KD-5966 series 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-5966 series 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.

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

For KD-5966, 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 results can also be classified and displayed by the function of blood pressure classification indicator, the memory capability is 2×60 times. If any irregular heartbeat is detected, it can also be stapular 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-5966 series Fully Automatic Electronic Blood Pressure Monitor does not contain sufficient information to comprehensively answer all aspects of your request regarding acceptance criteria and the study proving device performance in the format you've requested.

Specifically, it states that the device "conforms to the following standards," which implies that meeting these standards constitutes the acceptance criteria. However, it does not explicitly detail the performance metrics or numerical thresholds that comprise these criteria, nor does it provide a detailed study report that proves the device met those criteria.

Here's what can be extracted and what information is missing:

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

The document states that the device "conforms to the following standards" and that "appropriate test will be conducted and specified acceptance criteria will be met before KD-5966 is marketed." This implies the acceptance criteria are defined by these standards. However, the specific numerical performance targets (e.g., mean difference in mmHg, standard deviation) from these standards are not explicitly stated in this document. Thus, a table of "reported device performance" as direct numerical results is not available in the provided text.

Acceptance Criteria (Implied by adherence to standards)	Reported Device Performance
Conformance to IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety)	Not explicitly detailed
Conformance to EN 60601-1-2 (EMC - Requirements and Tests)	Not explicitly detailed
Conformance to AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers)	Not explicitly detailed
Conformance to AAMI / ANSI SP10:2002/A1:2003 (Amendment 1 to AAMI SP10)	Not explicitly detailed
Conformance to AAMI / ANSI SP10:2002/A2:2006 (Amendment 2 to AAMI SP10)	Not explicitly detailed

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

This information is not provided in the document. The document only mentions that "appropriate test will be conducted."

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. The determination of ground truth for a blood pressure monitor typically involves comparison against a reference method (e.g., auscultation by trained observers), not "experts" in the sense of image interpretation. However, the details of such a comparison are missing.

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

This information is not provided.

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, which is a standalone measurement device, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study is not applicable and was not performed.

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

Yes, implicitly. As an "Automatic Electronic Blood Pressure Monitor," the device operates in a standalone mode to measure blood pressure. Its performance would have been evaluated directly against a reference standard to demonstrate its accuracy. However, the details of this standalone performance evaluation, beyond stating conformance to standards, are not provided in this summary.

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

The ground truth for a blood pressure monitor is typically established by comparative measurements using a standardized oscillometric or auscultatory reference method, often involving simultaneous readings by trained observers using a mercury sphygmomanometer or validated automated oscillometric device. The document does not explicitly state the type of ground truth method used, but it would be based on these established clinical measurement practices.

8. The sample size for the training set

This device is an automated blood pressure monitor based on oscillometric principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set for this device is not applicable. The device's underlying algorithm is based on physiological principles and validated engineering rather than data-driven learning.

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

As previously stated, the concept of a training set is not applicable for this type of device.

In summary: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized performance and safety standards for blood pressure monitors. It does not provide the detailed study reports or specific numerical performance data against acceptance criteria that would typically be found in a more comprehensive clinical or validation study report. The document relies on the implicitly defined performance criteria within the cited AAMI SP10 standard.

Summary

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510(k) Summary

DEC - 9 2010

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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:	08/31/2010

2.0 Device information

Device name:

KD-5966 series Fully Automatic Electronic Blood Pressure Monitor Model No: KD-5966XY(X =A~~Z, Y= blank or A~~Z)

The model in KD-5966 series are the modification to KD-5966, and the small modification will rise no new 510(k) according to FDA's guidance document < Deciding When to Submit a 510(k) for a Change to an Existing Device>.

(Example, maybe KD-5966M will be a modification to the KD-5966 which will change the memory time, and KD-5966N will delete the average function, etc.)

3.0 Classification

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

4.0 Predicate device information

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Additional Information for K102609KD-5966 series Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
1	Manufacturer: Andon Health Co., Ltd.Device: KD-5963Fully Automatic Electronic Blood Pressure Monitor510(k) number: K093528
2	Manufacturer: Andon Health Co., Ltd.Device: KD-5963NU Fully Automatic Electronic Blood Pressure Monitor510(k) number: K101010

5.0 Device description

KD-5966 series 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.

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

6.0 Intended use

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102609

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circumference is limited to 22cm-48cm.

The intended use and the indication for use of KD-5966 series, as described in its labeling are the same as the predicate device KD-5963 and KD-5963NU.

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

ર- 3

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8.0 Performance summary

KD-5966 series Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

60601-1, Medical Electrical Equipment - Part 1: General ● IEC 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-5966 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5963NU whose 510(k) number is K101010 and the Fully Automatic Electronic Blood Pressure Monitor KD-5963 with the 510(k) number of K093528.

The KD-5966 series is very similar in the intended use, the design principle, the material, the performance and the applicable standards with its predicate devices. Only their appearance and the memory times is changed.

However, appropriate test will be conducted and specified acceptance criteria will be met before KD-5966 is marketed.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

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

DEC - 9 2010

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

K102609 Re:

Trade/Device Name: KD-5966 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: October 21, 2010 Received: October 25, 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/CDRHQffices/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,

R.V.M.M

A 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 :	K102609
Device name:	KD-5966 series Fully Automatic Electronic Blood

ully 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)

R.V.mmmmm

Division Sian-C Division of Cardiovascular Devices

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510(k) Number K102609

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).