KD-5905 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.

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 2×60 times. If any irreqular heartbeat is detected, it can be shown on the LCD. The RCC (radio controlled clock) function can automatically receive the radio clock signal to adjust the clock accurately.

AI/ML Overview

Acceptance Criteria and Study Details for Andon Health Co., Ltd. KD-5905 Fully Automatic Electronic Blood Pressure Monitor

The provided document describes the KD-5905 Fully Automatic Electronic Blood Pressure Monitor, which is substantially equivalent to the KD-5902. The performance summary explicitly states that the KD-5905 monitor conforms to the AAMI SP10:2002 standard for manual, electronic, or automated sphygmomanometers, including its amendments.

1. Acceptance Criteria and Reported Device Performance

The general acceptance criteria for blood pressure monitors, as per ANSI/AAMI SP10, typically involve a comparison of the device's readings against a reference method (e.g., auscultation by trained observers). The standard specifies accuracy requirements for both systolic and diastolic blood pressure measurements.

While the document states conformance to AAMI SP10, it does not explicitly list specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) or the precise reported device performance results from an accuracy study. The document only mentions that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness."

Hypothesized Acceptance Criteria (based on common AAMI SP10 requirements):

Metric	Acceptance Criteria (based on AAMI SP10)	Reported Device Performance
Mean difference (device vs. reference)	≤ ±5 mmHg	Not explicitly stated
Standard deviation of differences	≤ 8 mmHg	Not explicitly stated
Number of subjects meeting requirements	A sufficient percentage (e.g., 85%) of measurements within ±5 mmHg	Not explicitly stated
	More stringent requirements for a percentage within ±10 mmHg and ±15 mmHg	Not explicitly stated

Since the document states conformance to the AAMI SP10 standard, it implies that the device successfully met these types of criteria during its testing. However, the specific numerical results are not provided in this summary.

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not specify the sample size (number of subjects) used for the performance testing that demonstrated conformance to AAMI SP10.
Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that "Andon Health Co., Ltd." is located in Tianjin, P.R. China, it is plausible that the testing was conducted in China. The nature of performance testing for blood pressure monitors is typically prospective, as it involves taking active measurements from subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

For blood pressure monitor validation studies conforming to AAMI SP10, the ground truth (reference measurements) is established by human observers using a standardized method (e.g., auscultation with a mercury sphygmomanometer).

Number of Experts: AAMI SP10 usually requires at least two independent trained observers for simultaneous auscultatory measurements to establish the reference values.
Qualifications of Experts: These observers typically need to be trained medical professionals (e.g., physicians, nurses, or trained technicians) who have demonstrated proficiency in taking blood pressure measurements according to standardized protocols and who are blinded to the device's readings. The document does not explicitly state the number or qualifications of the experts who established the ground truth.

4. Adjudication Method (Test Set)

Adjudication Method: For AAMI SP10-compliant studies, the reference blood pressure is typically determined by taking the average of the two trained observers' readings, provided they are within a specified agreement range (e.g., 4 mmHg for systolic and diastolic). If their readings differ significantly, a third observer or a predefined adjudication process might be used, but the document does not explicitly describe the adjudication method beyond conforming to the AAMI SP10 standard. Based on AAMI SP10, it's typically a consensus or averaging of two observers.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this summary. This type of study is more common for diagnostic imaging AI systems and is not typically relevant for standalone blood pressure monitors. The device is intended for direct measurement rather than aiding human interpretation or diagnosis of complex cases.

6. Standalone Performance Study

Standalone Study: Yes, the described performance testing (conformance to AAMI SP10) constitutes a standalone performance study of the algorithm and device. The device itself (KD-5905) directly measures and displays blood pressure and pulse rate without requiring human interpretation or intervention in the measurement process. The AAMI SP10 standard assesses the accuracy of the device's output against a reference method, which is a standalone evaluation of the device's performance.

7. Type of Ground Truth Used

Ground Truth Type: The ground truth used for blood pressure monitor validation studies adhering to AAMI SP10 is expert auscultation (expert consensus). This involves simultaneous measurements taken by trained human observers using a validated reference method (e.g., a mercury sphygmomanometer).

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. Blood pressure monitors based on oscillometric principles are typically designed and calibrated based on physiological models and empirical data, but they don't usually involve "training sets" in the same way as machine learning algorithms that learn from labeled data. The core technology and algorithms are established during product development, prior to formal regulatory performance testing.

9. How Ground Truth for Training Set Was Established

As there is no explicit training set mentioned or implied for this type of device, the method for establishing its ground truth is not applicable in the context of this document. The device's underlying algorithms are developed and refined during R&D based on engineering principles and general physiological data, not typically through a formal "training set" with established ground truth in the context of a regulatory submission.

Summary

{0}------------------------------------------------

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR FDA CDRH DMC 807.92.

1.0 submitter's information

MAR 2-3-2009

JUN - 4 2009

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: II Panel: Cardiovascular

4.0 Predict device information

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

5.0 Device description

{1}------------------------------------------------

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-5905, 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

{2}------------------------------------------------

8.0 Performance summary

KD-5905 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 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 sphyqmomanometers.

9.0 Comparison to the predict device and the conclusion

Our device KD-5905 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 memory mode and the RCC (radio controlled clock) function are different, moreover, the KD-5905 use a different MCU from KD-5902, the performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-5902. 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.

: . . .

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

od and Drug Administration 200 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: K090770

Trade/Device Name: KD-5905 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.

{4}------------------------------------------------

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 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,

Steth 1861

Bram D. Zuckerman, M.D. Director · Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Statement of Indications for Use

1090 770 510(k) Number : KD-5905 Fully Automatic Electronic Blood Pressure Device name: Monitor

Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use YES AND/OR (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)

(Division Sign-Off) /
Division of Cardiovascular Devices

510(k) Number K096770

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).