(117 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using a pneumatic system and software to calculate blood pressure and heart rate from pressure changes. There is no mention of AI, ML, or any advanced algorithms beyond the standard oscillometric method.
No
The device measures blood pressure and heart rate for monitoring purposes, but it does not treat any condition.
Yes
Explanation: The device measures automatic human systolic, diastolic blood pressure and heart beat rate, providing objective measurements of physiological processes to aid in health monitoring, which fits the definition of a diagnostic device, even for home use.
No
The device description explicitly lists hardware components such as a pressure sensor, measuring cuff, pneumatic pump, inflation/deflation system, housing, and LCD display, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections.
- Device Function: The WA400 and AA300 blood pressure monitors measure blood pressure and heart rate directly from the human body (wrist or upper arm) using the Oscillometric method. They do not analyze samples taken from the body.
- Intended Use: The intended use is for measuring physiological parameters (blood pressure and heart rate) directly from the individual, not for analyzing biological samples.
Therefore, these devices fall under the category of non-IVD medical devices.
N/A
Intended Use / Indications for Use
WA400 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)
AA300 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, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).
Product codes
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 type of blood pressure monitors are to be included in this 510(K) submission, the wrist type/model WA400 and upper arm type/model AA300. The main intended use for these two type 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 WA400 and AA300 blood pressure monitors provide also the memory function for user to store the result of measurement. AA300 also provides the USB connection port for the transformation of measuring data.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
| SEP 21 2009 |
|---|
| 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.
091553 彩112
The assigned 510(k) number is:
- Submitter's Identifications: Ningbo Diaier Electronic Co., Ltd. No.1, Beixing Rd., Yaoxi Industrial Zone, Yuyao City, Zhejiang, China Contact: Lao XiKun Phone: 0574-62463008 Fax: 0574-62463005 E-mail: sales@diaier.com.cn Date of Summary Preparation: May 25, 2009
-
- Name of the Device: Blood Pressure Monitor, models WA400 for wrist type and AA300 for upper arm type.
-
- Classification information: Regulation Number 870.1130 Medical Specialty Neurology Product Code DXN Device Class Tier
4. 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 type of blood pressure monitors are to be included in this 510(K) submission, the wrist type/model WA400 and upper arm type/model AA300. The main intended use for these two type 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 WA400 and AA300 blood pressure monitors provide also the memory function for user to store the result of measurement. AA300 also provides the USB connection port for the transformation of measuring data.
1
5. Intended Use:
WA400 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)
09/553
AA300 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, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).
- Comparison to the 510(k) Cleared Device (Predicate Device): 6.
-
- 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.
Conclusions
The Diaier model WA400 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the cleared Zen Strong model ZSBP-001 (K070473) . and AA300 blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the Zen Strong cleared model ZSBP-101 (K070473).
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a bird with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Ningbo Diaier Electronic Co., Ltd. c/o Mr. Lao Xikun · General Manager and Official Correspondent No. 1 Beixing Road, Yaoxi Industrial Zone Yuyao City, Zheijang
CHINA
Re: K091553
Trade/Device Name: Blood Pressure Monitor, Model WA400 for wrist type and model AA300 for upper arm type
Regulatory Number: 21 CFR 870.1130
Regulation Name: Non-Invasive Blood Pressure Measurement System
Regulatory Class: Class II (Two)
Product Code: DXN
Dated: August 13, 2009
Received: August 18, 2009
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.
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.
SEP 2 1 2009
3
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 aft 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K09/553
Indications For Use
510(k) Number (if known):
Device Name: Blood Pressure Monitor, models WA400 for wrist type, and AA300 for upper
arm type.
Indications For Use:
WA400 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)
AA300 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, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).
Prescription Use (Part 21 CFR 801 Subpart D)
OR
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)
W.W. Watt.
Division Sian-Off) Division of Cardiovascular Devices Page 1 of
510(k) Number.