(83 days)
Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.
Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic 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. Electronic Blood Pressure Monitor can be divided into three models (YJ320, YJ321E, YJ326E) according to their appearance and functions.
The provided text is for an FDA 510(k) clearance for an Electronic Blood Pressure Monitor. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a comprehensive table of non-clinical performance and safety acceptance criteria, along with the reported "Conclusion" (Pass/Fail). For the clinical validation, it states the acceptance criteria are met based on deviations from a reference standard.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Inspecting Item | Acceptance Standard (Simplified) | Reported Device Performance (Conclusion) |
|---|---|---|
| 1. Identification requirement | Meets IEC 60601-1:2005 in 7.2. | Pass |
| 2. Life Span | After at least 10,000 full scale cycles, the sphygmomanometer should still meet safety and performance requirements. A full scale cycle: pressure rises from <= 2.67kPa (20mmHg) to max, then falls to <= 2.67kPa (20mmHg). | Pass |
| 3. Safety Requirements | 3.1 Maximum cuff pressure: Overpressure protection function: vent valve opens when display exceeds 39.33kPa (295mmHg), pressure reduces to < 2kPa (15mmHg) within 10s. Cuff pressure above 2kPa (15mmHg) for no more than 3 minutes. | Pass |
| 3.2 Venting: Simple/clearly marked measure to deflate cuff. Pressure drops from 34.67kPa (260mmHg) to 2kPa (15mmHg) in <= 10s when valve fully open. | Pass | |
| 4. Performance Index | 4.1 Range: At least 0kPa (0mmHg) to 39.3kPa (295mmHg). | Pass |
| 4.2 Resolution ratio: Display resolution 0.1kPa/1mmHg. | Pass | |
| 4.3 Repeatability: Max difference between repeated readings at each point <= 0.533kPa (4mmHg) for static continuous low pressure. All readings comply with 4.4. | Pass | |
| 4.4 Pressure sensor accuracy: Max error of cuff pressure measurement <= +/- 0.4kPa (+/- 3mmHg) at any point, increasing or decreasing pressure. | Pass | |
| 4.5 Pulse: (a) Pulse measurement range (40 ~ 199) times/min, resolution 1 time/min. (b) Pulse accuracy: +/- 5%. | Pass | |
| 5. Requirements for charging sources and pressure control valves | 5.1 Aeration source: Enough air within 10s to reach 40kPa (300mmHg) in a 200 (12 cubic inch) container. | Pass |
| 5.2 Pressure controlled air valve: 5.2.1 Air leakage: Max pressure drop <= 0.133kPa (1mmHg) for 10s from 33.33kPa (250mmHg), 20kPa (150mmHg), and 6.67kPa (50mmHg) in a container <= 80 volume. 5.2.2 Valve/cuff bleed rate: Pressure drop rate from 33.33kPa (250mmHg) to 6.67kPa (50mmHg) >= 0.267kPa/s (2mmHg/s). 5.2.3 Venting: Rapid venting from 34.67kPa (260mmHg) to 2kPa (15mmHg) in <= 10s. | Pass | |
| 6. Cuff with air bag | 6.1 Size: Air bag length ~0.8 * limb circumference, width ~0.5 * length. | Pass |
| 6.2 Compression resistance: Cuff, air bag, and pipeline withstand max expected internal pressure. | Pass | |
| 6.3 Cuff interface, structure: After 1,000 opening/closing & 10,000 40kPa (300mmHg) pressure cycles, closure/sealing remain intact to meet other standard requirements. | Pass | |
| 7. System air leakage | Rate of pressure drop from air leakage <= 0.133kPa/s (1mmHg/s). | Pass |
| 8. Function | 8.1 Display function: LCD displays systolic, diastolic BP, pulse rate, with "kPa" or "mmHg" units. | Pass |
| 8.2 Automatic zeroing function: Automatically returns to zero after turn on, automatically opens for BP test. | Pass | |
| 8.3 Error prompt function: Displays incorrect indication if fails to measure BP/pulse rate correctly. | Pass | |
| 8.4 Low voltage prompt function: Battery symbol "☐" flashes when battery voltage <= 4.2V +/- 0.2V. | Pass | |
| 8.5 Automatic shutdown function: Auto-shutdown if no operation within 2 minutes after measurement. | Pass | |
| 8.6 Memory function: Stores 2*99 groups of data for users A and B. Clears data via [Start/Stop] + [memory/read] for 3s (displays CLR). | Pass | |
| 8.7 Clock setting function: Displays/sets time (year, month, day, hour, minute). | Pass | |
| 8.8 Arrhythmia prompt function: Indicates irregular heartbeat with "♥" symbol. | Pass | |
| 8.9 Voice broadcast prompt function: Voice broadcast in "mmHg" unit display mode. | Pass | |
| 8.10 Cuff detection prompt function: Displays " "[check] symbol when cuff connected correctly, " "[error] symbol if exception. | Pass | |
| 9. Appearance and structure | 9.1: Shape correct, surface bright, clean, color uniform. | Pass |
| 9.2: Characters and symbols clear, accurate, firm. | Pass | |
| 9.3: Function keys flexible, reliable, fasteners not loose. | Pass | |
| 9.4: Cuff not damaged. | Pass | |
| 9.5: No missing strokes in LCD display. | Pass | |
| 10. Electrical safety requirements | Meets IEC 60601-1. | Pass |
| 11. Electromagnetic compatibility | Meets IEC60601-1-2. | Pass |
| 12. Environmental requirements | Meets IEC 60601-1-11. | Pass |
Clinical Validation Acceptance Criteria (Simplified, based on ISO 81060-2:2018):
For the clinical study, the acceptance criteria are implicit in the statement: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018."
- Reported Device Performance: The device (YJ320) met these limits, indicating it performed within the required accuracy for blood pressure measurement against a reference standard.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Clinical Data: 86 adult subjects (49 females, 37 males).
- Non-Clinical Data: Not explicitly stated as a "test set" in terms of subject count, but performance was evaluated based on the device itself and its components against established standards.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study participants or if it was retrospective or prospective. Given it's a 510(k) submission from a Chinese company, common practice would be for the clinical study to be prospective and likely conducted in China or a region where the standard is recognized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Clinical Ground Truth: The clinical validation was conducted according to ISO 81060-2:2018, which is "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard outlines specific methods for clinical validation, typically involving simultaneous measurements by trained observers (auscultation) against the automated device being tested. The number of experts (observers) involved in establishing the reference measurement (ground truth) is usually prescribed by this standard, but not explicitly stated in this summary. The standard generally requires at least two trained observers. Their qualifications would typically involve being trained and validated to perform accurate auscultatory blood pressure measurements.
- Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993, IEC 80601-2-30). Test equipment and calibrated reference standards are used by technical personnel to verify compliance.
4. Adjudication method for the test set
- Clinical Data: The "Same Arm Sequential Method" was used as per ISO 81060-2:2018. This method involves taking sequential measurements from the same patient's arm using both the test device and a reference method (typically auscultation by trained observers). The standard itself dictates how discrepancies are handled and how the mean error and standard deviation of differences are calculated, which serves as the "adjudication" against the standard's limits. No explicit "expert adjudication" process like 2+1 or 3+1 is mentioned, as the standard relies on the statistical agreement of measurements.
- Non-Clinical Data: Not applicable in the context of expert adjudication for defining a "ground truth" in the same way as clinical or image-based studies. Tests are performed against objective criteria and measured by calibrated equipment.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. This device is an automated blood pressure monitor, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, the clinical validation study (ISO 81060-2:2018) is essentially a standalone performance assessment of the automated blood pressure monitor against a reference standard. The device's algorithm performs the measurement autonomously, and its output (systolic and diastolic pressure) is compared directly to the ground truth.
7. The type of ground truth used
- Clinical Ground Truth: The ground truth for blood pressure measurements in the clinical study was established by comparison with a reference method as defined by ISO 81060-2:2018. This standard typically refers to invasive measurements or, more commonly for non-invasive validation, simultaneous auscultatory measurements performed by trained observers. The document also states, "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018," which confirms adherence to this specific standard for ground truth establishment.
- Non-Clinical Ground Truth: The "ground truth" for non-clinical tests (e.g., accuracy, range, safety features) is based on the objective technical specifications and performance requirements outlined in referenced international standards, tested using appropriate calibrated measuring equipment.
8. The sample size for the training set
- This device is an Electronic Blood Pressure Monitor, which likely uses traditional signal processing and algorithms (oscillometric principle) rather than deep learning or AI that requires a "training set" in the modern machine learning sense. Therefore, a distinct "training set" of data for algorithm development, as seen in AI/ML medical devices, is not referenced or applicable here. The algorithms are based on established physiological principles and engineering.
9. How the ground truth for the training set was established
- As explained in point 8, the concept of a "training set" as it applies to establishing ground truth for machine learning models is not relevant to this traditional medical device. The underlying algorithms are based on established physical and biological principles, and their accuracy is demonstrated through the clinical and non-clinical validation studies described.
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December 5, 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: K232814
Trade/Device Name: Electronic 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) K232814
Device Name Electronic Blood Pressure Monitor
Indications for Use (Describe)
Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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: | Electronic 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 | K222994 |
|---|---|
| Trade Name of Device: | Electronic Blood Pressure Monitor |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Name: | Electronic Blood Pressure Monitor |
| Regulatory Class | II |
| Product Code: | DXN |
IV Device Description
Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries.
Electronic 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.
Electronic Blood Pressure Monitor can be divided into three models (YJ320、YJ321E、
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YJ326E) according to their appearance and functions. The differences among these models are shown as below:
| Model | Air pumps and airvalves | Cuffs | Software Function | Hardware |
|---|---|---|---|---|
| YJ320 | Same | Same | Same | Black and whitebacklit screen |
| YJ321E | Same | Same | Removed cuff detectionand misoperation promptfunctions | Black and whitebacklit screen |
| YJ326E | Different | Different | Same | Color backlitscreen |
V Indications for use
Electronic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. lt can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.
VI Technological Characteristics Comparison
VI-1: Comparison of Electronic Blood Pressure Monitor
| DeviceCharacteristic | Subject Device | Predicate Device(K222994) | Discussionn |
|---|---|---|---|
| Type of BloodPressureMonitor | Electronic Blood PressureMonitorYJ320、YJ321E、YJ326E | Electronic Blood PressureMonitorAOJ-33 series | - |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Indications forUse | Electronic Blood PressureMonitor is a digital monitorintended for use inmeasuring blood pressureand pulse rate in adult | The Arm Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulserate of adult person via | Same |
| patient population. It is non-invasive oscillometric intended to measure the technique in which an inflatable diastolic, systolic blood CUFF is wrapped around the pressures and pulse rate upper arm at medical facilities or through an inflatable cuff at home. wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm. | |||
| Measurement site | Upper arm | Upper arm | Same |
| Patient Population | Adult | Adult | Same |
| Measurement Item | SYS, DIA, Pulse Rate | SYS, DIA, Pulse Rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| Blood pressure measurement range | pressure:0 to 295mmHgSYS: 55 to 255 mmHgDIA: 25 to 200 mmHg | 30 ~ 255 mmHg | Different 1 |
| Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Pulse Rate Range | 40~199beat/min | 40-199 bpm | Same |
| Accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same |
| Cuff size | 22~42cm | 22~42cm | Same |
| Power supply | 4 "AA" batteries(d.c.6v) orUSB-C INPUT 5V d.c~6V d.c/600mA | Lithium-ion battery, D.C. 3.7V | Different 2 |
| Operation condition | +5°C~+40°C,15%RH | +5°C~+40°C15%RH-90%RH70 kPa -106 kPa | Different 3 |
| Storage condition | -20°C~+55°C,15%RH | -20°C~+55°C10%RH-93%RH70 kPa -106 kPa | Different 4 |
| Patient Contacting | Surface-contacting,Less than 24 h | Surface-contacting,Less than 24 h | Same |
| Biocompatibility evaluation | Cytotoxicity, skin sensitization and irritation | Cytotoxicity, skin sensitization and irritation | Same |
| ElectricalSafety | IEC 60601-1IEC 60601-1-11ISO 80601-2-30 | IEC 60601-1IEC 60601-1-11ISO 80601-2-30 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-1ISO 10993-5ISO 10993-10 | Different 5 |
| Clinical data | ISO 81060-2: 2018 | ISO 81060-2: 2018 | Same |
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Different 1- Blood pressure measurement 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- Power supply
The difference between subject device and predicate device (K222994) is the batteries, the predicate device use Lithium-ion battery, D.C. 3.7V while the subject device use 4 "AA" batteries (d.c.6v) or USB-C INPUT 5V d.c-6V d.c/600mA, 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 3- Operation condition
The difference between subject device and predicate device (K222994) is the humidity and Atmospheric pressure, the predicate device is 15%RH-90%RH, 70 kPa -106 kPa, while the subject device is 15%RH-85%RH, 80kPa~105kPa, it is included in predicate device. Therefore, this item is considered as substantial equivalence.
Different 4- Storage condition
The difference between subject device and predicate device (K222994) is the humidity
Section 3-4
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K232814
and Atmospheric pressure, the predicate device is 15%RH-90%RH, 70 kPa -106 kPa, while the subject device is 15%RH-85%RH, 80kPa~105kPa, it is included in predicate device. Therefore, this item is considered as substantial equivalence.
Different 5- Biocompatibility
The predicate device (K222994) was tested by ISO 10993-5, ISO 10993-10, and the testing part included the battery.
While 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 cover and cuff. The material of cover 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 cuff has tested by ISO 10993-5 and ISO 10993-10.
Based on the above description, these differences do not affect the achievement of the product's intended use, nor do they compromise the safety of patients and operators.
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VII Summary of Non-Clinical Testing and Clinical Testing
Non-Clinical Data:
Non-clinical testing for Electronic 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. Identification requirement | Meets the requirements of IEC 60601-1:2005 in 7.2 | Pass | |
| 2. life span | After at least 10,000 full scale cycles, the sphygmomanometer should still meet the safety requirements and performance requirements in the standard. | Pass | |
| A full scale cycle is when the pressure rises from 2.67kPa(20mmHg) or less to a maximum pressure value and then falls to 2.67kPa(20mmHg) or less. | |||
| 3. Safety requirements | The sphygmomanometer should have overpressure protection function. When the pressure display exceeds 39.33kPa(295mmHg), the sphygmomanometer's vent valve should be opened, and the gas path pressure should be reduced to less than 2kPa(15mmHg) within 10s. In addition, the equipment should | Pass | |
| 3.1 Maximum cuff pressure | |||
| 4.Performanceindex | |||
| ensure that the cuff pressure isabove 2kPa(15mmHg) for no morethan 3 minutes. | |||
| 3.2 venting | The sphygmomanometer shouldprovide a simple and clearlymarked measure allowing the userto deflate the cuff. When the valveof the charging system is fully openand quickly deflated, the time forthe pressure to drop from34.67kPa(260mmHg) to2kPa(15mmHg) should not exceed10s. | Pass | |
| 4.1 Range | A blood pressure monitor has arange of at least 0kPa(0mmHg) to39.3kPa(295mmHg). | Pass | |
| 4.2 Resolutionratio | The display resolution of thesphygmomanometer should be0.1kPa/1mmHg. | Pass | |
| 4.3Repeatability | For a sphygmomanometer,measured at static continuous lowpressure, the difference betweenrepeated readings measured ateach point within the scale rangeshould be no greater than 0.533kPa(4mmHg). All readings shallcomply with the requirements in 4.4 | Pass | |
| 4.4 Pressuresensoraccuracy | The maximum error of the pressuremeasurement in the cuff should be$\pm$ 0.4kPa( $\pm$ 3mmHg) at anymeasuring point in the range,regardless of whether the pressureis increased or decreased. | Pass | |
| (a) The pulse measurement range | Pass | ||
| 4.5 Pulse | of the sphygmomanometer should | ||
| be (40 ~ 199) times/min, and the | |||
| resolution should be 1 time/min. | |||
| (b) Pulse accuracy: ±5%. | |||
| 5.1 Aerationsource | The sphygmomanometer inflation | Pass | |
| source should provide enough air | |||
| within 10 seconds to reach | |||
| 40kPa(300mmHg) in a 200(12 | |||
| cubic inch) container. | |||
| 5Requirementsfor chargingsources andpressurecontrolvalves. | 5.2 Pressurecontrolled airvalve | 5.2.1 air leakage | Pass |
| The sphygmomanometer valve is | |||
| closed, and the maximum pressure | |||
| drop in a container with a volume | |||
| not exceeding 80 at initial | |||
| pressures of 33.33kPa(250mmHg), | |||
| 20kPa (150 MMHG) and | |||
| 6.67kPa(50mmHg) should not | |||
| exceed 0.133kPa(1mmHg) for 10s. | |||
| 5.2.2 Valve/cuff bleed rate | |||
| When the valve is in the pressurecontrol position, the pressure droprate from 33.33kPa(250mmHg) to6.67kPa(50mmHg) should not beless than 0.267kPa/s (2mmHg/s);5.2.3 VentingThe rapid venting of a gas-filled | |||
| system when the valve is fully openshould not take longer than 10s forthe pressure to drop from34.67kPa(260 mmHg) to2kPa(15mmHg). | |||
| 6 Cuff with airbag | 6.1 Size | The length of the cuff air bag isabout 0.8 times the circumferenceof the limb measured at the medianline of the cuff's intended use area,and the width of the cuff air bag isabout half the length; | Pass |
| 6.2compressionresistance | The cuff, the integrated air bag andthe entire pipeline should be able towithstand the internal pressureequal to the maximum pressureexpected to be used by the cuff; | Pass | |
| 6.3 Cuffinterface,structure | After 1,000 opening and closingcycles and 10,00040kPa(300mmHg) pressure cycles,the closure and sealing off the cuffand the integrated airbag shallremain intact enough to meet theother requirements of this standard. | Pass | |
| 7 System air leakage | The rate of pressure drop causedby air leakage of the entire systemof the sphygmomanometer shouldnot be greater than0.133kPa/s(1mmHg/s). | ||
| 8 function | 8.1 displayfunction | The liquid crystal display of thesphygmomanometer should beable to display systolic blood | |
| pressure, diastolic blood pressureand pulse rate, and there should be"kPa" or "mmHg" blood pressuredisplay form. | |||
| 8.2 Automaticzeroingfunction | The sphygmomanometer should beable to automatically return to zeroafter each turn on, andautomatically open to test bloodpressure. | Pass | |
| 8.3 Errorpromptfunction | The sphygmomanometer shoulddisplay an incorrect indication if itfails to measure blood pressurecorrectly or fails to measure pulserate correctly. | Pass | |
| 8.4 Lowvoltagepromptfunction | When the sphygmomanometer isturned on, when the battery voltageis low to 4.2V±0.2V, the batterysymbol "☐" should flash on thedisplay screen. | Pass | |
| 8.5 Automaticshutdownfunction | The sphygmomanometer willautomatically shut down if nooperation is performed within 2minutes after the measurement iscompleted. | Pass | |
| 8.6 memoryfunction | The sphygmomanometer canmemory store 2*99 groups ofmeasurement data, 99 groups ofusers A and B, in the memory state,press the [Start/Stop] key and the[memory/read] key at the sametime, 3 seconds later the screen willdisplay CLR, release the doublekey can clear all the memory data. | Pass | |
| 8.7 Clocksettingfunction | The sphygmomanometer should beable to display time and set time,including year, month, day, hourand minute. | Pass | |
| 8.8 | The sphygmomanometer should be | Pass | |
| Arrhythmiapromptfunction8.9Voicebroadcastpromptfunction | able to indicate the irregularheartbeat of the human body andcan display the "♥" symbol.In the "mmHg" unit display mode,sphygmomanometer shouldthehave a voice broadcast promptfunction. | Pass | |
| Cuff8.10detectionpromptfunction | The sphygmomanometer has cuffdetection function, and the display" "screen displays "symbolcuff is connectedthewhencorrectly, If an exception occurs,4 " symbol is displayedthe " | Pass | |
| 9.1 Sphygmomanometer shape should be correct,the surface should be bright, clean, color should beuniform.9.2 The characters and symbols of the blood | PassPass | ||
| 9 Appearanceand structure | pressure monitor should be clear, accurate and firm.9.3 The function keys of the sphygmomanometershould be flexible and reliable, and the fastenersshould not be loose. | Pass | |
| 9.4 The cuff should not be damaged. | Pass | ||
| 9.5 There should be no missing strokes in the LCDdisplay process. | Pass | ||
| Electrical10safetvrequirements | Thesphygmomanometer shallmeet the requirements specified inIEC 60601-1. | Pass | |
| 11compatibility | electromagnetic | sphygmomanometer shouldThemeet the requirements specified inIEC60601-1-2 Medical electrical1-2:Generalequipment-Part - Partrequirements for basic safety andperformance-Collateralessential | Pass |
| standard: Electromagneticcompatibility-Requirements andtests. | |||
| 12 Environmentalrequirements | The environmental test of thesphygmomanometer shall complywith IEC 60601-1-11 Part1-11:General requirements forbasic safety and essentialperformance-Collateral Standard:Requirements for medical electricalequipment and medical electricalsystems used in the homehealthcare environment. | Pass |
Table VII-1: Performance testing was conducted on the subject device
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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 cover and cuff. The material of cover 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 and ISO 10993-10.
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Electronic Blood Pressure Monitor.
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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 software for this device was considered as a "Moderate" level of concern.
Performance testing
The Electronic 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 Electronic Blood Pressure Monitor. The device complies with the IEC60601-1-6.
Clinical data:
YJ320 was tested to ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. the clinical validation data on YJ320 can cover YJ321E、YJ326E. The Same Arm Sequential Method was chosen and performed on YJ320. This study included 86 adult subjects (49 females, 37 male) with an age range of 17 to 76 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.
VIII Conclusion
The conclusions drawn from the non-clinical tests and clinical test demonstrate that the Electronic 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).