KD-391 Semi 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-391 Semi 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 device is 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, 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 which is according to WHO standard.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the KD-391 Semi Automatic Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/AAMI SP-10-2002 Accuracy Requirements	The clinical tests were performed, and the results "meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002."

Study Information

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated in the provided text. The document only mentions that "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-2002." This standard defines the required number of participants for clinical validation, but the exact number used in this specific study is not provided.
Data Provenance: Not explicitly stated. The document doesn't specify the country of origin for the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not stated. The document references compliance with ANSI/AAMI SP-10-2002, which typically involves expert comparison measurements (e.g., from a trained observer using a mercury sphygmomanometer), but the number and qualifications of these experts are not detailed in this submission.

4. Adjudication method for the test set:

Not stated. The ANSI/AAMI SP-10-2002 standard sets forth methods for comparing automated blood pressure devices to a reference method, which inherently involves some form of comparison and "agreement" between an automated reading and an expert's reading, but specific adjudication processes (like 2+1 or 3+1) are not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case comparative effectiveness study was not conducted or described. This type of study is typically for image-based diagnostic aids or decision support systems. Blood pressure monitors are standalone measurement devices and do not involve human readers interpreting output in the same way.

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

Yes, the performance described is a standalone (algorithm only) performance. The device itself measures and displays blood pressure and pulse rate. The clinical tests evaluate the accuracy of the device's measurements against a reference standard, not its performance in assisting a human.

7. The type of ground truth used:

The ground truth would be established through a reference standard method as defined by ANSI/AAMI SP-10-2002, typically involving:
- Expert auscultation: Simultaneous measurements by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device) as the gold standard.

8. The sample size for the training set:

Not applicable/Not stated. Blood pressure monitors that use oscillometric principles are generally developed and calibrated using engineering principles and laboratory testing, rather than a "training set" in the machine learning sense. The clinical validation (test set) is performed to verify the accuracy of the final, developed device.

9. How the ground truth for the training set was established:

Not applicable. See point 8. The "ground truth" during development would be associated with engineering validation and calibration processes, ensuring the device accurately converts oscillations into blood pressure values.

Summary

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510(k) Summary

JUL 3 1 2008

ldentification of the submitter:

Submitter:	Andon Health Co., Ltd.
	No 31, Changjiang Road, Nankai District, Tianjin,
	P.R. China, 300193
Telephone number:	86-22-6052 6161
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Application:	29/01/08

Identification of the product:

Device proprietary Name: KD-391 Semi Automatic Electronic Blood PressureMonitor
Common name: Noninvasive blood pressure measurementsystems
Classification name: Noninvasive blood pressure measurement systemClass II per 21 CFR 870.1130

Marketed Devices to which equivalence is claimed:

Device	manufacture	510(k)	number
KD-322	Andon Health Co., Ltd		K052676

Device description:

Intended use:

KD-391 Semi 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-391 Electronic Blood Pressure Monitors 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.

Cuff pressure should be displayed on the LCD during inflating process. The user pressurizes the cuff by the inflating bulb manually, which is same with the predicated device.

Comparing with KD-322 Semi Automatic Electronic Automatic Blood Pressure Monitor, KD-391 has some new functions, such as memory 60 times recent test results with time and date, which display on a large LCD, blood pressure level classification according to WHO standard 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.

See the submission for more details.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Adon Health Co., Ltd c/o Ms. Mona 7th Floor Hua Qiao Chuang Ye Plaza No 10, JinPing Road, Ya An Road Nankai District, Tianjin, China 300190

JUL 3 1 2008

Re: K080326

Trade/Device Name: KD-391 Semi Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: June 26, 2008 Received: June 30, 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 (Act 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 requirements for annual registrations, institutions 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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Page 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 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); 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,

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):

080726

Applicant: Andon Health Co., Ltd

Semi Automatic Electronic Blood Pressure Device name: KD-391 Monitor

Indications for use:

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K080326
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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).