KD-5971 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.

KD-7971 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 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 of KD-5971 and KD-7971 are both 2*30 times. If any irregular heartbeat is detected, it can be shown on the LCD, KD-5971 and KD-7971 also have the voice function.

AI/ML Overview

The provided text describes a submission for a 510(k) premarket notification for fully automatic electronic blood pressure monitors (KD-5971 and KD-7971). It outlines the device information, classification, comparison to predicate devices, and a performance summary. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., in terms of accuracy metrics like sensitivity, specificity, or comparison to a gold standard with statistical analysis).

Instead, the document states that the devices conform to certain recognized standards for medical electrical equipment and sphygmomanometers (AAMI SP10). The primary claim of the submission is substantial equivalence to predicate devices (KD-5915 and KD-7962). The "Performance summary" section only lists the standards to which the devices conform, implying that meeting these standards is sufficient for demonstrating performance.

Based on the provided text, here's what can be extracted and what information is missing:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy ranges for blood pressure measurements compared to a reference method) or report specific device performance data against such metrics. Instead, it states conformity to recognized standards.

Implicit Acceptance Criteria (based on standards adherence):

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Implied)
Conformity to IEC 60601-1 (General Requirements for Safety)	Conforms
Conformity to IEC 60601-1-2 (Electromagnetic Compatibility)	Conforms
Conformity to AAMI SP10:2002 and its amendments (Manual, electronic or automated sphygmomanometers)	Conforms

Note: The AAMI SP10 standard itself specifies accuracy requirements for blood pressure devices (e.g., mean difference and standard deviation between the device and a reference measurement). However, the specific values obtained for these parameters for the KD-5971 and KD-7971 devices are not reported in this 510(k) summary.

2. Sample Size for Test Set and Data Provenance

The document does not report any specific sample size for a test set used in a performance study or the data provenance (e.g., country of origin, retrospective/prospective). Instead, it relies on conformity to standards.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for a test set. This type of information would typically be found in a detailed study report comparing the device to a reference standard with expert-validated measurements.

4. Adjudication Method for Test Set

The document does not describe any adjudication method like 2+1 or 3+1. This is not applicable as no specific test set requiring expert adjudication is discussed.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

The document does not explicitly describe a standalone performance study in terms of reporting specific accuracy metrics. It states conformity to AAMI SP10, which implies that such a study (comparing the device to a reference standard like mercury sphygmomanometry) was likely performed to demonstrate compliance. However, the results of such a study are not presented in this summary.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For blood pressure monitors conforming to AAMI SP10, the ground truth is typically established by simultaneous or sequential auscultatory measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer) in a clinical environment.

8. Sample Size for Training Set

The device is a traditional electronic blood pressure monitor based on oscillometric technology and does not appear to utilize machine learning or AI that would require a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable to this device as described.

9. How Ground Truth for Training Set Was Established

As there is no mention of a training set for machine learning/AI, the method for establishing its ground truth is not applicable.

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 ..

UEL Z 3 2009

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:	10/30/2009

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. Device: KD-5915 Fully Automatic Electronic Blood Pressure Monitor KD-7962 Fully Automatic Electronic Blood Pressure Monitor 510(k) number: K091737, K091997

5.0 Device description

KD-5971 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 systelic 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.

ર- 1

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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-5971 and KD-7971, as described in its labeling are the same as the predict device KD-5915 and KD-7962.

7.0 Summary comparing technological characteristics with predicate device

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ત્ત્વ

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	Similar

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8.0 Performance summary

KD-5971 and KD-7971 Fully Automatic Electronic Blood Pressure Monitor conform 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-5971 and KD-7971 Fully Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-5915 and KD-7962 whose 510(k) number is K091737 and K091997.

KD-7971 and KD-7962 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different, they have different memory times. KD-7971 has a new function of histogram.The cuff pressure range of KD-7971 is different from KD-7962. KD-7971 also has a different MCU.

KD-5971 and KD-5915 is very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Their appearance are different, they have different memory times. KD-7971 has new functions of histogram and touch button. The cuff pressure range of KD-7971 is different from KD-7962. KD-7971 also has a different MCU.

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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

DEC 2 3 2009

Andon Health Co., Ltd. c/o Mr. Liu Yi President No. 31, Changjiang Road, Nankai District Tianjin, P.R. China, 300193

Re: K093452

Trade/Device Name: KD-5971, KD-7971 Fully Automatic Electronic Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement systems Regulatory Class: Class II (two) Product Code: DXN Dated: November 2, 2009 Received: November 9, 2009

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 - Ms. 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 (OS) 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,

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 :

6093457

Device name:

KD-5971 and KD-7971 Fully Automatic Electronic Blood Pressure Monitor

Indications for use:

KD-5971 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 syst olic 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.

Prescription use AND/OR Over-The-Counter Use YES Part 21 CFR 801 Subpart D) (21 CFR-807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH evice Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K69345

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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).