(89 days)
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.
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
The provided text describes the non-clinical testing and a clinical validation study for a Wrist Blood Pressure Monitor (models YJ110, YJ111) to demonstrate its substantial equivalence to a predicate device (K223291).
It is important to note that the document primarily focuses on non-clinical testing (e.g., appearance, safety indices, performance indices, electrical safety, EMC, software verification) and a clinical validation study that demonstrates the accuracy of the device against a reference method, rather than a comparative effectiveness study involving human readers with and without AI assistance. The device is a blood pressure monitor, not an AI-powered diagnostic tool requiring expert interpretation of images. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, expert adjudication, AI standalone performance) would not be applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a detailed table (Table VII-1) of "Inspecting item" with "Inspection content and acceptance standard" and the "Conclusion". Below is a summary, focusing on performance-related criteria:
| Inspecting Item / Acceptance Standard | Reported Device Performance (Conclusion) |
|---|---|
| Appearance and Structure Test: | Pass |
| 1.1 Correct shape, clean surface, no obvious scratches/damage/deformation | Pass |
| 1.2 Text/logo accurate, clear, firm | Pass |
| 1.3 Function clearly marked/indicated | Pass |
| 1.4 Reliable connections, free key activity | Pass |
| 1.5 Display number clear, no missing/breaking | Pass |
| Identification Requirement: | Pass |
| 2.1 Device Identification (traceability, warnings, instructions, parameters) | Pass |
| 2.2 External Packing (wrist circumference, battery info) | Pass |
| 2.3 Specification (manual content, instructions, common arrhythmias, recalibration, measurement method, affected by posture, storage conditions, warranty, neonates, airbag risks, failure method, disinfection, correlation) | Pass |
| 2.4 Low voltage prompt function (battery label, wristband ID) | Pass |
| Safety Index: | Pass |
| 3.1 Maximum band pressure (<= 40kPa, pressure above 2kPa <= 3min) | Pass |
| 3.2 Aerofluxus (deflation measure, time to drop 34.67kPa to 2kPa <= 10s) | Pass |
| Performance Index: | Pass |
| 4.1 Range (Pressure: 0-39.3kPa, max 40kPa; Pulse: 40-199 times/min) | Pass |
| 4.2 Resolution (Pressure: 0.133kPa; Pulse: 1 time/min) | Pass |
| 4.3 Repeatability (difference <= 0.533kPa) | Pass |
| 4.4 Pressure sensor and pulse measurement accuracy: | Pass |
| 4.4.1 Pressure measurement max error: <= ±0.4kPa (±3mmHg) | Pass |
| 4.4.2 Pulse measurement error: <= ±5% | Pass |
| 4.5 Requirements for charging sources and pressure control valves | Pass |
| 4.5.1 Aeration source (reach 40kPa in 200cm3 within 10s) | Pass |
| 4.5.2 Pressure controlled air valve | Pass |
| 4.5.2.1 Air leakage (max pressure drop <= 0.133kPa in 10s) | Pass |
| 4.5.2.2 Valve/wristband bleed rate (pressure reduction >= 0.267kPa/s) | Pass |
| 4.5.2.3 Blow-by (time to drop 34.67kPa to 2kPa <= 10s) | Pass |
| 4.6 Airbag and wristband requirements | Pass |
| 4.6.1 Size (length 0.4x wrist, width 0.5x length) | Pass |
| 4.6.2 Compression resistance (withstand 39.3kPa) | Pass |
| 4.7 Wrist strap port/Structure (intact after 1000/10000 cycles) | Pass |
| 4.8 System air leakage (rate of pressure drop <= 0.133kPa/s) | Pass |
| 4.9 Lifetime (meet requirements after 10,000 full scale cycles) | Pass |
| 4.10 Prompt facility (low battery, irregular heart rate warning) | Pass |
| 4.11 Clock setting function | Pass |
| 4.12 Memory function (60 sets) | Pass |
| 4.13 Automatic shutdown function (after 3 minutes) | Pass |
| 5. Electromagnetic compatibility (IEC60601-1-2) | Pass |
| 6. Electrical safety (IEC 60601-1) | Pass |
| 7. Environmental requirements test (IEC 60601-1-11) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The clinical validation study for the Wrist Blood Pressure Monitor (model YJ110, covering YJ111) used:
- Sample Size: 86 adult subjects (47 females, 39 males).
- Data Provenance: Not explicitly stated, but given the manufacturer is based in China, it is highly probable the study was conducted there.
- Retrospective/Prospective: The text describes the study as "performed," indicating a prospective clinical validation study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the device is a blood pressure monitor, not an AI diagnostic tool requiring expert interpretation of medical images. The ground truth for blood pressure is established through a reference measurement method (e.g., auscultatory mercury sphygmomanometer in a supervised setting, following a recognized standard).
4. Adjudication Method for the Test Set
This section is not applicable for the same reason as above. Blood pressure measurement accuracy is typically assessed by comparing device readings to a reference standard, not through expert adjudication in the context of diagnostic interpretation. The study was performed using the "Same Arm Sequential Method" according to ISO 81060-2:2018.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is being evaluated with and without AI assistance. This device is a direct measurement device (blood pressure monitor), not an AI-powered image interpretation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the primary evaluation of the device's performance is essentially a standalone evaluation of the device's ability to accurately measure blood pressure. The clinical validation adhered to ISO 81060-2:2018, which is a standard for validating automated measurement type non-invasive sphygmomanometers. This standard assesses the device's measurement accuracy, which is its inherent algorithmic function for determining blood pressure and pulse rate from oscillometric signals.
7. The Type of Ground Truth Used
The ground truth for the clinical validation study was established by comparison to a reference measurement method per ISO 81060-2:2018. This standard specifies clinical procedures for validating the accuracy of automated non-invasive sphygmomanometers. Typically, this involves simultaneous or sequential measurements by the device under test and a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer) using an auscultatory method by trained observers. The "Same Arm Sequential Method" was chosen. The standard dictates the statistical analysis (mean error and standard deviation of differences) against the reference values.
8. The Sample Size for the Training Set
The document does not provide information on a specific "training set" sample size, as this device is not explicitly described as an AI/ML model that undergoes a distinct training phase. Its operation is based on the oscillometric principle with a non-invasive blood pressure (NIBP) algorithm, which implies a fixed, deterministic algorithm rather than a continuously learning or adaptable AI model. The "software function is justified by the software documents," as stated in "Different 2- Records Quantity" implies a validated software rather than a trained one.
9. How the Ground Truth for the Training Set was Established
As there is no explicit mention of a training set or a distinct AI/ML training phase, this question is not directly applicable based on the provided text. The device uses an established "oscillometric principle" and "NIBP algorithm," suggesting a conventional engineering approach to device development and calibration, rather than a machine learning approach where "ground truth" is established for a training dataset. Accuracy is demonstrated via clinical validation against a reference standard.
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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.
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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
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)
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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
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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
| DeviceCharacteristic | Subject Device | Predicate Device(K223291) | Discussion |
|---|---|---|---|
| Type of BloodPressureMonitor | Wrist Blood PressureMonitorYJ110, YJ111 | Wrist Blood Pressure MonitorPG-800A18, PG-800A19,PG-800A28, PG-800A51,PG-800A52, PG-800A11-1,PG-800A36-1 andPG-800A37-1 | - |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Indications forUse | Wrist Blood PressureMonitor is used to measureadult systolic bloodpressure. diastolic bloodpressure and pulse rate.The values are fordiagnostic reference only.Suitable for medicalinstitutions (such ashospitals, clinics, healthcenters, etc.) and homeuse. | The Electronic Blood PressureMonitor is intended to measurethe systolie and diastolic bloodpressure as well as the pulserate of adult person vianon-invasive oscillometrictechnique in which an inflatablecuff is wrapped around the wrist.It can be used at medicalfacilities or at home. Theintended wrist circumference is13.5-19.5 cm. The patientpopulation does not includeadolescents aged 12 to <18years of age. The patientpopulation includes transitionadolescent B (18 to < 22 yearsof age but treated like adult) andadults (at least 22 years of age). | Same |
| MeasurementType | Wrist | Wrist | Same |
| PatientPopulation | Adult | Adult | Same |
| MeasurementItem | Systolic Pressure, DiastolicPressure, Pulse Rate | Systolic Pressure, DiastolicPressure, Pulse Rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| MainComponent | LCD/Key/Cuff/MCU/Pump/Transducer/ Batteries | LCD/Key/Cuff/MCU/Pump/Transducer/ Batteries | Same |
| Blood PressureRange | Pressure:0 | 30 ~ 280 mmHg | Different 1 |
| Pulse RateRange | 40~199beat/min | 40-199 bpm | Same |
| Intendedwristcircumference | 13.5~19.5cm | 13.5cm-19.5cm | Same |
| RecordsQuantity | 60 sets of memory | Double patients mode: 90/90records | Different 2 |
| Power supply | d.c.3V (2 AAA sizebatteries) | Two AAA or LR03 batteries formodels PG-800A18,PG-800A19, PG-800A28, PG-800A523.7V for models PG-800A51,PG-800A11-1,PG-800A36-1,PG-800A37-1 | Different 3 |
| Operationcondition | +5℃ | +5°C~+40°C30%RH-80%RHAtmospheric pressure | Different 4 |
| Storagecondition | -20℃ | -20°C~+55°C10%RH-93%RHAtmospheric pressure | Different 5 |
| Patient ContactMaterial | Cuff-NylonEnclosure-ABSKey-ABS | Cuff-NylonEnclosure-ABSKey-ABS | Same |
| Biocompatibility | Comply with ISO10993series standardsNo cytotoxicity; No irritationto skin; No significantevidence of sensitization | Comply with ISO10993 seriesstandardsNo cytotoxicity; No irritation toskin; No significant evidence ofsensitization | Same |
| ElectricalSafety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| ParticularPerformance | Comply with IEC80601-2-30 and ISO81060-2 | Comply with IEC 80601-2-30and ISO 81060-2 | Same |
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Different 1- Blood Pressure Range
The Blood Pressure Range of the subject device includes the blood pressure range of predicate devices and meets the requirements of IEC 80601-2-30. Therefore, the difference will not affect the safety and effectiveness of the subject device.
Different 2- Records Quantity
The records quantity of subject device is 60 while for predicate device is 90/90, yet the subject device adopted same measurement principle and NIBP algorithm as predicate device, software function is justified by the software documents. This difference will not affect the safety and effectiveness.
Different 3- Power supply
The difference between subject device and predicate device (K223291) is the batteries, the predicate device use 2 x 1.5V Batteries (for models: PG-800A18, PG-800A19, PG-800A28, PG-800A52) and Rechargeable Li-ion Battery PL 552233 for model: PG-800A51, PG-800A11-1, PG-800A36-1 and PG-800A37-1 while the subject device use two AAA, but the power supply safety of subject device is justified by the IEC60601-1 electricity test reports. Thus this difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.
Different 4- Operation condition
The difference between subject device and predicate device (K223291) is the humidity, the predicate device is 30%RH-80%RH, while the subject device is 15%RH-85%RH, but the humidity of subject device is meets the requirements of IEC 80601-2-30. therefore, the difference will not affect the safety and effectiveness of the subject device.
Different 5- Storage condition
The difference between subject device and predicate device (K223291) is the humidity, the predicate device is 10%RH-93%RH, while the subject device is 15%RH-85%RH, it is included in predicate device, therefore this item is considered as substantial equivalence.
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VII Summary of Non-Clinical Testing
The non-clinical testing for Wrist Blood Pressure Monitor was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
| Inspecting item | Inspection content and acceptance standard | Conclusion | |
|---|---|---|---|
| 1.Appearanceandstructure test | 1.1 The shape of the product should be correct, the surface bright and clean, there should be no obvious scratches, damage and deformation. | Pass | |
| 1.2 The text and logo on the control panel of the product should be accurate, clear and firm. | Pass | ||
| 1.3 The function of the product shall be clearly marked and indicated. | Pass | ||
| 1.4 The connection of each part of the product should be reliable, the key activity should be free, no card key and affect the operation phenomenon. | Pass | ||
| 1.5 The display number of the product should be clearly distinguishable, and there is no missing or breaking phenomenon. | Pass | ||
| 2.Identificationrequirement | 2.1 Device identification a) Display enough information for easy traceability and identification. In addition, the following information should also be displayed:b) Use warnings, including a statement that you need to consult a medical professional to interpret the blood pressure value measured.c) Appropriate operating instructions.d) Instrument performance parameters | Pass | |
| relevant to the accuracy requirements of this standard. | |||
| e) Wrist girth for matching wristbands | |||
| 2.2 Externalpacking | The outer package should include the following information:a) Applicable wrist circumference (can be identified by "cm");b) Any special requirements for battery-operated equipment shall also be indicated. | Pass | |
| 2.3Specification | Each piece of equipment should be accompanied by a manual, which should include at least the following:a) Complete instructions for use, including a section summarizing warnings for use. This section should be indexable in the table of contents and direct the user to the relevant section in the information manual;b) A dedicated chapter with information on: how to unpack, install, perform pre-service checks, where to get help, standard operating procedures, general maintenance, recalibration and cleaning frequency recommendations;c)How to contact the manufacturer for after-sales service;d)Whether the device can achieve the claimed performance when common arrhythmias such as atrial premature, ventricular premature, and atrial fibrillation occur;e) Check the accuracy of the wristband pressure sensor/indicator at the time | Pass |
Table VII-1: Performance testing was conducted on the subject device
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| interval specified by the manufacturer, andgive suggestions on the validity verificationmethod; | |
|---|---|
| f) The detailed measurement methodshould be indicated, including at least thelocation of the measurement, theappropriate time to rest before the bloodpressure measurement, the applicable wristcircumference, and a statement that theblood pressure value measured should beinterpreted by a professional; | |
| g) The user is reminded that any bloodpressure measurement is affected by theposture of the person being measured aswell as his/her physical condition. Otherfactors that interfere with blood pressuremeasurement should also be listed; | |
| h) A statement that if stored or used outsidethe manufacturer's specified temperatureand humidity ranges, the system may notachieve the claimed performancespecifications (Manufacturer's specifiedtemperature and humidity ranges should begiven together in the statement); | |
| i) Product warranty information; | |
| j) It should be indicated that the device isnot intended for neonates; | |
| k) Risks that may exist when the airbag isoverinflated for a prolonged period of time; | |
| l) Method of determining display devicefailure; | |
| m) Recommended disinfection procedures; | |
| n) A statement regarding the correlation |
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| between blood pressure measurements(including systolic, diastolic and mean bloodpressure) obtained by this product andmeasurements obtained using one or twoother different independent methodsmentioned in this standard; | |||
|---|---|---|---|
| 2.4Lowvoltagepromptfunction | 2.4.1 Label of the battery powered deviceThe device should be marked with thecorrect battery model.2.4.2 Wristband identificationThe wrist strap should indicate or indicatethe range of wrist girth to which it applies. | Pass | |
| 3.Safetyindex | 3.1 Maximumbandpressure | 1) Wrist pressure should not exceed 40kPa(300mmHg);2) The device should ensure that thewristband pressure is kept above 2kPa(15mmHg) for no more than 3 minutes. | Pass |
| 3.2Aerofluxus | The device shall provide a simple andclearly marked measure allowing the userto deflate the wristband.When the valve of the charging system isfully open and quickly deflated, the time forthe pressure to drop from 34.67kPa(260mmHg) to 2kPa (15mmHg) should notexceed 10s. | Pass | |
| 4.Performanceindex | 4.1 Range | Pressure measurement range: 0kPa(0mmHg) | Pass |
| 4.2Resolutionratio | The pressure display resolution should be0.133kPa (1mmHg).The pulse display resolution should be 1 | Pass | |
| time/min. | |||
| 4.3Repeatability | When measured at static continuous low pressure, the difference between the readings measured repeatedly at each point within the scale range should not be greater than 0.533kPa (4mmHg). All readings shall comply with the requirements in 4.4. | Pass | |
| 4.4 Pressuresensor andpulsemeasurementaccuracy | 4.4.1 The maximum error of the pressure measurement in the wristband should not be greater than ±0.4kPa (±3mmHg) at any measuring point in the range, whether the pressure is increased or decreased.4.4.2 Pulse measurement error: ±5%. | Pass | |
| 4.5Requirementsfor chargingsources andpressurecontrol valves | 4.5.1 Aeration sourceThe aeration source should provide enough air to reach a pressure of 40kPa (300mmHg) in a 200cm3 (12 cubic inches) container within 10 seconds.4.5.2 Pressure controlled air valve4.5.2.1 air leakageWhen the valve is closed and the initial pressure is 33.33kPa (250mmHg), 20kPa (150mmHg) and 6.67kPa (50mmHg) respectively, the maximum pressure drop in a container with a volume not exceeding 80cm3 should not exceed 0.133kPa (1mmHg) within 10s.4.5.2.2 Valve/wristband bleed rateWhen the valve is in the pressure control position (using the accompanying wristband), the pressure reduction rate from 33.33kPa (250mmHg) to 6.67kPa | Pass | |
| (50mmHg) should not be lessthan0.267kPa/s (2mmHg/s).4.5.2.3 blow-byThe rapid venting of a gas-filled systemwhen the valve is fully open should not takelonger than 10s for the pressure to dropfrom 34.67kPa (260 MMHG) to 2kPa(15mmHg). | |||
| 4.6Airbagand wristbandrequirements | 4.6.1 sizeThe length of the airbag is about 0.4 timesthat of the covering wrist, and the width ofthe airbag is about half the length.4.6.2 compression resistanceIt should be able to withstand an internalpressure equal to the maximum pressure of39.3kPa (295mmHg) expected to be usedby the wristband. | Pass | |
| 4.7Wriststrapport/Structure | After 1,000 opening and closing cycles and10,000 40kPa (300mmHg) pressure cycles,the closure and sealing of the wristbandand integrated airbag should still be intactenough to meet other requirements. | Pass | |
| 4.8Systemair leakage | The rate of pressure drop caused by airthroughoutleakagethesphygmomanometer system should not begreater than 0.133kPa/s (1mmHg/s). | Pass | |
| 4.9 Lifetime | After at least 10,000 full scale cycles, theequipment should still meet the safety andperformance requirements of the standard.A full scale cycle is when the pressure risesfrom 2.67 kPa (20 mmHg) or less to amaximum pressure value and then falls to2.67 kPa (20 mmHg) or less. | Pass | |
| 4.10 Prompt | 4.10.1 Low battery prompt | Pass | |
| facility | Whenthevoltageof ofthe | ||
| sphygmomanometer is d.c. (2.2-2.5) ± | |||
| 0.1V, there should be a battery symbol | |||
| indicating that there is one grid of electricity | |||
| left. When it is lower than 2.2V±0.1V, the | |||
| battery symbol displays empty power and | |||
| blinked for three times before automatically | |||
| shutting down. | |||
| 4.10.2 Irregular heart rate warning | |||
| The sphygmomanometer should be able to | |||
| indicate the irregular heartbeat of the | |||
| human body and can display the " | |||
| symbol. | |||
| 4.11Clock | The sphygmomanometer should be able to | Pass | |
| setting | display time and set time, including year, | ||
| function | month, day, hour and minute. | ||
| 4.12 Memory | The sphygmomanometer has memory and | Pass | |
| function | deletion functions and can remember 60 | ||
| sets of measurements. | |||
| 4.13Automatic | No operation automatically shuts down after3 minutes. | Pass | |
| shutdown | |||
| function | |||
| 5 | Electromagnetic | equipment shouldThemeetthe | Pass |
| compatibility | requirements specified in IEC60601-1-2 | ||
| Medicalelectricalequipment-Part | |||
| 1-2:General requirements for basic safetyperformance-Collateralandessential | |||
| standard: | Electromagneticcompatibility-Requirements and tests. | ||
| 6. Electrical safety | The equipment shall meet the requirementsspecified in IEC 60601-1. | Pass | |
| 7.Environmentalrequirements | test Climatic and environmental tests shallcomply with IEC 60601-1-11 Part1-11:General requirements for basic safetyand essential performance-CollateralStandard: Requirements for medicalelectrical equipment and medical electricalsystems used in the home healthcareenvironment. | Pass |
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Biocompatibility Testing
The main part of subject device that comes into contact with the patient is the cuff, the part that comes into contact with the operator is mainly the Enclosure, key and cuff. The material of Enclosure and key is ABS, which is a commonly used material in the market. It has Limited contact with intact skin. Per FDA's 2020 guidance document, Use of International Standard ISO 10993-1, ABS materials are exempt from biological testing.
In addition, the material of cuff is Nylon, it has Limited contact with intact skin and has
tested by ISO 10993-5, ISO 10993-10 and ISO 10993-23.
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Wrist Blood Pressure Monitor. The device complies with the IEC60601-1, IEC60601-1-2, IEC 60601-1-8 and IEC60601-1-11.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The
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software for this device was considered as a "Moderate" level of concern.
Performance testing
The Wrist Blood Pressure Monitor were test according to the standard which is IEC 80601-2-30, and the cuff to monitor connector was tested based on IEC 80369-5:2016 + C1:2017, the test result meets the requirements.
Usability
Usability was conducted on the Wrist Blood Pressure Monitor. The device complies with the IEC60601-1-6.
VIII 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 Y J110. 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.
IX Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Wrist Blood Pressure Monitor is as safe as effective, and performs as well as or better than the legally marketed device.
§ 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).