KD-7961 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches. 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 LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use.

AI/ML Overview

The Andon Health Co., Ltd. KD-7961 Fully Automatic Electronic Blood Pressure Monitor is designed and manufactured according to the ANSI/AAMI SP10 standard for manual, electronic, or automated sphygmomanometers. This standard sets the acceptance criteria for devices measuring blood pressure non-invasively through an oscillometric method.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for accuracy (e.g., mean difference and standard deviation from a reference measurement) or the reported device performance in this format. However, compliance with AAMI SP10 implies meeting its accuracy requirements.

AAMI SP10 typically requires:

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

The submission states that the device "conforms to the following standards: ... AAMI SP10:2002..." This conformity implies that the device met these performance criteria, although specific values from the testing are not presented in this summary.

Acceptance Criteria (from AAMI SP10, implied)	Reported Device Performance
Mean difference ≤ ±5 mmHg (Systolic)	(Implied to meet AAMI SP10 standards, specific data not provided in summary)
Standard deviation ≤ 8 mmHg (Systolic)	(Implied to meet AAMI SP10 standards, specific data not provided in summary)
Mean difference ≤ ±5 mmHg (Diastolic)	(Implied to meet AAMI SP10 standards, specific data not provided in summary)
Standard deviation ≤ 8 mmHg (Diastolic)	(Implied to meet AAMI SP10 standards, specific data not provided in summary)

2. Sample Size Used for the Test Set and Data Provenance

The summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). However, AAMI SP10 typically requires a clinical validation study on a sufficient number of subjects (usually at least 85 with a specified distribution of blood pressures) to demonstrate accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth. For AAMI SP10 validation, ground truth is typically established by trained observers (often two or three) using a auscultatory reference method (e.g., mercurial sphygmomanometer).

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For AAMI SP10 studies using multiple observers for ground truth, a common method is to average their readings or use a defined adjudication rule if there are discrepancies (e.g., removing outliers or consulting a third observer).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or described. This study type is typically relevant for interpretative devices (e.g., AI for medical imaging) to assess how AI assistance affects human reader performance. This blood pressure monitor is a direct measurement device rather than an interpretative one.

6. Standalone (Algorithm Only) Performance Study

The device itself is a standalone (algorithm only, without human-in-the-loop performance) blood pressure monitor. The conformity to AAMI SP10 implies that a standalone performance study was conducted to validate its accuracy against a reference method. The summary does not provide the results of this standalone performance study, but states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," thus implying the device met the AAMI SP10 requirements in a standalone capacity.

7. Type of Ground Truth Used

Based on the explicit mention of AAMI SP10 compliance, the ground truth used would be auscultatory blood pressure measurements taken by trained observers using a reference sphygmomanometer (e.g., merchanism blood pressure device) on the same subjects, simultaneously or in quick succession, with the device being tested.

8. Sample Size for the Training Set

The document does not specify any training set sample size. Blood pressure monitors based on oscillometric principles are typically engineered and calibrated rather than "trained" in the machine learning sense. The underlying algorithm is based on physiological principles and validated through clinical studies. If there were any machine learning components, details are not provided.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the machine learning sense is described, information on how its ground truth was established is not applicable or not provided. The device's calibration and validation would rely on the clinical study outlined in point 7.

Summary

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K090769

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMBA @DRAID MER 807.92.

JUN - 4 2009

1.0 submitter's information

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: 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: = Panel: Cardiovascular

4.0 Predict device information

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

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 LCD. The LCD backlight, the touch key button and the voice function make it more convenient to use.

6.0 Intended use

The intended use and the indication for use of KD-7961, as described in its labeling are the same as the predict device KD-795.

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-7961 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.
0 IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requiremants for Safety - Collateral standard: Electromagnetic Compalibirity - 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-7961 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-795 whose 510(k) number is K070826.

The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance and some functions such as touch button and LCD backlight are different. The Environmental parameters are 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 depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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: K090769

Trade/Device Name: KD-7961 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.

Thathster

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 :	K090769
Device name:	KD-7961 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 øf Device Evaluation (ODE)

Hthlsk /s BZuckeru

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

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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).