WA100WA200MA300/WB100/WB200/WD100/WE100/WF100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use (without the involvement of professional physician)

AA100/AA200/AB100/AC100/AD100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory for home care use (without the involvement of professional physician)

Device Description

Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on.

The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base:

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric . method).
· · Heart beat rate.

For this submission, two different types of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WD100/WE100/WF100/WB200 and A series upper arm type/model AÁÍ00/AA200/AD100/AC100/AF100/AE100/AC200/AC300.

In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200WA300/WB100/WB200/ WD100/WE100/WF100 and A series opper arm type/model AA100/AA200/AB100/AC100/AD100 blood pressure monitors provide also the mpen an function for user to store the result of measurement.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ningbo Diaier Electronic Co., Ltd. Blood Pressure Monitor:

Disclaimer: The provided 510(K) summary and correspondence focus heavily on substantial equivalence to predicate devices and compliance with voluntary standards (like ANSI/AAMI SP 10-2002). It does not contain detailed information about specific acceptance criteria or the full study protocol/results in the manner typically presented for clinical trials or performance studies of diagnostic algorithms. The information below is extracted directly from the provided text, and where details are missing, it is noted.

Acceptance Criteria and Device Performance

The core of the acceptance criteria appears to be compliance with established voluntary standards for blood pressure monitors, specifically ANSI/AAMI SP 10-2002. This standard sets benchmarks for accuracy and other performance aspects of automated sphygmomanometers. While the specific numerical acceptance criteria from ANSI/AAMI SP 10-2002 are not explicitly stated in the document, compliance with this standard implies that the device meets those established criteria.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text)

Acceptance Criterion	Specific Metric (Implicitly from ANSI/AAMI SP 10-2002)	Reported Device Performance
Accuracy of Blood Pressure Measurement	Mean Difference (Device vs. Reference) ± Standard Deviation for Systolic BP	Achieves compliance with ANSI/AAMI SP 10-2002
	Mean Difference (Device vs. Reference) ± Standard Deviation for Diastolic BP	Achieves compliance with ANSI/AAMI SP 10-2002
	Absolute Difference (Device vs. Reference) for Systolic BP	Achieves compliance with ANSI/AAMI SP 10-2002
	Absolute Difference (Device vs. Reference) for Diastolic BP	Achieves compliance with ANSI/AAMI SP 10-2002
Heart Rate Measurement	Accuracy of Heart Rate	Achieves compliance with ANSI/AAMI SP 10-2002
Safety	Electrical Safety (e.g., leakage current, shock)	Achieves compliance with EN 60601-1
Electromagnetic Compatibility (EMC)	Immunity to interference, emissions	Achieves compliance with EN 60601-1-2
Software Performance	Software verification based on FDA guidance	Verification carried out according to FDA guidance

Note on Reported Device Performance: The document states "Compliance to applicable voluntary standards includes ANSI/AAMI SP 10-2002." This is a general statement of compliance, not a presentation of the numerical performance results (mean difference, standard deviation, etc.) that would typically be reported from a validation study against the standard. The study (or "discussion of non-clinical tests") is presented as demonstrating this compliance.

Study Details

The provided text describes the "Discussion of Non-Clinical Tests Performed" as the basis for determining substantial equivalence. This "study" primarily consists of testing for compliance with voluntary standards.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. ANSI/AAMI SP 10-2002, which the device claims compliance with, typically dictates specific subject numbers for clinical validation (e.g., at least 85 subjects with specific age and BP ranges). However, the document does not break down the number of subjects used for this specific submission's testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given the company is Chinese, the testing likely occurred in China, but this is an inference, not stated fact. The phrasing "discussion of non-clinical tests performed" suggests prospective testing done for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not explicitly stated. For validation against ANSI/AAMI SP 10-2002, at least two trained observers (experts in auscultatory measurement) are required for reference BP measurements, typically using a mercury sphygmomanometer or validated equivalent. The qualifications would include specific training and demonstrated proficiency in auscultatory blood pressure measurement. The document implies that such standard procedures were followed by claiming compliance to the standard.
Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. For ANSI/AAMI SP 10-2002, the reference blood pressure is typically the average of the two expert observers' measurements, provided they are within a specified agreement. If not, a third expert or repeat measurement might be involved, but details are not provided here.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where human interpretation is involved. This device is a standalone blood pressure monitor, not an AI assistance tool for human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the testing described (compliance with ANSI/AAMI SP 10-2002) is a standalone performance test. It evaluates the device's accuracy in measuring blood pressure and heart rate without human intervention influencing the measurement process itself, other than proper application of the cuff and initiation of the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The ground truth for blood pressure measurement, as per ANSI/AAMI SP 10-2002, is typically established by simultaneous auscultatory measurements performed by trained observers using a calibrated reference device (like a mercury sphygmomanometer). This can be considered a form of "expert measurement" or "reference standard measurement."
The sample size for the training set:
- Training Set Sample Size: Not applicable/not stated. As a standalone diagnostic device based on an Oscillometric method, it's not a machine learning model that undergoes "training" in the sense of a deep learning algorithm requiring a separate training set. The device's algorithm would have been developed and validated internally, but the concept of an external "training set" as understood for AI is not present here.
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable, as there isn't a "training set" in the context of an AI/ML algorithm. The device's internal algorithms would have been developed and refined using internal methods and potentially reference data, but this is part of product development, not a separate "training set ground truth" for regulatory submission.

Summary

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K123839 pg lap2

JAN 1 1 2013

510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(K) number is: (

1) Submitter's Identifications:

Ningbo Diaier Electronic Co., Ltd.

NO 55, Beixing Rd., Mazhu Town, Yuyao City, Zhejiang Province, P. R. China

Contact: Lao XiKun

Phone: 0574-62463008

Fax: 0574-62463005

E-mail: laurens@diaier.net

Date of Summary Preparation: Dec. 10, 2012

2) Name of the Device:

Blood Pressure Monitor; WA & AA Series including the following models:

Wrist type: WA100; WA200; WD100; WE100; WF100; WF100; WB200

Arm type: AA100; AA200; AD100; AB100; AC100; AF100; AE100; AC200; AC300

3) Classification information:

Regulation Number :	870.1130
Medical Specialty :	Cardiovascular Devices
Product Code :	DXN
Device Class :	II
Tier :	II

Device Description: 4)

Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric . method).
· · Heart beat rate.

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main intended use for these two types of blood pressure monitor is as the description of the following section:

1. Intended Use:
WA100/WA200WD100/WE100/WB200 blood pressure monitor measures automatically . human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use (without the invalvement of professional physician).
AA100/AA200/AD100/AB100/AC100/AF100/AC200/AC300 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory for home care use (without the involvement of professional physician).
Comparison to the 510(K) Cleared Device (Predicate Device): 6) Diaier model WA400 (K091553) for W series wrist model models: . WA100/WA200/WD100/WE100/WF100/WB200
Diaier model AA300(K091553) for A series upper arm model : . AA100/AA200/AD100/AB100/AC100/AF100/AE100/AC200/AC300
Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence is as 7) follows:
. Compliance to applicable voluntary standards includes ANSI/AAMI SP 10-2002, as well as EN 60601-1, and EN 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software quidance.

8) Conclusions:

The Diaier W series model WA100/WA200WD100/WE100/WF100/WB200 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the Dia nor (10(K) cleared model WA400 (K091553), and A series model

AA100/AA200/AD100/AB100/AC100/AE100/AC200/AC300 blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the Diaier 510(() cleared model AA300 (K091553).

Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintiain the same safety and effectiveness as that of cleared devices.

In the other words, those engineering difference do not:

1. affect the intended use or
alter the fundamental scientific technology of the device, and the new models as mentioned on 2) this submission are considered substantial equivalent to the predicate devices

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 1 2013

Ningbo Diaier Electronic Co., LTD c/o Mr. Lao Xikun Yaoxi Industrial Zone, Yuyao City, Zhejiang China 315400

Re: K123839

Trade/Device Name: Blood Pressure Monitor wa100, wa200, wd100, we100, wf100, wb200, aa100, aa200, ab100, ac100, af100, ac200, ac200, ac300 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 4, 2012 Received: December 13, 2012

Dear Mr. Xikun:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Lao Xikun

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indication for use statement

510(K) Number (if known):

Device Name: Blood Pressure Monitor

WA series wrist models: WA100/WA200/WD100/WE100/WF100/WB200 and

AA series upper arm models: AA100/AA200/AD100/AC100/AC100/AC100/AC200/AC300

Indications for use:

"WA100WA200MA300/WB100/WB200/WD100/WE100/WF100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use (without the involvement of professional physician)"

"AA100/AA200/AB100/AC100/AD100 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory for home care use (without the involvement of professional physician)"

Prescription Use_ or (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

123859 510(k) Number

Page 1 of 1

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).