KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor are 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-726N. KD-737. KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor are 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.

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurements results can also be classified by the function of blood pressure classification indicator. Achieves its function by an LCD.

AI/ML Overview

The provided text describes the KD-726N (and other models) Fully Automatic Electronic Blood Pressure Monitor and its substantial equivalence determination by the FDA. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

The device's performance is assessed against recognized standards, specifically ANSI/AAMI/ISO 81060-2:2009, "Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type." This standard sets the clinical validation criteria for automated non-invasive blood pressure measurement devices.

While the document explicitly states the device will conform to this standard, it does not provide a specific table of acceptance criteria with numerical targets and the reported device performance against these targets directly within the provided text. It only indicates that the device's performance was evaluated against this standard.

However, based on the ANSI/AAMI/ISO 81060-2:2009 standard, the general acceptance criteria typically involve:

Mean difference between the device measurement and the reference measurement (auscultation): Usually, the mean difference should be within ±5 mmHg for both systolic and diastolic blood pressure.
Standard deviation of the differences: The standard deviation of these differences should typically be 8 mmHg or less.

Therefore, without the actual study results included in this document, a table of acceptance criteria and reported device performance cannot be fully constructed. The document only confirms the intent to conform to the standard.

Study Details

The document states that the device's performance was evaluated to demonstrate that differences from the predicate device do not raise new questions of safety and effectiveness. This implies a clinical validation study was conducted in accordance with ANSI/AAMI/ISO 81060-2:2009.

Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the sample size used for the clinical validation test set.
- Data provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical validation for such devices is typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The standard ANSI/AAMI/ISO 81060-2:2009 dictates that reference measurements (ground truth) should be obtained by trained observers using auscultation. While the document doesn't explicitly state the number or qualifications of "experts" as in radiologists, it implies that the reference measurements were taken by trained personnel as per the standard. Specific details are not provided in this document.
Adjudication method for the test set:
- The ANSI/AAMI/ISO 81060-2:2009 standard typically involves simultaneous auscultatory measurements by two independent observers (or more) to establish reference blood pressure, with a defined tolerance for their agreement. Discrepancies often require a third observer or specific rules for resolution. While the document does not explicitly state the adjudication method, adherence to this standard implies such a process.
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. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool requiring human interpretation. Therefore, the concept of "human readers improve with AI" is not applicable here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone validation was performed. The clinical validation per ANSI/AAMI/ISO 81060-2:2009 evaluates the device's accuracy in measuring blood pressure compared to a reference standard (auscultation) without human intervention in the measurement process after the cuff is applied and the device is initiated.
The type of ground truth used:
- The ground truth used for clinical validation in accordance with ANSI/AAMI/ISO 81060-2:2009 is expert auscultation, which involves trained human observers listening to Korotkoff sounds through a stethoscope to determine systolic and diastolic blood pressures.
The sample size for the training set:
- The document does not provide information on a "training set." For an automated blood pressure monitor, the "training" (calibration, algorithm development) is typically part of the engineering and design process, and the clinical validation serves as the independent test set. The document focuses on the validation of the final device.
How the ground truth for the training set was established:
- Since information about a specific "training set" and its ground truth is not provided, this question cannot be answered from the document. The inherent design and calibration within the device by the manufacturer would have relied on various forms of data and established metrology, but these are not described as a "training set" in the context of clinical validation in this document.

Summary

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

August 4, 2016

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

Re: K160563

Trade/Device Name: KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M 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 26, 2016 Received: March 4, 2016

Dear Ms. 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. 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

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Page 2 - Ms. Liu Yi

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 devicerelated 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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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 vours.

Mude Jellman
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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Indications for Use

510(k) Number (if known) K160563

Device Name

KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor

Indications for Use (Describe)

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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K160563

Page 1 of 4

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 Application: 02/26/2016

2.0 Device information

KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, Trade name: KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor
Common name: Noninvasive blood pressure measurement system 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

Manufacturer: Andon Health Co., Ltd. Device: KD-7966 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K111830

5.0 Device description

KD-726N. KD-737. KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and

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K160563 Page 2 of 4

KD-798M Fully Automatic Electronic Blood Pressure Monitor are 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.

6.0 Intended use

KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor are 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.

The intended use and the indication for use of these monitors, as described in their labeling are the same as the predicate device KD-7966.

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	The weight(excluding batteries) anddimensions are changed.
Patients contact Materials	Identical
Function	The memory time, function of display IHB,voice and touch function, averagingfunction, time format displayed arechanged.
Biocompatibility	Identical

7.0 Summary comparing technological characteristics with predicate device

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KD-726N, 737, 7902B, 7902BT, 7903W, 791(V1), 7941B, 795B, 795M, 7961N, 797M, 798B and 798M Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Performance	The cuff pressure range and microprocessor are changed.
Environmental	The temperature and humidity for operation, storage and transport are changed.

8.0 Performance summary

IEC60601-1:2005+CORR.1(2006)+CORR.2(2007)/EN60601-1:2006/A11: 2011, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
· IEC 60601-1-2:2007/EN 60601-1-2:2007+AC:2010, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - 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 Non-Invasive Sphygmomanometers
· ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometer part 2: Clinical validation of automated measurement type

9.0 Comparison to the predicate device and the conclusion

device KD-726N, KD-737, KD-7902B, KD-7902BT, KD-7903W, Our KD-791(V1), KD-7941B, KD-795B, KD-795M, KD-7961N, KD-797M, KD-798B and KD-798M Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7966 whose 510(k) number is K111830.

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K160563 Page 4 of 4

These devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance, the memory time, and the user interface are different.

However, the test in this submission provides demonstration 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).