(107 days)
Not Found
No
The description mentions software analyzing pulse waveform data using the oscillometric method and detecting irregular heartbeats based on a fixed percentage deviation from the average rhythm. There is no mention of AI, ML, training data, or adaptive algorithms.
No.
The device is a digital monitor for measuring blood pressure and pulse rate, not for treating or providing therapy for a medical condition.
Yes
The device measures blood pressure and pulse rate, and it also detects and provides a warning signal for irregular heartbeats, which are all diagnostic functions.
No
The device description explicitly states it is an "automatic, non-invasive blood pressure system" with a physical wrist cuff, integral pump, and electric valve, indicating it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The tests are performed outside of the body (in vitro).
- Device Function: This device is a blood pressure monitor that measures blood pressure and pulse rate non-invasively on the wrist. It does not analyze any samples taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. This is a physiological measurement taken directly from the body.
Therefore, based on the provided information, the device is a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Wrist Blood Pressure Monitor,Models: 222,222BT,W1681BL, W1681BT, W1681R are powered by a rechargable Li-ion battery, automatic, non-invasive blood pressure system intended for home use. The devices are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). The devices' wrist cuff inflates using an integral pump and deflates via an electric valve. During deflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse rate range from 40 to 199 beats/min.
When the device detected irregular rhythms, " W " will display on screen. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2 x 99 readings can be stored in memory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical test: We performed a clinical study to verify clinical accuracy of the subject devices in accordance with ISO 81060-2:2018. The study was conducted by Shenzhen Cihai Hospital. The quantity of clinical investigation subjects is 86 subjects. Of these, 44 are men and 42 are women, with a minimum age of 16 and a maximum age of 87. The patient's Wrist size is required between 22 cm and 32cm. We selected auscultatory method (mercury sphygmomanometer) as the reference standard to determine the clinical accuracy by calculating the mean value and standard deviation according to ISO 81060-2:2018. 86 subjects were selected and 344 valid paired blood pressure values of systolic and diastolic data were obtained. According to the method of criterion 1 in ISO81060-2 : 2018, 5.2.4. 1.2 . The mean value of the differences of systolic blood pressure between the sphygmomanometers-under-test and mercury sphygmomanometer was 1.0, and the standard deviation was 3.1. The mean value of the differences of diastolic blood pressure between test and mercury sphygmomanometer was 0.9 and the standard deviation was 3.4. According to the method of criterion 2 in ISO 81060-2 : 2018,5.2.4. 1.2 , the standard deviation of systolic blood pressure of sphygmomanometers-under-test and mercury sphygmomanometer is 2.4 . The standard deviation of diastolic blood pressure for test and mercury sphygmomanometer is 2.6 in table 1. The statistical analysis results were within the ISO 81060-2-2018 standard acceptance standard, compared with the results of the mercury sphygmomanometer, determine that the subject device have enough clinical accuracy.
Non-clinical data: The Wrist Blood Pressure Monitor comply with IEC 60601-1:2005+ A1:2012+A2:2020, IEC 60601-1-11:2015, IEC 80601-2-30:2018, IEC 60601-1-2:2014, ISO 10993-10:2010, ISO 10993-5:2009. Software Verification and Validation was performed according to FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Accuracy:
Criterion 1 (ISO 81060-2:2018, 5.2.4.1.2):
Systolic blood pressure: mean difference = 1.0, standard deviation = 3.1
Diastolic blood pressure: mean difference = 0.9, standard deviation = 3.4
Criterion 2 (ISO 81060-2:2018, 5.2.4.1.2):
Systolic blood pressure: standard deviation = 2.4
Diastolic blood pressure: standard deviation = 2.6
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
March 15, 2024
Shenzhen Yuezhongxing Technology Co., Ltd. Yuchao Chen Sales Manager No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen, Guangdong 518015 China
Re: K233799
Trade/Device Name: Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: February 29, 2024 Received: February 29, 2024
Dear Yuchao Chen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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.
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
Indications for Use (Describe)
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Shenzhen Yuezhongxing Technology Co., Ltd. |
|---|---|
| Address: | No.2, Zhenye Road, Liulian Community, Pingshan Avenue, |
| Pingshan District, Shenzhen,518015,CHINA | |
| Contact person: | Yuchao Chen |
| Title: | Sales manager |
| E-mail: | 718145238@qq.com |
| Tel: | +86-135 1039 4198 |
2. Device Identification
| Trade/Device Name: | Wrist Blood Pressure Monitor |
|---|---|
| Models: | 222, 222BT, W1681BL, W1681BT, W1681R |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Name: | Noninvasive blood pressure measurement system |
| Common Name: | System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation Class: | Class II |
| Product Code: | DXN |
| Panel: | Cardiovascular |
3. Predicate Device
| 510(K) number: | K211041 |
|---|---|
| Device Name: | Wrist Blood Pressure Monitor |
| Models: | W1681 |
| Manufacturer: | Shenzhen Yuezhongxing Technology Co., Ltd. |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Name: | Noninvasive blood pressure measurement system |
| Common Name: | System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation Class: | Class II |
| Product Code: | DXN |
| Panel: | Cardiovascular |
5
4. Device Description
The Wrist Blood Pressure Monitor,Models: 222,222BT,W1681BL, W1681BT, W1681R are powered by a rechargable Li-ion battery, automatic, non-invasive blood pressure system intended for home use. The devices are intended for use in adult patient population with wrist circumference ranging from 5 3/8 inches to 7 2/3 inches (13.5 cm). The devices' wrist cuff inflates using an integral pump and deflates via an electric valve. During deflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 295 mmHg, and the pulse rate range from 40 to 199 beats/min.
When the device detected irregular rhythms, " W " will display on screen. An irregular heartbeat rhythm is defined as a rhythm that is 25% less or 25% more than the average rhythm detected while your monitor is measuring blood pressure. The WHO blood pressure indicator bar can classify by WHO and ISH recommendation. The devices display the latest blood pressure reading, while up to 2 x 99 readings can be stored in memory.
5. Indication for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 3/8 inches (13.5cm to 19.5cm). The device detects the appearance of irregular hearbeats during measurement and gives a warning signal with reading.
6. Compared to Predicate Device
Compare to the predicate devices, the subject device has same intended use, similar product design, same performance,same safety as the predicate device, the summarized comparison information is listed in the following table
6
| Traditional 510(k) Submission of Wrist Blood Pressure Monitor | |||
|---|---|---|---|
| ---------------------------------------------------------------- | -- | -- | -- |
Yuezhongxing
| SE Comparisons | Subject
device
Wrist Blood
Pressure
Monitor,
Model:202 | Subject
device
Wrist Blood
Pressure
Monitor,
Model:202BT | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
BL | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
BT | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
R | Predicate device
Automatic Wrist Blood
Pressure Monitor,
Model: W1681
(K211041) | Note |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indication for use | The device is a digital monitor intended for use in measuring blood pressure
and pulse rate in adult patient population with wrist circumference ranging from
5 3/8 inches to 7 2/3 inches (13.5cm to 19.5cm). The device detects the
appearance of irregular hearbeats during measurement and gives a warning
signal with reading. | | | | | The device is a digital
monitor intended for use in
measuring blood pressure
and pulse rate in adult
patient population with wrist
circumference ranging from
5 3/8 inches to 7 2/3 inches
(13.5cm to 19.5cm).
The devices detect the
appearance of irregular
hearbeats during
measurement and gives a
warning singal with reading | Same |
| Environment of
use | Home | | | | | Home | Same |
| Patient
population | Adult | | | | | Adult | Same |
| Contraindication | The monitor is contraindicated for use in ambulatory environment.
The monitor is contraindicated in aircraft.
Use of this instrument on patients under dialysis therapy or on anticoagulant,
antiplatelets, or steroids could cause internal bleeding. | | | | | The monitor is
contraindicated for use in
ambulatory environment.
The monitor is
contraindicated in aircraft. | Note 1 |
| Principle of
operation | Cuff oscillometric method | | | | | Cuff oscillometric method | Same |
| Measurement
range | Cuff Pressure: 0-295 mmHg,
Pulse: 40-195/minute,
Diastolic Pressure: 30-180mmHg | | | | | Cuff Pressure:
0-295 mmHg,
Pulse: 40-195/minute | Same |
510(k) Summary
7
| Traditional 510(k) Submission of Wrist Blood Pressure Monitor | |
|---|---|
| ---------------------------------------------------------------- | -- |
Yuezhongxing
| SE Comparisons | Subject
device
Wrist Blood
Pressure
Monitor,
Model:202 | Subject
device
Wrist Blood
Pressure
Monitor,
Model:202BT | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
BL | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
BT | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
R | Predicate device
Automatic Wrist Blood
Pressure Monitor,
Model: W1681
(K211041) | Note |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| | | Systolic Pressure: 50-270mmHg | | | | Diastolic Pressure:
30-180mmHg,
Systolic Pressure:
50-270mmHg | |
| Pressure sonsor | Semiconductor pressure sensor | | | | | Semiconductor pressure
sensor | Same |
| Wrist
circumference | 13.5-19.5 cm | | | | | 13.5-19.5 cm | Same |
| Accuracy | Cuff Pressure: ±3mmHg
Pulse: ±5% of reading
The accuracy of diastolic and systolic pressure meets the requirements of ISO
81060-2:2018 | | | | | Cuff Pressure: ±3mmHg
Pulse: ±5% of reading
The accuracy of diastolic
and systolic pressure meets
the requirements of ISO
81060-2:2018 | Same |
| Inflation method | Automatic inflation with piezoelectric pump | | | | | Automatic inflation with
piezoelectric pump | Same |
| Deflation method | Automatic rapid deflation valve | | | | | Automatic rapid deflation
valve | Same |
| Screen | LED | LED | LCD | LCD | LCD | LCD | Note 2 |
| Power source | | Rechargeable Li-ion battery. 3.7Vdc300mAh
Charged by Adapter, Input:100-240V 50/60Hz 0.2A,Output:5.0Vdc 1.0A | | | | 2 x AAA batteries | See
Note 3 |
| Bluetooth | No | Yes | No | Yes | No | No | Note 4 |
8
| Traditional 510(k) Submission of Wrist Blood Pressure Monitor | |
|---|---|
| ---------------------------------------------------------------- | -- |
Yuezhongxing
| SE Comparisons | Subject
device
Wrist Blood
Pressure
Monitor,
Model:202 | Subject
device
Wrist Blood
Pressure
Monitor,
Model:202BT | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
BL | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
BT | Subject
device
Wrist Blood
Pressure
Monitor,
Model:W1681
R | Predicate device
Automatic Wrist Blood
Pressure Monitor,
Model: W1681
(K211041) | Note |
|---------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------|
| Operation
condition | +5°C~+40°C,15%80%RH,70106kPa | +5°C~+40°C,15%80%RH,70106kPa | +5°C~+40°C,15%80%RH,70106kPa | +5°C~+40°C,15%80%RH,70106kPa | +5°C~+40°C,15%80%RH,70106kPa | +5°C~+40°C,
15%80%RH,106kPa | See
80
Note 5 |
| Storage condition
And
Transportation
condition | -20~+55°C,10%~ 93%RH, 70106kPa | -20+55°C,10%~ 93%RH, 70106kPa | -20+55°C,10%~ 93%RH, 70106kPa | -20+55°C,10%~ 93%RH, 70106kPa | -20+55°C,10%~ 93%RH, 70106kPa | -20+55°C,
10%~93%RH | See
Note 6 |
| Irregular heart
beat feature | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Hypertension
indication | Yes | Yes | Yes | Yes | Yes | Yes | Same |
Note 1:The subject devices have additional contraindication, the subject device are prohibited use for on anticoagulant, antiplatelets, or steroids could cause internal bleeding. This does not impact the safety and effectiveness.
Note 2: The subject devices 202 and 202BT employ LED screen.This does not impact the safety and effectiveness.
Note 3: The predicate device is powered by AAA battery, the subject devices are powered by recharge by an AC adapter.The subject devices, Li-ion batter were conducted IEC 60601-1:2005+A1:2012+A2:2020 tests, the results showed meet safety requirements. So this does not impact the safety and effectiveness.
Note 4: The subject devices 202BT and W1681BT have bluetooth function, can connect to Smartphone App. The EMC, Wirelessocexist and Cybersecurity are evaluated. So this does not impact the safety and effectiveness.
9
Yuezhongxing
Note 5: The subject devices comply with IEC 60601-1: 2005+A1:2012, no energy risk and mechanical risk arices can be operated in operation conditions manufacture specified.
Note 6: The subjected devices comply with IEC 60601-11:2015, they can be transported and storage conditions manufacture specified, and the conditions are indicated in user manual.
10
8. Performance Data
Clinical test:
We performed a clinical study to verify clinical accuracy of the subject devices in accordance with ISO 81060-2:2018. The study was conducted by Shenzhen Cihai Hospital.
The quantity of clinical investigation subjects is 86 subjects. Of these, 44 are men and 42 are women, with a minimum age of 16 and a maximum age of 87. The patient's Wrist size is required between 22 cm and 32cm.
We selected auscultatory method (mercury sphygmomanometer) as the reference standard to determine the clinical accuracy by calculating the mean value and standard deviation according to ISO 81060-2:2018.
86 subjects were selected and 344 valid paired blood pressure values of systolic and diastolic data were obtained.
According to the method of criterion 1 in ISO81060-2 : 2018, 5.2.4. 1.2 . The mean value of the differences of systolic blood pressure between the sphygmomanometers-under-test and mercury sphygmomanometer was 1.0, and the standard deviation was 3.1. The mean value of the differences of diastolic blood pressure between test and mercury sphygmomanometer was 0.9 and the standard deviation was 3.4.
According to the method of criterion 2 in ISO 81060-2 : 2018,5.2.4. 1.2 , the standard deviation of systolic blood pressure of sphygmomanometers-under-test and mercury sphygmomanometer is 2.4 . The standard deviation of diastolic blood pressure for test and mercury sphygmomanometer is 2.6 in table 1.
The statistical analysis results were within the ISO 81060-2-2018 standard acceptance standard, compared with the results of the mercury sphygmomanometer, determine that the subject device have enough clinical accuracy.
Non-clinical data
The Wrist Blood Pressure Monitor comply with:
Safety and performance:
- IEC 60601-1:2005+ A1:2012+A2:2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for 2. basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 80601-2-30:2018 Medical electrical equipment - Part 2-30: Particular requirements for 3. the basic safety and essential performance of automated non-invasive sphygmomanometers
Electromagnetic Compatibility:
11
Traditional 510(k) Submission of Wrist Blood Pressure Monitor
- IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility:
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation 5. and skin sensitization
- I SO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
9. Conclusion
The conclusions drawn from the nonclinical tests and clinical tests demonstrate that the subject devices are as safe, as effective, and performs as well as the predicate device (K211041).