(29 days)
Not Found
No
The description focuses on the Oscillometric method and standard blood pressure measurement components. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is a blood pressure monitor, which measures blood pressure and heart rate. It is described as a diagnostic or monitoring device, not a device intended to treat or resolve a medical condition.
Yes
This device measures systolic and diastolic blood pressure and heart rate, which are physiological parameters used to assess a patient's health status and can indicate the presence of conditions like hypertension or arrhythmias. Therefore, it is a diagnostic device.
No
The device description explicitly lists hardware components such as a pressure sensor, measuring cuff, pneumatic pump, inflation and deflation system, housing, and display LCD, in addition to the measuring software. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device measures blood pressure and heart rate directly from the body (wrist or upper arm) using a physical method (Oscillometric). It does not analyze a biological sample.
The description clearly states it measures "human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method" and "from upper arm by using the Oscillometric method". This is a direct physiological measurement, not an in vitro analysis of a sample.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
DXN
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 AAÍ00/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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, upper arm
Indicated Patient Age Range
over 18 years old
Intended User / Care Setting
Home Care Use (without the involvement of professional physician)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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)
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. The
1
main intended use for these two types of blood pressure monitor is as the description of the following section:
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.
-
- 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:
-
- 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.
3
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
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