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

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, 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 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 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.

AI/ML Overview

The provided text describes the clinical tests and acceptance criteria for the Wrist Measurement Electronic Blood Pressure Monitor (Models: KD-791, KD-792, KD-793, KD-795, KD-796, KD-797, KD-798).

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Blood Pressure Accuracy	Meets or exceeds the accuracy requirements of ANSI/AAMI SP10-2002.
Electromagnetic Compatibility (EMC)	Coincides with EN60601-1-2-2001 (Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standards: Electromagnetic compatibility; Requirements and test).
Product Safety	Coincides with IEC60601-1: 1998+A1:1991+A2:1995 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
Biocompatibility - In vitro cytotoxicity	Coincides with ISO 10993-5 (Biological evaluation of medical device - part 5: Test for in vitro cytotoxicity).
Biocompatibility - Irritation and delayed type hypersensitivity	Coincides with ISO 10993-10 (Biological evaluation of medical device - part 10: Tests for irritation and delayed type hypersensitivity).

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

Sample Size: Not explicitly stated for the clinical accuracy test. The document only mentions "Clinical tests were performed."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For blood pressure monitoring, ground truth is typically established by trained medical personnel using a reference sphygmomanometer.

4. Adjudication method for the test set:

Not applicable/Not specified. For automated blood pressure monitors, the device's readings are directly compared to the reference standard, rather than involving expert adjudication of "results."

5. 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:

Not applicable. This device is an automated blood pressure monitor and does not involve human "readers" or AI assistance in the interpretation of complex medical imagery or data. Its primary function is to directly measure and display blood pressure and pulse rate.

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

Yes, performance evaluation was done in a standalone manner. The device is designed to automatically measure and display readings without real-time human intervention in the measurement process itself. The clinical tests assessed the accuracy of the device's measurements against a recognized standard (ANSI/AAMI SP10-2002).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the blood pressure accuracy, the ground truth would be established by reference measurements taken simultaneously or sequentially by trained personnel using a validated, traditionally accepted method (e.g., a mercury sphygmomanometer or another validated reference device) as dictated by the ANSI/AAMI SP10-2002 standard.

8. The sample size for the training set:

Not applicable/Not specified. This device is based on oscillometric technology and appears to be a deterministic algorithm rather than a machine learning model that would require a separate "training set" in the conventional sense. The "training" would be more akin to calibration and design optimization based on engineering principles and the chosen measurement method.

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

Not applicable for the reason stated above. If any iterative development involved comparing prototype readings to known values, those known values would follow the same ground truth principles as outlined in point 7.

Summary

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AUG 15 2007

510(k) Summary

ldentification of the submitter:

Submitter: Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 Telephone number: 86-22-6052 8012 Fax number: 86-22-6052 6162 Contact: Liu Yi Date of Application: 07/02/2007

ldentification of the product:

Trade Name:	Wrist Measurement Electronic Blood Pressure Monitor,Models: KD-791, KD-792, KD-793, KD-795, KD-796,KD-797, KD-798
Common name:	Noninvasive blood pressure measurementsystems
Classification name:	Noninvasive blood pressure measurement systemClass 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.	K030359

Device description:

Intended use:

Wrist Measurement Automatic Electronic Blood Pressure Monitor is intended

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

Comparison of technological characteristics of new device to predicate devices:

The design Wrist Measurement Electronic Blood Pressure Monitor utilizes Oscilliometric measurement method, with an electronic interface module and a silicon integrate pressure sensor and a 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.

In addition, we adopt a new technological method in developing the Wrist Memory Automatic Electronic Blood Pressure Monitor so that it has a series of new functions, such as blood pressure level classification and date and time displayed in large screen.

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.

Non-clinical Tests:

All non-clinical tests coincide the following standards, including Electromagnetic Compatibility test Product Safety test and Biocompatibility test.

EN60601-1-2-2001

Medical electrical equipment ---- Part 1-2:General requirements for safety[1] Collateral standards: Electromagnetic compatibility; Requirements and test, IEC60601-1: 1998+A1:1991+A2:1995

Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

ISO 10993-5

Biological evaluation of medical device-----part 5: Test for in vitro cytotoxicity. ISO 10993-10

Biological evaluation of medical device --- part 10: Tests for irritation and delayed type hypersensitivity.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2007

Kodon (Tianjin) Electronic & Electrical Apparatus, Co. c/o Mr. Liu Yi No. 31, Changjiang Road, Nankai District Tianjin, China 300193

Re: K070826

Trade Name: Wrist Measurement Electronic Blood Pressure Monitor, Models KD-791, KD-792, KD-793, KD-795, KD-796, KD-797, KD-798 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Date: Not provided Received: July 6, 2007

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 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,

B. Zumimmo for

Bram B. 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: K070826

Applicant: Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD

Device name: Wrist Measurement Electronic Blood Pressure Monitor, Models: KD-791, KD-792, KD-793, KD-795 KD-796, KD-797, KD-798

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)

B/humma

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ka 72826

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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).