KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor are for use by medical professionals or at home and are 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 sphygmanometers:

The operational principle is based on oscillometric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure, and display the result on the LCD. If any irregular heartbeat is detected, it can also be shown on the LCD. More over, it also calculates the average of the last three measurements.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The supplied document is a 510(k) summary for the KD-7902BTJ, KD-7963NJ, KD-7971J, and KD-7966 Fully Automatic Electronic Blood Pressure Monitors. This document primarily focuses on establishing substantial equivalence to a predicate device and outlines non-clinical and clinical tests performed.

Crucially, the document does not explicitly state specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation between device and reference method). Instead, it relies on compliance with the ANSI/AAMI SP10 standard as the benchmark for performance.

Therefore, I will extract the information based on the implicit acceptance criteria defined by adherence to ANSI/AAMI SP10 and the clinical study referenced.

Acceptance Criteria and Device Performance

The core acceptance criterion for the device's accuracy is its compliance with the ANSI/AAMI SP10: 2002 standard (including amendments A1:2003 and A2:2006). This standard sets forth requirements for the performance of manual, electronic, or automated sphygmomanometers.

The document states that the clinical test report of the predicate device, KD-7971 (K093452), is applicable to the subject devices because the "difference between the subject devices and their predicate device do not affect the clinical accuracy in terms of blood pressure detection."

Without the specific clinical report (K093452) for KD-7971, it is not possible to provide numerical reported device performance in the form of mean differences and standard deviations. The document only confirms that the device conforms to the standard.

Acceptance Criteria (from ANSI/AAMI SP10)	Reported Device Performance (Implicitly Meets SP10 Requirements)
Accuracy (Systolic BP): Implicitly meets requirements for mean difference and standard deviation against a reference standard.	Conforms to ANSI/AAMI SP10:2002 and its amendments.
Accuracy (Diastolic BP): Implicitly meets requirements for mean difference and standard deviation against a reference standard.	Conforms to ANSI/AAMI SP10:2002 and its amendments.
Pulse Rate Accuracy: (Not explicitly mentioned in the summary, but typically included in SP10 compliance for these devices).	Conforms to ANSI/AAMI SP10:2002 and its amendments.
Safety: Electrical safety (IEC 60601-1), EMC (IEC 60601-1-2).	All non-clinical tests (including electrical safety and EMC) demonstrate no new questions of safety and effectiveness.
Performance Characteristics: (As per SP10 for function, pressure measurement, display, alarms, etc.)	Conforms to ANSI/AAMI SP10:2002 and its amendments.

Study Details

Since the document relies on the clinical test report of the predicate device (KD-7971, K093452), the following information is based on the presumption that the original study for KD-7971 followed standard AAMI SP10 clinical validation protocols. The provided K111830 summary document does not contain these granular details itself.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided document. For AAMI SP10 validation, a typical minimum sample size is around 85 subjects, ensuring a broad range of blood pressures are captured.
- Data Provenance: Not specified in the provided document. Such studies are typically prospective clinical trials. The manufacturer is based in Tianjin, P.R. China, so the study could have been conducted there, but this is not confirmed.
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):
- Number of Experts: Not specified in the provided document. For AAMI SP10 validation, the ground truth (reference blood pressure) is typically established by at least two (and sometimes three) trained observers (e.g., clinicians, nurses, or trained technicians) using a calibrated mercury sphygmomanometer, auscultatory method.
- Qualifications of Experts: Not specified, but they would be trained in the auscultatory measurement of blood pressure according to a standardized protocol.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified in the provided document. For AAMI SP10, a simultaneous dual observer auscultatory measurement is typically used. If the readings between the two observers differ by more than a predefined threshold (e.g., 4 mmHg), a third observer might be used, or the measurement discarded. This is sometimes referred to as a "double blind" or "three-way auscultation" approach if a third person is also involved or if the device operator is blinded.
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:
- MRMC Comparative Effectiveness Study: No, this type of study was not done. The device is an automated 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:
- Standalone Performance: Yes, implicitly. The clinical study of the predicate device (KD-7971) assessed the accuracy of the automated device (algorithm only, as it's fully automatic) against a human auscultatory reference standard. This is the definition of a standalone performance evaluation for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth Type: Expert consensus/Reference Standard. The ground truth for blood pressure measurement in devices conforming to AAMI SP10 is established by trained human observers using a calibrated mercury sphygmomanometer (or an equivalent validated reference method) via the auscultatory technique.
The sample size for the training set:
- Training Set Sample Size: Not applicable/Not specified. For a traditional medical device like a blood pressure monitor, there isn't typically a "training set" in the machine learning sense with a separate ground truth for training. The oscillometric algorithm is developed and refined based on engineering principles and potentially internal validation, but not typically through a distinct, externally validated "training set" with ground truth in the way an AI algorithm for image analysis would be. The clinical study described is for validation, not training.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable. See point 7 above. The intrinsic algorithm development would involve internal testing and calibration, but not against a "ground truth for a training set" as typically understood in AI/ML validation studies.

Summary

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KD-7902BTJ, KD-7963NJ and KD-7971J Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

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

Name: Address: Andon Health Co., Ltd.

Phone number: Fax number: Contact: Date of Application:

No 3, Jinping Street Ya An Road, Nankai District, Tianjin, P.R. China 86-22-6052 6161 86-22-6052 6162 Liu Yi 06/20/2011

2.0 Device information

Device name

(1) KD-7902BTJ Fully Automatic Electronic Blood Pressure Monitor

(2) KD-7963NJ Fully Automatic Electronic Blood Pressure Monitor

(3) KD-7971J Fully Automatic Electronic Blood Pressure Monitor

(4) KD-7966 Fully Automatic Electronic Blood Pressure Monitor

3.0 Classification

Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130

Classification: ll

Panel: Cardiovascular

4.0 Predicate device information

1. Manufacturer:	Andon Health Co., Ltd.
Device:	KD-7971 Fully Automatic Electronic Blood PressureMonitor

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KD-7902BTJ, KD-7963NJ and KD-7971J

Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files

	510(k) number:	K093452
	Manufacturer:	Andon Health Co., Ltd.
2	Device:	KD-7964 Fully Automatic Electronic Blood PressureMonitor
	510(k) number:	K102906

5.0 Device description

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-7902BTJ, KD-7963NJ, KD-7971J and KD-7966, as described in the labeling are the same as their predicated device KD-7971.

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

8.0 Discussion of non-clinical and clinical test performed

Non-clinical Tests have been done as follows:

a. Electromagnetic compatibility evaluation according to IEC 60601-1-2;

b. Electrical safety test according test to IEC 60601-1 ;
c. Safety and performance characteristics of the test according to SP10

None of the test demonstrates that KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 bring new questions of safety and effectiveness.

Clinical Test Concerning the Compliance of ANSI/AAMI SP10

From the technical point of view, the subject device KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 are identical to their predicate device KD-7971. The difference between the subject devices and their predicate device do not affect the clinical accuracy in terms of blood pressure detection. The clinical test report of KD-7971(K093452) is applicable to our subject device.

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9.0 Performance summary

KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 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.
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.

Comparison to the predicate device and the conclusion 10.0

Our device KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7971 whose 510(k) number is K093452.

KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 are very similar with their predicate device in the intended use, the design principle, the material, the performance and the applicable standards. The main modification for the four new subject device is the appearance; except that, KD-7902BTJ, KD-7963NJ and KD-7971J use the JNC hypertension classification while their predicate devices KD-7971 and KD-7964 use the WHO hypertension classification.

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

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

DEC - 9 2011

Andon Health Co., Ltd. c/o Ms. M. Elizabeth Bierman Morgan, Lewis & Bockius LLP 1111 Pennsylvania Avenue, NW Washington, DC 20004

K111830 Re:

RT11030
Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor with models: KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: November 14, 2011 Received: November 15, 2011

Dear Ms. Bierman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro roved your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energours) to regardy the Medical Device Amendments, or to connered pror co may 2011/03/2017 accordance with the provisions of the Federal Food, Drug, de rices mat have been roomstilled require approval of a premarket approval application (PMA). and Cosmetic Fere, market the device, subject to the general controls provisions of the Act. The r ou may, merelory mans of the Act include requirements for annual registration, listing of general controls provinciting 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), 11 your device is classified (600 a00 10) is existing major regulations affecting your device can be it may be subject to adultional controllations, 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 - Ms. M. Elizabeth Bierman

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,

Bran 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

K111830 510(k) Number :

KD-7902BTJ, KD-7963NJ, KD-7971J and KD-7966 Device name: Fully Automatic Electronic Blood Pressure 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 &ffice of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

R 111830

Page 1 of

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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).