(144 days)
Not Found
No
The description details standard oscillometric blood pressure measurement and basic irregular heartbeat detection based on rhythm variation, without mentioning AI or ML algorithms.
No
Explanation: The device is a monitor intended for measuring blood pressure and pulse rate, providing information rather than directly treating or preventing a condition.
Yes
Explanation: The device is used for "measuring blood pressure and pulse rate," which are diagnostic measurements of vital signs. It also "detects the appearance of irregular heartbeats," providing a warning signal, further indicating its role in identifying potential medical conditions.
No
The device description explicitly details hardware components such as a battery, integral pump, electric valve, and wrist cuff, indicating it is a physical device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states that this device is a non-invasive blood pressure system that measures blood pressure and pulse rate by applying a cuff to the wrist. This is a measurement taken on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients, not to analyze biological samples for diagnostic purposes.
Therefore, based on the provided information, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device are digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging form 5 3/8 inches to 7 2/3 inches (13.5cm to 19.5cm) .
The devices detect the appearance of irregular heatbeats during measurement and gives a warning signal with readings.
Product codes
DXN
Device Description
The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are battery-powered, automatic, non-invasive blood pressure system intended for home use. The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). These devices are powered by 2 X AAA battery. The device wrist cuff inflates using an integral pump and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse rate range from 40 to 195 beats/min. When the device detected irregular rhythms, " Y " will display on screen. An irreqular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 99 readings can be stored in memory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
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:
IEC 80601-2-30:2018 require compliance of clinical accuracy should be checked by application of the tests of ISO 81060-2:2013, we conducted the the clinical study in accordance with this standard.
Non-clinical data
The Wrist Blood Pressure Monitor comply with:
Safety and performance:
- IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers Electromagnetic Compatibility:
- IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility: - ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of pressure: ±3mmHg
Accuracy of pulse rate: ±5% of reading
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
August 30, 2021
Shenzhen Yuezhongxing Technology Co., Ltd. Yuchao Chen Sales Manager No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen, Guangdong 518015 China
Re: K211041
Trade/Device Name: Wrist Blood Pressure Monitor (model: W203, W202, W1681) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 7, 2021 Received: July 27, 2021
Dear Yuchao Chen:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.
For comprehensive regulatory information about medical devices and radiation-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,
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
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Indications for Use
510(k) Number (if known) K211041
Device Name
Wrist Blood Pressure Monitor (model: W203, W202, W1681)
Indications for Use (Describe)
The device are digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging form 5 3/8 inches to 7 2/3 inches (13.5cm to 19.5cm) .
The devices detect the appearance of irregular heatbeats during measurement and gives a warning signal with readings.
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)
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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: March 18, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Shenzhen Yuezhongxing Technology Co., Ltd. |
|---|---|
| Address: | No.2, Zhenye Road, Liulian Community, Pingshan Avenue, |
| Pingshan District, Shenzhen,518015,CHINA | |
| Contact person: | Yuchao Chen |
| Title: | Sales manager |
| E-mail: | 718145238@qq.com |
| Tel: | +86-135 1039 4198 |
2. Device Identification
| 510(K) number: | K211041 | |
|---|---|---|
| Trade/Device Name: | Wrist Blood Pressure Monitor | |
| Models:W203,W202,W1681 | ||
| Regulation Number: | 21 CFR 870.1130 | |
| Regulation Name: | Noninvasive blood pressure measurement system | |
| Common Name: | System, Measurement, Blood-Pressure, Non-Invasive | |
| Regulation Class: | Class II | |
| Product Code: | DXN | |
| Panel: | Cardiovascular |
3. Predicate Device
| 510(K) number: | K190693 |
|---|---|
| Device Name: | HEM-6410T-ZL Wrist Blood Pressure Monitor |
| Manufacturer: | Omron Healthcare, Inc. |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Name: | Noninvasive blood pressure measurement system |
| Common Name: | System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation Class: | Class II |
| Product Code: | DXN |
| Panel: | Cardiovascular |
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4. Device Description
The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are battery-powered, automatic, non-invasive blood pressure system intended for home use. The Wrist Blood Pressure Monitor (model: W203,W202,W1681) are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). These devices are powered by 2 X AAA battery. The device wrist cuff inflates using an integral pump and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse
rate range from 40 to 195 beats/min. When the device detected irregular rhythms, " Y " will display on screen. An irreqular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2) 99 readings can be stored in memory.
5. Indication for use
The devices are a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 3/8 inches (13.5cm to 19.5cm). The devices detect the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
5
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE Comparisons | Proposed devices | Predicate device | Note |
|---|---|---|---|
| Indication for use | Automatic Wrist Blood | ||
| Pressure Monitor | |||
| (model: W203,W202,W1681) | |||
| K211041 |
The devices are a digital
monitor intended for use in
measuring blood pressure
and pulse rate in adult patient
population with wrist
circumference ranging from 5
3/8 inches to 7 2/3 inches
(13.5cm to 19.5cm).
The devices detect the
appearance of irregular
hearbeats during
measurement and gives a
warning singal with reading | Omron HEM-6410
K190693
The device is a digital
monitor intended for use in
measuring blood pressure
and pulse rate in adult
patient population with wrist
circumference ranging from
7.1 to 8.5 inches(18.0cm to
21.5cm)
The device detects the
appearance of irregular
hearbeats during
measurement and gives a
warning singal with reading | See Note 1 |
| Environment of
use | Home | Home | Same |
| Patient
population | Adult | Adult | Same |
| Contraindication | The monitor is contraindicated
for use in ambulatory
environment.
The monitor is contraindicated
in aircraft. | The monitor is
contraindicated for use in
ambulatory environment.
The monitor is
contraindicated in aircraft. | Same |
6
K211041
Traditional 510(k) Submission of Wrist Blood Pressure Monitor
Yuezhongxing
| Principle of
| operation | Cuff oscillometric method | Cuff oscillometric method | Same |
|---|---|---|---|
| Measurement | |||
| range | Pressure:0 to 295 mmHg | ||
| Pulse rate: 40 to 195 | |||
| beats/min | Pressure:0 to 299 mmHg | ||
| Pulse rate: 40 to 180 | |||
| beats/min | See Note 2 | ||
| Pressure sonsor | Semiconductor pressure | ||
| sensor | Semiconductor pressure | ||
| sensor | Same | ||
| Wrist | |||
| circumference | 13.5-19.5 cm | 18.0 to 21.5cm | See Note 1 |
| Accuracy of | |||
| pressure | ±3mmHg | ±3mmHg | Same |
| Accuracy of | |||
| pulse rate | ±5% of reading | ±5% of reading | Same |
| Inflation method | Automatic inflation with | ||
| piezoelectric pump | Automatic inflation with | ||
| piezoelectric pump | Same | ||
| Deflation method | Automatic rapid deflation | ||
| valve | Automatic rapid deflation | ||
| valve | Same | ||
| display | LCD | LCD | Same |
| Power source | 2 x AAA batteries | Rechargeable Li-ion battery | See Note 3 |
| Operation | |||
| condition | 5 to 40°C (41 to 104°F) | ||
| 15 to 85% RH | |||
| (non-condensing) | |||
| 800 to 1060hPa | 5 to 40°C (41 to 104°F) | ||
| 15 to 85% RH | |||
| (non-condensing) | |||
| 800 to 1060hPa | Same | ||
| Storage condition | -20 to 55°C | ||
| 10 to 93%RH | -20 to 40°C (-4 to 104°F) | ||
| 10 to 90%RH | |||
| (non-condensing) | See Note 4 | ||
| Transportation | |||
| condition | -20 to 55°C | ||
| 10 to 93%RH | -20 to 60°C (-4 to 140°F) 10 | ||
| to 90%RH | |||
| (non-condensing) | See Note 4 | ||
| Irregular heart | |||
| beat feature | Yes | Yes | Same |
| Body movement | |||
| detection | No | Yes | See Note 5 |
| Hypertension | |||
| indication | Yes | Yes | Same |
| Advanced | |||
| position sensor | No | Yes | See Note 5 |
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K211041
Traditional 510(k) Submission of Wrist Blood Pressure Monitor
Yuezhongxing
Note 1: Wrist cuff size is different. Do not impact safety or performance of device.
Note 2: The measurement range of blood pressure and pulse rate of proposed devices is wider than predicate device, the clinical accuracy tests were conducted on proposed devices, so it is equal to predicate device at safety and effectiveness.
Note 3: Proposed devices are powered by 2 x AAA batteries, safety risk is lower than Li-ion battery of predicate device.
Note 4: After conducting simulate transportation test, result shows no risk arise.
Note 5: Proposed devices are without Body movement detection and Advanced position sensor feature, this does not affect the safety and main measurement function.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
8. Performance Data
Clinical test:
IEC 80601-2-30:2018 require compliance of clinical accuracy should be checked by application of the tests of ISO 81060-2:2013, we conducted the the clinical study in accordance with this standard.
Non-clinical data
The Wrist Blood Pressure Monitor comply with:
Safety and performance:
-
IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
-
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
8
Traditional 510(k) Submission of Wrist Blood Pressure Monitor
- IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for
the basic safety and essential performance of automated non-invasive sphygmomanometers Electromagnetic Compatibility:
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic 4. safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility:
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro 6. cytotoxicity
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
9. Conclusion
Information included in this premarket notification supports the substantial equivalence of the proposed Wrist Blood Pressure Monitor (model: W203,W202,W1681). The proposed device has the identical indications for use and fundamental technology as the primary predicate device cleared under premarket notification K190693. The results of the testing support a determination of substantial equivalence. The minor differences in wrist strap size and Body movement detection and Advanced position sensor feature have been evaluated and determined to not raise different questions of safety or effectiveness. As such, the proposed devices are substantially equivalent to the predicate device.