KD-5913 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

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

The operational principle is based on oscillometric and silicon integrate 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 has the function of averaging the last three measurements.

AI/ML Overview

The provided 510(k) summary for the KD-5913 Fully Automatic Electronic Blood Pressure Monitor does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving device performance.

This document focuses on establishing substantial equivalence to a predicate device (KD-5917). It states that the device conforms to certain standards, but it does not provide a specific performance study with detailed acceptance criteria, test results, or methodology as would be expected for a comprehensive performance study.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

The document states that the device "conforms to" several standards, including:

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 sphygmomanoment.
AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanoment.

These standards typically define the acceptance criteria for blood pressure monitors (e.g., accuracy against a reference standard, standard deviation of differences). However, the document explicitly states "Performance summary" but then only lists the standards to which the device conforms, without providing the actual measured performance data or the specific acceptance criteria derived from these standards. It also does not explicitly state the reported device performance in terms of accuracy metrics (e.g., mean difference, standard deviation) against a reference.

Therefore, a table of acceptance criteria and reported device performance cannot be created from the provided text.

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 that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." However, it does not specify the sample size used for any performance testing, nor does it provide details on the data provenance (country of origin, retrospective/prospective nature).

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)

This information is not provided in the document. Blood pressure monitor validation studies typically involve medically trained personnel taking reference measurements, but the specifics are absent.

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

This information is not provided in the document.

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

This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool requiring "human readers." Therefore, an MRMC study is not applicable, and no such study or effect size is mentioned.

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

Yes, the device is designed to operate standalone as a "Fully Automatic Electronic Blood Pressure Monitor." Its performance would inherently be a standalone assessment. However, the document does not provide the results of such a standalone test, only that it conforms to standards.

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

While not explicitly stated, for blood pressure monitors conforming to standards like AAMI SP10, the "ground truth" for accuracy validation is typically established through simultaneous measurements by trained observers using a reference manual sphygmomanometer (auscultatory method), as per the requirements of such standards.

8. The sample size for the training set

This device is not described as an AI/ML device that requires a "training set." Its operation is based on oscillometric and silicon integrate pressure sensor technology. Therefore, the concept of a "training set" as it applies to AI/ML is not applicable here, and no information about it is provided.

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

As "training set" is not applicable, this question is not relevant.

In summary, the provided document serves as a 510(k) summary for substantial equivalence. It confirms adherence to relevant performance standards but does not detail the specific performance study, including acceptance criteria, sample sizes, ground truth establishment, or test results, which would be found in a more comprehensive testing report.

Summary

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K102353 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 SEP 1 7 2010 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: 08/16/2010

2.0 Device information

Trade name:	KD-5913 Fully Automatic Electronic Blood PressureMonitor
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 Predict device information

Manufacturer: Andon Health Co., Ltd. Device: KD-5917 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K091737

5.0 Device description

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cuff circumference is limited to 22cm-48cm.

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

6.0 Intended use

KD-5913 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 systelic 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.

The intended use and the indication for use of KD-5913, as described in its labeling are the same as the predict device KD-5917.

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

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8.0 Performance summary

KD-5913 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: - Frandard: 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 sphygmomanoment - I To ANSIA
AAMI / ANSI - CD10-800040 0000000 0000
· AAMI / ANSI SP10:2002/A2:2006 --, Amendment 2 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanoment . 2 10 ANSIA

9.0 Comparison to the predict device and the conclusion

Our device KD-5913 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor is Monitor KD-5917 whose 510(k) number is K091737.

The two devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Only their appearance and some functions are different. Compared to KD-5917, the KD-5913 does not have the display of "Blood pressure classification", and the MCU is changed, either.

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

ર- 3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.

Public Health Service

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

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

SEP 1 7 2010

Re: K102353

Trade/Device Name: KD-5913 Fully Automated Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 16, 2010 Received: August 19, 2010

Dear Mr. 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.

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.

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Page 2 - Mr. Liu Yi

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 (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 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

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Statement of Indications for Use

510(k) Number :	K102353
Device name:	KD-5913 Fully Automatic Electronic Blood Pressure Monitor

SEP 17 2010### Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (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 of

Page 1 of 1

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KJO235

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).