KD-7901, KD-7905 and KD-7911 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 14cm-25cm.

Device Description

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

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 of KD-7901, KD-7905 and KD-7911 are 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.

AI/ML Overview

The provided text indicates that the device is a Fully Automatic Electronic Blood Pressure Monitor (models KD-7901, KD-7905, and KD-7911) and that its performance conforms to several standards, including AAMI SP10:2002. However, the text does not directly state the specific acceptance criteria or report a direct "device performance" in terms of clinical accuracy (e.g., mean difference and standard deviation compared to a reference method) within a dedicated study section. Instead, it refers to conformity with standards.

Therefore, the response below will infer the acceptance criteria from the referenced AAMI SP10 standard and explain that a specific study showing "device performance" against these criteria is not explicitly detailed in the provided summary.

Acceptance Criteria and Device Performance Study for KD-7901, KD-7905, and KD-7911 Fully Automatic Electronic Blood Pressure Monitors

The provided 510(k) summary for the KD-7901, KD-7905, and KD-7911 Fully Automatic Electronic Blood Pressure Monitors states that the device conforms to several standards, including AAMI SP10:2002 (Manual, electronic or automated sphygmomanometers) and its amendments. The acceptance criteria for automated sphygmomanometers are generally defined within this standard.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from AAMI SP10:2002)	Reported Device Performance (from 510(k) Summary)
Accuracy (Mean Difference): Mean absolute difference between the device and reference standard should be ≤ 5 mmHg.*	The 510(k) summary states the device "conforms to... AAMI SP10:2002". No specific values for mean difference or standard deviation are provided in this summary.
Accuracy (Standard Deviation): Standard deviation of the differences should be ≤ 8 mmHg.*	No specific values for mean difference or standard deviation are provided in this summary.
Safety: Conformance to IEC 60601-1, IEC 60601-1-2.	Device conforms to IEC 60601-1 and IEC 60601-1-2.
Performance: General performance requirements as per AAMI SP10.	The summary lists "Performance: Similar" when comparing to the predicate device, and generally states the device "conforms to" AAMI SP10.

*Inferred from general requirements of AAMI SP10 for automated sphygmomanometers for clinical accuracy. AAMI SP10 typically requires a clinical validation study to demonstrate these accuracy metrics.

Study Proving Device Meets Acceptance Criteria:

The 510(k) summary states that the device's performance conforms to ANSI/AAMI SP10--manual, electronic or automated sphygmomanometers (and its amendments). This implies that a study was conducted to demonstrate this conformity, as per the requirements of the standard, particularly for clinical accuracy. However, the details of this specific study (e.g., sample size, experts, ground truth, detailed results of mean difference and standard deviation) are not detailed within this 510(k) summary. The summary primarily focuses on demonstrating substantial equivalence to a predicate device (KD-795) by stating conformity to relevant standards and highlighting similarities in technological characteristics. The statement, "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness," suggests tests were performed, but the results are not explicitly laid out.

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

Sample Size: Not specified in the provided 510(k) summary. Compliance with AAMI SP10 typically requires a defined (e.g., usually N≥85 for clinical accuracy) sample size for validation.
Data Provenance: Not specified in the provided 510(k) summary. Given the manufacturer's location (China), the study might have been conducted there, but this is not stated. The summary does not indicate if the data was retrospective or prospective.

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

Not specified in the provided 510(k) summary. For AAMI SP10 validation, ground truth is typically established by trained human observers using a auscultatory reference method (e.g., mercury sphygmomanometer) following a standardized protocol.

4. Adjudication Method for the Test Set:

Not specified in the provided 510(k) summary. For AAMI SP10 validation, typically two trained observers would independently measure blood pressure, and if their measurements differ by more than a specified amount, a third observer might be involved or the measurement discarded.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not relevant for an automated blood pressure monitor, which measures blood pressure autonomously without human interpretation of results against a traditional diagnostic image or parameter where human readers are involved.

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

Yes, implicitly. The device is a "Fully Automatic Electronic Blood Pressure Monitor," which means its primary function is standalone measurement without human-in-the-loop performance affecting the measurement itself. The conformity to AAMI SP10 directly assesses this standalone performance against a human-observed reference.

7. The Type of Ground Truth Used:

Based on conformity to AAMI SP10, the ground truth would have been established by expert auscultatory measurements (e.g., using a mercury sphygmomanometer) performed by trained observers. This is the standard reference method for validating automated blood pressure devices.

8. The Sample Size for the Training Set:

Not applicable/Not specified. Automated blood pressure monitors (like this oscillometric device) are generally based on a defined algorithm and physical principles, rather than AI models that require extensive "training data" in the conventional machine learning sense. The device's algorithm is fixed and does not learn from a "training set" in the same way an image recognition algorithm would.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As explained above, these devices do not typically have a "training set" with associated ground truth in the context of machine learning. The algorithm's parameters might be derived from physiological models and empirical studies during development, but this is different from a machine learning training set.

Summary

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

KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

510(k) Summary

DEC 2 3 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: 08/07/2009

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. Device: KD-795 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K070826

5.0 Device description

It is designed and manufactured according to ANSI/AAMI SP10--manual,

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

electronic or automated sphygmomanometers.

6.0 Intended use

The intended use and the indication for use of KD-7901, KD-7905 and KD-7911, as described in its labeling are the same as the predict device KD-795.

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}------------------------------------------------

3/4

8.0 Performance summary

ર્દ

KD-7901, KD-7905 and KD-7911 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 sphygmomanometers.

9.0 Comparison to the predict device and the conclusion

Our device KD-7901, KD-7905 and KD-7911 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.

KD-7901 and KD-795 are very similar in the design principle, the material, the energy source and the applicable standards. Their cuff circumference are different, their appearance are different. As regard to functions, KD-7901 has 2 ×60 times memory, no voice and LCD backlight. The operational humidity and the pulse rate are also different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-795. .

KD-7905 and KD-795 are very similar in the design principle, the material, the energy source, the functions and the applicable standards. Their cuff circumference are different, their appearance are different. The operational humidity and the pulse rate are also different.

KD-7911 and KD-795 are very similar in the design principle, the material, the energy source, the functions and the applicable standards. Their cuff circumference are different, their appearance are different. The operational humidity and the pulse rate are also different. The performance parameter of cuff pressure range and overpressure limit are different from the predicted device KD-795. KD-7911 and KD-795 also has different MCU.

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

ਾ ਕ

4/4

However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.

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

Image /page/4/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 image of a stylized eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 2 3 2009

Mr. Liu Yi President Andon Health Co., Ltd. No. 31 Changjiang Road, Nankai District Tianjin, 300190 CHINA

Re: K092510

KD-7901, KD-7905 and KD-7911 Fully Automatic Electronic Blood Pressure Monitors Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: December 1, 2009

Dear Mr. Liu:

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, Insting 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.

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

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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W.M.P.

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

Enclosure

{6}------------------------------------------------

Statement of Indications for Use

510(k) Number :	K092510
Device name:	KD-7901, KD-7905 and KD-7911 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 of Device Evaluation (ODE)

WMP

rdiovascular Dev

Page 1 of 1

510(k) Number__

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).