(100 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using a microprocessor and pressure sensor. It mentions a simple algorithm for detecting irregular heartbeats based on time intervals, which is not indicative of AI/ML. There are no mentions of AI, ML, DNN, or training/test sets.
No
The text describes the device as a digital monitor for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
No
Explanation: While the device measures blood pressure and pulse rate, which are physiological parameters, its primary function is measurement and providing a warning signal for irregular heartbeats. It does not provide a medical diagnosis of a disease or condition. The "irregular heart beat (IHB) indicator" is a warning signal based on detected pulse rhythm, not a diagnosis of an arrhythmia.
No
The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, pump, valve, and LCD. It 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 medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a blood pressure monitor. It measures physiological parameters (blood pressure and pulse rate) directly from the patient's body using a non-invasive technique (oscillometric method with a cuff). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
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 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
Weony Digital Blood Pressure Monitor WBP Series are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 135 and 215 mm, includes the inflatable bladder and PU shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries or adatpter.
The device has irregular heart beat (IHB) indicator which compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over a specified range.
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 patient population (at least 12 or above)
Intended User / Care Setting
Home and hospital facilities
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 Study:
In this clinical investigation, 85 patients (41 males and 44 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
Nonclinical, bench testing:
- Performance verification testing including Static Pressure accuracy, Static Leakage and Dynamic Pressure accuracy to confirm acceptable performance of device features and functions
- Cleaning verification testing to confirm device retains its performance when cuff is cleaned with household detergents (70% alcohol) as may be required in home use environment
- Product life verification testing to confirm device retains its performance when the device was used to measure blood pressure for at least 2 years as may be required in home use environment
- Irregular heart beat testing against the reference predicate WBP101 device (K210671)
Other nonclinical safety testing:
- Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
- Evaluation of relevant electrical safety, electromagnetic compatibility and electrostatic discharge requirements per IEC60601 and 80601 requirements
- Software verification and validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Pressure: ±3mmHg; Pulse: ±5%
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2023
Weony (Shenzhen) Technology Co., Ltd. Lucy Yan Consultant 401, the 6th building, Changfeng Industrial Zone Dongkeng Community, Fenghuang Street, Guangmi Shenzhen, GuangDong 518132 China
Re: K231542
Trade/Device Name: Digital Blood Pressure Monitor WBP Series Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 18, 2023 Received: May 30, 2023
Dear Lucy Yan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.
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
1
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,
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
2
Indications for Use
510(k) Number (if known) K231542
Device Name Digital Blood Pressure Monitor WBP Series
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 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K231542
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | May. 18, 2023 |
|---|---|
| Manufacturer | |
| information | Submitter's Name: WEONY (SHENZHEN) TECHNOLOGY |
| CO., LTD. | |
| Address: 401, the 6th building, Changfeng Industrial Zone, | |
| Dongkeng Community, Fenghuang Street, Guangming | |
| District, Shenzhen, 518132, PR. China. | |
| Contact person: Autumn Liu | |
| TEL: 86-755-86057437 | |
| E-Mail: autumn.liu@weony-sz.com | |
| Submission | |
| Correspondent | Contact person: Ms Lucy.Yan |
| E-Mail: Lucy.yan@aivikon.com | |
| Address: 401, the 6th building, Changfeng Industrial Zone, | |
| Dongkeng Community, Fenghuang Street, Guangming | |
| District, Shenzhen, 518132, PR. China. | |
| Establishment | |
| registration number | NA |
2 Device Information
| Common name of
| the device | System, Measurement, Blood-Pressure, Non-Invasive | |||
|---|---|---|---|---|
| Trade name of the | ||||
| device | Digital Blood Pressure Monitor WBP Series | |||
| Type/Model of the | ||||
| device | WBP203, WBP204, WBP205, WBP206 | |||
| Classification panel: Cardiovascular | ||||
| Classification | ||||
| information | Classification name: System, Measurement, Blood-Pressure, Non-Invasive | |||
| Regulation Number: 870.1130 | ||||
| Device Class: II |
4
| Product Code: DXN | ||
|---|---|---|
| type | ||
| submission | of | 510(k) |
| Traditional |
3 Predicate Device Information
Primary predicate device:
| Sponsor: | Omron Healthcare, Inc. |
|---|---|
| Device: | Model HEM-6131 |
| 510(K) Number: | K131742 |
Reference predicated device :
| Sponsor: | WEONY (SHENZHEN) TECHNOLOGY CO., LTD. |
|---|---|
| Device: | WBP101, WBP102, WBP103, WBP104, |
| WBP105, WBP106, WBP107. | |
| 510(K) Number: | K210671 |
4 Device Descriptions
Weony Digital Blood Pressure Monitor WBP Series are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual (at least 12 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Blood Pressure Monitor are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to wrist circumference approximately between 135 and 215 mm, includes the inflatable bladder and PU shell. All models of the wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve, and the LCD. The subject devices are powered by two AAA alkaline batteries or adatpter.
The device has irregular heart beat (IHB) indicator which compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over a specified range.
5
5 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 13.5cm to 21.5cm in home and hospital facilities by using a non-invasive oscillometric technique. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
6 SE Comparison
| Characteristics | Subject device | Primary Predicate device (K131742) | Reference Predicate device
(K210671) | Remark |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Device Name | Digital Blood Pressure Monitor WBP
Series | Model HEM-6131 | Digital Blood Pressure Monitor | NA |
| Device Model | WBP203, WBP204, WBP205,
WBP206, | HEM-6131 | WBP101, WBP102, WBP103,
WBP104, WBP105, WBP106,
WBP107. | NA |
| Manufacturer | WEONY (SHENZHEN)
TECHNOLOGY CO., LTD. | Omron Healthcare, Inc. | WEONY (SHENZHEN)
TECHNOLOGY CO., LTD. | NA |
| Intended Use/
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 13.5cm to
21.5cm in home and hospital facilities
by using a non-invasive oscillometric
technique. The device detects the
appearance of irregular heartbeats
during measurement and gives a
warning signal with readings. | 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 1/4
inches to 8 1/2 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. | The subject device intended to
measure the diastolic, systolic blood
pressures and pulse rate of an adult
individual in hospitals and home
environments by using a non-
invasive oscillometric technique with
a single upper arm cuff (22-36 cm).
The device detects the appearance
of irregular heart beats during
measurement and gives a warning
signal with readings. | SE |
| Intended
Population | adult | adult | adult | Same |
| Environment of
USE | Home | Home | Home | Same |
| Intended
Anatomical site | Wrist | Wrist | upper arm | Same as
K131742 |
| Prescription &
OTC | ОТС | ОТС | ОТС | Same |
| Patient
Connection | Yes via Cuff | Yes via Cuff | Yes via Cuff | Same |
| Working
Principle | Oscillometric method | Oscillometric method | Oscillometric method | Same |
| Pressure
sensor | Piezo resistance sensor | Piezo resistance sensor | Piezo resistance sensor | Same |
| Pressurization
Source | Automatic internal pump | Automatic internal pump for inflation
Automatic internal valve for deflation | Automatic internal pump | Same |
| Internal Power
supply | 2pcs "AAA" alkaline Batteries | 2 pcs "AAA" alkaline Batteries | 4pcs "AA" alkaline Batteries | Same as
K131742 |
| Memory
Function | 2 × 90 memories (SYS, DIA, Pulse) | 60 measurements | 2 × 90 memories (SYS, DIA, Pulse) | Same as
K231288 |
| Cuff Size | 13.5 cm to 21.5 cm | 13.5 cm to 21.5 cm | 220mm~360mm | Same as
K131742 |
Table 1. Substantial Equivalence Comparison
6
WEONY (SHENZHEN) TECHNOLOGY CO., LTD
| Measuring
range | Pressure: 0 to 299 mmHg (in 1 mmHg
increment); | Pressure: 0 to 299 mmHg (in 1 mmHg
increment); | Pressure: 0 to 299 mmHg (in 1
mmHg increment); | Same |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| | Pulse: 40 to 180 beat/minute | Pulse: 40 to 180 beat/minute | Pulse: 40 to 180 beat/minute | |
| Measuring
resolution | 1 mmHg | 1 mmHg | 1 mmHg | Same |
| Accuracy | Pressure: ±3mmHg; Pulse: ±5% | Pressure: ±3mmHg or 2% of reading;
Pulse ±5%. | Pressure: ±3mmHg; Pulse: ±5% | Same |
| Display Type | LCD digital display | LCD digital display | LCD digital display | Same |
| Irregular
Heartbeat
Detection | Yes | Yes | Yes | same |
| Operating
Condition | 1040℃, | 1040℃, | 10~40℃, | Different
Note01;
Same as
K231288 |
| | 15%85%RH | 15%55°C, | Different85%RH | 15%60℃, | -2090%RH | |55℃, | -20
| Storage
Condition | -20
Note02:
Same as
K231288 |
| | 10%~95%RH | 10%~95%RH | 10%~95%RH | |
| Dimension | L78mmW65mmH66mm | 78(W)60(D)21(H)mm | L140mmW116mmH55mm | SE |
| Weight | Approx. 81.5g(batteries not included) | Approximately 101g | Approx. 265.5g(batteries not
included) | SE |
| Materials | Patient contact materials of the cuff
have been tested in accordance with
ISO 10993 tested in accordance with
accordance with ISO 10993 and FDA
guidance | Patient contact materials of the cuff have
been tested in accordance with ISO
10993 tested in accordance with
accordance with ISO 10993 and FDA
guidance | Patient contact materials of the cuff
have been tested in accordance with
ISO 10993 tested in accordance
with accordance with ISO 10993 and
FDA guidance | Same |
Product: Digital Blood Pressure Monitor WBP Series
Note01 &02: The subject devices have different environment conditions of operation and storage from predicate device, but the subject devices have been tested by IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30 and ISO81060-2.
The subject device is as same as predicate device in Working Principle, intended patient population, intended application site, measuring accuracy. Only their environment conditions are a little bit different (refer to Note01 to Note 02) which had been validated. Als, the differences would not raise any safety or effectiveness issue based on tests in this submission.
Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US.
7 Brief discussions of the non-clinical tests [807.92(b)(1)]:
The subject device conforms to the following guidances and standards:
- や Non-Invasive Blood Pressure (NIBP) Monitor Guidance
- IEC 60601-1:2005+A1:2012+A2:2020: Medical Electrical Equipment Part 1: ゃ
General Requirements for Basic Safety and Essential Performance;
7
- � IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- 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;
- ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: � Tests for In Vitro cvtotoxicity:
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for ゃ irritation and skin sensitization;
- 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
The nonclinical, bench testing included:
· Performance verification testing including Static Pressure accuracy, Static Leakage and Dynamic Pressure accuracy to confirm acceptable performance of device features and functions
• Cleaning verification testing to confirm device retains its performance when cuff is cleaned with household detergents (70% alcohol) as may be required in home use environment
• Product life verification testing to confirm device retains its performance when the device was used to measure blood pressure for at least 2 years as may be required in home use environment
· Irregular heart beat testing against the reference predicate WBP101 device (K210671)
Other nonclinical safety testing included:
- · Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
- · Evaluation of relevant electrical safety, electromagnetic compatibility and electrostatic discharge requirements per IEC60601 and 80601 requirements
- Software verification and validation
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of WBP203 SERIES meet the established specifications necessary for consistent performance during its
8
intended use. In addition, the collective bench testing demonstrates that WBP203 SERIES does not raise different questions of safety or effectiveness for measurement of blood pressure and pulse in a home use environment when compared to the predicates.
8 Brief discussions of clinical tests [807.92(b)(2)]:
- ISO 81060-2:2018 Non-invasive sphygmomanometers Part 2: Clinical ゃ validation of automated measurement type;
In this clinical investigation, 85 patients (41 males and 44 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
9 Other information (such as required by FDA guidance)
No other information.
11 Conclusions
The subject device:
Digital Blood Pressure monitor manufactured by WEONY (SHENZHEN) TECHNOLOGY CO., LTD. is respectively substantially equivalent to the primary predicate device Blood Pressure Monitor manufactured by Omron Healthcare, Inc. (K131742) and the reference predicate device Digital Blood Pressure Monitor manufactured by WEONY (SHENZHEN) TECHNOLOGY CO., LTD. (K210671).