KD-5961,KD-5962,KD-5902 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a noninvasive 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, the result will be shown on a LCD with an electronic interface module, the result can also be classified and displayed by the function of blood pressure classification indicator, If any irregular heartbeat is detected, it can be shown on the LCD.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

This device is a Fully Automatic Electronic Blood Pressure Monitor, and the 510(k) summary focuses heavily on its substantial equivalence to previously cleared predicate devices rather than detailing a de novo performance study with specific acceptance criteria and outcome metrics.

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

The document does not explicitly state device-specific acceptance criteria for performance metrics (like accuracy targets for blood pressure readings) in a quantifiable table. Instead, it relies on conformance to recognized standards.

Acceptance Criteria (Stated as conformance to standards)	Reported Device Performance
Conforms to IEC 60601-1 (Medical Electrical Equipment Safety)	Stated as conforming. No specific performance metrics for this standard are provided beyond general safety.
Conforms to IEC 60601-1-2 (Electromagnetic Compatibility)	Stated as conforming. No specific performance metrics for this standard are provided beyond general EMC.
Conforms to AAMI SP10:2002, A1:2003, A2:2006 (Manual, electronic or automated sphygmomanometers)	Stated as conforming. This standard sets the accuracy requirements for non-invasive blood pressure monitors. The document implies that by conforming to AAMI SP10, the device meets the accepted performance criteria for accuracy and precision for blood pressure measurement. However, specific accuracy results (e.g., mean difference and standard deviation between device and reference measurements) are not provided in this summary.

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 does not provide details about a specific test set, its sample size, or data provenance for a dedicated clinical performance study. The statement "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness" implies that tests were conducted, likely to demonstrate conformance to the AAMI SP10 standard, but the specifics are not included in this summary.

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 given 510(k) summary. For blood pressure monitors, ground truth is typically established by trained human observers using a reference method (e.g., auscultation with a mercury sphygmomanometer), but the details of such a process are absent.

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

This information is not provided in the given 510(k) summary.

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 MRMC comparative effectiveness study was done or reported. This device is a standalone blood pressure monitor, not an AI-powered diagnostic tool requiring human reader involvement.

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

Yes, a standalone performance evaluation would have been conducted as this is an algorithm-only device in terms of its measurement function. The performance of the blood pressure monitor itself, as per AAMI SP10, is a standalone assessment of its accuracy against a reference measurement. However, the results of this standalone performance test (e.g., mean difference, standard deviation) are not detailed in this 510(k) summary. The summary only states that the device conforms to the AAMI SP10 standard, which implies successful standalone performance.

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

While not explicitly stated for this specific submission, the "ground truth" for non-invasive blood pressure monitors conforming to AAMI SP10 is typically established by trained human observers performing auscultatory measurements using a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer). This is generally considered the "expert consensus" or reference standard for blood pressure.

8. The sample size for the training set

Not applicable/Not provided. This device is a traditional electronic medical device based on oscillometric principles, not a machine learning or AI device that requires a "training set" in the computational sense. Its design and calibration would be based on engineering principles and established physiological models, and its performance validated against clinical standards.

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

Not applicable/Not provided. As stated above, this is not an AI/ML device that requires a training set.

Summary

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510(k) Summary

K093.387

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

NOV 2 7 2009

Name:	Andon Health Co., Ltd.
Address:	No 31, Changjiang 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:	10/23/2009

2.0 Device information

Trade name: 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: 11

Panel: Cardiovascular

4.0 Predict device information

Andon Health Co., Ltd. Manufacturer: KD-5961 Fully Automatic Electronic Blood Pressure Monitor Device: KD-5962 Fully Automatic Electronic Blood Pressure Monitor KD-5902 Fully Automatic Electronic Blood Pressure Monitor KD-795 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K083246 K090771 K083317 K070826

5.0 Device description

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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.

6.0 Intended use

The intended use and the indication for use of KD-5961,KD-5962,KD-5902, as described in its labeling are the same as the predict device KD-5961.KD-5962.KD-5902(K083246 K090771 K083317).

		7.0 Summary comparing technological characteristics with predicate
device

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

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8.0 Performance summary

KD-5961, KD-5962, KD-5902 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.
· IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
· 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 predict device and the conclusion

Our device KD-5961,KD-5962,KD-5902 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5961,KD-5962,KD-5902 whose 510(k) number is K083246, K090771, K083317.

The several devices are identical in the intended use, the design principle, the material, the appearance, the functions, the performance, the energy source and the applicable standards. KD-5961,KD-5962,KD-5902 only adds a new cuff (cuff circumstance: 22cm-36cm) when compared with the predicted device(K083246, K090771, K083317).

The Environmental parameters of KD-5961 and KD-5902 is changed, the operational range for humidity (<90%) are changed from the predict device whose operational range for humidity is <80%. The pulse rate range is changed from 30-180 times/min to 40-180 times/min.

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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 31, Changjiang Road, Nankai District Tianjin, P.R. China, 300193

NOV 2 7 2009

Re: K093387

Trade/Device Name: KD-5961, KD-5962, KD-5902 Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement systems Regulatory Class: Class II (two) Product Code: DXN Dated: October 26, 2009 Received: October 30, 2009

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.

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

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Page 2 – Ms. Liu Yi

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/CDRHQffices/ucm115809.htm1for 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/ReportalProblem/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 :

K093367

Device name:

KD-5961,KD-5962,KD-5902 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)

W.M.P.

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numbe

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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).