(221 days)
Not Found
No
The description details standard oscillometric blood pressure measurement and basic irregular heartbeat detection based on fixed thresholds, with no mention of AI or ML algorithms.
No
The device is used to monitor and display blood pressure and pulse rate, which are diagnostic measurements, not therapeutic treatments.
Yes
The device measures and displays blood pressure and pulse rate, it also identifies irregular heart rhythms ("W" display) and classifies blood pressure based on WHO recommendations, which directly aids in the diagnosis and monitoring of cardiovascular conditions.
No
The device description explicitly mentions hardware components such as a battery-powered or DC-powered system, an air cuff, an integral pump, and an electric valve, which are essential for its function. While software is used for data analysis, the device is not solely 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 Arm Blood Pressure Monitor measures blood pressure and pulse rate non-invasively by applying a cuff to the arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor and display blood pressure and pulse rate, which is a physiological measurement taken directly from the body.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
Product codes
DXN
Device Description
The Arm Blood Pressure Monitor (model: 111, B1681, B1683) are battery-powered or DC powered, automatic, non-invasive blood pressure system and intended to be use in hospital environment or at home. The Arm Blood Pressure Monitor (model: 111, B1682, B1683) are intended for use in adult patient population with arm circumference ranging from 22 cm to 32 cm. These devices are powered by 4 x AA batteries or an AC adaptor (output:5V DC). The device arm cuff inflates using an integral pump and deflates via an electric valve. During deflation, the arm cuff pressure is monitored and pulse waveform data is 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 280 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 2x99 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
Arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
medical professionals or at 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
Clinical study to verify clinical accuracy in accordance with ISO 81060-2:2018.
Study type: Clinical
Sample size: 86 subjects (44 male, 42 female), aged 16 to 87 years old.
Key Results:
- Mean value of differences of systolic blood pressure between sphygmomanometer-under-test and mercury sphygmomanometer was 1.0, and standard deviation was 3.1.
- Mean value of differences of diastolic blood pressure between sphygmomanometer-under-test and mercury sphygmomanometer was 0.9, and standard deviation was 3.4.
- Standard deviation of systolic blood pressure of sphygmomanometer-under-test and mercury sphygmomanometer was 2.4.
- Standard deviation of diastolic blood pressure of sphygmomanometer-under-test and mercury sphygmomanometer was 2.6.
- No adverse effect and complication was found during study.
- Statistical analysis results were within the ISO 81060-2-2018 standard acceptance standard.
Key Metrics
Accuracy of pressure: ± 3 mmHg
Accuracy of pulse rate: ± 5 % of reading
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 5, 2023
Shenzhen Yuezhongxing Technology Co., Ltd. Yuchao Chen Sales Manager No.2, Zhenye Road, Liulian Community, Pingshan Avenue Pingshan District Shenzhen, Guangdong 518015 China
Re: K222926
Trade/Device Name: Arm Blood Pressure Monitor, Model Name: 111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 29, 2023 Received: March 30, 2023
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 (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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 medical devices and radiation-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.
Robert T. Kazmierski -S
for
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
2
Indications for Use
510(k) Number (if known) K222926
Device Name
Arm Blood Pressure Monitor (Models: 111,B1681,B1682,B1683)
Indications for Use (Describe)
Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.
| 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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: May 03, 2023
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
| 510(K) number: | K222926 |
|---|---|
| Trade/Device Name: | Arm Blood Pressure Monitor |
| Models: | 111, B1681, B1682, B1683 |
| 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: | K193627 |
|---|---|
| Device Name: | Automatic Upper Arm Blood Pressure Monitor |
| Models: | BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, |
| BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, | |
| BA-818,BA-819 | |
| Manufacturer: | DONGGUAN E-TEST 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 |
4
Traditional 510(k) Submission of Arm Blood Pressure Monitor
| Product Code: | DXN |
|---|---|
| Panel: | Cardiovascular |
4. Device Description
The Arm Blood Pressure Monitor (model: 111, B1681, B1683) are battery-powered or DC powered, automatic, non-invasive blood pressure system and intended to be use in hospital environment or at home. The Arm Blood Pressure Monitor (model: 111, B1682, B1683) are intended for use in adult patient population with arm circumference ranging from 22 cm to 32 cm. These devices are powered by 4 x AA batteries or an AC adaptor (output:5V DC). The device arm cuff inflates using an integral pump and deflates via an electric valve. During deflation, the arm cuff pressure is monitored and pulse waveform data is 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 280 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 2x99 readings can be stored in memory.
5. Indication for use
Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's quide manual.
5
Traditional 510(k) Submission of Arm Blood Pressure Monitor
6. Comparison to Predicate Device
Compared to the predicate devices, the subject device has the same intended use, similar product design, same performance effectiveness as the predicate device, the summarized comparison information is listed in the following table:
| SE Comparisons | Subject devices | Predicate devices
K193627 | Note |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Company | Shenzhen Yuezhongxing
Technology Co., Ltd. | DONGGUAN E-TEST
TECHNOLOGY CO.,LTD | / |
| Product Name | Arm Blood Pressure Monitor | Automatic Upper Arm Blood
Pressure Monitor | / |
| Model Name | 111, B1681, B1682, B1683 | BA-801X, BA-802X,
BA-803X, BA-805X,
BA-806X, BA-811X,
BA-812X, BA-813X,
BA-821X, BA-822X,
BA-823X, BA-826X,
BA-818,BA-819 | / |
| Product Code | DXN | DXN | Same |
| Regulation name | Noninvasive blood pressure
measurement system | Noninvasive blood pressure
measurement system | Same |
| Indication for use | Arm Blood Pressure Monitor
is intended for use by medical
professionals or at home to
monitor and display diastolic,
systolic blood pressure and
pulse rate on adult each time,
with an air cuff buckled
around one's arm according
to the instruction in the user's
guide manual. | Automatic Upper Arm Blood
Pressure Monitor is intended
for use by medical
professionals or at home to
monitor and display
diastolic, systolic blood
pressure and pulse rate on
adult each time, with an air
cuff buckled around one's
arm according to the
instruction in the user's
guide manual. | Same |
| Environment of
use | Hospital, Home | Hospital, Home | Same |
| Patient
population | Adult | Adult | Same |
| SE Comparisons | Subject devices | Predicate devices
K193627 | Note |
| Contraindication | The monitor is contraindicated
for use in ambulatory
environment.
The monitor is contraindicated
in aircraft. | The monitor is
contraindicated for use in
ambulatory environment.
The monitor is
contraindicated in aircraft. | Same |
| Principle of
operation | Cuff oscillometric method | Cuff oscillometric method | Same |
| Measurement
site | Upper Arm | Upper Arm | Same |
| Measurement
range | Pressure:0 to 280 mmHg
Pulse rate: 40 to 199
beats/min | Pressure:0 to 280mmHg
Pulse rate: 40 to 199
beats/min | Same |
| Pressure sensor | Semiconductor pressure
sensor | Semiconductor pressure
sensor | Same |
| Arm
circumference | 22 cm to 32 cm | size A: 17cm-22cm
(SMALL ADULT CUFF)
size B: 22cm-30cm
(ADULT CUFF-1)
size C: 24cm-34cm
(ADULT CUFF-2)
size D: 22cm-42cm
(LARGE
ADULT CUFF)
size E: 30cm-42cm
(LARGE ADULT CUFF)
size F: 42cm-50cm
(EXTRA LARGE ADULT
CUFF) | See Note 1 |
| Accuracy of
pressure | $ ± 3 mmHg $ | $ ± 3 mmHg $ | Same |
| Accuracy of
pulse rate | $ ± 5 % of reading $ | $ ± 5 % of reading $ | 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 |
| display | LCD | LCD | Same |
| Power source | 4 x AAA batteries, or | 4 x AAA batteries | See Note 2 |
| SE Comparisons | Subject devices | Predicate devices
K193627 | Note |
| | AC adapter
(input:
100-240V~,50/60Hz,0.2A
output:5V DC, 1.0A,5.0W) | | |
| Operation
condition | 5 to 40°C
15 to 93% RH
700 to 1060hPa | 5 to 40 °C
15 to 80% RH
800 to 1050 hPa | See Note 3 |
| Storage condition | -25 to 70°C
0 to 93%RH | -20 to 65 °C
10 to 95% RH
86 kPa to 106 kPa | See Note 3 |
| Transportation
condition | -25 to 70°C
0 to 93%RH | -20 to 65 °C
10 to 95% RH
86 kPa to 106 kPa | See Note 3 |
| Irregular heart
beat feature | Yes | Yes | Same |
| Hypertension
indication | Yes | Yes | Same |
6
Traditional 510(k) Submission of Arm Blood Pressure Monitor
Yuezhongxing
7
Traditional 510(k) Submission of Arm Blood Pressure Monitor
Yuezhongxing
Note 1: Arm cuff size is different. Do not impact safety or performance of device.
Note 2: The subject device can be powered by an AC adaptor (output:5V DC) beside 4 x AAA batteries. IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2 can demonstrate that the subject device can maintain the safety and performance when is powered by an AC adaptor(output:5V DC). Thus, this difference does not raise different questions of safety and effectiveness.
Note 3: After conducting simulate transportation test, result shows no risk arise.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
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 at Wanxiang Xintian Community Health Serve Center,Xixiang Street, Bao'an District, Shenzhen City China by Shenzhen Cihai Hospital.
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.
510(k) Summary
8
Traditional 510(k) Submission of Arm Blood Pressure Monitor
Subject
Number: A total of 86 subjects voluntarily participated in this study,
Gender:44 of them were male and 42 were female,
Age: ranging in age from 16 to 87 years old.
Race: Asian
Ethnicity: Not Hispanic or Latino
Arm size distribution:
37 (43%) subjects have an arm circumference which lies within the upper half of the specified range of use of the cuff,
49 (57%) subjects have an arm circumference within the lower half of the specified range of use of the cuff,
22 (26%) subjects I have an arm circumference which lies within the upper quarter of the specified range of use of the cuff,
26 (30%) subjects have an arm circumference within the lower quarter of the specified range of use of the cuff;
15 (17%) subjects have an arm circumference which lies within the upper eighth of the specified range of use of the cuff,
and 10(12%) subjects have an arm circumference within the lower eighth of the specified range of use of the cuff.
Procedure:
- a. Either arm may be utilized
- b. Using the reference sphygmomanometer (mercury sphygmomanometer), have the observers determine the subject's blood pressure
- Interchange cuffs and wait at least 60s ﻥ
- d. Use the sphygmomanometer-under-test (subject device) to determine the subject's blood pressure
- e. Clear the sphygmomanometer-under-test memory of the previous determination and then wait at least 60s
- f. Do not use the data points obtained in b) and d) in the calculation of accuracy.
- Using the reference sphygmomanometer (mercury sphygmomanometer), have the g. observers determine the subject's blood pressure
- h. Interchange cuffs and wait at least 60 s.
- i. Use the sphygmomanometer-under-test (subject device) to determine the subject's blood pressure
9
Traditional 510(k) Submission of Arm Blood Pressure Monitor
Interchange cuffs and wait at least 60 s. i.
k. Have the observers use the reference sphygmomanometer (mercury sphygmomanometer) to determine the subject's blood pressure reference reading.
l. Interchange cuffs and wait at least 60 s.
m. Repeat i) to I) until the required number of valid reference readings and determinations have been performed.
Result
Blood pressure distribution:
7 (8%) subjects of the reference blood pressure readings have a systolic blood pressure ≤100 mmHg
11 (13%) subjects of the reference blood pressure readings have a systolic blood pressure≥160 mm Hq.
20 (23%) subjects of the reference blood pressure reading have a systolic blood pressure ≥140mmHg.
8 (9%) subjects of the reference blood pressure reading have a diastolic blood pressure ≤ 60 mmHg.
11 (13%) subjects of the reference blood pressure readings have a diastolic blood pressure ≥ 100 mm Hg.
21 (24%)subiects of the reference blood pressure readings have a diastolic blood pressure ≥85 mm Hg.
Adverse effects and complications:
There is no adverse effect and complication was found during study.
Data analysis:
According to the method of criterion 1 in ISO 81060-2:2018,5.2.4.1.2, the mean value of the differences of systolic blood pressure between the sphygmomanometer-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 the sphygmomanometer-under-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 the sphygmomanometer-under-test and mercury sphygmomanometer was 2.4, the standard deviation of diastolic blood pressure of the sphygmomanometer-under-test and mercury sphygmomanometer was 2.6.
Conclusion
The statistical analysis results were within the ISO 81060-2-2018 standard acceptance standard,
510(k) Summary
10
Traditional 510(k) Submission of Arm Blood Pressure Monitor
compared with the results of the mercury sphygmomanometer, determine that the subject device have enough clinical accuracy.
Non-clinical data
The Arm Blood Pressure Monitor comply with:
Safety and performance:
IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for 1. basic safety and essential performance.
-
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for 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 the basic safety and essential performance of automated non-invasive sphygmomanometers
Electromagnetic Compatibility:
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic 4. 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
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro 6. cytotoxicity
Software Verification and Validation:
FDA software validation quidance "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 demonstrate that the subject device is as safe and effective as the predicated device(K193627).