The KD-726 Memory Wrist 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-726 Memory Wrist Automatic Electronic 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) document for the KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor:

Acceptance Criteria and Device Performance Study for KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor

The device demonstrated compliance with the accuracy requirements of ANSI/AAMI SP10-1992.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Test Type/Parameter	Required Performance (from ANSI/AAMI SP10-1992)	Reported Device Performance
ANSI/AAMI SP10-1992	Accuracy	Meets or exceeds general accuracy requirements for non-invasive automated sphygmomanometers.	"The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992."

Note: The 510(k) summary does not explicitly break down specific quantitative metrics (e.g., mean difference, standard deviation) for blood pressure accuracy as outlined in ANSI/AAMI SP10-1992. It broadly states compliance with the standard's accuracy requirements.

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

The document does not specify the sample size used for the clinical test set.
The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not explicitly stated. It can be inferred that the study was likely prospective given it's a clinical test for device validation.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood pressure monitors, ground truth is typically established by trained observers using a reference standard like a mercury sphygmomanometer, not necessarily "experts" in the sense of radiologists.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. For blood pressure monitor accuracy studies, a robust methodology typically involves multiple trained observers taking readings and potentially averaging them or performing statistical comparisons to a reference. However, these specific details are not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For an automated blood pressure monitor, the focus is on the device's accuracy relative to a reference standard, not on human reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical test described is inherently a standalone performance evaluation. The KD-726 is an automatic electronic blood pressure monitor, meaning its measurement is performed by the algorithm/device itself, without human intervention in the measurement process (though a human applies the cuff and initiates the reading). The clinical test assesses the accuracy of these automated measurements.

7. The Type of Ground Truth Used

Based on common practices for blood pressure monitor validation and the reference to ANSI/AAMI SP10-1992, the ground truth would typically be established by:

Reference standard measurement: Simultaneous or near-simultaneous measurements taken by trained observers using a validated reference method (e.g., a mercury sphygmomanometer) on the same subjects.
Expert consensus (implied for accuracy): While not 'expert consensus' in the typical imaging sense, the "correct" blood pressure readings used as ground truth would be agreed upon by qualified personnel following a standardized protocol.

The document itself does not explicitly state the type of ground truth beyond fulfilling the ANSI/AAMI SP10-1992 requirements, which implicitly defines the ground truth method.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. As an automated blood pressure monitor based on oscillometric technology, it is not a machine learning or AI device in the modern sense that typically requires a large 'training set' for model development. The device's algorithms are likely based on established physiological principles and signal processing, rather than learning from a large dataset.

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

Since there is no mention of a "training set" in the context of machine learning/AI, the question of how its ground truth was established is not applicable. The device's operational principles and algorithms would have been developed using engineering and physiological knowledge, not through a data-driven training process with ground truth labels.

Summary

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K030359

510k document for KD-726 Memory Wrist Automatic Electronic Blood Pressure Mor

NOV - 6 2003

510(k) Summary

ldentification of the submitter:

Submitter:	Kodon (Tianjin) Electronic & Electrical ApparatusCo., LTDNo 31, Changjiang Road, Nankai District, Tianjin,P.R. China, 300193
Telephone number:	86-22-27470070
Fax number:	86-22-27371293
Contact:	Liu Yi
Date of Application:	01/28/2003

ldentification of the product:

Device proprietary Name:	KD-726 Memory Wrist Automatic 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
HEM-630	OMRON HEALTHCARE, INC.	K001671

Device description:

Intended use:

KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor is 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

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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-726 Memory Wrist Automatic 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:

non-clinical tests coincide the following standards, including All 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2003

Kondon (Tianjin) Electronic & Electrical Apparatus Co., Ltd. c/o Mr. Liu Yi Presdient, Board of Directors No. 31. Changjiang Road Nankai District Tianjin CHINA 300193

Re: K030359

Trade Name: KD-726 Memory Wrist Automatic Electronic 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: September 22, 2003 Received: September 22, 2003

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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely yours,

cmeyar moye

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

Applicant:	Kondon (Tianjin) Electronic & Electrical Apparatus Co., LTD
510(k) number:	K030359
Device name:	KD-726 Memory Wrist Automatic Electronic Blood Pressure Monitor

Indications for use:

Marta Mayer for BDZ

Author Sign on

510(k) Number K030354

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).