WA100/WA200/WA300/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.

In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200/WA300/WB100/WB200/ WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/AC100/AC100/AD100 blood pressure monitors provide also the memory function for user to store the result of measurement.

AI/ML Overview

The provided 510(k) summary for the Diaier Blood Pressure Monitor does not contain a detailed study report with specific acceptance criteria and performance data for the device itself. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (Diaier model WA400 (K091553) for wrist type and Diaier model AA300 (K091553) for upper arm type).

The document states that "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices." However, the specifics of these tests, including acceptance criteria and reported device performance with numerical data, are not provided in this summary.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an attempt to answer the questions based on the available information and highlighting what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary of Device and Performance Claim:
The Diaier Blood Pressure Monitors (W series for wrist, A series for upper arm) automatically measure human systolic and diastolic blood pressure and heart rate using the oscillometric method. The primary claim for these devices is that they maintain the same safety and effectiveness as their predicate devices (WA400 and AA300 respectively).

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance	Comments
Blood Pressure Accuracy	Not explicitly stated in numerical terms within this summary, but implied to be equivalent to predicate devices.	The document does not provide specific accuracy ranges (e.g., mean difference and standard deviation compared to a reference method, such as those specified in ANSI/AAMI SP10).
Heart Rate Accuracy	Not explicitly stated in numerical terms within this summary, but implied to be equivalent to predicate devices.	Similar to blood pressure, specific heart rate accuracy metrics (e.g., beat-to-beat accuracy) are not provided.
Compliance to Standards	* ANSI/AAMI SP 10-2002 (likely for performance accuracy methods)	The submission states compliance with these standards, implying that the device was tested to meet their requirements. However, the exact performance results against the criteria within these standards are not presented here.
	* EN 60601-1 (medical electrical equipment safety)
	* EN 60601-1-2 (electromagnetic compatibility)
Software Verification	Carried out according to FDA software guidance.	This indicates that software controls and testing were performed, but no specific performance metrics related to software are given.

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

Sample Size: Not specified in the provided summary.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The summary only mentions "verification and validation tests contained in this submission," implying internal testing.

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

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses) using a reference sphygmomanometer following a recognized protocol (e.g., those outlined in ANSI/AAMI SP10).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided. For blood pressure accuracy studies, adjudication would typically involve multiple observers for the reference measurements.

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:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where human readers interpret medical images or data. The Diaier Blood Pressure Monitor is a direct measurement device and does not involve human "readers" or AI assistance in a diagnostic capacity.

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

Yes, performance testing would inherently be standalone (algorithm only) for a blood pressure monitor. The device itself performs the measurement and calculation of blood pressure and heart rate without human intervention during the measurement process. The primary study type would be a clinical accuracy study comparing the device's readings to directly measured or auscultatory reference values. Details of such a study are not provided in this summary.

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

While not explicitly stated, for blood pressure monitors, the ground truth is typically established through simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., auscultatory method with a mercury or aneroid sphygmomanometer). This is a form of expert reference measurement rather than consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not applicable / not provided. Blood pressure monitors using the oscillometric method are based on established physiological principles and algorithms, not typically on machine learning models requiring large "training sets" in the conventional AI sense. The algorithms are usually developed and validated through engineering and clinical trials directly.

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

This information is not applicable / not provided for the same reasons as #8. The algorithms are developed based on physiological models and extensive testing to derive the relationship between oscillations and blood pressure values.

Summary

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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: K093739 .

MAY - 7 2010

Submitter's Identifications: Ningbo Dialer Electronic Co., Ltd. No.1, Beixing Rd., Yaoxl Industrial Zone, Yuyao City, Zhejiang, China Contact: Lao XiKun Phone: 0574-62463008 Fax: 0574-62463005 E-mail: laurens@diaier.net Date of Summary Preparation: May 25, 2009

1. Name of the Device:
  Blood Pressure Monitor; W & A series including the following models;
WA100/WA200/WB100/WB100/WB200/WD100/WE100/WF100 for wrist type, and -
AA100/AA200/AB100/AC100/AD100 for upper arm type.

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

1. 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.

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

For this submission, two different type of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WA300/WB100/ WB200/WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/ AB100/AC100/AD100. The main intended use for these two type of blood pressure monitor is as the description of the following section:

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5. Intended Use:

"WA100/WA200/WB100/WB200/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)"

1. Comparison to the 510(k) Cleared Device (Predicate Device):
- 1> Diaier model WA400 (K091553) for W series wrist model models: WA100/WA200/ WA300/WB100/WB200/WD100/WE100/WF100 .
- 2> Diaier model AA300(K91553) for A series upper arm model : AA100/AA200/AB100 IAC100/AD100.
1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as 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/WA200/WA300/WB100/WB200/WD100/WF100 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the Diaier 510K cleared model WA400(K091553) , and A series model AA100/AA200/AB100/AC100/AD100 blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the Diaier 510K 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 maintain 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 (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ningbo Diaier Electronic, Co., Ltd. c/o Mr. Lao XiKun Official Correspondent No 1., Beixing Rd., Yaoxi Industrial Zone Yuyao City, Zhejiang CHINA

MAY - 7 2010

Re: K093739

Device Name: Blood Pressure Monitor, Models WA100, WA200, WA300, WB100, WB200, WD100, WE100, WF100, AA100, AA200, AB100, AC100, and AD100 Regulation Number: 21 CFR 870.1130 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DXN Dated: April 16, 2010 Received: April 21, 2010

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 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); 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.

W. Wood

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 (if known):

K0937339

Device Name: Blood Pressure Monitor, W series wrist type models : WA100/WA200/ WA300/WB100/WB200/ WD100/WE100/WF100 and A series upper arm type models: AA100/AA200/AB100/AC100/AD100

Indications For Use:

"WA100/WA200/WA300/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)"

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use V (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)

W.M.R.

diovascular Devices

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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).