "ISO 81060-2 compliant sphygmomanometer" and that the study design "adhered to the acceptance criteria of ISO 81060-2." This strongly implies that the ground truth for blood pressure measurements was established using a reference standard device (the compliant sphygmomanometer) and not necessarily by a panel of human experts. Therefore, the concept of "number of experts" for establishing ground truth via consensus (as might be seen in image-based AI studies) does not directly apply here. The "experts" would be the clinical personnel performing the reference measurements according to the ISO standard.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Since the ground truth for blood pressure measurements in this context is established by a reference device (ISO 81060-2 compliant sphygmomanometer) and not by subjective interpretation of medical images or conditions by multiple human readers, a numerical adjudication method (like 2+1 or 3+1) is not applicable or mentioned. The accuracy of the sphygmomanometer itself is the standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done as described in the document. This type of study is commonly used for AI in diagnostic imaging (e.g., radiology) where AI assists human interpretation. ArteVu is a continuous non-invasive blood pressure monitoring system, so its primary function is measurement, not assisting human readers in interpreting complex medical data.
Therefore, there is no mention of effect size related to human readers improving with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, a standalone performance assessment was conducted for the device's core function. ArteVu is described as an "automatic, continuous, and non-invasive blood pressure (CNBP) monitoring system." Its performance (accuracy against a reference standard) is evaluated directly, implying it operates as an algorithm determining BP from the pulse waveform. The clinical study validated the device's ability to "achieve comparable safety and effectiveness" to the predicate device, which is a standalone measurement. While it displays measurements for "clinicians or other properly trained medical personnel," the core measurement derivation is done by the device itself, making it a standalone function in terms of its output.

7. The type of ground truth used

The primary ground truth used is a reference standard measurement from an ISO 81060-2 compliant sphygmomanometer. This standard specifies the requirements for non-invasive sphygmomanometers and their clinical validation. The document explicitly states, "ArteVu is calibrated using an ISO 81060-2 compliant sphygmomanometer" and that the "study design adhered to the acceptance criteria of ISO 81060-2."

8. The sample size for the training set

The document does not specify the sample size for the training set used to develop or train the ArteVu algorithm. The 109 subjects mentioned are for the validation/test set. Typical 510(k) summaries often do not disclose detailed training set information unless it's critical to the novelty or specific performance claims of an AI/ML device. While ArteVu uses a "scientific method of pulse waveform decomposition," it's unclear if this involves a machine learning model that requires a dedicated training set as opposed to an algorithm based on established physiological models.

9. How the ground truth for the training set was established

Since the training set size is not provided, the method for establishing its ground truth is also not described in this document. If ArteVu's algorithm involved machine learning, it's highly probable that similar methods (i.e., reference standard measurements from compliant sphygmomanometers) would have been used for training data as for the test data.

Summary

FDA 510(k) Clearance Letter - ArteVu

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 30, 2025

Cardio Ring Technologies, Inc. Taiwan Branch
℅ Alexia Haralambous
Senior Principal
Rqm+
2790 Mosside Blvd #800
Monroeville, Pennsylvania 15146

Re: K244007
Trade/Device Name: ArteVu
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive blood pressure measurement system
Regulatory Class: Class II
Product Code: DXN
Dated: July 1, 2025
Received: July 1, 2025

Dear Alexia Haralambous:

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.

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"

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K244007 - Alexia Haralambous Page 2

(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 (QS) 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K244007 - Alexia Haralambous Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-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,

Stephen C. Browning -S

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

Enclosure

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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K244007

Device Name: ArteVu

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K244007 Page 1 of 2

510(k) Summary

510(k)#: K244007
Prepared on: 2025-07-27

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	Cardio Ring Technologies, Inc. Taiwan Branch
Applicant Address	No.37 Wugong 5th Rd., Wugu Dist. New Taipei City 248020 Taiwan
Applicant Contact Telephone	+886277527660
Applicant Contact	Dr. Wen-Pin Shih
Applicant Contact Email	benshih@cardioring.co
Correspondent Name	RQM+
Correspondent Address	2790 Mosside Blvd #800 Monroeville PA 15146 United States
Correspondent Contact Telephone	(267) 778-5114
Correspondent Contact	Ms. Alexia Haralambous
Correspondent Contact Email	aharalambous@rqmplus.com

Device Name

21 CFR 807.92(a)(2)

Field	Information
Device Trade Name	ArteVu
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

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K163255	CareTaker4 Physiological Monitor	DXN

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

K244007 Page 1 of 2

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K244007 Page 2 of 2

86 years who are resting in a supine or similarly reclined position.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject ArteVu device has the same intended use as the predicate CareTaker4 System (K163255). They are both intended to noninvasively and continuously measure a patient's blood pressure and pulse rate, which are derived from the pulse pressure waveform using the scientific method of pulse waveform decomposition for use on adult patients at rest. Both devices include calibration, analysis, display, and alarms and are intended for use by clinicians or other properly trained medical personnel.

Technological Comparison

21 CFR 807.92(a)(6)

The subject ArteVu device is similar to the predicate CareTaker4 device. Both devices utilize an analysis of pulse decomposition derived from piezoresistive inputs to quantify key hemodynamic parameters, including blood pressure. Both are calibrated using an ISO 81060-2 compliant blood pressure device, and all parameters are displayed on a monitor via wired transmission. The blood pressure measurement ranges are similar between the two devices. Both devices are intended for continuous monitoring and consist of a finger-contact mechanism. However, CareTaker4 uses an oscillometric cuff on a digit, which requires constant coupling pressure. In contrast, ArteVu uses a Finger Clip and a tactile sensor, which only requires the clip to be secured and comfortably placed on a digit without applying additional pressure. This design minimizes the risk of occluding blood flow to the monitored digit during extended use, as it does not require more pressure than necessary to keep the Finger Clip in place. Additionally, while the CareTaker4 does not contain any electrical components in the finger cuff, ArteVu incorporates passive electronic components inside the Finger Clip.

The different technological characteristics of the subject ArteVu system do not raise different questions of safety and effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

To establish substantial equivalence to the CareTaker4, ArteVu adheres to the same nonclinical testing standards and meets all the essential performance requirements outlined in those standards. The test results demonstrate that ArteVu and CareTaker4 exhibit comparable levels of safety and effectiveness, ensuring compliance with regulatory benchmarks. Please refer to the eSTAR attachment titled "12.1 Bench Testing Summary" for additional information.

ArteVu's safety and effectiveness have been validated through a clinical study conducted in Taiwan involving 109 subjects. To establish substantial equivalence to the predicate device, CareTaker4, study design adhered to the acceptance criteria of ISO 81060-2, which was also utilized in the clinical evaluation of CareTaker4. Moreover, to ensure compliance with state-of-the-art standards, the clinical study incorporated elements from IEEE 1708, ISO 81060-3, ISO 80601-2-61, and IEC 60601-2-27.

The study population included subjects recruited from operating rooms and intensive care units. The clinical data demonstrated that ArteVu achieves comparable safety and effectiveness to CareTaker4, supporting the determination of substantial equivalence.

Based on the results of the nonclinical and clinical tests, ArteVu has been demonstrated to be as safe, as effective, and to perform as well as or better than the predicate device, CareTaker4. The nonclinical tests, conducted in accordance with FDA-recognized consensus standards such as ISO 10993, IEC 60601-1, and IEC 60601-1-2, confirmed ArteVu's compliance with essential performance and safety requirements.

The clinical study, conducted with 109 subjects, further validated ArteVu's safety and effectiveness. The study adhered to ISO 81060-2 standards for substantial equivalence evaluation and incorporated elements of IEEE 1708, ISO 81060-3, ISO 80601-2-61, and IEC 60601-2-27, ensuring compliance with state-of-the-art guidelines. The study demonstrated that ArteVu achieves comparable levels of safety and effectiveness to the predicate device, CareTaker4, with adverse effects reported being unrelated to the device or study interventions.

In conclusion, the cumulative evidence supports the determination that the performance of ArteVu is substantially equivalent to the legally marketed CareTaker4 device in terms of safety and effectiveness.

K244007 Page 2 of 2

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).