(89 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using basic calculations, with no mention of AI or ML terms, training/test data, or complex algorithms.
No.
This device measures blood pressure and pulse rate for diagnostic reference, but it does not treat or alleviate a disease or condition. Its purpose is solely for measurement and diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The values are for diagnostic reference only."
No
The device description explicitly lists hardware components such as a pressure sensor, air pump, valve, cuff, main board, and plastic case, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Wrist Blood Pressure Monitor measures blood pressure and pulse rate using an oscillometric principle applied to the wrist. This is a non-invasive measurement taken directly from the body, not from a sample outside the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate for diagnostic reference. While the values are used for diagnosis, the measurement method itself is not an in vitro test.
Therefore, the Wrist Blood Pressure Monitor falls under the category of a non-invasive medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
Product codes
DXN
Device Description
Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case.
Wrist Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body.
The Wrist Blood Pressure Monitor include two models: YJ110, YJ111
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist (radial artery)
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
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)
Clinical Test Conclusion: YJ110 was tested to ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. the clinical validation data on YJ110 can cover YJ111. The Same Arm Sequential Method was chosen and performed on YJ110. This study included 86 adult subjects (47 females, 39 male) with an age range of 18 to 72 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2023
Zhuhai Yueja Medical Device Technology Co.,Ltd. Feng Yan Department Manager Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone Zhuhai. Guangdong 519000 China
Re: K232815
Trade/Device Name: Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 30, 2023 Received: September 13, 2023
Dear Feng Yan:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232815
Device Name Wrist Blood Pressure Monitor
Indications for Use (Describe)
Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Section 3 510(k) Summary
l 510(k) Submitter
Device Submitter: Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone, Zhuhai, 519000, China
Contact Person: Feng yan Department Manager Phone: +86-18826906029 E-mail: fengy@myzr.com.cn
II Device
| Trade Name of Device: | Wrist Blood Pressure Monitor |
|---|---|
| Regulation Number: | 21 CFR 870.1130 |
| Classification Name: | Electronic Blood Pressure Monitor |
| Product Code: | DXN |
| Regulation Number: | Electronic Blood Pressure Monitor |
| Regulatory Class | II |
| Review Panel | Cardiovascular |
III Predicate Devices
| 510k Number | K223291 |
|---|---|
| Trade Name of Device: | Wrist Blood Pressure Monitor |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Name: | Electronic Blood Pressure Monitor |
| Regulatory Class | II |
| Product Code: | DXN |
IV Device Description
Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case.
Wrist Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body.
The Wrist Blood Pressure Monitor include two models: YJ110, YJ111
5
V Indications for use
Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure. diastolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.
VI Technological Characteristics Comparison
VI-1: Comparison of Wrist Blood Pressure Monitor
| Device
Characteristic | Subject Device | Predicate Device
(K223291) | Discussion |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Type of Blood
Pressure
Monitor | Wrist Blood Pressure
Monitor
YJ110, YJ111 | Wrist Blood Pressure Monitor
PG-800A18, PG-800A19,
PG-800A28, PG-800A51,
PG-800A52, PG-800A11-1,
PG-800A36-1 and
PG-800A37-1 | - |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Indications for
Use | Wrist Blood Pressure
Monitor is used to measure
adult systolic blood
pressure. diastolic blood
pressure and pulse rate.
The values are for
diagnostic reference only.
Suitable for medical
institutions (such as
hospitals, clinics, health
centers, etc.) and home
use. | The Electronic Blood Pressure
Monitor is intended to measure
the systolie and diastolic blood
pressure as well as the pulse
rate of adult person via
non-invasive oscillometric
technique in which an inflatable
cuff is wrapped around the wrist.
It can be used at medical
facilities or at home. The
intended wrist circumference is
13.5-19.5 cm. The patient
population does not include
adolescents aged 12 to