KD-5962 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 puise rate of on adult index malling in bon-mvasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48mm. 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, the memory capability is 60 times. If any irregular heartbeat is detected, it can be shown on the n.CD. The touch key button and the voice furnition make it more convertion of to use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-5962 Fully Automatic Electronic Blood Pressure Monitor:

Unfortunately, the provided text does not contain a detailed study description with specific acceptance criteria and performance data in the format requested. The document is primarily a 510(k) summary focused on establishing substantial equivalence to a predicate device based on adherence to recognized standards and technological similarities rather than a comprehensive clinical study report.

The text states that the device conforms to several standards, implying that meeting these standards serves as the acceptance criteria. However, it does not explicitly list numerical acceptance criteria (e.g., accuracy ranges for systolic/diastolic pressure) or show the device's actual performance against those criteria in a table format.

Therefore, many sections of your request cannot be fulfilled directly from the provided document. I will fill in what can be inferred and explicitly state where information is missing.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy of Blood Pressure Measurement: Conformance to AAMI SP10:2002 standards for manual, electronic, or automated sphygmomanometers.	The document states: "KD-5962 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... AAMI SF10:2002, 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." Specific numerical performance data (e.g., mean difference and standard deviation of blood pressure readings compared to a reference method) are NOT provided in this document. The statement of conformance implies the device met the AAMI SP10 accuracy requirements.
Electrical Safety: Conformance to IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety.	The document states: "KD-5962 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."
Electromagnetic Compatibility (EMC): Conformance to IEC 60601-1-2, Medical Electrical Equipment Part 1-2.	The document states: "KD-5962 Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards: ... 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)."
Other safety and performance aspects for establishing substantial equivalence to predicate device KD-5902.	The document states: "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that any tests performed confirmed the device's safety and effectiveness despite minor differences from the predicate, but specific test results are not detailed.

Detailed Study Information (Based on available text):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "the test in this submission provides demonstration," but does not provide details of any specific clinical or performance test sample size. For AAMI SP10 validation, a minimum of 85 subjects is typically recommended, but this document does not confirm if such a study was performed or its specifics.
- Data Provenance: Not specified. (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For blood pressure monitors, "ground truth" typically involves simultaneous or near-simultaneous measurements by trained observers using a reference standard (e.g., mercury sphygmomanometer) following a specific protocol (like the AAMI SP10 protocol). The document does not describe such a process or the experts involved.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not described in the provided text. Adjudication methods are typically used when subjective assessments are made (e.g., reading medical images). For blood pressure device validation, the protocol itself dictates how measurements are taken and compared, not typically an "adjudication" in this sense.
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. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers and MRMC studies.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "device performance" in this context refers to the standalone performance of the blood pressure monitor's algorithm and hardware in accurately measuring blood pressure. The entire device functions as a "standalone" system for generating a blood pressure reading. The document states it "conforms" to AAMI SP10, which validates this standalone performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but for blood pressure monitor validation (as per AAMI SP10), the ground truth is typically established by auscultatory measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer), often involving multiple measurements and averaging. This is an expert-derived ground truth based on a standardized protocol.
The sample size for the training set:
- Not applicable. This type of medical device (a blood pressure monitor) is not typically developed using a machine learning "training set" in the way an AI diagnostic algorithm would be. Its operational principle is based on oscillometric technology and direct pressure sensing, rather than being "trained" on a dataset of blood pressure readings.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device's development as described.

Summary of what's provided for acceptance criteria:

The primary acceptance criteria presented in this 510(k) summary are the conformance to several international and national standards, particularly AAMI SP10:2002 and its amendments for non-invasive blood pressure measurement systems, as well as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC. The document explicitly states that the device "conforms to" these standards. This implies that the device underwent testing (likely by the manufacturer or a third-party lab) to demonstrate compliance with the performance and safety requirements outlined in these standards, meeting their inherent acceptance criteria, although the specific numerical results of these tests are not included in this summary. The general conclusion is that "the test in this submission provides demonstration that these small differences [from the predicate device] do not raise any new questions of safety and effectiveness."

Summary

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510(k) Summary

JUN - 4 2009

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 31, Changjiang Road, Nankai District. Tianjo PR. China Phone number: 86-22-6052 6161 Fax number. 86-22-6052 6162 Contact: Liu Yi Date of Application: 03/16/2009

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

Manufacturer: -Andon Health Co., Ltd. Device: 510(k) number: K083317

5.0 Device description

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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, the memory capability is 60 times. If any irregular heartbeat is detected, it can be shown on the n.CD. The touch key button and the voice furnition make it more convertion of to use.

6.0 Intended use

KD-5962 Fully Automatic Electronic Blood Pressure Monitor is for use by rnedical 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 KO-5962, as described in its labeling are the same as the predict device KD-5902.

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

7.0 Summary comparing technological characteristics with predicate device

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8.0 Performance summary

KD-5962 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 SF10:2002, 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-5962 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5902 whose 510(k) number is K083317.

The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance and some functions such as touch button are different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5902. The Environmental parameters 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2009

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

Re: K090771

Trade/Device Name: KD-5962 Fully Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: undated Received: May 7, 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.

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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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

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 :	K090771
Device name:	KD-5962 Fully Automatic Electronic Blood PressureMonitor

Indications for use:

KD 5662 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.

Prescription use Part 21 CFR 801 Subpart Fü ANDIOR ്ver-The-Counter Use (21 CFR 807 Subpart (1)

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

Concurrence of CDP Office of Depice Evaluation (ODE)

for B Zuckerman

(Division Sign-Off) 6/4/09
Division of Cardiovascular Devices

15090771

Page 1 of 1

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).