Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

Device Description

Fully Automatic Electronic Blood Pressure Monitor (KD-743V, KD-743B, KD-752) is designed and manufactured according to IEC 80601-2-30.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.

AI/ML Overview

This document is a 510(k) summary for a blood pressure monitor, not an AI/ML device. Therefore, the detailed information typically required for describing an AI/ML model's acceptance criteria and validation study (such as training/test set sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not provided in this document.

The document discusses the substantial equivalence of the "Fully Automatic Electronic Blood Pressure Monitor" (models KD-743V, KD-743B, KD-752) to predicate devices (KD-753, K183535 and KD-721, K163276). The "acceptance criteria" here refer to meeting established performance standards for non-invasive blood pressure monitors, rather than the performance metrics of an AI algorithm.

Here's a breakdown of what can be extracted and what information is not available from the provided text, in the context of your specific questions:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for blood pressure monitors are generally based on international standards like ISO 81060-2, which specifies requirements for the accuracy of automated non-invasive sphygmomanometers. The document states:

"Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2."

While the specific numeric criteria (e.g., mean difference and standard deviation of differences between device and reference measurements) are not explicitly listed in a table within this document, meeting ISO 81060-2 criteria 1 and 2 is the acceptance benchmark.

Acceptance Criteria (General for NIBP Devices per ISO 81060-2)	Reported Device Performance
Criteria 1: Mean difference between the device measurement and the reference measurement, and the standard deviation of differences, for systolic and diastolic blood pressure. (Specific thresholds are in the ISO standard, typically mean difference within ±5 mmHg and standard deviation within 8 mmHg for at least 85 subjects).	"Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." (Implies the device met these statistical requirements, but the specific statistical values are not given in this summary.)
Criteria 2: Cumulative percentage of subjects for whom the device measurement difference from the reference measurement is within specific ranges (e.g., within ±5 mmHg, ±10 mmHg, ±15 mmHg). (Specific thresholds are in the ISO standard).	"Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." (Implies the device met these threshold requirements, but the specific percentages are not given in this summary.)
Pulse Rate Accuracy: Within ±5%	Within ±5%
Pressure Accuracy: Within ±3mmHg	Within ±3mmHg

Detailed Information as Requested for AI/ML Studies:

A table of acceptance criteria and the reported device performance: See table above. This is based on NIBP standards, not AI performance metrics.
Sample sizes used for the test set and the data provenance:
- The document refers to "clinical test report of KD-7961" and "clinical test report of KD-972" being used as reference for the subject devices. These reports verified accuracy by meeting ISO 81060-2 criteria.
- ISO 81060-2 typically recommends a minimum of 85 subjects for validation. While not explicitly stated here for the specific test, it's implied that the reference clinical tests adhered to this.
- Data Provenance: Not specified (e.g., country of origin). The document states the company is based in Tianjin, China.
- Retrospective or Prospective: Not specified. Clinical validation studies for medical devices are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of this device study. Ground truth for blood pressure monitors is established by simultaneously measuring blood pressure using a calibrated reference method (e.g., auscultation by trained observers) and the device under test. It's not a consensus-based reading like for imaging. ISO 81060-2 requires a minimum of three trained observers for reference measurements. Their specific qualifications (e.g., years of experience) are not detailed in this summary, beyond "trained observers."
Adjudication method for the test set: Not applicable in the AI/ML sense. For NIBP validation, the "adjudication" is the comparison of device readings against the mean of the reference observers' readings, as per ISO 81060-2. There's no consensus or 2+1/3+1 adjudication of images.
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: Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs the measurement. The "algorithm" here refers to the oscillometric method of blood pressure determination, not a separate AI algorithm that provides diagnostic interpretations.
The type of ground truth used: Reference blood pressure measurements obtained by trained observers using a reference method (e.g., auscultation), according to ISO 81060-2.
The sample size for the training set: Not applicable. This is a conventional medical device, not an AI/ML device that requires a distinct "training set" for model development. The "algorithm" for blood pressure measurement is based on established oscillometric principles and does not "learn" from a training set in the way an AI model does.
How the ground truth for the training set was established: Not applicable, as there's no training set for this type of device.

In summary: The provided document is a regulatory submission for a conventional medical device (blood pressure monitor), not an AI/ML product. Therefore, many of the detailed questions regarding AI/ML model validation are not addressed, as they are not relevant to this type of device. The "acceptance criteria" revolve around established performance standards for blood pressure measurement accuracy (ISO 81060-2).

Summary

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July 30, 2021

Andon Health Co., Ltd. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin, Tianjin 300190 China

Re: K210768

Trade/Device Name: Wrist Blood Pressure Monitor, Wireless Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 24, 2021 Received: July 1, 2021

Dear Liu Yi:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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,

Jennifer Shih Kozen 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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Indications for Use

510(k) Number (if known) K210768

Device Name

Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 14cm-25cm.

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

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

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K210768

510(K) SUMMARY

(In accordance with 21 CFR 807.92)

1.0 Submitter's Information

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping Street, Ya An Road, Nankai District, Tianjin,300190, P.R. China
Phone Number:	86-22-87611660
Fax Number:	86-22-87612379
Contact:	Mr. Liu Yi
Date of Preparation:	March 1, 2021

2.0 Device Information

Device Name:	Fully Automatic Electronic Blood Pressure Monitor
Common Name:	Non-Invasive Blood Pressure Measurement System
Classification Name:	Non-Invasive Blood Pressure Measurement System

3.0 Classification

Product Code:	DXN
Regulation Number:	21 CFR 870.1130
Classification:	II
Review Panel:	870 Cardiovascular

4.0 Predicate Device Information

Manufacturer:	Andon Health Co., Ltd.	Andon Health Co., Ltd.
Device:	Fully Automatic Electronic BloodPressure Monitor	Wireless Blood Pressure WristMonitor
510(k)Number:	K183535	K163276
Classification	II	II
Product Code	DXN	DXN

5.0 Indications for Use

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6.0 Device Descrintion

Fully Automatic Electronic Blood Pressure Monitor (KD-743V, KD-743B, KD-752) is designed and manufactured according to IEC 80601-2-30.

7.0 Comparison of Technological Characteristics with Predicate Device

The following table is the summary of the technological characteristics of the proposed subject device and predicate device.

Item	Subject Device(KD-743V,KD-743B,KD-752)	PredicateDevice(KD-753K183535)	PredicateDevice(KD-721)(K163276)	Comparison Result
Name andmode	Fully AutomaticElectronic BloodPressure Monitor	FullyAutomaticElectronicBlood PressureMonitor	Fully AutomaticElectronic BloodPressure Monitor	Same
Model	KD-743V, KD-743BKD-752	KD-753	KD-721	--
Rx or OTC	OTC	OTC	OTC	Same
Population	Adult	Adult	Adult	Same
Cuff Location	Wrist	Wrist	Wrist	Same
Physical Attributes
Weight(excludebatteries andcuff)	KD-743V: 80gKD-743B: 78gKD-752: 80g	71g	About 67g	Changed
Dimensions	KD-743V:87mm×66.3mm×33.3mmKD-743B:87mm×66.3mm×33.3mmKD-752:100mm×70mm×23.5mm	83mm×74mm×26mm	78mm×60mm×28mm	Changed
Item	Subject Device(KD-743V,KD-743B,KD-752)	PredicateDevice(KD-753K183535)	PredicateDevice(KD-721)(K163276)	Comparison Result
Memory	KD-743V& KD-743B:1×120 times1×60 times2×60 times4×30 timesKD-752:2×120 times4×60 times2×60 times4×30 times	1×120 times1×60 times2×60 times4×30 times	2×60 times	KD-743V&KD-743B are samewith predicatedevice KD-753KD-752 add morememory function onmeter
DisplayedCalculatedParameters	SYSDIAPulseIHB	SYSDIAPulseIHB	SYSDIAPulseIHB	Same
Displaycomponent	KD-743V&KD-743B:LCDKD-752:LCD withbacklight	LCD	LCD	KD-743V&KD-743B are samewith predicatedeviceKD-752 addadditional backlight
Averagefunction	KD-743V&KD-743B:1. Average value of allresults in the current usermemory zone.2. Average the value ofthe latest 3 timesKD-752:1. Average value of allresults in the current usermemory zone.2. Average the value ofthe latest 3 times3. Average value of allthe results in last 7 daysAM4. Average value of all	1.Averagevalue of allresults in thecurrent usermemory zone.2. Average thevalue of thelatest 3 times	average value ofall the resultsmeasured from 5o'clock to 9o'clock in last 7days	KD-743V&KD-743B are samewith predicatedevice KD-753KD-752 add morefunctions
Item	Subject Device(KD-743V,KD-743B,KD-752)the results in last 7 days PM	Predicate Device(KD-753K183535)	Predicate Device(KD-721)(K163276)	Comparison Result
OtherDisplayedInformation	DateTimeMemoryBattery usageBlood pressureclassification	DateTimeMemoryBattery usageBlood pressureclassification	DateTimeMemoryBattery usageBluetoothsymbolBlood pressureclassification(Displayed ondevice)	Similar
Electrical Power
DC Mains	3V	3V	3V	Same
Battery	2 ×1.5V SIZE AAA	2 ×1.5V SIZE AAA	2 ×1.5V SIZE AAA	Same
Environmental Operation
Temperature	10~40°C	10~40°C	10~40°C	Same
Humidity	≤85%	≤85%	≤85%	Same
Environmental Storage
Temperature	-20~50°C	-20~50°C	-20~50°C	Same
Humidity	≤85%	≤85%	≤85%	Same
Performance NIBP
Pulse RateRange	40 -180times/min	40 -180times/min	40 -180times/min	Same
Pulse RateAccuracy	Within ±5%	Within ±5%	Within ±5%	Same
Technique/Method	Oscillometric	Oscillometric	Oscillometric	Same
Measureprocess	KD-743V&KD-743B:Measure during deflatingKD-752:Measure during inflating	Measureduringdeflating	Measureduringinflation	KD-743V&KD-743B are samewith predicatedevice KD-753KD-752 are samewith predicatedevice KD-721
PressureAccuracy	Within ±3mmHg	Within ±3mmHg	Within ±3mmHg	Same
Item	Subject Device(KD-743V,KD-743B,KD-752)	Predicate Device(KD-753K183535)	Predicate Device(KD-721)(K163276)	Comparison Result
Cuff PressureRange	0-300mmHg	0-300mmHg	0-300mmHg	Same
OverpressureLimit	300mmHg	300mmHg	300mmHg	Same
Algorithm	Amplitude	Amplitude	Amplitude	Same

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There are no significant differences between the two products and they are identical in terms of intended use, materials, design, manufacturing methods.

8.0 Discussion of Non-Clinical Testing

Non-clinical tests conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General . Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: ● General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 80601-2-30:2009 & A1:2013,Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers

None of the tests demonstrate that the new Blood Pressure Monitors raise new questions of safety and effectiveness as compared to the predicate.

9.0 Clinical Test

Comparison and evaluation are carried out between the subject device and cleared devices, and it is showed that:

The proposed devices KD-743V and KD-743B has the same algorithm and design principle with cleared device KD-7961 (K090769), so the clinical test report of KD-7961 can be used as a reference when considering the clinical effect of KD-743V and KD-743B.

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The proposed devices KD-752 has the same algorithm and design principle with cleared device KD-972 (K121470), and so the clinical test report of KD-972 can be used as a reference when considering the clinical effect of KD-752.

Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.

10. Comparison to the Predicate Device and Conclusion

The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject device, Fully Automatic Electronic Blood Pressure Monitor (KD-743V, KD-743B, KD-752), is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-753 whose 510(k) number is K183535 and KD-721 whose 510(k) number is K163276.

The subject devices are very similar with its predicate device in the intended use, design principle, materials, performance and applicable standards. Their appearance, the memory capacity, the average function is different, and MCU used is different.

However, the tests in this submission demonstrates that these differences do not raise any new questions of safety and effectiveness and the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate K183535 and K163276.

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).