KD-513LU and KD-513LC 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-513LU and KD-513 LC 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 upper arm. The cuff circumference is limited to 22cm-48cm.

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 calculates the average of the all stored measurement of the same period(example: morning or afternoon) of the last 7 days.

AI/ML Overview

The provided FDA 510(k) summary for the KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitors focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for the new device itself.

Therefore, many of the requested details about acceptance criteria, study specifics, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document. The 510(k) essentially argues that because the new device is technologically similar to previously cleared devices and meets relevant standards, it is safe and effective.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table, detailing explicit numeric acceptance criteria and the new device's performance against them, is not provided in the given text.

The document states that the new devices conform to standards, which implicitly means they meet the performance requirements of those standards. The relevant standard mentioned for performance is:

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.

These standards define the accuracy requirements for blood pressure monitors. For AAMI SP10, typical acceptance criteria for accuracy are:

Mean difference: ≤ ±5 mmHg
Standard deviation: ≤ 8 mmHg

However, the specific "reported device performance" (e.g., actual mean difference and standard deviation achieved by KD-513LU/LC in a clinical trial) against these criteria is not explicitly stated in this 510(k) summary. The document only states "appropriate test have been conducted and conform that the new devices are the same safe and effective as the predicate devices."

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

Not explicitly stated for the KD-513LU and KD-513LC.

For blood pressure monitors seeking ISO 81060-2 or AAMI SP10 compliance, a clinical validation study typically involves a minimum of 85 participants (both genders, various age groups, and blood pressure levels). The document only generally states that "appropriate test have been conducted." There is no mention of the country of origin of the data or whether it was retrospective or prospective.

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

Not explicitly stated. For AAMI SP10 compliance, the ground truth (reference blood pressure measurements) is typically established by trained observers (often medical professionals) using a auscultatory method (stethoscope and sphygmomanometer) following a specific protocol, with multiple observers for inter-observer variability assessment.

4. Adjudication method for the test set

Not explicitly stated. For clinical validation according to AAMI SP10, a specific protocol involving multiple observers and averaged readings from a mercury sphygmomanometer against which the device readings are compared is used. This is less about "adjudication" in the sense of expert consensus on a diagnosis, but rather a direct comparison to a validated reference method.

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

Not applicable and not done. This device is a blood pressure monitor, not an AI-powered diagnostic imaging tool. MRMC studies are not relevant for this type of device.

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

Yes, implicitly. Blood pressure monitors are inherently standalone devices in their primary function of measuring blood pressure. The performance testing (conformance to AAMI SP10) assesses the algorithm's ability to accurately measure blood pressure without human interpretation of the measurement itself (though a human activates the device).

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

Implicitly, reference measurements from a validated standard method (typically auscultatory measurements using a mercury sphygmomanometer) obtained by trained observers. This is the standard for blood pressure device validation.

8. The sample size for the training set

Not applicable/Not stated. This device is not described as using machine learning that would require a separate "training set." Its operational principle is based on oscillometric and silicon integrated pressure sensor technology, which relies on established physiological principles and signal processing, not a "training set" in the AI sense.

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

Not applicable. See point 8.

Summary

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KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

510(k) Summary 《ノミノシア2

SEP 10 2012

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:
Address:

Phone number:

Fax number:

Contact:

Andon Health Co., Ltd. No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China 86-22-6052 6161. Ext. 8060 86-22-6052 6162 Liu Yi 04/27/2012 Date of Application:

2.0 Device information

KD-513LU Fully Automatic Electronic Blood Pressure Monitor Device name: KD-513LC Fully Automatic Electronic Blood Pressure Monitor

3.0 Classification

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

4.0 Predicate device information

1	Manufacturer:Andon Health Co., Ltd.Device:KD-5964 Fully Automatic Electronic Blood Pressure Monitor510(k) number:K102906	Manufacturer:	Andon Health Co., Ltd.
Manufacturer:	Andon Health Co., Ltd.
Device:	KD-5964 Fully Automatic Electronic Blood Pressure Monitor
510(k) number:	K102906
2	Manufacturer:Andon Health Co., Ltd.	Manufacturer:	Andon Health Co., Ltd.
Manufacturer:	Andon Health Co., Ltd.

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KD-556J Fully Automatic Electronic Blood Pressure Monitor

510(k) number: K110330

5.0 Device description

Device:

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

6.0 Intended use

KD-513LU and KD-513LC 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 upper arm. The cuff circumference is limited to 22cm-48cm.

The intended use and the indication for use of KD-513LU and KD-513LC, as described in the labeling are the same as the predicate device KD-5964 and KD-5567.

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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-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor conform 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.

9.0 Comparison to the predicate device and the conclusion

Our device KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor are substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5964 whose 510(k) number is K102906 and the Fully Automatic Electronic Blood Pressure Monitor KD-556J with the 510(k) number of K110330.

KD-513LU and KD-513LC are very similar in the intended use, the design principle, the material, the performance and the applicable standards with their predicate devices. Only their appearance and the memory times are changed.

However, appropriate test have been conducted and conform that the new devices are the same safe and effective as the predicate devices.

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Public Health Service

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

SEP 10 2012

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

Re: K121372

Trade Names: KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 9, 2012 Received: August 13, 2012

Dear Mr. Liu:

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 :	K121372
Device name:	KD-513LU and KD-513LC Fully Automatic Electronic Blood Pressure Monitor

Indications for use:

Prescription use Part 21 CFR 801 Subpart D) 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 of Cardiovascular Devices 510(k) Number 5 + 6

Page 1 of

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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).