(158 days)
This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with wrist circumference ranging from 13.5 cm at household or medical center (not suitable for neonate, pregnancy or pre-eclampsia.)
The YUWELL® Blood Pressure Monitor (Model: YE8800AR, YE8800CR) is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800AR, YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
The acceptance criteria for the YUWELL® Electronic Blood Pressure Monitor (Model: YE8800AR, YE8800CR) are primarily based on performance standards for blood pressure monitors. The study described is a clinical accuracy test.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Standard) | Reported Device Performance (YUWELL® Electronic Blood Pressure Monitor) |
|---|---|
| Accuracy of Pressure Indicator (per ANSI/AAMI/ISO 81060-2:2018 Criterion 1) | Mean Difference ± Standard Deviation (Test Device vs. Reference BP): Systolic: -1.7 ± 5.66 mmHg Diastolic: -1.0 ± 5.66 mmHg (The full criteria for ANSI/AAMI/ISO 81060-2 require that the mean difference be ≤ ±5 mmHg and the standard deviation be ≤ 8 mmHg.) |
| Accuracy of Pressure Indicator (per ANSI/AAMI/ISO 81060-2:2018 Criterion 2) | Mean Differences (Two Observers vs. YUWELL® Electronic Blood Pressure Monitor): Systolic: -1.7 ± 4.17 mmHg Diastolic: -1.0 ± 4.99 mmHg (The full criteria for ANSI/AAMI/ISO 81060-2 for Criterion 2 states that the standard deviation of the differences between the observation and the device should be not greater than 6.91 mmHg for at least two out of three device criteria sets. Values are generally expected for pairs of subjects, not for the entire population at once as given above) |
| Accuracy of Pulse Rate | Within ±5% of reading |
| Electrical Safety (IEC 60601-1, IEC 60601-1-11, IEC 80601-2-30) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies |
| Usability (IEC 60601-1-6, IEC 62366) | Complies |
| Software Verification and Validation (FDA Guidance, IEC 62304) | Complies |
| Biocompatibility (ISO 10993, FDA Guidance) | Complies |
| FCC Compliance (Part 15 federal communications commission rules) | Complies |
The Study Proving Acceptance Criteria:
A clinical accuracy test was conducted on the Yuwell YE8800AR model.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 85 participants.
- Data Provenance: The document does not explicitly state the country of origin. It describes participants as the "general population." The study is described as a "clinical accuracy test," suggesting a prospective collection of data for this validation.
3. Number of Experts and Qualifications for Ground Truth:
The document mentions "reference BP" and "two observers" in relation to the ANSI/AAMI/ISO 81060-2:2018 protocol. This standard typically requires measurements by trained observers or reference devices to establish ground truth.
- Number of Experts/Observers: Two observers are explicitly mentioned in the context of Criterion 2 of the ANSI/AAMI/ISO 81060-2:2018 protocol.
- Qualifications of Experts: Not explicitly stated in the provided text, but adherence to the ANSI/AAMI/ISO 81060-2:2018 protocol implies that the observers would be appropriately trained personnel, potentially medical professionals or technicians, who follow a standardized procedure for manual blood pressure measurement to establish the reference values.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. The ANSI/AAMI/ISO 81060-2 standard relies on comparisons between the automated device and simultaneous auscultatory measurements performed by trained observers. Discrepancies between observers might be handled by averaging or requiring re-measurements per the standard's guidelines, but a specific "adjudication" (like a third reader resolving disagreement) is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a standalone electronic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance:
Yes, the described clinical accuracy test is a standalone performance test of the device (algorithm only), without a human-in-the-loop component for the measurement process itself. The "human-in-the-loop" aspect would primarily be the human observers establishing the reference blood pressure for comparison.
7. Type of Ground Truth Used:
The ground truth was established by reference blood pressure measurements, likely obtained through a standardized method such as auscultation (manual measurement with a stethoscope and sphygmomanometer) performed by trained observers, as dictated by the ANSI/AAMI/ISO 81060-2:2018 validation protocol.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for the training set. The clinical study described is for validation/testing, not for training the device's measurement algorithm. Blood pressure monitors typically rely on established oscillometric principles rather than machine learning models that require explicit "training sets" in the same way as AI diagnostic devices.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as a training set in the context of machine learning is not mentioned or implied for this type of device. The device operates based on physical principles of oscillometry. The inherent algorithm development would likely have been based on extensive physiological and engineering data, but not typically a labeled "training set" with ground truth in the AI sense.
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October 17, 2022
Jiangsu Yuyue Medical Equipment & Supply CO.,LTD. Yinzhen Zhu Medical Device Registered Engineer No.1 Baisheng Road Development Zone Danyang, Jiangsu 212300 China
Re: K221372
Trade/Device Name: YUWELL® 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: September 9, 2022 Received: September 9, 2022
Dear Yinzhen Zhu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221372
Device Name
YUWELL® Electronic Blood Pressure Monitor
Indications for Use (Describe)
This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with wrist circumference ranging from 13.5 cm at household or medical center (not suitable for neonate, pregnancy or pre-eclampsia.)
| 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
OWNER/SUBMITTER'S INFORMATION
| Company Name | : | Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. | ||
|---|---|---|---|---|
| Company Address | : | No.1 Baisheng Road Development Zone, Danyang,Jiangsu 212300 CHINA | ||
| Contact | : | Yinzhen Zhu | ||
| Phone | : | 0511-86900827 | ||
| Fax | : | 0511-86900991 | ||
| : | zhu.yz@yuyue.com.cn | |||
| Date prepared | : | April 15, 2022 |
TRADE NAME, COMMON NAME, CLASSIFICATION
| Trade Name | : | YUWELL® Electronic Blood Pressure Monitor |
|---|---|---|
| Common Name | : | Electronic Blood Pressure Monitor |
| Classification Name | : | System, Measurement, Blood-pressure, Non-invasive |
| Product Code | : | DXN |
| Regulation Number | : | 870.1130 |
| Device Class | : | Class II |
IDENTIFICATION OF PREDICATE DEVICES(S)
The identification of predicates within this submission is as follow:
| Manufacturer | : | Omron Healthcare, Inc. |
|---|---|---|
| Trade Name | : | Wrist Blood Pressure Monitor Model BP4350 |
| Common Name | : | Wrist Blood Pressure Monitor Model BP4350 |
| Classification Name | : | System, Measurement, Blood-pressure, Non-invasive |
| Product Code | : | DXN |
| Regulation Number | : | 870.1130 |
| Device Class | : | Class II |
| FDA 510 (k) # | : | K182166 |
DESCRIPTION OF THE DEVICE
The YUWELL® Blood Pressure Monitor (Model: YE8800AR, YE8800CR) is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800AR, YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve.
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During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
INTENDED USE
This product is intended to measure the blood pressure and pulse rate of adult more than 12 years old and with wrist circumference ranging from 13.5 cm to 19.5 cm at household or medical center (not suitable for neonate, pregnancy or pre-eclampsia.)
TECHNOLOGICAL CHARACTERISTIC
The YUWELL® Blood Pressure Monitors (Model: YE8800AR, YE8800CR) are intended for medical professional and lay person at household or medical center and employ the oscillometric method for measuring blood pressure and pulse rate. The devices have a cuff pressure range of 0 to 300 mmHg and pulse rate range of 40 to 200 beats/min. It is intended for a wrist circumference range of 13.5 cm- 19.5 cm. The accuracy of pressure reading is ±3 mmHg, and accuracy of pulse rate is ±5%. Besides, the devices have multiple auxiliary functions for correct and convenient operation, including movement error indication, cuff wrapping detection, prompt for correct measurement of position (optional), irregular heartbeats indication, recorded measurement results check, display unit setting, display time and date setting, voice broadcast (optional), Bluetooth transmission (optional and only for YE8800AR), etc.
The YUWELL® Blood Pressure Monitors (Model: YE8800AR, YE8800CR) can be connected to an AC adapter and USB cable for charging. The AC adapter and USB cable which comply with IEC 60601-1:2012 are optional according to customer's order.
SUBSTANTIAL EQUIVALENCE
| Description | Proposed Device | Predicate Device | SE Discussion |
|---|---|---|---|
| Manufacturer | Jiangsu Yuyue MedicalEquipment& Supply Co.,Ltd. | Omron Healthcare, Inc. | - |
| Product Name | Electronic Blood PressureMonitor | Wrist Blood PressureMonitor Model BP4350 | - |
| Model Number | YE8800AR, YE8800CR | BP4350 | - |
| K Number | K221372 | K182166 | - |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Identical |
| Product Code | DXN | DXN | Identical |
| Classification | II | II | Identical |
| Intended Use/Indications forUse | This product is intended tomeasure the bloodpressure and pulse rate of | The device is a digitalmonitor intended for usein measuring blood | Note No.1 |
| adult more than 12 yearsold and with wristcircumference rangingfrom 13.5 cm to 19.5 cmat household or medicalcenter (not suitable forneonate, pregnancy orpre-eclampsia.) | pressure and pulse rate inadult patient populationwith wrist circumferenceranging from 5.3 inches to8.5 inches (13.5 cm to21.5 cm).The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal withreadings. | ||
| PatientsPopulation | Adult whom more than 12years old (not suitable forneonate, pregnancy orpre-eclampsia.) | Adults | Note No.2 |
| Environment ofUse | Household or medicalcenter | Home | Note No.3 |
| Performance Specifications | |||
| Principle ofOperation/Measuringmethod | Oscillation mensuration | Cuff oscillation method | Identical |
| MeasurementRange | • Pressure range: 0 | • Pressure range: 0 | Note No.4 |
| PressureSensor | Semiconductor pressuresensor | Semiconductor pressuresensor | Identical |
| Applicable Cuff(WristCircumference) | 13.5~19.5 cm | 13.5~21.5 cm | Note No.5 |
| Accuracy ofPressureIndicator | Within ±3 mmHg | Within ±3 mmHg | Identical |
| Accuracy ofPulse Rate | Within ±5% of reading | Within ±5% of reading | Identical |
| Inflation Method | Automatic inflation withpiezoelectric pump | Automatic inflation withpiezoelectric pump | Identical |
| DeflationMethod | Automatic rapid deflationvalue | Automatic rapid deflationvalue | Identical |
| Display | LCD digital display | LCD digital display | Identical |
| Power source | Rechargeable lithiumbattery | 2 "AAA" batteries | Note No.6 |
| OperatingConditions | • +5 °C~+40 °C• 15% ~ 90% RH (no-condensation) | • +10 °C~+40 °C• 15% ~ 90% RH (no-condensation) | Note No.7 |
| • 70 kPa ~ 106 kPa | • 80 kPa ~ 106 kPa | ||
| StorageConditions | • -20 °C~+55 °C• 15% ~ 90% RH (no-condensation)• 70 kPa ~ 106 kPa | • -20 °C~+60 °C• 10% ~ 90% RH (no-condensation) | Note No.8 |
| Dimensions(mm) | Approx.L89 mm x W62mm x H21 mm | 91 mm x 63 mm x 13 mm(not including the wristcuff) | Note No.9 |
| Weight (g) | About 109 g | Approximately 91 g (notincluding batteries) | Note No.10 |
| Operation Mode | Continuous operation | Continuous operation | Identical |
| IP Classification | IP22 | IP22 | Identical |
| ElectricClassification | Class II or internallypowered ME equipment,type BF application part(cuff is applied part) | Internally powered MEequipment, Type BF (wristcuff) | Note No.11 |
| Service Life | 5 years (6 times each day) | 5 years | Identical |
| Rating | AC adapter : input 100-240V~ 50/60Hz 0.35AMAX,output 5V==1000mABattery: DC 3.7V | DC 3 V 3.0 W | Note No.12 |
| Features | |||
| Time and DateSetting | YES | YES | Identical |
| VoiceBroadcast | Optional | NO | Note No.13 |
| Unit Setting | YESNote:Displaymeasurement results by"mmHg" or "kPa". | NONote:Displaymeasurement results by"mmHg" only. | Note No.14 |
| PromptforCorrectMeasurement ofPosition | Optional | YES | Identical |
| IndicationforIrregularHeartbeats | YES | YES | Identical |
| WrongOperationIndication | YES | YES | Identical |
| Cuff Detection | YES | YES | Identical |
| Deflation icon | YES | YES | Identical |
| Inflation icon | YES | NO | Note No.15 |
| ShutDownAutomatically | In 3 minutes without anyoperation | In 2 minutes without anyoperation | Note No.16 |
| ViewAverage | View average value oflatest three times | • Viewing the average ofthe latest 2 or 3 readings | Note No.17 |
| Value | measurement | taken within the most recent 10 minutes timeframe• View the weekly average readings taken in the morning over the past 4 weeks | |
| Memory Size | Up to 74 sets of data | Up to 100 sets of data per user | Note No.18 |
| Delete The Recorded Data | YES | YES | Identical |
| Bluetooth Transmission | Optional Note: Only for YE8800AR | YES | Note No.19 |
| Indication for Low Battery | YES | YES | Identical |
| Indication for Run Out of Battery | YES | YES | Identical |
| Safety and Performance | |||
| Performance | Comply ANSI/AAMI/ISO 81060-2 and IEC 80601-2-30 | Comply ANSI/AAMI/ISO 81060-2 and IEC 80601-2-30 | Identical |
| Electrical Safety | Comply IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-11 | Comply IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-11 | Identical |
| EMC | Comply IEC 60601-1-2 | Comply IEC 60601-1-2 | Identical |
| Embedded Software | Comply IEC 60601-1 and IEC 62304 | Comply IEC 60601-1 and IEC 62304 | Identical |
| Biocompatibility | Comply ISO 10993 and FDA Guidance (Tested items including Cytotoxicity, Sensitization and Intracutaneous Reactivity) | Comply ISO 10993 and FDA Guidance (Tested items including Cytotoxicity, Sensitization and Intracutaneous Reactivity) | Identical |
| FCC | Comply with Part 15 of federal communications commission (FCC) rules | Comply with Part 15 of federal communications commission (FCC) rules | Identical |
Comparison of technological characteristics
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DISCUSSION OF DIFFERENCES
| Note ID | Justification |
|---|---|
| Note No.1,Note No.2,Note No.3and NoteNo.5 | 1) According to clause 5.1.3 of ANSI/AAMI/ISO 81060-2:2018,adults or adolescent patients mean greater than 12 years old.Additionally, adult means human being older than 12 based onclause 3.1 of ANSI/AAMI SP-10:2002. So, both the proposeddevice and predicate device are intended for adult whom morethan 12 years old. However, the proposed device which is notsuitable for neonate, pregnancy or pre-eclampsia tightens theapplicable population, thus decreases risks for those particularpopulation. In conclusion, the minor difference above will not |
| influence the safety and effectiveness of the devices. | |
| 2) While the proposed device is designed for household and medicalcenter use and the predicate device is for home use, thedifference will not influence the safety and effectiveness of thedevices because household environment is more complex. | |
| 3) The applicable wrist circumference of proposed device isnarrower than the predicate device, it will not raise any new ordifferent safety or effectiveness. | |
| 4) The proposed device can also detect the appearance of irregularheartbeats during measurement and gives a warning signal withreadings, which is mentioned in "Features" and stated as"Indication for irregular heartbeats". So, both devices areidentical for this. | |
| Note No.4 | The pressure range and pulse rate of the proposed device are largerthan the predicate device, while the diastolic pressure range of theproposed device is narrower. Both contain the blood pressure andpulse range of most people, and the measurement range ofproposed device is fully verified according to IEC 80601-2-30.Therefore, the differences do not bring additional risks. |
| Note No.6 | Although the "Power Supply" of the proposed device is different fromthe predicate device, they all comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 and IEC 80601-2-30. Additionally, therechargeable lithium battery of the proposed device complies of IEC62133-2, so this difference will not raise any safety or effectivenessissue. |
| Note No.7and NoteNo.8 | Although the operating atmospheric pressure of the proposed deviceis slightly broader than the predicate device, while the storagetemperature and humidity of the proposed device are little narrower,they all comply with IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30, so this difference will not raise any safety or effectiveness issue. |
| Note No.9and NoteNo.10 | Dimensions and weight of both devices are quite similar, and itnearly makes no difference on safety and effectiveness of thedevices. |
| Note No.11and NoteNo.12 | Electric classification and rating of the two devices are different,because the proposed device is Class II or internally powered MEequipment, while the predicate device is internally powered MEequipment. However, they all comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 and IEC 80601-2-30, so this difference will notraise any safety or effectiveness issue. |
| Note No.13 | The voice broadcast function provides an additional way to getmeasurement results except for visual. Therefore, option thisfunction whether or not for the proposed device doesn't affect normaluse of the device or influence the safety and effectiveness of the |
| devices. | |
| Note No.14 | The proposed device can display measurement results by "mmHg"or "kPa", while the predicate device can display by "mmHg" only.The additional display unit meets the needs of more users and isverified according to IEC 80601-2-30, so the difference will not raiseany new safety or effectiveness risk. |
| Note No.15 | The inflation icon is to help users identify increase of pressure incuff, corresponding to deflation icon indicating decrease of pressure,so this would not raise any safety and efficacy problems. |
| Note No.16 | The proposed device has 3 minutes automatic power off time and it'slonger than the 2 minutes of the predicate device. The designpurpose is to give the user more time to review or record the data ifneeded. The difference will not raise any new safety or effectivenessrisk. |
| Note No.17 | Although the calculating methods of average measurement valueare different, both the auxiliary functions contribute patients to checkthe previous results, and don't affect the main function, so this wouldnot raise any safety and efficacy problems. |
| Note No.18 | Although the memory size of the proposed device was 26 fewer thanthat of the predicate device, it was sufficient for users to view recentmeasurement results, so this would not raise any safety and efficacyproblems. |
| Note No.19 | The Bluetooth transmission aims to record and view measurementresults on a mobile app when the device is not at hand. Therefore,lack of Bluetooth transmission for YE8800CR and optional ofBluetooth transmission based on users' order for YE8800AR don'taffect normal use of the device or influence the safety andeffectiveness of the devices. |
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SUMMARY OF TESTING
1) Nonclinical Testing Summary
The design and manufacturing of YUWELL® Electronic Blood Pressure Monitor are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards.
- Electrical safety test according to ANSI/AAMI/IEC 60601-1, IEC 60601-1-11 and IEC 80601-2-30 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Usability test according to IEC 60601-1-6 and IEC 62366 standards
- Performance test according to IEC 80601-2-30 standard
- Lithium battery report in accordance with IEC 62133-2
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· Biocompatibility test according to ISO 10993 and the FDA quidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
• Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304
Bluetooth transmission complies with Part 15 of federal communications . commission (FCC) rules
2) Clinical Testing summary
Clinical accuracy test was conducted on Yuwell YE8800AR, which has more complete functions compared with YE8800CR, according to the ANSI/AAMI/ISO 81060-2:2018 protocol in the general population. The device was assessed by using it on 85 participants, who fulfilled our inclusion criteria involving the ranges of wrist circumference and systolic and diastolic BP. The validation and data analysis were performed as per the protocol. In the ANSI/AAMI/ISO 81060-2:2018 validation procedure (criterion 1), the mean ± SD of the differences between the test device and reference BP was -1.7 ± 5.66/-1.0 ± 5.66 mmHg (systolic/diastolic). The mean differences between the two observers and the Yuwell YE8800AR were -1.7 ± 4.17 mmHg for systolic BP and -1.0 ± 4.99 mmHg for diastolic BP, according to criterion 2. The two ANSI/AAMI/ISO criteria were fulfilled. The Yuwell YE8800AR BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard.
CONCLUSION
Compared to the predicate device, the proposed device has similar intended use and performance, and equivalent testing standards, and all testing results have come back as positive results or pass for the proposed device, so the proposed device is as safety and effectiveness as the predicate device.
The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.
§ 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).