The KD-768 Wrist Measurement 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 6.1023 inches to 9.8425 inches.

Device Description

KD-768 Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling an air cuff around a wrist 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 120 times measuring result with the month, day and time of measuring.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the KD-768 Wrist Measurement Electronic Blood Pressure Monitor, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy requirements of ANSI/AAMI SP10-1992	"The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992."

Study Details

The provided text describes clinical tests that were performed to comply with the accuracy requirements of ANSI/AAMI SP10-1992. However, it does not provide specific details on many of the requested categories.

Here's what can be extracted and what is not available in the provided text:

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.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
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):
- Not specified. For blood pressure monitors, the "ground truth" often refers to reference measurements (e.g., auscultatory method by trained observers). The text does not elaborate on this.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor and does not involve AI or human readers in the context of diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The "clinical tests" described, focusing on compliance with ANSI/AAMI SP10-1992, assess the device's accuracy in measuring blood pressure independently. The device itself is an automated system for measurement.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for blood pressure monitor accuracy studies typically involves simultaneous measurements using a recognized reference standard, such as Riva-Rocci/auscultatory method performed by trained observers, as specified by standards like ANSI/AAMI SP10. The text does not explicitly state this, but compliance with ANSI/AAMI SP10-1992 implies such a method for ground truth.
The sample size for the training set:
- Not applicable/Not specified. This device is a physical measurement device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "clinical tests" described are for validation of the device's accuracy rather than training an algorithm.
How the ground truth for the training set was established:
- Not applicable. (See point 7).

Summary

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JAN 5 2006

K05/847

510(k) Summary

Identification of the submitter:

Submitter:	Kodon (Tianjin) Electronic & Electrical ApparatusCo., LTDNo 31, Changjiang Road, Nankai District, Tianjin,P.R. China, 300193
Telephone number:	86-22-6052 6082
Fax number:	86-22-6052 6162
Contact:	Liu Yi
Date of Application:	07/05/2005

Identification of the product:

Device proprietary Name:	KD-768 Wrist Measurement Electronic BloodPressure Monitor
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-726	Kodon (Tianjin) Electronic andElectrical Co., Ltd.

Device description:

Intended use:

KD-768 Wrist Measurement Automatic Electronic Blood Pressure Monitor is

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intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with an air cuff buckled around one's wrist according to the instruction in the user's guide manual.

Comparison of technological characteristics of new device to predicate devices:

The design of KD-768 Wrist Measurement Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a air cuff automatically inflated and released by an internal pump over the wrist to obtain blood pressure signals in the same manner as the predicate device.

Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.

Non-clinical Tests:

tests coincide the following All non-clinical standards, including Electromagnetic Compatibility test.

IEC601-1 (1988)

Medical electrical equipment --- Part 1: General requirements for safety IEC601-1 (1988)

Amendment 2

IEC 60602-2-30: 1995

Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977

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Image /page/2/Picture/0 description: The image shows a black and white logo. The logo consists of a circle with text around the perimeter. Inside the circle is a stylized image of a bird or abstract shape with three curved lines. The text around the circle is difficult to read due to the image quality.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 5 2006

Kodon (Tianjin) Electronic and Electrical Apparatus Co., Ltd. c/o Mr. Liu Yi President No. 31 Changjiang Road Nankai District, Tianjin CHINA

Re: K051847

Trade Name: Kodon KD-768 Wrist Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: December 05, 2005 Received: December 05, 2005

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 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 - 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); 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bhimmarfor

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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Indications for Use

510(k) number:

Device name:

KD-768 Wrist Measurement Automatic Electronic Blood Pressure Monitor

Indications for use:

Prescription Use

AND/OR

Over-The-counter Use YES

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Bhummon

510(k) Number

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).