KD-930 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 sphygmomanometers. The operational principle is based on oscillometric method and silicon integration pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified and displayed by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown on to the user. More over, it can also calculate the average of the last three measurements.

AI/ML Overview

The provided text describes the KD-930 Fully Automatic Electronic Blood Pressure Monitor. However, it does not contain details about a specific study proving the device meets acceptance criteria in the format requested. While it references standards the device conforms to, it does not explicitly outline a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically seen in a detailed performance study summary.

The document mainly focuses on:

Device information: Trade name, common name, classification, and predicate device.
Device description: How it works (oscillometric method), what it measures (systolic, diastolic, pulse rate), and features (irregular heartbeat detection, average of last three measurements).
Intended use: Measuring blood pressure and pulse rate in adults with an upper arm cuff.
Comparison to predicate device: Stating similarities and differences with the KD-556 and a general statement that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies tests were done but provides no specifics.
Standards conformance: A list of relevant IEC, UL, and AAMI standards.

Given the absence of the specific study details you requested, I can only extract information that is present. Below is a structured response reflecting the available data and explicitly stating what aspects are not provided in the text.

Acceptance Criteria and Device Performance Study for KD-930 Fully Automatic Electronic Blood Pressure Monitor

The provided 510(k) summary for the KD-930 Fully Automatic Electronic Blood Pressure Monitor states conformance to several standards, including AAMI SP10:2002. Compliance with AAMI SP10 typically defines the acceptance criteria for blood pressure monitors. However, the document does not explicitly present a table of acceptance criteria and reported device performance from a specific study within the summary itself. Instead, it indicates that the device "conforms to" these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document states the device "conforms to" AAMI SP10:2002 (and its amendments). For non-invasive blood pressure monitors, AAMI SP10 specifies accuracy requirements, typically:
- Mean difference: ≤ 5 mmHg
- Standard deviation: ≤ 8 mmHg
- These apply to both systolic and diastolic blood pressure measurements when compared to a reference method (e.g., auscultation by trained observers).
Reported Device Performance: The provided text does not include a table or specific data showing the KD-930's measured mean difference and standard deviation against these AAMI SP10 criteria. It generally states that "the test in this submission provides demonstration that these small differences [from the predicate] do not raise any new questions of safety and effectiveness," implying a study was conducted but not detailing its results in this summary.

Acceptance Criteria (based on AAMI SP10:2002)	Reported Device Performance (Not explicitly stated in summary)
Mean difference ≤ 5 mmHg (Systolic BP)	Details not provided in the summary.
Standard deviation ≤ 8 mmHg (Systolic BP)	Details not provided in the summary.
Mean difference ≤ 5 mmHg (Diastolic BP)	Details not provided in the summary.
Standard deviation ≤ 8 mmHg (Diastolic BP)	Details not provided in the summary.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not specified in the provided summary.
Data Provenance: Not specified in the provided summary (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified in the provided summary.
Qualifications of Experts: Not specified in the provided summary.

4. Adjudication Method for Test Set

Not specified in the provided summary.

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

No information about an MRMC study is provided. This device is an automated blood pressure monitor, not an imaging interpretation device typically assessed with MRMC studies.

6. Standalone Performance (Algorithm Only)

The device itself is a standalone algorithm/device for blood pressure measurement, as it is an "Automatic Electronic Blood Pressure Monitor." It measures and displays readings without human interpretation being part of the core measurement process. The conformance to AAMI SP10, if demonstrated, would be for its standalone performance. However, specific standalone performance metric values are not provided.

7. Type of Ground Truth Used

The ground truth for blood pressure monitor validation per AAMI SP10 is typically established by simultaneous measurements by trained human observers using a mercury sphygmomanometer (auscultation method), often with a double-blind protocol. While not explicitly stated for this specific study summary, conformance to AAMI SP10 implies this method of ground truth establishment.

8. Sample Size for Training Set

This device is based on the oscillometric method and silicon integration pressure sensor technology, and likely uses established algorithms rather than a "training set" in the machine learning sense. Therefore, information about a training set sample size is not applicable in the context of this traditional medical device validation. If there were any internal calibration data or look-up tables based on population data, it is not mentioned.

9. How Ground Truth for Training Set Was Established

As above, the concept of a "training set" and associated ground truth establishment is not applicable for this type of traditional blood pressure monitoring device based on physical principles, rather than a machine learning model that requires a labeled dataset for training.

Summary

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101950

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

AUG 3 1 2010

Name:	Andon Health Co., Ltd.
Address:	No 3, Jinping 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:	06/25/2010

2.0 Device information

Trade name:	KD-930 Fully Automatic Electronic Blood PressureMonitor
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 Predicate device information

Manufacturer: Andon Health Co., Ltd. Device: KD-556 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K090963

5.0 Device description

ર- I

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

The operational principle is based on oscillometric method and silicon integration pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified and displayed by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown on to the user. More over, it can also calculate the average of the last three measurements.

6.0 Intended use

The intended use and the indication for use of KD-930, as described in its labeling are the same as the predicate device KD-556.

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

7.0 Summary comparing technological characteristics with predicate device

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8.0 Performance summary

KD-930 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.
60601-1, Medical Electrical Equipment Part 1: General . UL Requirements for Safety, 2003.
· IEC 60601-1-1, Medical Electrical Equipment Part 1: General Requirements for Safety - 1. Collateral standard: Safety Requirements for Medical Electrical Systems, 2000.
· EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007.
· 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 predicate device and the conclusion

Our device KD-930 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-556 whose 510(k) number is K090963.

The two devices are very similar in the intended use, the design principle, the material, the performance and the applicable standards. Their appearance, memory times, energy source and MCU are different. KD-930 does not contain a LCD, which is different from the predicate device. Their temperature of operational parameter is also changed.

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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Image /page/3/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 31 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: K101950

Trade/Device Name: KD-930 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: August 12, 2010 Received: August 13, 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 Fedral 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, isting 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 devil (1 in be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, EDA 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 (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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. A. William

for 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 :

AUG 3 1 2010

Device name: KD-930 Fully Automatic Electronic Blood Pressure Monitor

Indications for use:

Prescription use Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR 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)

M. A. Willelmen

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number_K101950

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).