KD-5901 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.

KD-7909 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-5901 and KD-7909 are all designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmanometers.

The operational principle of KD-5901 and KD-7909 are 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. KD-5901 also has a voice function.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-5901 and KD-7909 Fully Automatic Electronic Blood Pressure Monitors:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly define specific numerical acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or report the device's performance against such criteria. Instead, it states that the devices conform to recognized standards. These standards implicitly contain the acceptance criteria for performance.

Implicit Acceptance Criteria (from conformity to standards):

Acceptance Criteria	Reported Device Performance
IEC 60601-1 (General Requirements for Safety)	Conforms
IEC 60601-1-2 (Electromagnetic Compatibility)	Conforms
AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers)	Conforms
AAMI/ANSI SP10:2002/A1:2003 (Amendment 1 to AAMI SP10:2002)	Conforms
AAMI/ANSI SP10:2002/A2:2006 (Amendment 2 to AAMI SP10:2002)	Conforms

Note: To find the specific numerical acceptance criteria for blood pressure measurement accuracy, one would need to consult the AAMI SP10 standard itself. The submission only states that the devices conform to this standard.

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

The document does not explicitly state the sample size (number of subjects/measurements) used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It broadly states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," referring to performance testing.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, ground truth is typically established by trained technicians or clinicians using a reference standard device (like a mercury sphygmomanometer) following a specific protocol.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. This type of study is more common for diagnostic imaging AI devices, rather than blood pressure monitors.

6. Standalone Performance Study

The document implies that a standalone performance study was conducted in the sense that the devices were tested for their conformity to the AAMI SP10 standard. AAMI SP10 outlines methodologies for testing the accuracy of automated sphygmomanometers against a reference standard. Therefore, the "algorithm only" (which in this case refers to the device's internal measurement algorithm) performance was assessed.

7. Type of Ground Truth Used

The ground truth used for performance validation would be established by measurements from a reference standard device (e.g., a mercury sphygmomanometer or another validated oscillometric device) in accordance with the AAMI SP10 standard. The document doesn't explicitly state "reference standard device" but its conformity to AAMI SP10 implies this methodology.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. Since this device likely uses a pre-programmed oscillometric algorithm based on principles rather than a learning-based AI model, there wouldn't typically be a "training set" in the machine learning sense. The device's algorithm would be developed and validated against a representative population, consistent with the AAMI SP10 standard.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of a machine learning model, this information is not applicable/not provided in the document. The oscillometric algorithm itself is based on established physiological principles and empirical validation data as part of its development, conforming to standards like AAMI SP10.

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, 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. Requlation number: 870.1130 Classification: l l Panel: Cardiovascular

4.0 Predict device information

Manufacturer: Andon Health Co., Ltd. KD-5902 Fully Automatic Electronic Blood Pressure Monitor Device: KD-791 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K083317 K070826

5.0 Device description

5- 1

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cuff circumference is limited to 22cm-48cm.

KD-5901 and KD-7909 are all 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-5901, as described in its labeling are the same as the predict device KD-5902; the intended use and the indication for use of KD-7909, as described in its labeling are the same as the predict device KD-791.

..............................................................................................................................................................................

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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	Identical

The difference of technological characteristic between KD-5901 and its predicted device KD-5902 is the appearance and the performance, the difference of technological characteristic between KD-7909 and its predicted device KD-791 is the appearance and the performance.

...

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8.0 Performance summary

KD-5901, KD-7909 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 60601-12. Medical Electrical Equipment Part 1-2 General Requirements for Safety - Collateral standard: Electroniquetic Compatibility - Requirements and Tests (Edition 2:2001 with Amandment 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-5901 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, KD-7909 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-791 whose 510(k) number is K070826.

KD-5901 and KD-5902 are very similar in the intended use, the design principle, the material, the energy source, the applicable standards and the functions. Their appearances are different. 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.

KD-7909 and KD-791 are very similar in the intended use, the design principle, the material, the energy source, the applicable standards and the functions. Their appearances are different. 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

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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/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird.

Public Health Service

od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN -4 20

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

Re: K090768

Trade/Device Name: KD-5901. KD-7909 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 (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.

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 :	K090768
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Device name: KD-5901, KD-7909 Fully Automatic Electronic Blood Pressure Monitor

Indications for use:

KD-5901 Fully Automatic Electronic Blocd 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 D) AND/OR Over-The-Counter Use YES (2) CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K090768

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).