(161 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor using a microprocessor and pressure sensor to analyze signals, which is a well-established, non-AI/ML technique. The irregular heartbeat detection is based on comparing time intervals, not complex pattern recognition typically associated with AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is intended to measure blood pressure and pulse rate, not to treat a condition or disease.
Yes
The device measures blood pressure and pulse rate, and detects irregular heartbeats, providing information that can be used to inform a diagnosis.
No
The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, pump, valve, and LCD.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this device measures blood pressure and pulse rate directly from the patient's upper arm using a non-invasive technique. It does not analyze blood, urine, tissue, or any other bodily fluid or substance.
- The measurement is performed on the patient directly. The device interacts with the patient's arm via a cuff to obtain the readings. This is a direct physiological measurement, not an analysis of a sample taken from the body.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-36 cm). The device detects the appearance of irregular heats 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 18 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. 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 arm circumference approximately between 220 and 360 mm, includes the inflatable bladder and nylon shell. All models of the arm 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 four AA alkaline batteries or adatpter.
The device has irreqular 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
upper arm
Indicated Patient Age Range
adult
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 tests: ISO 81060-2:2018 Non-invasive sphygmomanometers Part 2: Clinical validation of automated measurement type;
Sample size: 85 patients (47 males and 38 females)
Study type: Clinical study using same arm sequential method.
Key results: The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
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August 13, 2021
Weony (Shenzhen) Technology Co., Ltd. Lucy Yan Consultant 3rd Floor B. Building 19. He Yi BeiFang YongFa Science & Technology Park, HeYi Community, ShaJing Street, Shenzhen, GuangDong 518104 China
Re: K210671
Trade/Device Name: Digital Blood Pressure Monitor WBP Series: WBP102, WBP103. WBP104, WBP105, WBP106, WBP107 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: July 13, 2021 Received: July 23, 2021
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.
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 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,
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) K210671
Device Name
Digital Blood Pressure Monitor WBP Series: WBP102, WBP103, WBP104, WBP105, WBP106, WBP107
Indications for Use (Describe)
The device intended to measure the diastolic, systolic blood pressures and pulse rate for adult population in home and hospital facilities by using a non-invasive oscillometric technique with a single upper arm cuff (22-36 cm). The device detects the appearance of irregular heats during measurement and gives a warning signal with readings.
| Type of Use (Select one or both, as applicable) | Remediation Use (Part 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
WEONY (SHENZHEN) TECHNOLOGY CO., LTD
Product: Digital Blood Pressure Monitor
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | Jan. 8, 2021 |
|---|---|
| Submitter's Name: WEONY (SHENZHEN) TECHNOLOGY CO., | |
| LTD. | |
| Manufacturer | |
| information | Address: Address: 3rd Floor B, Building 19, HeYi BeiFangYongFa |
| Science & Technology Park, HeYi Community, ShaJing Street, | |
| BaoAn District, ShenZhen, 518104, P.R. 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
3rd Floor B, Building 19, HeYi BeiFangYongFa Science &
Technology Park, HeYi Community, ShaJing Street, BaoAn
District, ShenZhen, 518104, P.R. 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 | WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 |
| Classification information | Classification panel: Cardiovascular |
| Classification name: System, Measurement, Blood-Pressure, Non-Invasive | |
| Regulation Number: 870.1130 | |
| Device Class: II | |
| Product Code: DXN | |
| type of submission | 510(k) Traditional |
4
Product: Digital Blood Pressure Monitor
3 Predicate Device Information
| Sponsor: | Truly Instrument Limited |
|---|---|
| Device: | Truly Automatic Arm Blood Pressure Monitor |
| 510(K) Number: | K091434 |
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 18 or above) by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. 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 arm circumference approximately between 220 and 360 mm, includes the inflatable bladder and nylon shell. All models of the arm 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 four AA alkaline batteries or adatpter.
The device has irreqular 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 Intended Use/ Indications for Use
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.
6 SE Comparison
5
Product: Digital Blood Pressure Monitor
Version: A/0
| Characterist
| ics | Subject device | Predicate device (K091434) | Remark |
|---|---|---|---|
| Device | |||
| Name | Digital Blood Pressure Monitor | Truly Automatic Arm Blood | |
| Pressure Monitor DB series | NA | ||
| Device | |||
| Model | WBP101, WBP102, WBP103, | ||
| WBP104, WBP105, WBP106, | |||
| WBP107. | DB21, DB22, DB23, DB31, | ||
| DB32, DB61M, DB62M, DB63M, | |||
| DB71M | NA | ||
| Manufacture | |||
| r | WEONY (SHENZHEN) | ||
| TECHNOLOGY CO., LTD. | Truly Instrument Limited | NA | |
| Intended | |||
| Use/ | |||
| Indication | |||
| for Use | 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. | Truly Automatic Arm Blood | ||
| Pressure Monitor DB series, | |||
| Models DB21, DB22, DB23, | |||
| DB31, DB32, DB61M, DB62M, | |||
| DB63M, DB71M are a series | |||
| device intended to measure the | |||
| systolic and diastolic blood | |||
| pressure and pulse rate of an | |||
| adult individual, by using a non- | |||
| invasive technique in which an | |||
| inflatable cuff is wrapped around | |||
| the upper arm. | |||
| The devices features include | |||
| irregular pulse rhythm detection | |||
| during measurement, and | |||
| display a warning signal with the | |||
| reading once the irregular | |||
| heartbeat is detected. | SE | ||
| Intended | |||
| Population | adult | adult | same |
| Intended | |||
| Anatomical | |||
| site | upper arm | upper arm | same |
| Prescription | |||
| & OTC | OTC | OTC | same |
| Working | |||
| Principle | Oscillometric method | Oscillometric method | same |
| Pressurizati | |||
| on Source | Automatic internal pump | Automatic internal pump | same |
| Internal | |||
| Power | |||
| supply | 4pcs "AA" alkaline Batteries | 4- size "AA" alkaline Batteries | same |
| Memory | |||
| Function | 2 × 90 memories (SYS, DIA, | ||
| Pulse) | DB21: 2×60; DB22: 2×50; | ||
| DB23: 4×99; DB31: 2×60; | |||
| DB32: 1×99; DB61M: | |||
| 4×99; DB62M: 4×99; | |||
| DB63M: 4×99; DB71M: | |||
| 4×99 | SE | ||
| Cuff Size | 220mm~360mm | 220mm~340mm | Similar |
| Note01 | |||
| Measuring | |||
| range | Pressure: 0 to 299 mmHg (in 1 | ||
| mmHg increment); | |||
| Pulse: 40 to 180 beat/minute | Pressure: (20mmHg~280mmHg) | ||
| Pulse rate range (40-195) | Similar | ||
| Note02 |
| Table 1. Substantial Equivalence Comparison |
|---|
6
WEONY (SHENZHEN) TECHNOLOGY CO., LTD
Product: Digital Blood Pressure Monitor
Version: A/0
| Measuring
| resolution | 1 mmHg | 1 mmHg | same |
|---|---|---|---|
| Accuracy | Pressure: ±3mmHg; Pulse: | ||
| ±5% | Pressure: ±3mmHg; Pulse ±5%. | same | |
| Display | |||
| Type | LCD digital display | LCD digital display | same |
| Cuff | |||
| attachment | |||
| method | By plastic host connected to | ||
| monitor | By plastic host connected to | ||
| monitor | same | ||
| Irregular | |||
| Heartbeat | |||
| Detection | The subject devices have the | ||
| IHB function. | DB22, DB23, DB61M, DB62M, | ||
| DB63M, DB71M have the IHB | |||
| feature. | same | ||
| Operating | |||
| Environmen | |||
| t | 10~40℃, | 10~40℃, | same |
| 15%~90%RH | 15%~90%RH | ||
| 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 | Same |
Note01: The subject devices have the larger arm circumference than predicate device, but the subject devices have been tested by ISO81060-2.
Note02: The subject device has a different measuring range of pressure and pulse from the predicate device, but the subject devices have been validated all the full claimed range.
The subject device is as same as predicate device in Working Principle. Intended patient population, intended application site, measuring accuracy. Only their Cuff size, measuring ranges 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
The subject device conforms to the following guidances and standards:
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance や
- IEC 60601-1:2005+A1:2012: Medical Electrical Equipment Part 1: General や Requirements for Basic Safety and Essential Performance;
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General や Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- IEC 60601-1-11: 2010 Medical Electrical Equipment Part 1-11: General ゃ Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems
7
Used in The Home Healthcare Environment;
- ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices Part 5: ゃ Tests for In Vitro cytotoxicity;
- や ISO 10993-10: 2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization;
- ゃ IEC 80601-2-30: 2013 Medical electrical equipment - Part 2-30: Particular Requirements for the Basic Safety and Essential Performance of Automated Non-invasive Sphygmomanometers
8 Brief discussions of clinical tests
- ISO 81060-2:2018 Non-invasive sphygmomanometers Part 2: Clinical ゃ validation of automated measurement type;
In this clinical investigation, 85 patients (47 males and 38 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 predicate device Arm Blood Pressure Monitor manufactured by Truly Instrument Limited (K091434).