KD-557 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. 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 irregular heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the KD-557 Fully Automatic Electronic Blood Pressure Monitor. However, it does not explicitly detail a study conducted to demonstrate the device's performance against specific acceptance criteria in the way typically expected for an AI/ML medical device. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (KD-556).

The key approach described is conformity to established medical device standards for non-invasive blood pressure monitors.

Here's a breakdown based on the information provided, with an emphasis on what is not present given the context of an AI/ML device performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table with explicit acceptance criteria for a new performance study of the KD-557, nor does it present "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity, accuracy against a gold standard) typically found in AI/ML device studies. Instead, it states conformity to standards relevant for blood pressure monitors.

Acceptance Criteria	Reported Device Performance
Accuracy (as per AAMI/ANSI SP10:2002)	KD-557 conforms to AAMI/ANSI SP10:2002, 2003, and 2006 amendments for manual, electronic, or automated sphygmomanometers. This standard specifies accuracy requirements, typically a mean difference and standard deviation between the device and a reference measurement (e.g., intra-arterial blood pressure or auscultatory method). Specific numerical performance values are not given in this summary.
Safety (as per IEC 60601-1)	KD-557 conforms to IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety.
EMC (as per IEC 60601-1-2)	KD-557 conforms to IEC 60601-1-2, Medical Electrical Equipment Part 1-2: Electromagnetic Compatibility.

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

The document does not describe a new clinical test set with a specific sample size, data provenance (country, retrospective/prospective), or patient characteristics for the KD-557. The "performance summary" indicates adherence to standards, implying testing was done to meet those standards, but the details of such testing (e.g., number of subjects, demographic breakdown) are not provided in this 510(k) summary.

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

Since a specific clinical test set and ground truth adjudication process for the KD-557's performance are not detailed, information on the number and qualifications of experts for ground truth establishment is not provided. For blood pressure devices conforming to AAMI SP10, ground truth is typically established by trained observers using auscultatory methods against a reference standard or by invasive arterial pressure measurements.

4. Adjudication Method for the Test Set

No adjudication method for a test set is described, as the summary focuses on standards conformity and substantial equivalence rather than a new clinical study with expert consensus for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC study is mentioned. This type of study is more common for diagnostic imaging AI algorithms where human readers interpret cases with or without AI assistance. This device is an automated blood pressure monitor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The KD-557 is a "Fully Automatic Electronic Blood Pressure Monitor," implying its operation and measurement output are standalone ("algorithm only" in a broader sense of an automated device). The performance is assessed by comparing its automated readings against reference methods as specified by standards like AAMI SP10, without direct human intervention in the measurement process itself beyond placing the cuff and initiating the measurement.

7. The Type of Ground Truth Used

For blood pressure monitors conforming to AAMI SP10, the ground truth for accuracy testing is typically established by:

Simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer or validated aneroid device.
Invasive intra-arterial blood pressure measurements, which are considered the gold standard for accuracy.

The specific "ground truth" method used for demonstrating the KD-557's conformity to AAMI SP10 is not explicitly detailed in this summary but would align with these established methods for blood pressure device validation.

8. The Sample Size for the Training Set

No training set is mentioned for the KD-557. This product is a device based on oscillometric technology and pressure sensors, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device largely involves engineering calibration and validation against physical standards and clinical data to meet the performance specifications of the AAMI SP10 standard.

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

As no training set (for an AI/ML algorithm) is applicable here, this information is not provided.

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 807.92.

1.0 submitter's information

JAN 2 9 2010

(100014

$1/3

Name:	Andon Health Co., Ltd.
Address:	No. 3 Jin Ping Street, Ya An 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:	12/28/2009

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. KD-556 Fully Automatic Electronic Blood Pressure Monitor Device: 510(k) number: K091500

5.0 Device description

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

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 irregular heartbeat is detected, it can be shown on the LCD. It also has the function of averaging the last three measurements.

6.0 Intended use

The intended use and the indication for use of KD-557, as described in its labeling are the same as the predict device KD-556.

Technological Characteristics	Comparison result
Design principle	Identical
Appearance	Similar
Patients contact Materials	Identical
Performance	Identical
Biocompatibility	Identical
Mechanical safety	Identical
Energy source	Identical
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Identical

7.0 Summary comparing technological characteristics with predicate device

5- 2

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

8.0 Performance summary

KD-557 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 Safety - Collateral standard: Electromagnetic Requirements for 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-557 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K091500.

The two devices are very similar in the intended use, the design principle, the material, the performance, the safety, the energy source and the applicable standards. Only their appearances are different.

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

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 9 2010

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 3 Jin Ping Street, Ya An Road, Nankai District Tianjin China 300190

Re: K100014

Trade/Device Name: KD-557 Fully Automated Electronic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: December 30, 2009 Received: January 4, 2010

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 (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/CDRH/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 vours.

W.M.

s/ 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

K100014 510(k) Number :

Device name:

KD-557 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)

W.W.W.

ision of Cardiovascular Devices

Page 1 of

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).