KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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

They are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

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. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.

AI/ML Overview

The provided text is a 510(k) summary for a Fully Automatic Electronic Blood Pressure Monitor. It includes information about device descriptions, intended use, and comparisons to predicate devices, but it does not contain the detailed clinical study information typically required to fully address your request in the context of advanced AI/medical imaging devices.

Specifically, for a blood pressure monitor, the "acceptance criteria" generally refer to accuracy standards set by organizations like AAMI (Association for the Advancement of Medical Instrumentation) or ISO (International Organization for Standardization). The study that proves the device meets these criteria would involve comparative measurements against a reference standard.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

The document states the device conforms to AAMI SP10:2002 (and its amendments), which is the standard for manual, electronic, or automated sphygmomanometers. This standard defines the acceptance criteria for accuracy.

Acceptance Criteria (from AAMI SP10 standard)	Reported Device Performance
Accuracy for blood pressure measurement is defined by the AAMI SP10 standard. Typical criteria include mean difference and standard deviation between the device and a reference measurement.	The document states that the device conforms to AAMI SP10. However, it does not provide specific numerical results (e.g., mean difference, standard deviation) from a performance study for the subject device or its predicates. It implies satisfying the standard.

2. Sample size used for the test set and the data provenance

The document mentions clinical tests were done for predicate devices and that those reports are applicable to the subject devices due to identical or similar design principles and algorithms.

"The clinical test report of KD-598(K083395) is applicable to our subject devices."
"the clinical test report of KD-5961 is applicable to KD-5031NJ."

However, the document does NOT provide the following specific details for the test sets:

Sample size: Not explicitly stated for any of the devices.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For blood pressure monitors, the "ground truth" in clinical validation studies is typically established by trained observers using auscultatory methods with a mercury sphygmomanometer (or an equivalent reference standard) as per the AAMI SP10 protocol. The document does not detail how many observers were used or their qualifications for the underlying studies it references.

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

This information is not provided. In blood pressure validation studies following standards like AAMI SP10, often multiple trained observers measure blood pressure, and their readings are compared to ensure agreement, playing a role similar to an "adjudication method" in establishing the reference. However, the exact methodology is not detailed here.

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

N/A. This device is a fully automatic electronic blood pressure monitor, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable to this type of device.

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

Yes, the device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner, providing measurements without direct human interpretation in the measurement process. The clinical tests mentioned (conforming to AAMI SP10) would evaluate this standalone performance against a reference standard.

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

For blood pressure monitors, the ground truth is typically established by simultaneous measurements using a recognized reference standard, usually a mercury sphygmomanometer with trained observers using auscultatory methods, as defined by protocols like AAMI SP10. The document states conformance to AAMI SP10, which implies this type of ground truth methodology.

8. The sample size for the training set

N/A / Not provided. Blood pressure monitors based on oscillometric technology generally do not employ machine learning models in the same way modern AI systems do, which require "training sets." Their algorithms are typically fixed based on established physiological principles and signal processing. Therefore, the concept of a "training set" in the AI sense is not applicable to this device, or at least not described in the provided regulatory document.

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

N/A / Not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

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:	06/20/2011

2.0 Device information

Fully Automatic Electronic Blood Pressure Monitor Trade name: Noninvasive blood pressure measurement system Common name: Noninvasive blood pressure measurement system Classification name:

3.0 Classification

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

4.0 Predicate device information

	Manufacturer: Andon Health Co., Ltd.
1	Device: KD-557 Fully Automatic Electronic Blood PressureMonitor
	510(k) number: K100014
	Manufacturer: Andon Health Co., Ltd.
2	Device: KD-5963NU Fully Automatic Electronic Blood PressureMonitor
	510(k) number: K101010

{1}------------------------------------------------

2/4

5.0 Device description

They are designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

6.0 Intended use

"ﺩﻳﺮ ﺑﺘﺎﺭﻳﺨﺎ

The intended use and the indication for use of KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J, as described in the labeling are the same as their predicate devices KD-557 and KD-5963NU.

{2}------------------------------------------------

3/4

7.0 Summary comparing technological characteristics with predicate device

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

8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility evaluation according to IEC 60601-1-2;
b. Electrical safety test according test to IEC 60601-1 :
c. Safety and performance characteristics of the test according to SP10

None of the test demonstrates that KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J bring new questions of safety and effectiveness.

Clinical Test Concerning the Compliance of ANSI/AAMI SP10

From the technical point of view, the subject device KD-557J, KD-5963NGJ, KD-5963NUJ and KD-5971J are identical to its predicate device KD-557 and KD-5963NU. The difference between the subject devices and their predicate devices do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-598(K083395) is applicable to our subject devices. KD-5031NJ use the same cuff, the same design principle and the same algorithm with KD-5961(K093387), so the clinical test report of KD-5961 is applicable to KD-5031NJ.

{3}------------------------------------------------

4/4

9.0 Performance summary

KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

· IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2. 1995.
· EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
AAMI SP10:2002, Manual, electronic or automated sphygmomanometers. .
AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
· AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.

10.0 Comparison to the predicate device and the conclusion

Our device KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-557(K100014) and KD-5963NU(K101010).

KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J are very similar with their predicate devices in the intended use, the design principle, the material, the performance and the applicable standards. The main difference is that the hypertension classification of KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J are changed. KD-557J. KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J will use the JNC hypertension classification while their predicate device KD-557 and KD-5963NU use the WHO hypertension classification.

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

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

DEC - 9 2011

Andon Health Co., Ltd. c/o Ms. Elizabeth M. Bierman Morgan, Lewis & Bockius LLP 1111 Pennsylvania Avenue, NW Washington, DC 20004

Re: K111826

Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor with models: KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ and KD-5971J

Regulatory Number: 21 CFR 870.1130

Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: November 10, 2011 Received: November 10, 2011

Dear Ms. Bierman:

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.

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.

{5}------------------------------------------------

Page 2 – Ms. Elizabeth M. Bierman

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Statement of Indications for Use

510(k) Number:	K111826
----------------	---------

Device name:

KD-557J, KD-5031NJ, KD-5963NGJ, KD-5963NUJ Fully Automatic Electronic and KD-5971J Blood Pressure Monitor

Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

... j

AND/OR Over-The-Counter Use YES (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

4- |

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).