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 upper arm. The cuff circumference is limited to 22cm-48cm.

Device Description

Fully Automatic Electronic Blood Pressure Monitor ( KD-5811A, KD-5811V and KD-5815) 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

Here's a breakdown of the acceptance criteria and the study information for the "Fully Automatic Electronic Blood Pressure Monitor," based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pressure Accuracy	Within ±3mmHg
Pulse Rate Accuracy	Within ±5%

Note: The provided document states that the new device models (KD-5811A, KD-5811V, and KD-5815) have the same pressure and pulse rate accuracy as the predicate device (KD-5811, K210770). The predicate device's performance aligned with these criteria. The specific methods used to measure and verify these performances against the acceptance criteria are detailed in the study section.

Study Information

The document refers to a "clinical test report" for a previously cleared device (KD-5961, K083246) as a reference, stating that the subject devices (KD-5811A, KD-5811V, KD-5815) share the same algorithm and design principle. The acceptance criteria for accuracy were verified by meeting ISO 81060-2.

Here's the breakdown of the study details based on the provided text, recognizing that details for KD-5961 are referenced rather than presented explicitly for the current submission:

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

Test Set Sample Size: Not explicitly stated for the referenced clinical test report of KD-5961 or for the current submission. The document only mentions that accuracy was verified by meeting ISO 81060-2 criteria.
Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).

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

Not specified. The ISO 81060-2 standard typically involves trained observers for reference measurements, but the exact number and qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not specified. ISO 81060-2 outlines procedures for reference measurements and statistical analysis for accuracy, but specific adjudication methods like 2+1 or 3+1 are not mentioned.

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

No, an MRMC comparative effectiveness study is not mentioned or implied. The device is a "Fully Automatic Electronic Blood Pressure Monitor," which typically implies standalone operation without human-in-the-loop assistance in the measurement itself. The comparison is between automated devices and a reference standard (likely auscultation) as per ISO 81060-2.

6. Standalone Performance Study

Yes, a standalone performance study was done for the reference device KD-5961, as implied by the statement: "Accuracy of the blood pressure monitors for the clinical test report was verified by meeting criteria 1 and criteria 2 of ISO 81060-2." This standard specifically assesses the performance of automated non-invasive sphygmomanometers without human assistance.

7. Type of Ground Truth Used

The ground truth used would be the reference measurements obtained through a validated method, as prescribed by ISO 81060-2. For blood pressure monitors, this typically involves simultaneously comparing the device's readings to those obtained by skilled observers using a standardized auscultatory method (e.g., mercury sphygmomanometer) on the same subjects.

8. Sample Size for the Training Set

Not applicable. This device is an electronic blood pressure monitor based on oscillometric technology, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The "algorithm" mentioned (amplitude) refers to the computational method used to derive blood pressure values from oscillometric pulses.

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

Not applicable, as there is no training set in the AI/ML context for this type of device. The device's "algorithm" (amplitude) is based on established oscillometric principles and likely calibrated during manufacturing based on engineering specifications and potentially clinical validation data.

Summary

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February 15, 2023

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

Re: K222869

Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 26, 2022 Received: January 4, 2023

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Robert T. Kazmierski -S

for

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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Indications for Use

510(k) Number (if known) K222869

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 upper arm. The cuff circumference is limited to 22cm-48cm.

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)

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K222869

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:	September 15, 2022

2.0 Device Information

Device Name:	Fully Automatic Electronic Blood Pressure Monitor
Common Name:	Arm Blood Pressure Monitor
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.
Device:	Fully Automatic Electronic Blood Pressure Monitor
510(k) Number:	K210770
Classification	II
Product Code	DXN

5.0 Intended Use

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6.0 Device Description

Fully Automatic Electronic Blood Pressure Monitor ( KD-5811A, KD-5811V and KD-5815) 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	Predicate Device(KD-5811K210770)	ComparisonResult
Name andmode	Fully Automatic ElectronicBlood Pressure Monitor	Fully Automatic ElectronicBlood Pressure Monitor	--
Model	KD-5811A, KD-5811V,KD-5815	KD-5811	--
Rx or OTC	OTC	OTC	Same
Population	Adult	Adult	Same
CuffLocation	Upper arm	Upper arm	Same
Physical Attributes
Weight(excludebatteries andcuff)	KD-5811A: About 223gKD-5811V:About 239gKD-5815:About 189g	About 239g	KD-5811V issame withpredicate.KD-5811A andKD-5815 arechanged.
Dimensions	KD-5811A:139.4mm×93.8mm×42mmKD-5811V:139.4mm×93.8mm×43.4mmKD-5815:138mm×98mm×48.9mm	139.4mm×93.8mm×43.4mm	KD-5811V issame withpredicate.KD-5811A andKD-5815 arechanged.
Memory	KD-5811A, KD-5811V:2×120 times2×60 times2×30 times	2×120 times2×60 times2×30 times	KD-5811A andKD-5811V aresame withpredicate.
Item	Subject Device	Predicate Device(KD-5811K210770)	ComparisonResult
	KD-5815:1×60 times		KD-5815 is lessmemory timesthan predicate..
DisplayedCalculatedParameters	SYS	SYS	Same
	DIA	DIA
	Pulse	Pulse
	IHB	IHB
Displaycomponent	KD-5811A, KD-5811V:LCD with backlightKD-5815: LCD	LCD with backlight	KD-5811A andKD-5811V aresame withpredicate.KD-5815 iswithoutbacklight.
Averagefunction	1.Average value of all results inthe current user memory zone.2.Average the value of the latest3 times.	1.Average value of all resultsin the current user memoryzone.2.Average the value of thelatest 3 times	Same
OtherDisplayedInformation	KD-5811A:DateTimeMemoryBattery usageBlood pressure classificationBodymoveKD-5811V:DateTimeMemoryBattery usageBlood pressure classificationKD-5815MemoryBattery usageBlood pressure classification	DateTimeMemoryBattery usageBlood pressure classification	KD-5811A ismore functionthan predicate.KD-5811V issame withpredicate.KD-5815 is lessfunction thanpredicate.
Electrical Power
DC Mains	5V	6V	Changed
Battery	4 ×1.5V SIZE AA	4 ×1.5V SIZE AA	Same
Item	Subject Device	Predicate Device(KD-5811K210770)	ComparisonResult
Environmental Operation
Temperature	10~40°C	10~40°C	Same
Humidity	<85%	<85%	Same
Environmental Storage
Temperature	-20~50°C	-20~50°C	Same
Humidity	<85%	<85%	Same
Performance NIBP
Pulse RateRange	40 -180times/min	40 -180times/min	Same
Pulse RateAccuracy	Within ±5%	Within ±5%	Same
Technique/Method	Oscillometric	Oscillometric	Same
Measureprocess	Measure during deflating	Measure during deflating	Same
PressureAccuracy	Within ±3mmHg	Within ±3mmHg	Same
Cuff
PressureRange	0-300mmHg	0-300mmHg	Same
OverpressureLimit	300mmHg	300mmHg	Same
Algorithm	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:

60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And . IEC 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

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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: Edition 2.0 2018-03 Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

None of the test demonstrate that the new Blood Pressure Monitors raises 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-5811A, KD-5811V and KD-5815 has the same algorithm and design principle with cleared device KD-5961 (K083246), so the clinical test report of KD-5961 can be used as a reference when considering the clinical effect of KD-5811A, KD-5811V and KD-5815.

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-5811A , KD-5811V, and KD-5815) is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5811 (K210770).

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,displayed information, DC mains and MCU is different.

However, the tests in this submission demonstrates that these small differences do not raise any new questions of safety and effectiveness. And the subject device is as safe and effective as the legally marketed predicate K210770.

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).