KD-5920, KD-5920L and KD-5923 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

KD-5920, KD-5920L and KD-5923 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 is related to a 510(k) premarket notification for a blood pressure monitor and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information necessary to fully complete all aspects of the requested table and study description regarding acceptance criteria and performance against those criteria as would be found in a clinical study report.

However, based on the available text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The document references ANSI/AAMI/ISO 81060-2:2009, Non-invasive sphygmomanometers part 2: Clinical validation of automated measurement type as a standard met. This standard defines acceptance criteria for blood pressure measurement devices. While the exact acceptance criteria and the specific performance data against those criteria are not explicitly listed in a detailed table within the document, the mention of conforming to this standard implies that the device met its requirements.

The core acceptance criteria from ANSI/AAMI/ISO 81060-2:2009 typically involve:

Mean difference: The absolute mean difference between the device measurements and auscultatory reference measurements should be ≤ 5 mmHg for both systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Standard deviation: The standard deviation of the difference between the device measurements and auscultatory reference measurements should be ≤ 8 mmHg for both SBP and DBP.

The document states: "None of the test demonstrates that KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness." and "KD-5920, KD-5920L and KD-5923 are very similar with its predicate device in the intended use, the design principle, the material, the performance...". This implicitly suggests that the device's performance aligns with the predicate device and meets the clinical validation standard's acceptance criteria. Specific numerical performance values are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-clinical Tests have been done as follows:" and then lists standards. For clinical validation, it specifically mentions conformance to ANSI/AAMI/ISO 81060-2:2009. This standard requires a specific sample size for its clinical validation protocol, typically aiming for at least 85 subjects (some sources suggest minimum 35 to 85, depending on the specific protocol variant, but 85 is common for AAMI).

Sample size for test set: Not explicitly stated, but conformance to ANSI/AAMI/ISO 81060-2:2009 implies a sample size that meets the standard's requirements (typically at least 85 subjects).
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Clinical validation studies conforming to such standards are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For blood pressure measurement validation according to standards like ANSI/AAMI/ISO 81060-2, ground truth is established by simultaneous auscultatory measurements performed by at least two trained observers (usually clinicians).

Number of experts: At least two trained observers.
Qualifications of experts: Typically clinicians or blood pressure technicians highly trained in auscultatory measurement, following a standardized protocol (e.g., mercurial sphygmomanometer with stethoscope, double-headed stethoscope, etc.). Specific experience (e.g., specific number of years) is not mentioned in this document but is implicitly part of being "trained observers" in such a protocol.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

For clinical validation of blood pressure devices using auscultation, the standard often involves:

Two observers making simultaneous, blinded measurements.
If the readings between the two observers differ by more than a predefined threshold (e.g., 4 mmHg), a third observer or a re-measurement may be required.
This is a form of consensus/adjudication. The specific method used (e.g., direct average of two, third observer if discrepancy) is not detailed but is part of the standard's methodology.

5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI assistance does not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. Blood pressure monitors are inherently standalone devices that provide a measurement directly. The reference to ANSI/AAMI/ISO 81060-2:2009 confirms that the algorithm (device) performance was evaluated against a reference standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for blood pressure measurement validation is expert auscultatory measurements (often referred to as reference measurements) taken simultaneously by trained observers using a mercury or calibrated aneroid sphygmomanometer. This is a form of expert consensus / reference standard as defined by the AAMI/ISO standard.

8. The sample size for the training set

This document does not specify a separate "training set" sample size. The device is validated against the AAMI/ISO standard; blood pressure monitors typically undergo calibration and internal testing during development (which might use various datasets), but the primary clinical performance assessment for regulatory purposes is the validation study, not a distinct "training set" in the context of machine learning.

9. How the ground truth for the training set was established

As there is no explicitly mentioned "training set" in the context of the regulatory submission for this device type, the method for establishing its ground truth is not applicable or detailed in this document. The focus for regulatory submission is on the clinical validation/test set.

Summary

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

November 18, 2016

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

Re: K162230

Trade/Device Name: KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 5. 2016 Received: August 11, 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 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

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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 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 yours,

Mada 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) K162230

Device Name

KD-5920, 5920L and KD-5923 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)	Over-The-Counter Use (21 CFR 801 Subpart C)

Counter Use (21 CFR 801 Suppart C)

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510(k) Summary - K162230

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:	8/3/2016

2.0 Device information

Trade name:	KD-5920, KD-5920L and KD-5923 Fully AutomaticElectronic 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-5964 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K102906

K162230

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5.0 Intended use

The intended use and the indication for use of KD-5920, KD-5920L and KD-5923, as described in its labeling are the same as the predicate device KD-5964 (K102906).

6.0 Device description

KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to IEC 80601-2-30.

7.0 Summary comparing technological characteristics with predicate device

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Similar
Performance	Similar
Biocompatibility	Identical
Mechanical safety	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

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8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

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

None of the test demonstrates that KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic Blood Pressure Monitor bring new questions of safety and effectiveness.

9.0 Performance summary

KD-5920, KD-5920L and KD-5923 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 60601-1-2:2007,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 81060-2:2009, Non-invasive sphygmomanometers part 2: Clinical validation of automated measurement type

10.0 Comparison to the predicate device and the conclusion

Our device KD-5920, KD-5920L and KD-5923 Fully Automatic Electronic are substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5964 whose 510(k) number is K102906.

KD-5920, KD-5920L and KD-5923 are very similar with its predicate device in the intended use, the design principle, the material, the performance, memory average function, average measure function and the applicable standards. Only their appearance, the memory capacity, the battery and the MCU are 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).