KD-591 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.

Device Description

KD-591 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the devices are used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the left upper arm automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Besides, the devices have the function of blood pressure level classification. And the cuff size is limited to 22-48cm.

AI/ML Overview

The provided text describes a 510(k) submission for the KD-591 Fully Automatic Electronic Blood Pressure Monitor. Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI SP10-2002 Accuracy Requirements	The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002.

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

Test Set Sample Size: Not explicitly stated. The document only mentions "Clinical tests were performed."
Data Provenance: Not explicitly stated. Given that the submitting company is based in Tianjin, P.R. China, and no other location is mentioned, it's most likely that the clinical tests were conducted in China. The nature (retrospective/prospective) is not specified.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For blood pressure monitor validation, this typically involves trained observers (e.g., medical professionals) using a reference method (e.g., auscultation with a manometer) simultaneously with the device being tested.

4. Adjudication Method for the Test Set:

Not specified. In blood pressure measurement validation studies, this often involves multiple observers taking readings and comparing them to the device, with specific protocols for handling discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No MRMC study was done. This is a standalone device validation against a standard, not an AI-assisted human-in-the-loop system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone study was done. The clinical tests evaluated the KD-591 Fully Automatic Electronic Blood Pressure Monitor as a standalone device to measure blood pressure and pulse rate, comparing its readings to a reference standard (implicit in the ANSI/AAMI SP10-2002 compliance).

7. The Type of Ground Truth Used:

The ground truth for the clinical tests was established by comparison to a reference method compliant with the ANSI/AAMI SP10-2002 standard. This standard specifies requirements for accuracy and clinical validation, usually involving simultaneous measurements against a calibrated reference sphygmomanometer by trained observers.

8. The Sample Size for the Training Set:

Not applicable/Not specified. This device is a traditional oscillometric blood pressure monitor, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its underlying algorithm is based on established oscillometric principles.

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

Not applicable/Not specified. As mentioned above, there isn't a "training set" in the context of an AI algorithm. The device's foundational principles and calibration are based on established engineering and medical standards.

Summary

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510(k) Summary

Submitter:

K080319

JUL - 2 2008

Identification of the submitter:

Telephone number: Fax number: Contact: Date of Application:

Andon Health Co., Ltd. No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-6052 6161 86-22-6052 6162 Liu Yi 30/05/08

Identification of the product:

Device proprietary Name: KD-591 Fully Automatic Electronic Blood Pressure Monitor Common name: Noninvasive blood pressure measurement systems Noninvasive blood pressure measurement system Classification name: Class II per 21 CFR 870,1130

Marketed Devices to which equivalence is claimed:

Device	manufacture	510(k) number
KD-595	Andon Health Co., Ltd	K070828

Device description:

Intended use:

KD-591 Fully Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic

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blood pressure and pulse rate on adult each time, with the cuff around the left upper arm according to the instruction in the user's guide manual.

Comparison of technological characteristics of new device to predicate devices:

KD-591 Electronic Blood Pressure Monitor has the same principle with predicated device, which utilizes Oscilliometric measurement method to monitor the blood pressure and the result can be shown on the LCD.

The main functions of proposed device is same with the predicated device except for the appearance, lacking voice function and cuff size range, which from 22cm-48cm.

The accuracy and effectiveness of the extra large cuffs used in KD-391 Blood Pressure Monitor has been validated through the ANSI/AAMI SP-10 standard.

Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-2002.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol to the right, resembling a person embracing or supporting another. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2008

Andon Health Co., Ltd. c/o Ms. Mona Technology Department No. 31, Changjiang Road, Nankia District, Tianjin P.R. China 300193

Re: K080319

Trade Name: Fully Automatic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 3, 2008 Received: June 11, 2008

Dear Ms. Mona:

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 such 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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Pagc 2 - Ms. Mona

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 Fedcral 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ashley B. Boan

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 (if known):	K080319
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Andon Health Co., Ltd Applicant:

Device name: KD-591 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)

Ashlee Boaine fa BDZ

(Division Sign-off)
Division of Cardiovascular Devices
510(k) Number K080319

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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).