(107 days)
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 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
The Wrist Blood Pressure Monitor,Models: 222,222BT,W1681BL, W1681BT, W1681R are powered by a rechargable Li-ion battery, automatic, non-invasive blood pressure system intended for home use. The devices 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). The devices' wrist cuff inflates using an integral pump and deflates via an electric valve. During deflation, 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 199 beats/min.
When the device detected irregular rhythms, " W " will display on screen. An irregular 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 x 99 readings can be stored in memory.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name(s): Wrist Blood Pressure Monitor (Models: 222, 222BT, W1681BL, W1681BT, W1681R)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Requirement) | Reported Device Performance (Subject Device) |
|---|---|
| ISO 81060-2:2018 Criterion 1: Mean difference (device vs. reference) | Systolic BP: 1.0 mmHg Diastolic BP: 0.9 mmHg |
| ISO 81060-2:2018 Criterion 1: Standard deviation of differences (device vs. reference) | Systolic BP: 3.1 mmHg Diastolic BP: 3.4 mmHg |
| ISO 81060-2:2018 Criterion 2: Standard deviation (device vs. reference) | Systolic BP: 2.4 (from Table 1, assumed to be an overall standard deviation) Diastolic BP: 2.6 (from Table 1, assumed to be an overall standard deviation) |
| Cuff Pressure Accuracy | ±3 mmHg |
| Pulse Accuracy | ±5% of reading |
| ISO 81060-2:2018 standard acceptance | Met |
| IEC 60601-1:2005+A1:2012+A2:2020 (Basic Safety & Essential Performance) | Complies |
| IEC 60601-1-11:2015 (Home Healthcare Environment) | Complies |
| IEC 80601-2-30:2018 (Automated Non-Invasive Sphygmomanometers) | Complies |
| IEC 60601-1-2:2014 (Electromagnetic Compatibility) | Complies |
| ISO 10993-10:2010 (Biocompatibility - Irritation/Sensitization) | Complies |
| ISO 10993-5:2009 (Biocompatibility - Cytotoxicity) | Complies |
| FDA Software Validation Guidance (General Principles of Software Validation) | Complies (for moderate level of concern) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 86 subjects.
- Data Provenance: Clinical investigation conducted by Shenzhen Cihai Hospital (China), prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience for physicians/nurses performing the reference measurements). It states that the "auscultatory method (mercury sphygmomanometer)" was used as the reference standard, implying trained human operators.
4. Adjudication Method for the Test Set
The document states that the mean value and standard deviation of differences between the device and the mercury sphygmomanometer were calculated according to ISO 81060-2:2018. This suggests a direct comparison rather than a multi-reader adjudication process in the traditional sense for medical imaging or diagnostic algorithms. For blood pressure measurement, the reference standard (auscultatory method) intrinsically relies on trained observers.
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 MRMC comparative effectiveness study was done. This type of study is not applicable to a standalone wrist blood pressure monitor, which directly measures physiological parameters rather than assisting human readers in interpreting complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done for the device's accuracy in measuring blood pressure and pulse rate. The device operates independently to provide these measurements.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy study was established using the auscultatory method with a mercury sphygmomanometer, as described in ISO 81060-2:2018. This is considered a gold standard for non-invasive blood pressure measurement.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The clinical study described appears to be for validation/testing, not for training a model. Blood pressure monitors typically implement algorithms based on established physiological principles (oscillometry) and are calibrated, rather than "trained" in the machine learning sense with a distinct training dataset.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" for an AI algorithm is mentioned in the context of the device's accuracy claims, this question is not directly applicable. The device's underlying measurement principle (oscillometric method) and its calibration would rely on established scientific and engineering practices, not on ground truth established from a training dataset in the AI sense.
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March 15, 2024
Shenzhen Yuezhongxing Technology Co., Ltd. Yuchao Chen Sales Manager No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen, Guangdong 518015 China
Re: K233799
Trade/Device Name: Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 29, 2024 Received: February 29, 2024
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 (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.
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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.
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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
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Indications for Use
Submission Number (if known)
Device Name
Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
Indications for Use (Describe)
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 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
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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510(K) Summary
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
| Trade/Device Name: | Wrist Blood Pressure Monitor |
|---|---|
| Models: | 222, 222BT, W1681BL, W1681BT, W1681R |
| 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: | K211041 |
|---|---|
| Device Name: | Wrist Blood Pressure Monitor |
| Models: | W1681 |
| Manufacturer: | Shenzhen Yuezhongxing Technology Co., Ltd. |
| 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,Models: 222,222BT,W1681BL, W1681BT, W1681R are powered by a rechargable Li-ion battery, automatic, non-invasive blood pressure system intended for home use. The devices 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). The devices' wrist cuff inflates using an integral pump and deflates via an electric valve. During deflation, 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 199 beats/min.
When the device detected irregular rhythms, " W " will display on screen. An irregular 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 x 99 readings can be stored in memory.
5. Indication for use
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 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
6. Compared to Predicate Device
Compare to the predicate devices, the subject device has same intended use, similar product design, same performance,same safety as the predicate device, the summarized comparison information is listed in the following table
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| Traditional 510(k) Submission of Wrist Blood Pressure Monitor | |||
|---|---|---|---|
| ---------------------------------------------------------------- | -- | -- | -- |
Yuezhongxing
| SE Comparisons | SubjectdeviceWrist BloodPressureMonitor,Model:202 | SubjectdeviceWrist BloodPressureMonitor,Model:202BT | SubjectdeviceWrist BloodPressureMonitor,Model:W1681BL | SubjectdeviceWrist BloodPressureMonitor,Model:W1681BT | SubjectdeviceWrist BloodPressureMonitor,Model:W1681R | Predicate deviceAutomatic Wrist BloodPressure Monitor,Model: W1681(K211041) | Note |
|---|---|---|---|---|---|---|---|
| Indication for use | The device is a digital monitor intended for use in measuring blood pressureand pulse rate in adult patient population with wrist circumference ranging from5 3/8 inches to 7 2/3 inches (13.5cm to 19.5cm). The device detects theappearance of irregular hearbeats during measurement and gives a warningsignal with reading. | The device is a digitalmonitor intended for use inmeasuring blood pressureand pulse rate in adultpatient population with wristcircumference ranging from5 3/8 inches to 7 2/3 inches(13.5cm to 19.5cm).The devices detect theappearance of irregularhearbeats duringmeasurement and gives awarning singal with reading | Same | ||||
| Environment ofuse | Home | Home | Same | ||||
| Patientpopulation | Adult | Adult | Same | ||||
| Contraindication | The monitor is contraindicated for use in ambulatory environment.The monitor is contraindicated in aircraft.Use of this instrument on patients under dialysis therapy or on anticoagulant,antiplatelets, or steroids could cause internal bleeding. | The monitor iscontraindicated for use inambulatory environment.The monitor iscontraindicated in aircraft. | Note 1 | ||||
| Principle ofoperation | Cuff oscillometric method | Cuff oscillometric method | Same | ||||
| Measurementrange | Cuff Pressure: 0-295 mmHg,Pulse: 40-195/minute,Diastolic Pressure: 30-180mmHg | Cuff Pressure:0-295 mmHg,Pulse: 40-195/minute | Same |
510(k) Summary
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| Traditional 510(k) Submission of Wrist Blood Pressure Monitor | |
|---|---|
| ---------------------------------------------------------------- | -- |
Yuezhongxing
| SE Comparisons | SubjectdeviceWrist BloodPressureMonitor,Model:202 | SubjectdeviceWrist BloodPressureMonitor,Model:202BT | SubjectdeviceWrist BloodPressureMonitor,Model:W1681BL | SubjectdeviceWrist BloodPressureMonitor,Model:W1681BT | SubjectdeviceWrist BloodPressureMonitor,Model:W1681R | Predicate deviceAutomatic Wrist BloodPressure Monitor,Model: W1681(K211041) | Note |
|---|---|---|---|---|---|---|---|
| Systolic Pressure: 50-270mmHg | Diastolic Pressure:30-180mmHg,Systolic Pressure:50-270mmHg | ||||||
| Pressure sonsor | Semiconductor pressure sensor | Semiconductor pressuresensor | Same | ||||
| Wristcircumference | 13.5-19.5 cm | 13.5-19.5 cm | Same | ||||
| Accuracy | Cuff Pressure: ±3mmHgPulse: ±5% of readingThe accuracy of diastolic and systolic pressure meets the requirements of ISO81060-2:2018 | Cuff Pressure: ±3mmHgPulse: ±5% of readingThe accuracy of diastolicand systolic pressure meetsthe requirements of ISO81060-2:2018 | Same | ||||
| Inflation method | Automatic inflation with piezoelectric pump | Automatic inflation withpiezoelectric pump | Same | ||||
| Deflation method | Automatic rapid deflation valve | Automatic rapid deflationvalve | Same | ||||
| Screen | LED | LED | LCD | LCD | LCD | LCD | Note 2 |
| Power source | Rechargeable Li-ion battery. 3.7Vdc300mAhCharged by Adapter, Input:100-240V 50/60Hz 0.2A,Output:5.0Vdc 1.0A | 2 x AAA batteries | SeeNote 3 | ||||
| Bluetooth | No | Yes | No | Yes | No | No | Note 4 |
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| Traditional 510(k) Submission of Wrist Blood Pressure Monitor | |
|---|---|
| ---------------------------------------------------------------- | -- |
Yuezhongxing
| SE Comparisons | SubjectdeviceWrist BloodPressureMonitor,Model:202 | SubjectdeviceWrist BloodPressureMonitor,Model:202BT | SubjectdeviceWrist BloodPressureMonitor,Model:W1681BL | SubjectdeviceWrist BloodPressureMonitor,Model:W1681BT | SubjectdeviceWrist BloodPressureMonitor,Model:W1681R | Predicate deviceAutomatic Wrist BloodPressure Monitor,Model: W1681(K211041) | Note |
|---|---|---|---|---|---|---|---|
| Operationcondition | +5°C~+40°C,15% | +5°C~+40°C,15% | +5°C~+40°C,15% | +5°C~+40°C,15% | +5°C~+40°C,15% | +5°C~+40°C,15% | SeeNote 5 |
| Storage conditionAndTransportationcondition | -20~+55°C,10%~ 93%RH, 70~106kPa | -20~+55°C,10%~ 93%RH, 70~106kPa | -20~+55°C,10%~ 93%RH, 70~106kPa | -20~+55°C,10%~ 93%RH, 70~106kPa | -20~+55°C,10%~ 93%RH, 70~106kPa | -20~+55°C,10%~93%RH | SeeNote 6 |
| Irregular heartbeat feature | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Hypertensionindication | Yes | Yes | Yes | Yes | Yes | Yes | Same |
Note 1:The subject devices have additional contraindication, the subject device are prohibited use for on anticoagulant, antiplatelets, or steroids could cause internal bleeding. This does not impact the safety and effectiveness.
Note 2: The subject devices 202 and 202BT employ LED screen.This does not impact the safety and effectiveness.
Note 3: The predicate device is powered by AAA battery, the subject devices are powered by recharge by an AC adapter.The subject devices, Li-ion batter were conducted IEC 60601-1:2005+A1:2012+A2:2020 tests, the results showed meet safety requirements. So this does not impact the safety and effectiveness.
Note 4: The subject devices 202BT and W1681BT have bluetooth function, can connect to Smartphone App. The EMC, Wirelessocexist and Cybersecurity are evaluated. So this does not impact the safety and effectiveness.
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Yuezhongxing
Note 5: The subject devices comply with IEC 60601-1: 2005+A1:2012, no energy risk and mechanical risk arices can be operated in operation conditions manufacture specified.
Note 6: The subjected devices comply with IEC 60601-11:2015, they can be transported and storage conditions manufacture specified, and the conditions are indicated in user manual.
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8. Performance Data
Clinical test:
We performed a clinical study to verify clinical accuracy of the subject devices in accordance with ISO 81060-2:2018. The study was conducted by Shenzhen Cihai Hospital.
The quantity of clinical investigation subjects is 86 subjects. Of these, 44 are men and 42 are women, with a minimum age of 16 and a maximum age of 87. The patient's Wrist size is required between 22 cm and 32cm.
We selected auscultatory method (mercury sphygmomanometer) as the reference standard to determine the clinical accuracy by calculating the mean value and standard deviation according to ISO 81060-2:2018.
86 subjects were selected and 344 valid paired blood pressure values of systolic and diastolic data were obtained.
According to the method of criterion 1 in ISO81060-2 : 2018, 5.2.4. 1.2 . The mean value of the differences of systolic blood pressure between the sphygmomanometers-under-test and mercury sphygmomanometer was 1.0, and the standard deviation was 3.1. The mean value of the differences of diastolic blood pressure between test and mercury sphygmomanometer was 0.9 and the standard deviation was 3.4.
According to the method of criterion 2 in ISO 81060-2 : 2018,5.2.4. 1.2 , the standard deviation of systolic blood pressure of sphygmomanometers-under-test and mercury sphygmomanometer is 2.4 . The standard deviation of diastolic blood pressure for test and mercury sphygmomanometer is 2.6 in table 1.
The statistical analysis results were within the ISO 81060-2-2018 standard acceptance standard, compared with the results of the mercury sphygmomanometer, determine that the subject device have enough clinical accuracy.
Non-clinical data
The Wrist Blood Pressure Monitor comply with:
Safety and performance:
- IEC 60601-1:2005+ A1:2012+A2:2020 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 2. 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 3. the basic safety and essential performance of automated non-invasive sphygmomanometers
Electromagnetic Compatibility:
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Traditional 510(k) Submission of Wrist Blood Pressure Monitor
- 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 5. and skin sensitization
- I SO 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
9. Conclusion
The conclusions drawn from the nonclinical tests and clinical tests demonstrate that the subject devices are as safe, as effective, and performs as well as the predicate device (K211041).
§ 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).