KD-753, KD-738BR, KD-733 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

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor 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

The provided text describes the 510(k) premarket notification for the KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitors. The primary purpose of this submission is to demonstrate the substantial equivalence of these devices to a legally marketed predicate device (KD-7920).

The key study proving the device meets acceptance criteria is a clinical test performed in accordance with ISO 81060-2. This standard specifies requirements for the clinical validation of automated non-invasive sphygmomanometers.

Here's an organized breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2. This standard sets forth statistical requirements for accuracy by comparing the device's measurements against a reference method (auscultation).

While the exact numerical acceptance criteria are not explicitly listed in a detailed table format within the provided document (e.g., mean difference and standard deviation), the text states that the device was verified by "meeting criteria 1 and criteria 2 of ISO 81060-2." These criteria specify the allowable differences between the device measurements and the reference measurements for systolic and diastolic blood pressure.

Table of Acceptance Criteria and Reported Device Performance (Inferred from ISO 81060-2 compliance):

Parameter	Acceptance Criteria (Based on ISO 81060-2)	Reported Device Performance
Blood Pressure Accuracy (mean difference)	Mean difference between the device and reference method should be ≤ ±5 mmHg. (This is "Criterion 1" of ISO 81060-2:2013)	"verified by meeting criteria 1 and criteria 2 of ISO 81060-2." (Implies compliance)
Blood Pressure Accuracy (standard deviation)	Standard deviation of the differences between the device and reference method should be ≤ 8 mmHg. (This is "Criterion 2" of ISO 81060-2:2013)	"verified by meeting criteria 1 and criteria 2 of ISO 81060-2." (Implies compliance)
Pulse Rate Accuracy	Within ±5% (as stated in the comparison table on page 4)	Within ±5% (Same, as stated in the comparison table)

Note: The exact numerical results (e.g., specific mean differences and standard deviations) from the clinical study are not provided in this 510(k) summary, only the statement that the device met the ISO 81060-2 criteria.

Study Details:

Sample size used for the test set and data provenance:
- Sample Size: 85 patients (40 males and 45 females).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical validation according to ISO standards usually implies a prospective study conducted in a clinical setting.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- The standard auscultation method was used as the reference blood pressure measurement. ISO 81060-2 requires two trained observers to perform the auscultatory measurements simultaneously and independently, or in a specific sequence, and their readings are averaged to establish the reference (ground truth).
- The text does not specify the number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). However, for auscultation in such a study, the experts would typically be medical professionals trained and experienced in blood pressure measurement using the auscultation method.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text states, "same sequential method was chosen." In the context of ISO 81060-2, the "sequential method" typically refers to the procedure where the test device and the reference (auscultation) measurements are performed one after another on the same subject. The standard generally requires two independent observers for auscultation, with their readings averaged or adjudicated if they differ beyond a certain threshold. The specific details of adjudication (e.g., 2+1) are not provided, but it's implied that the methodology adheres to the standard's requirements for establishing a reliable reference.
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. This is a study validating the accuracy of an automated non-invasive blood pressure monitor against a reference standard. It is not an MRMC study designed to evaluate how human readers (e.g., radiologists interpreting images) improve with AI assistance. Therefore, no effect size for human reader improvement is applicable or provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "clinical test" described evaluates the accuracy of the automated blood pressure device itself (the "algorithm only" in a broader sense of an automated device) in comparison to a human-performed reference standard (auscultation). While a human applies the cuff and initiates the measurement, the blood pressure reading itself is generated by the device's internal algorithm. The study assesses the device's output independently, which parallels a "standalone performance" evaluation for an automated medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by the standard auscultation method (reference blood pressure monitor measuring), performed by medical professionals (experts). This falls under expert-derived reference standard/ground truth.
The sample size for the training set:
- Not applicable / Not provided. The clinical study described in the 510(k) summary is for validation (test set performance), not for training. Blood pressure monitors like these are typically designed and calibrated during their development phase, which would involve internal testing and potentially specific datasets. The 510(k) submission focuses on the final performance validation.
How the ground truth for the training set was established:
- Not applicable / Not provided. As mentioned above, the text describes the validation study, not the development or training phase of the device.

Summary

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June 4, 2019

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

Re: K183535

Trade/Device Name: KD-733, KD-738BR, KD-733 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: February 19, 2019 Received: May 9, 2019

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,

for

Matthew Hillebrenner Director (Acting) 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) K183535

Device Name

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure ment 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.

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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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 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,
	P.R. China
Phone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Preparation:	11/28/2018

2.0 Device information

Trade name:	KD-753,	KD-738BR,	KD-733	Fully	Automatic
Electronic Blood Pressure Monitor

Noninvasive blood pressure measurement system Common name:

Classification name: Noninvasive blood pressure measurement system

3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular

4.0 Predicate device information

Primary Predicate:

Manufacturer: Andon Health Co., Ltd. KD-7920 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K162915

Reference Predicate:

Manufacturer: Andon Health Co., Ltd. Device: KD-7901 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K092510

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5.0 Intended use

The intended use and the indication for use of KD-753, KD-738BR, KD-733 , as described in its labeling are the same as the predicate device KD-7920(K162915).

6.0 Device description

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor 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.

7.0 Summary comparing technological characteristics with predicate device

Item	SubjectDevice	Predicate Device	Conclusion
Name andmode	Fully Automatic ElectronicBlood Pressure Monitor	Fully Automatic ElectronicBlood Pressure Monitor	Same
Model	KD-753KD-738BRKD-733	KD-7920	The model isdifferent
Rx or OTC	OTC	OTC	Same
Population	Adult	Adult	Same
Cuff Location	Wrist	Wrist	Same

Physical Attributes
Weight	KD-753: 71gKD-738BR: 80gKD-733: 78.7g	69.5g	Changed
Dimensions(mm)	KD-753:83mm x 74mm x 26mmKD-738BR:83mm x 64mm x 28mmKD-733:87mm×66.3mm×31.5mm	80mm x 60mm x 31mm	changed
Memory	1×120 times1×60 times2×60 times4×30 times	4 x 30 times	Added memoryfunction on meter
DisplayedCalculatedParameters	SYSDIAPulseIHB	SYSDIAPulseIHB	Same
Displaycomponent	LCD	LCD	Same
Averagefunction	KD-753:1.Average value of allresults in the current usermemory zone.2. Average the value ofthe latest 3 times.KD-738BR: Average thevalue of the latest 3 times.KD-733: Average value ofall results in the currentuser memory zone.	Average value of all theresults which is measuredfrom 5 o'clock to 9 o'clockand 18 o'clock to 20o'clock in last 7 days.	Average functionis different
OtherDisplayedInformation	DateTimeMemoryBattery usageBlood pressureclassification	DateTimeMemoryBattery usageBlood pressureclassification	Same
Electrical
Power
DC Mains	3 VDC	3 VDC	Same
Battery	2 x 1.5 VDC AAA size	2 x 1.5 VDC AAA size	Same
Environmental
Operation
Temperature	10~40°C	10~40°C	Same
Humidity	≤85%	≤85%	Same
EnvironmentalStorage
Temperature	-20~50°C	-20~50°C	Same
Humidity	≤85%	≤85%	Same
PerformanceNIBP
Pulse RateRange	40 --- 180times/min	40 --- 180times/min	Same
Pulse RateAccuracy	Within ±5%	Within ±5%	Same
Technique/Method	Oscillometric	Oscillometric	Same
Measure process	Measure during deflating	Measure during deflating	Same
Systolic Range	60-260mmHg	60-260mmHg	Same
Diastolic Range	40-199mmHg	40-199mmHg	Same
PressureAccuracy	Within ±3mmHg	Within ±3mmHg	Same
Cuff PressureRange	0-300mmHg	0-300mmHg	Same
Over pressureLimit	300mmHg	300mmHg	Same
Algorithm	Amplitude	Amplitude	Same

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K183535

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K183535

KD-753 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests

Bench testing was conducted to demonstrate that the device meets its requirements and specification. The following performance tests were completed:

a. Electromagnetic compatibility test according to IEC 60601-1-2;

b. Electrical safety according test to IEC 60601-1;

c. Safety and performance characteristics of the test according to IEC 80601-2-30

The proposed devices KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor meets all the applicable requirements.

Clinical Tests

Clinical test has been performed in accordance with ISO 81060-2. 85 patients

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(40 males and 45 females) were invited for the study, standard auscultation method was used as the reference blood pressure monitor measuring, and same sequential method was chosen. Accuracy of the blood pressure monitors was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.

9.0 Performance summary

KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor conforms to 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 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
ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type

10.0 Comparison to the predicate device and the conclusion

Our device KD-753, KD-738BR, KD-733 Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the predicate device KD-7920 Fully Automatic Electronic Blood Pressure Monitor.

The intended use, the design principle, the material of the new devices is exactly the same as the predicate device, their appearance, memory capacity, average function and MCU used is different.

However, the test in this submission provides demonstrates that these small differences do not raise any new questions of safety and effectiveness.

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).