KD-5965 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

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

For KD-5965, 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 LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use. The RCC (radio controlled clock) function can automatically receive the radio clock signal to adjust the clock accurately.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-5965 series Fully Automatic Electronic Blood Pressure Monitor:

Disclaimer: The provided summary does not contain a detailed performance study with specific acceptance criteria and results. It primarily focuses on the device's adherence to relevant standards and its substantial equivalence to predicate devices. Therefore, much of the requested information cannot be extracted directly from the given text.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states that the KD-5965 series will conform to several standards. These standards implicitly contain the acceptance criteria for a blood pressure monitor. However, the document does not explicitly state the acceptance criteria in a table format with corresponding device performance results. Instead, it only lists the standards to which the device is intended to conform.

Acceptance Criteria (Implied by Standard Conformance)	Reported Device Performance
Conformance to IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety)	Stated that the device "will conform" to this standard before marketing. No specific performance metrics or detailed results are provided.
Conformance to IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests)	Stated that the device "will conform" to this standard before marketing. No specific performance metrics or detailed results are provided.
Conformance to AAMI SP10:2002, A1:2003, A2:2006 (Manual, electronic or automated sphygmomanometers)	Stated that the device "will conform" to these standards before marketing. No specific performance metrics or detailed results are provided. These standards typically set accuracy requirements for blood pressure readings.

Study Information (Based on Available Text)

Sample size used for the test set and the data provenance:
- The document states: "However, appropriate test will be conducted and specified acceptance criteria will be met before KD-5965 is marketed." This indicates that testing will be done, but the details of the test set sample size or data provenance (e.g., country of origin, retrospective/prospective) are not provided in this 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned in the provided text. The document refers to conformance with AAMI SP10, which typically involves clinical validation against auscultatory measurements performed by trained observers. However, the details of such a study, including the number and qualifications of experts, are not present here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not mentioned in the provided text.
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. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is described as "Fully Automatic Electronic Blood Pressure Monitor," indicating its standalone measurement capability. The "Performance Summary" section refers to conformance with AAMI SP10, which requires validation of the device's accuracy against a reference standard. This would constitute a standalone performance evaluation. However, the details of this standalone study (e.g., specific accuracy metrics, cohort demographics, methodology) are not included in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on conformance with AAMI SP10, the ground truth for blood pressure measurement devices is typically established through simultaneous auscultatory measurements (manual blood pressure readings using a stethoscope and sphygmomanometer) performed by trained observers.
The sample size for the training set:
- Not applicable/not mentioned. This device does not appear to involve machine learning in a way that requires a distinct "training set" in the common AI sense. Its operational principle is based on "oscillometric and silicon integrate pressure sensor technology."
How the ground truth for the training set was established:
- Not applicable/not mentioned. (See point 7).

Summary of Limitations:

The provided 510(k) summary is high-level and, as is common for these types of documents, it focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized standards. It does not contain the detailed results of the performance testing that would explicitly list acceptance criteria and a comprehensive report of the device's performance against those criteria. The statement "appropriate test will be conducted and specified acceptance criteria will be met before KD-5965 is marketed" implies that such detailed testing and reporting would occur internally as part of the manufacturer's quality system procedures, but the specific details are not part of this public K-summary.

Summary

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510(k) Summary

JUN 2 9 2010

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: 03/16/2010

2.0 Device information

KD-5965 series Fully Automatic Electronic Blood Device name: Pressure Monitor

Model No: KD-5965XY(X =A~~Z, Y= blank or A~~Z)

The model in KD-5965 series are the modification to KD-5965, and the 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>. 3.0 Classification

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

4.0 Predict device information

1	Manufacturer:	Andon Health Co., Ltd.
	Device:	KD-5905 Fully Automatic Electronic Blood PressureMonitor
	510(k) number:	K090770
2	Manufacturer:	Andon Health Co., Ltd.
	Device:	KD-5963 Fully Automatic Electronic Blood PressureMonitor

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510(k) number: K093528

5.0 Device description

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-5965 series, as described in its labeling are the same as the predict device KD-5905 or KD-5963.

7.0 Summary comparing technological characteristics with predicate device

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Identical

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KD-5965 series Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

100940 3/4

i. ে

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-5965 series Fully Automatic Electronic Blood Pressure Monitor will conform to the following standards before marketing:

60601-1, Medical Electrical Equipment Part 1: General ● EC 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-5965 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5905 whose 510(k) number is K090770 and the Fully Automatic Electronic Blood Pressure Monitor KD-5963 with the 510(k) number of K093528.

The KD-5965 is very similar with the predicted devices in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance is different, moreover, the KD-5965 uses different MCU from the two predicted devices.

However, appropriate test will be conducted and specified acceptance criteria will be met before KD-5965 is marketed.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

JUN 2 9 2010

Andon Health Co., Ltd. c/o Ms. Liu Yi President No. 3 JinPing Street, Ya An Road, NanKai District Tianjin 300190 CHINA

Re: K100940

Trade/Device Name: KD-5965 Series Fully Automatic Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: May 27, 2010 Received: June 1, 2010

Dear Ms. 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 - Ms. 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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KI00940

Statement of Indications for Use

510(k) Number :

KD-5965 series Fully Automatic Electronic Blood Device name: Pressure Monitor

Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR 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. Wood

iovascular Devices

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).