KD-7902 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.

Device Description

KD-7902 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the wrist, which cuff circumference is limited to 6.1023 inches to 9.8425 inches, the device can analyze the signals promptly and display the results. It has some other functions, such as 120 memory recall / 2 users and calculating average of last 3 readings.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Andon Health Co., Ltd. KD-7902 Fully Automatic Electronic Blood Pressure Monitor, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Standard	Reported Device Performance (Compliance)
ANSI/AAMI SP-10 standard	Device meets this standard.
IEC 60601-1	Device meets this standard.
IEC 60601-1-2	Device meets this standard.

Note: The 510(k) summary only states that the device "meets the following standards" without providing specific performance metrics within each standard. For blood pressure monitors, compliance with ANSI/AAMI SP-10 typically implies accuracy requirements (e.g., mean difference and standard deviation between device and reference measurements) for both systolic and diastolic pressures.

2. Sample size used for the test set and the data provenance

The provided 510(k) summary does not explicitly state the sample size used for the test set in its summary for the KD-7902, nor does it specify the country of origin or whether the study was retrospective or prospective. It only indicates that the device meets the listed standards. Generally, for ANSI/AAMI SP-10, a minimum of 85 subjects is required for clinical validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The 510(k) summary does not provide this information. For ANSI/AAMI SP-10 validation, ground truth is typically established by trained observers using a mercury sphygmomanometer or another validated reference device, following a specific protocol. These observers are trained to accurately read the reference device.

4. Adjudication method for the test set

The 510(k) summary does not provide this information. For clinical validation of blood pressure monitors, ground truth measurements are often obtained by two trained observers blinded to each other's readings and to the test device's readings, with protocols for resolving discrepancies (e.g., a third observer). This is a form of adjudication, but the specifics are not detailed here.

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. This device is a fully automatic electronic blood pressure monitor, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Yes, in essence. The testing against standards like ANSI/AAMI SP-10 for blood pressure monitors is a standalone performance assessment of the device's accuracy without a human "interpreter" in the loop. The device's algorithm performs the measurement and displays the result.

7. The type of ground truth used

For blood pressure monitors validated against ANSI/AAMI SP-10, the ground truth is typically expert-measured reference blood pressure readings obtained using a validated reference method (e.g., mercury sphygmomanometer) by trained observers.

8. The sample size for the training set

The 510(k) summary does not provide this information. As this is a traditional medical device (not an AI/ML device in the modern sense), the concept of a "training set" in the context of machine learning is not directly applicable. The device's "training" involves its design, calibration, and engineering to meet specific physiological measurement principles.

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

Not applicable as there is no explicitly mentioned "training set" in the context of machine learning for this device. The device's underlying principles are based on established oscillometric measurement techniques and engineering, rather than being "trained" on a dataset in the way an AI algorithm would be. The design and calibration would have been based on extensive physiological knowledge and previous device performance data, but not a distinct "training set" as understood in current AI parlance.

Summary

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510(k) Summary

Identification of the submitter:

Submitter:	Andon Health Co., Ltd.No 31, Changjiang Road, Nankai District, Tianjin,P.R. China, 300193
Telephone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi	JAN 29 2009
Date of Application:	10/29/08

ldentification of the product:

	Device proprietary Name: Fully Automatic Electronic Blood Pressure Monitor
Common name:	Noninvasive blood pressure measurement systems
Classification name:	Noninvasive blood pressure measurement system
	Class II per 21 CFR 870.1130

Marketed Devices to which equivalence is claimed:

Device KD-795

manufacture Andon Health Co., Ltd 510(k) number K070826

Device description:

Intended use:

KD-7902 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate of adult each time, with the cuff around the wrist according to the instruction in the user's guide manual, which is same as predicated device.

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KD-7902 Fully Automatic Electronic Blood Pressure Monitor has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD.

The modifications that were made are:

1. Appearance

1. No voice
1. Change into 120 memory recall / 2 users (2x60) from 1x60
1. Memory average function: calculating the average of last 3 readings
1. Change microprocessor

Please find the following tabulated comparison supporting that the proposed device is substantially equivalent to the predicated device.

FDA file reference number	510K# K070826
Technological Characteristics	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Identical
Performance	Identical
Sterility	Not Applicable
Biocompatibility	Identical
Mechanical safety	Identical
Chemical safety	Not Applicable
Energy used and/or delivered	Identical
Where used	Identical
Standards met	Identical
Electrical safety	Identical

Device testing:

KD-7902 Fully Automatic Electronic Blood Pressure Monitor meet the following standards:

· ANSI/AAMI SP-10 standard
· IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety
· IEC 60601-1-2 Electromagnetic Compatibility

Refer to the submission for more information.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines. The overall design is simple and conveys a sense of government authority and public service.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 2 9 2009

Re: K083248

Trade/Device Name: KD-7902 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: December 19, 2008 Received: December 29, 2008

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 such 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

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Page 2 - Ms. Liu Yi

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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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510K submission for KD-7902 Fully Automatic Electronic Blood Pressure Monitor

Ko83248

Statement of Indications for Use

510(k) Number :

Applicant: Andon Health Co., Ltd

Device name:

KD-7902 Fully Automatic Electronic Blood Pressure Monitor

Indications for use:

Prescription use Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

YES

(Please Do Not WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K083248
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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).