(158 days)
Not Found
No
The summary describes standard oscillometric blood pressure measurement and analysis software, with no mention of AI or ML terms or methodologies.
No
The device is intended to measure blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic. It does not actively treat or alleviate a medical condition.
Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to assess and monitor health conditions. These measurements can aid in the diagnosis of various cardiovascular conditions, despite the device being intended for OTC use. For instance, high blood pressure readings can indicate hypertension.
No
The device description explicitly states it is a "rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system" that uses an "air pump" and "exhaust valve" to inflate and deflate a cuff. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The YUWELL® Blood Pressure Monitor measures blood pressure and pulse rate using a non-invasive method (oscillometric method) applied to the wrist. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate, which are physiological parameters, not to diagnose conditions based on in vitro analysis.
Therefore, this device falls under the category of a non-invasive medical device for monitoring physiological signs, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.)
Product codes
DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult more than 12 years old (not suitable for neonate, pregnancy or pre-eclampsia.)
Intended User / Care Setting
Household or medical center
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical accuracy test was conducted 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 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.
Key Metrics
Criterion 1: mean ± SD of the differences between the test device and reference BP was -1.7 ± 5.66/-1.0 ± 5.66 mmHg (systolic/diastolic).
Criterion 2: 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.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). 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.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
4
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 Medical | ||
| Equipment& Supply Co., | |||
| Ltd. | Omron Healthcare, Inc. | - | |
| Product Name | Electronic Blood Pressure | ||
| Monitor | Wrist Blood Pressure | ||
| Monitor 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 for | |||
| Use | This product is intended to | ||
| measure the blood | |||
| pressure and pulse rate of | The device is a digital | ||
| monitor intended for use | |||
| in measuring blood | Note No.1 | ||
| 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.) | pressure and pulse rate in | ||
| adult patient population | |||
| with wrist circumference | |||
| ranging from 5.3 inches to | |||
| 8.5 inches (13.5 cm to | |||
| 21.5 cm). | |||
| The device detects the | |||
| appearance of irregular | |||
| heartbeats during | |||
| measurement and gives a | |||
| warning signal with | |||
| readings. | |||
| Patients | |||
| Population | Adult whom more than 12 | ||
| years old (not suitable for | |||
| neonate, pregnancy or | |||
| pre-eclampsia.) | Adults | Note No.2 | |
| Environment of | |||
| Use | Household or medical | ||
| center | Home | Note No.3 | |
| Performance Specifications | |||
| Principle of | |||
| Operation/ | |||
| Measuring | |||
| method | Oscillation mensuration | Cuff oscillation method | Identical |
| Measurement | |||
| Range | • Pressure range: 0~300 | ||
| mmHg | |||
| • Pulse rate: 40~200 | |||
| beats/min | |||
| • Diastolic: 40-210 mmHg | |||
| • Systolic: 60~260 mmHg | • Pressure range: 0~299 | ||
| mmHg | |||
| • Pulse rate: 40~180 | |||
| beats/min | |||
| • Diastolic: 40-215 mmHg | |||
| • Systolic: 60~260 mmHg | Note No.4 | ||
| Pressure | |||
| Sensor | Semiconductor pressure | ||
| sensor | Semiconductor pressure | ||
| sensor | Identical | ||
| Applicable Cuff | |||
| (Wrist | |||
| Circumference) | 13.5~19.5 cm | 13.5~21.5 cm | Note No.5 |
| Accuracy of | |||
| Pressure | |||
| Indicator | Within ±3 mmHg | Within ±3 mmHg | Identical |
| Accuracy of | |||
| Pulse Rate | Within ±5% of reading | Within ±5% of reading | Identical |
| Inflation Method | Automatic inflation with | ||
| piezoelectric pump | Automatic inflation with | ||
| piezoelectric pump | Identical | ||
| Deflation | |||
| Method | Automatic rapid deflation | ||
| value | Automatic rapid deflation | ||
| value | Identical | ||
| Display | LCD digital display | LCD digital display | Identical |
| Power source | Rechargeable lithium | ||
| battery | 2 "AAA" batteries | Note No.6 | |
| Operating | |||
| Conditions | • +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 | ||
| Storage | |||
| Conditions | • -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 W62 | ||
| mm x H21 mm | 91 mm x 63 mm x 13 mm | ||
| (not including the wrist | |||
| cuff) | Note No.9 | ||
| Weight (g) | About 109 g | Approximately 91 g (not | |
| including batteries) | Note No.10 | ||
| Operation Mode | Continuous operation | Continuous operation | Identical |
| IP Classification | IP22 | IP22 | Identical |
| Electric | |||
| Classification | Class II or internally | ||
| powered ME equipment, | |||
| type BF application part | |||
| (cuff is applied part) | Internally powered ME | ||
| equipment, Type BF (wrist | |||
| cuff) | Note No.11 | ||
| Service Life | 5 years (6 times each day) | 5 years | Identical |
| Rating | AC adapter : input 100- | ||
| 240V~ 50/60Hz 0.35A | |||
| MAX, | |||
| output 5V==1000mA | |||
| Battery: DC 3.7V | DC 3 V 3.0 W | Note No.12 | |
| Features | |||
| Time and Date | |||
| Setting | YES | YES | Identical |
| Voice | |||
| Broadcast | Optional | NO | Note No.13 |
| Unit Setting | YES | ||
| Note: | |||
| Display | |||
| measurement results by | |||
| "mmHg" or "kPa". | NO | ||
| Note: | |||
| Display | |||
| measurement results by | |||
| "mmHg" only. | Note No.14 | ||
| Prompt | |||
| for | |||
| Correct | |||
| Measurement of | |||
| Position | Optional | YES | Identical |
| Indication | |||
| for | |||
| Irregular | |||
| Heartbeats | YES | YES | Identical |
| Wrong | |||
| Operation | |||
| Indication | YES | YES | Identical |
| Cuff Detection | YES | YES | Identical |
| Deflation icon | YES | YES | Identical |
| Inflation icon | YES | NO | Note No.15 |
| Shut | |||
| Down | |||
| Automatically | In 3 minutes without any | ||
| operation | In 2 minutes without any | ||
| operation | Note No.16 | ||
| View | |||
| Average | View average value of | ||
| latest three times | • Viewing the average of | ||
| the 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
5
6
7
DISCUSSION OF DIFFERENCES
| Note ID | Justification |
|---|---|
| Note No.1, | |
| Note No.2, | |
| Note No.3 | |
| and Note | |
| No.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 on | |
| clause 3.1 of ANSI/AAMI SP-10:2002. So, both the proposed | |
| device and predicate device are intended for adult whom more | |
| than 12 years old. However, the proposed device which is not | |
| suitable for neonate, pregnancy or pre-eclampsia tightens the | |
| applicable population, thus decreases risks for those particular | |
| population. 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 medical | |
| center use and the predicate device is for home use, the | |
| difference will not influence the safety and effectiveness of the | |
| devices because household environment is more complex. | |
| 3) The applicable wrist circumference of proposed device is | |
| narrower than the predicate device, it will not raise any new or | |
| different safety or effectiveness. | |
| 4) The proposed device can also detect the appearance of irregular | |
| heartbeats during measurement and gives a warning signal with | |
| readings, which is mentioned in "Features" and stated as | |
| "Indication for irregular heartbeats". So, both devices are | |
| identical for this. | |
| Note No.4 | The pressure range and pulse rate of the proposed device are larger |
| than the predicate device, while the diastolic pressure range of the | |
| proposed device is narrower. Both contain the blood pressure and | |
| pulse range of most people, and the measurement range of | |
| proposed 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 from |
| the predicate device, they all comply with IEC 60601-1, IEC 60601- | |
| 1-2, IEC 60601-1-11 and IEC 80601-2-30. Additionally, the | |
| rechargeable lithium battery of the proposed device complies of IEC | |
| 62133-2, so this difference will not raise any safety or effectiveness | |
| issue. | |
| Note No.7 | |
| and Note | |
| No.8 | Although the operating atmospheric pressure of the proposed device |
| is slightly broader than the predicate device, while the storage | |
| temperature 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.9 | |
| and Note | |
| No.10 | Dimensions and weight of both devices are quite similar, and it |
| nearly makes no difference on safety and effectiveness of the | |
| devices. | |
| Note No.11 | |
| and Note | |
| No.12 | Electric classification and rating of the two devices are different, |
| because the proposed device is Class II or internally powered ME | |
| equipment, while the predicate device is internally powered ME | |
| equipment. 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 not | |
| raise any safety or effectiveness issue. | |
| Note No.13 | The voice broadcast function provides an additional way to get |
| measurement results except for visual. Therefore, option this | |
| function whether or not for the proposed device doesn't affect normal | |
| use 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 is | |
| verified according to IEC 80601-2-30, so the difference will not raise | |
| any new safety or effectiveness risk. | |
| Note No.15 | The inflation icon is to help users identify increase of pressure in |
| cuff, 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's |
| longer than the 2 minutes of the predicate device. The design | |
| purpose is to give the user more time to review or record the data if | |
| needed. The difference will not raise any new safety or effectiveness | |
| risk. | |
| Note No.17 | Although the calculating methods of average measurement value |
| are different, both the auxiliary functions contribute patients to check | |
| the previous results, and don't affect the main function, so this would | |
| not raise any safety and efficacy problems. | |
| Note No.18 | Although the memory size of the proposed device was 26 fewer than |
| that of the predicate device, it was sufficient for users to view recent | |
| measurement results, so this would not raise any safety and efficacy | |
| problems. | |
| Note No.19 | The Bluetooth transmission aims to record and view measurement |
| results on a mobile app when the device is not at hand. Therefore, | |
| lack of Bluetooth transmission for YE8800CR and optional of | |
| Bluetooth transmission based on users' order for YE8800AR don't | |
| affect normal use of the device or influence the safety and | |
| effectiveness of the devices. |
8
9
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
10
· 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.