KD-931D 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. 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 also has the function of averaging the last three measurements. Compared to KD-556, KD-931D does not contain an LCD, it will display the measurement result on the iPhone which is connected to the device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the KD-931D Fully Automatic Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

The KD-931D Fully Automatic Electronic Blood Pressure Monitor states Performance: Similar when compared to its predicate device, KD-556. Both devices are designed and manufactured according to ANSI/AAMI SP10, which specifies performance requirements for manual, electronic, or automated sphygmomanometers. While specific numerical acceptance criteria (e.g., mean difference, standard deviation) are not explicitly stated in the provided text as a table, the device's conformance to AAMI SP10:2002 and its amendments implies meeting the accuracy standards outlined in that standard.

Implied Acceptance Criteria (based on AAMI SP10 compliance):

Parameter	Acceptance Criteria (from AAMI SP10)	Reported Device Performance
Blood Pressure Accuracy (Systolic & Diastolic)	Mean Difference: <= +/- 5 mmHgStandard Deviation: <= 8 mmHg(These are general AAMI SP10 requirements; specific subgroups and measurement conditions also apply.)	The device conforms to AAMI SP10:2002 and its amendments, indicating it meets these accuracy standards.
Pulse Rate Accuracy	AAMI SP10 typically focuses on BP accuracy, but devices often include pulse rate. If specified, acceptable deviation from reference would be low.	The device measures pulse rate and achieves `Performance: Similar` to the predicate, which is also AAMI SP10 compliant.
Measurement Range	Cuff circumference for adult individuals: 22cm-48cm (This is a design specification, not a direct performance accuracy, but essential for proper use).	Cuff circumference limited to 22cm-48cm.

Note: The provided 510(k) summary only explicitly states conformance to AAMI SP10, which implies meeting its accuracy requirements. Specific tabular data for the KD-931D's performance (mean difference, standard deviation against a reference) is not included in this document but would be part of the testing supporting the AAMI SP10 compliance.

Study Details

The provided document is a 510(k) summary for premarket notification. It references the standards and comparisons used to demonstrate substantial equivalence, but it does not contain the detailed study report with specific statistical results from clinical trials that would prove the device meets all acceptance criteria. Instead, it makes claims of adherence to standards and similarity to a predicate device.

Here's what can be inferred from the text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not provide details on the sample size, data provenance, or whether the study was retrospective or prospective. It only states that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies testing was conducted, likely in accordance with AAMI SP10, but the specifics are not disclosed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. For blood pressure monitor validation against AAMI SP10, "experts" typically refers to trained observers (often two) using auscultation with a reference sphygmomanometer, whose readings are averaged or reconciled. Qualifications would usually involve specific training in blood pressure measurement.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Standard AAMI SP10 testing often involves two independent observers and a third if there's a significant discrepancy, but the specifics are absent here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done or mentioned. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for "human readers."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance evaluation in this context would be considered standalone for the device itself. It's a fully automatic electronic blood pressure monitor, meaning its "algorithm" (oscillometric principle) measures blood pressure without direct human real-time intervention during the measurement process. The comparison would be against a "ground truth" (e.g., auscultation), not against human interpretation of device output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The type of ground truth for blood pressure monitors adhering to AAMI SP10 is typically simultaneous auscultation by trained observers using a calibrated mercury sphygmomanometer or another validated reference device. This method establishes an "expert consensus" or reference standard for blood pressure.
The sample size for the training set:
- Not applicable / not provided in this context. Blood pressure monitors like the KD-931D are typically developed based on established oscillometric principles and validated through clinical testing rather than "training" an AI model on a dataset. There is no mention of a machine learning or AI training set.
How the ground truth for the training set was established:
- Not applicable / not provided as there is no mention of a training set for an AI model.

Summary

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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

NOV - 4 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:	09/06/2010

2.0 Device information

Trade name:	KD-931D 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 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

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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. 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 also has the function of averaging the last three measurements.

6.0 Intended use

The intended use and the indication for use of KD-931D, as described in its labeling are the same as the predicate device KD-556.

		7.0 Summary comparinq 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	Similar
Standards met	Identical
Electrical safety	Identical
EMC	Identical
Function	Similar

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8.0 Performance summary

KD-931D Fully Automatic Electronic Blood Pressure Monitor conforms to the following standards:

03/3

· IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
10 UL 60601-1, Medical Electrical Equipment - Part 1: General 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-931D 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. Compared to KD-556, KD-931D does not contain an LCD, it will display the measurement result on the iPhone which is connected to the 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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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 features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

NOV - 4 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: K102631

Trade/Device Name: KD-931D 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: October 15, 2010 Received: October 18, 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.

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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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W.M.

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

NOV - 4 2010

510(k) Number :

KD-931D Fully Automatic Electronic Blood Pressure Device name: 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. Wood.

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Numbe

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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).