Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals at office or patients at home under the supervision of a trained professional. The device is not intended for ambulatory use. The device is designed for wearing on the left wrist only. The device provides a HRV parameter which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

Device Description

The non-invasive blood pressure measuring system HRVWatch Wrist Monitor measures blood pressures (BP) (systolic pressure SYS and diastolic pressure DIA) and heart rate (HR), using the oscillometric method commonly employed by electronic blood pressure meters. In addition, the device utilizes piezo-electrical sensors embedded in the cuff to obtain detailed radial arterial waveforms. The 5-minute continuous waveform recording allows the device to detect and report irregular heartbeats. Heart rate variability (HRV) parameters are also obtained by time- and frequency-domain analyses of peak-to-peak intervals. The main body of the device has the full functions of testing, display, and data storage. A mini-USB port is provided for connection and data download to a PC. A device-specific software, HRVWatch Manager, is included in the product package for database management and report printing running on a Windows-based PC. HRVWatch Wrist Monitor is intended to provide only patient parameter measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

AI/ML Overview

The provided text describes the HRVWatch Wrist Monitor and its performance evaluation, but it does not specify explicit acceptance criteria in a table format with reported device performance against those criteria. Instead, it states compliance with international standards and substantial equivalence to predicate devices.

However, based on the information provided, I can infer the "acceptance criteria" through the standards the device claims to meet, particularly ANSI/AAMI SP10 for blood pressure measurements and the 1996 HRV International Standard for heart rate variability and irregular heartbeats. The study's results are then presented as demonstrating compliance with these standards and substantial equivalence.

Here's an attempt to structure the information based on your request, with inferred acceptance criteria based on the cited standards:

Acceptance Criteria and Study for HRVWatch Wrist Monitor

1. Table of Acceptance Criteria and Reported Device Performance

Measurement/Parameter	Inferred Acceptance Criteria (Based on Cited Standards)	Reported Device Performance (as stated in submission)
Blood Pressure (SYS, DIA)	Compliance with ANSI/AAMI SP10-1992 Electronic or Automatic Sphygmomanometers standard.	"HRVWatch conforms to ANSI/AAMI SP10" and demonstrated "substantially equivalent to the predicate devices of manual mercury sphygmomanometers for the measurement of systolic and diastolic pressures."
Heart Rate (HR)	Substantial equivalence to predicate ECG devices.	"substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats." (HR is part of this overall assessment)
Heart Rate Variability (HRV)	Compliance with 1996 HRV International Standard.	"The data acquisition and analytical steps follow the guideline listed in 1996 HRV International Standard." and "substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats."
Irregular Heartbeats (IrrHB)	Detection of peak intervals > 4 standard deviations; substantial equivalence to predicate ECG devices.	"Peak intervals greater than 4 standard deviations are reported as irregular heartbeats." and "substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats."
Safety	Compliance with EN60601-1, IEC 60601-1, ISO 13485 (general medical device safety standards).	"The clinical test results showed HRVWatch to be safe for its intended use"

Note: The document states that the "clinical test results showed HRVWatch to be safe for its intended use and substantially equivalent to the predicate devices for technical designs, functions, and data accuracy," and that it "conforms to ANSI/AAMI SP10." Specific numerical deviations or ranges for BP accuracy are not provided in this summary, but are typically required for ANSI/AAMI SP10 compliance.

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

Total Subjects for Human Clinical Study: 88 subjects.
Subjects for Intra-device variability test: 10 subjects (subset of total).
Subjects for SP10 BP test: All 88 subjects (stated as "all in the SP10 BP test").
Subjects for Heart Rate, Heart Rate Variability, and Irregular Heartbeats test: 50 subjects (subset of total).
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given the applicant is from Taiwan, it is plausible the study was conducted there. It is a "human clinical study," implying a prospective design for data collection, although not explicitly stated.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth.

Blood Pressure Ground Truth: The device was compared to a "manual mercury sphygmomanometer," which serves as the reference standard. The operation of such a device typically relies on a trained observer, but their specific qualifications are not mentioned.
Heart Rate, HRV, and Irregular Heartbeats Ground Truth: The device was compared to an "ECG" (Electrocardiogram), which serves as the reference standard. Similarly, the interpretation of ECGs for ground truth would be performed by qualified personnel (e.g., cardiologists or trained technicians), but their specific number or qualifications are not mentioned.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies or establishing ground truth based on multiple expert opinions. The ground truth was established by direct comparison to predicate devices/reference standards (manual mercury sphygmomanometer for BP, ECG for HR/HRV/IrrHB).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a measurement system and not an AI-assisted diagnostic tool designed to augment human reader performance. The study focused on the device's accuracy compared to reference standards.

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

Yes, the studies described are essentially "standalone" performance evaluations of the device's measurements (SYS, DIA, HR, HRV, IrrHB) against established reference standards. The device itself is intended to provide measurements ("patient parameter measurements") and is "not intended to produce any interpretation of those measurements or any kind of diagnosis." Therefore, its performance is assessed directly, without considering a human-in-the-loop scenario for diagnostic improvement.

7. The Type of Ground Truth Used

Blood Pressure (SYS, DIA): The ground truth was established using a manual mercury sphygmomanometer, which is considered a traditional clinical reference standard for blood pressure measurement.
Heart Rate (HR), Heart Rate Variability (HRV), and Irregular Heartbeats (IrrHB): The ground truth was established using an ECG (Electrocardiogram), which is the clinical gold standard for cardiac rhythm and heart rate analysis.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. The description of the clinical study appears to be a single test set used for performance evaluation. Device development and algorithm 'training' (if any, for the oscillometric method or HRV analysis) would typically occur prior to this validation study.

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

As no training set is described in the provided text, information on how its ground truth was established is not available.

Summary

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K123130 P 1/3

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of Safe Medical Devices Act (SMDA) and 21 CFR 807.92.

5.1 510(k) Number: K123130

5.2 Applicant Information:

SEP 17 2013

Date Prepared: September 25th, 2012 Name: Taiwan Scientific Corporation Address: 10 F, 88-4, Ming-Chiuan Rd., Shin-Dian District, New Taipei 23141, Taiwan Phone:+886-2-8667-3362 Fax: +886-2-8667-3387 Contact Person: Dehchuan Sun Phone Number: Office: +886-2-8667-3362 / Cell +886-953-933-962 Fax Number: +886-2-8667-3387 E-mail: sundc@taiwanscientific.com.tw

5.3 Device Information:

Classification: DXN /Class II/870.1130 Trade Name: HRVWatch Wrist Monitor Common Name: Non-invasive blood pressure meter system Classification Name: Noninvasive blood pressure measurement system

5.4 Predicate Devices:

The Aneroid Mercury Sphygmomanometer K990638 The KD-788 Wrist Measurement Electronic Blood Pressure Monitor K052450 The Philips Pagewriter Touch Cardiograph K020708 The Portable ANSiscope K071188 The ReadMyHeart - Model RMHI3 K050620

5.5 Device Description:

The non-invasive blood pressure measuring system HRVWatch Wrist Monitor measures blood pressures (BP) (systolic pressure SYS and diastolic pressure DIA)

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K123130 P 2/3

and heart rate (HR), using the oscillometric method commonly employed by electronic blood pressure meters. In addition, the device utilizes piezo-electrical sensors embedded in the cuff to obtain detailed radial arterial waveforms. The 5-minute continuous waveform recording allows the device to detect and report irregular heartbeats. Heart rate variability (HRV) parameters are also obtained by time- and frequency-domain analyses of peak-to-peak intervals. The main body of the device has the full functions of testing, display, and data storage. A mini-USB port is provided for connection and data download to a PC. A device-specific software, HRVWatch Manager, is included in the product package for database management and report printing running on a Windows-based PC. HRVWatch Wrist Monitor is intended to provide only patient parameter measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

5.6 Intended Use:

5.7 Comparison to Predicate Device(s):

(i) HRVWatch conforms to ANSI/AAMI SP10 (confirmed by in-vitro and human clinical studies) and is substantially equivalent to the predicate devices of manual mercury sphygmomanometers for the measurement of systolic and diastolic pressures. (ii) HRVWatch employs the oscillometric method for the measurement of systolic pressure, diastolic pressure, and heart rate and is substantially equivalent to the predicate devices of wrist-worn automatic electronic BP meters. (iii) HRVWatch employs piezo-electrical sensors embedded in the cuff to measure radial pulse waveforms. From the 5-minute continuous pulse waveforms, peak-to-peak intervals are obtained. Peak intervals greater than 4 standard deviations are reported as irregular heartbeats. Heart rate variability (HRV) parameters are then calculated by time-domain and frequency-domain analyses. The data acquisition and analytical steps follow the guideline listed in 1996 HRV

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International Standard. Confirmed by in-vitro and human clinical studies, HRVWatch is substantially equivalent to the predicate devices of electrocardiograph HRV analyzers for the measurements of HRV and irregular heartbeats.

5.8 Performance Summary (Bench and Clinical):

HRVWatch Wrist Monitor has been tested extensively by both in-vitro (bench) and human clinical studies. The test results show that HRVWatch Wrist Monitor is in compliance with the following international standards:

(i) FDA "Noninvasive blood pressure meter submission guide" (March 10, 1997)
(ii) ANSI/AAMI SP10-1992 Electronic or Automatic Sphygmomanometers
(iii) EN60601-1: 1990 (including Amendments A1 (1993), A2 (1995)) Medical electrical equipment. General requirements for safety
(iv) IEC 60601-1: 1988 (including Amendment A1(1991) and A2 (1995)) Medical electrical equipment (this standard covers EMC safety)
(v) ISO 13485:2003 Medical Devices
(vi) 1996 Heart Rate Variability International Standard

5.9 Discussion of Clinical Test

(i) A total of 88 subjects were recruited for the human clinical study
(ii) Among the total, 10 subjects participated in the intra-device variability test. all in the SP10 BP test, and 50 subjects in the heart rate, heart rate variability, and irregular heartbeats test
(iii) Tests were conducted comparing HRVWatch to a manual mercury sphygmomanometer for measurement of BP and to an ECG for measurements of heart rate, heart rate variability, and irregular heartbeats
(iv) The clinical test results showed HRVWatch to be safe for its intended use and substantially equivalent to the predicate devices for technical designs, functions, and data accuracy

5.10 Conclusions:

After extensive bench and clinical performance tests, HRVWatch was shown to be safe in use and substantially equivalent to the predicate devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2013

Taiwan Scientific Corporation c/o Dr. Dehchuan Sun General Manager 10 F, 88-4, Ming-Chiuan Rd. Shin-Dian District New Taipei 23141 TAIWAN

K123130 Re:

Trade/Device Name: HRVWatch Wrist Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: August 12, 2013 Received: August 19, 2013 .

Dear Dr. Sun:

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. Iisting 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. 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

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Page 2 - Dr. Dehchuan Sun

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen=P.Faris-S

for 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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K123130

Indications for Use Statement

Indication for Use 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: HRVWatch Wrist Monitor

Indications for Use: Non-invasive measurement of systolic pressure (SYS), diastolic pressure (DIA), heart rate (HR), heart rate variability (HRV), and irregular heartbeats (IrrHB) for professionals at office or patients at home under the supervision of a trained professional. The device is not intended for ambulatory use. The device is designed for wearing on the left wrist only. The device provides a HRV parameter which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis.

Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Digitally signed by
	Owen P. Faris -S
	Date: 2013.09.17
	13:44:00 -04'00'

Page 1 of 1

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).