The KD-788 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-788 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 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 infernal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can divide into 4 groups and record 30 memory each group with the month, day and time of measuring.

AI/ML Overview

Here's an analysis of the provided text regarding the KD-788 Wrist Measurement Electronic Blood Pressure Monitor, focusing on the acceptance criteria and the study proving it.

Important Note: The provided document is a 510(k) summary and FDA clearance letter. It states that clinical tests were performed, but it does not provide detailed reporting of the acceptance criteria nor the full study report. It only states that the device "complied with the accuracy requirements of ANSIIAAMISP10-1992" and "The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992." Therefore, I will derive the acceptance criteria from this standard and indicate where specific data would typically be found in a comprehensive study report, even if it's not present here.

Acceptance Criteria and Device Performance Study for KD-788 Wrist Measurement Electronic Blood Pressure Monitor

The KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor is a non-invasive device intended to measure systolic and diastolic blood pressure and pulse rate at the wrist. The 510(k) submission, K052450, indicates that clinical tests were performed to demonstrate substantial equivalence and meet the accuracy requirements of the ANSI/AAMI SP10-1992 standard.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the ANSI/AAMI SP10-1992 standard, which is referenced, the acceptance criteria for automated sphygmomanometers typically involve two main components: mean difference and standard deviation of differences between the test device and a reference measurement (auscultation).

Acceptance Criteria (ANSI/AAMI SP10-1992 derived)	Reported Device Performance	Comments from K052450 Summary
Mean Difference (Δ): ≤ ± 5 mmHg	Not explicitly stated (e.g., "Systolic Mean Diff: X mmHg")	The K052450 summary states: "Clinical tests were performed and complied the accuracy requirements of ANSIIAAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992." This implies that the device achieved a mean difference within the ±5 mmHg limit for both systolic and diastolic pressures.
Standard Deviation of Differences (SD): ≤ 8 mmHg	Not explicitly stated (e.g., "Systolic SD: Y mmHg")	Similar to the mean difference, the summary implies the standard deviation was within the ≤ 8 mmHg limit to meet the standard's accuracy requirements.

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

Test Set Sample Size: The 510(k) summary does not explicitly state the specific number of subjects used in the clinical test set. The ANSI/AAMI SP10-1992 standard typically recommends a minimum of 85 subjects for validation studies. It is implied that at least this number, or more, was used to meet the standard's requirements.
Data Provenance: The document does not specify the country of origin for the clinical data. Given the submitter's location (Tianjin, P.R. China), it is plausible the study was conducted there, but this is not confirmed. The study was prospective, as it involved performing clinical tests to evaluate the device’s accuracy.

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

Number of Experts: The 510(k) summary does not explicitly state the number of experts used for ground truth. For blood pressure validation studies according to ANSI/AAMI SP10-1992, it is standard practice to use at least two trained observers (experts) to take auscultatory reference measurements.
Qualifications of Experts: The document does not explicitly state the qualifications of the experts. However, per the AAMI standard, these observers would typically be trained healthcare professionals (e.g., nurses, physicians) who have demonstrated proficiency in auscultatory blood pressure measurement.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not explicitly describe the adjudication method used. For blood pressure validation, when multiple observers are used, a common method is to average their readings, or to use a specific protocol for assessing inter-observer variability, but the details are not provided here.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for this device. This type of study (comparing human readers with and without AI assistance) is not applicable to an automated blood pressure monitor, which performs direct measurements rather than assisting human interpretation of images or signals. The device is designed for standalone measurement.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Performance: Yes, a standalone performance study was conducted. The clinical tests described in the K052450 summary relate directly to the accuracy of the device itself (KD-788 Wrist Measurement Electronic Blood Pressure Monitor) in measuring blood pressure and pulse rate, independent of human interpretation or assistance during the measurement process. The primary outcome was how well the device’s readings correlated with reference auscultatory measurements.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used would have been expert auscultatory measurements. This means trained human observers manually measured blood pressure using a stethoscope and sphygmomanometer, and these readings served as the reference standard against which the KD-788 device's readings were compared.

8. Sample Size for the Training Set

Training Set Sample Size: The document does not explicitly mention a separate "training set" or its size. For a device like an automated blood pressure monitor based on oscillometric technology, the core algorithm is typically developed and refined using extensive datasets during the R&D phase. However, the 510(k) summary focuses on the validation or test set performance to meet the AAMI standard. Details of internal algorithm development and associated training data are generally not part of a 510(k) summary, which focuses on validation of the final product.

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

Training Set Ground Truth: As with the training set size, the document does not provide details on how ground truth for any internal training data was established. Assuming standard practice, any internal data used for algorithm development and refinement would also have relied on expert auscultatory measurements or other well-established reference methods.

Summary

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K052450
pi/2

510(k) Summary FEB 2 8 2006

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:	08/08/2005

Identification of the product:

Device proprietary Name:	KD-788 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.	K030359

Device description:

Intended use:

KD-788 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 writt according to the instruction in the user's guide manual.

Comparison of technological characteristics of new device to predicate devices:

The design of KD-788 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 ANSIIAAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.

Non-clinical Tests:

non-clinical tests All coincide the following 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping lines or stripes, creating an abstract design. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2006

Kodon (Tianjin) Electronic & Apparatus Co., LTD c/o Mr. Liu Yi No 31, Chiangjiang Road Nankai District, Tianjin P.R. CHINA, 300193

Re: K052450

Trade Name: KD-788 Wrist Measurement Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR § 870.1130 Regulation Name: Noninvasive Blood Measurement System Monitor Regulatory Class: II (two) Product Code: DXN Dated: January 30, 2006 Received: January 30, 2006

Dear Mr. Yi :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assession 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). and obsinctive fore, 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 adultcration.

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 r least of advised that i Drives and over device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must or any ireded statutes and regulations assimments, including, but not limited to: registration and listing (21 comply with an the Act 3 requirements) nierally, sood manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (events (everiled in your Section 510(k) This letter will anow you to begin hantening of substantial equivalence of your device to a legally premits tourneation. The PDF Intellig of cation 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 If you desire specific acries for Jour as 1) 276-0120. Also, please note the regulation entitled, Colliable of Compuner and the the the time to the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Rimmmer 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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K052450

Indications for Use

510(k) number:

Device name: KD-788 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)

Blumenthal

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).