(130 days)
This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification according to WHO recommendation, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular Heart Beat (IHB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 applied). There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 2 minute the device will shut down automatically. The device includes model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrist Electronic Blood Pressure Monitor (K231367):
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a full clinical study report. Therefore, some of the requested information, particularly regarding the internal workings of the "AI" (which appears to be an oscillometric method, not AI in the modern sense) and detailed expert qualifications, is limited.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard ISO 81060-2:2018) | Reported Device Performance |
|---|---|
| Accuracy within ±5 mmHg | Meets requirements of ISO 81060-2:2018 within the ±5 mmHg |
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: 130 subjects.
- Data Provenance: The document states "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement." It does not specify the country of origin, but given the manufacturer's location (Shenzhen, China) and the correspondent's location (Shanghai, China), it's highly probable the study was conducted in China.
- Retrospective or Prospective: Prospective, as it involved "actual clinical trial" with volunteers.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The ground truth method was "Auscultation applied as gold standard with the qualified calibrated mercurial sphygmomanometer." This implies trained medical professionals (e.g., doctors or nurses) were performing these measurements, but their specific qualifications or number are not detailed.
-
Adjudication method for the test set:
- Not explicitly described. The text mentions "Auscultation applied as gold standard" and comparison with the subject device. It doesn't detail if multiple auscultation readings were taken and adjudicated.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This study was a clinical validation of an automated non-invasive sphygmomanometer against a gold standard, not an AI-assisted diagnostic study. The "AI" mentioned in the request refers to a modern interpretation of AI; this device uses the "oscillometric method" which is an automated algorithm but not typically categorized as advanced AI in the context of diagnostic image interpretation or complex decision support.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance test described is essentially a standalone algorithm performance test. The device (algorithm) measures blood pressure independently, and its readings are compared to the gold standard (auscultation). The device is an automated non-invasive sphygmomanometer.
-
The type of ground truth used:
- Expert consensus (indirectly): The primary ground truth was "Auscultation applied as gold standard with the qualified calibrated mercurial sphygmomanometer." Auscultation is performed by human operators. While not explicitly stated as "expert consensus" in terms of multiple experts reaching agreement after individual assessments, it relies on human expert measurement as the reference.
-
The sample size for the training set:
- The document does not provide information about a separate training set. For devices like automated blood pressure monitors, the underlying oscillometric algorithms are typically developed and refined using extensive datasets during their engineering phase, but this information is not part of the clinical validation study cited here. The ISO 81060-2:2018 standard focuses on clinical validation, not algorithm development.
-
How the ground truth for the training set was established:
- Not applicable/Information not provided, as no training set details are given in this document.
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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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
September 18, 2023
Shenzhen Finicare Co., Ltd. % Boyle Wang, Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K231367
Trade/Device Name: Wrist Electronic Blood Pressure Monitor (Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 21, 2023 Received: August 25, 2023
Dear Boyle Wang:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231367
Device Name
Wrist Electronic Blood Pressure Monitor (Model:FC-BP200, FC-BP210,FC-BP211,FC-BP211,FC-BP221)
Indications for Use (Describe)
This blood pressure monitor (Model: FC-BP20), FC-BP201, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
| 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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510(k) Summary
K231367
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
| Name: | Shenzhen Finicare Co., Ltd. |
|---|---|
| Address: | 201, No.50, the 3rd Industrial Park, Houting Community, ShajingStreet, Bao'an District, Shenzhen 518104 China |
| Tel: | 86-755-23013503 |
| Contact: | Chao Li |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lu Jiazui Rd., Pudong,Shanghai,200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Aug.23,2023
2.0 Device Information
| Trade name: | Wrist Electronic Blood Pressure Monitor |
|---|---|
| Common name: | Noninvasive Blood Pressure Measurement System |
| Classification name: | Noninvasive Blood Pressure Measurement System |
| Model(s): | FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221 |
| Production code: | DXN |
| Regulation number: | 21 CFR 870.1130 |
| Classification: | Class II |
| Panel: | Cardiovascular |
3.0 Predicate Device Information
| Manufacturer: | Shenzhen Kingyield Technology Co., Ltd. |
|---|---|
| Trade/Device name: | Bluetooth Blood Pressure Monitor, BPW1 |
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510(k) number: K182018
4.0 Indication for Use Statement
This blood pressure monitor (Model: FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221) is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a symbol with reading. The device is intended for using in only adult population, not applied to the other populations such as neonatal baby. It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The wrist circumference is limited to 13.5cm - 21.5cm.
5.0 Device Description
The subject device, Wrist Electronic Blood Pressure Monitor, is an automatic noninvasive blood pressure monitor which can be driven by AAA alkaline battery, DC3V. It uses an inflatable cuff which is wrapped around the patient's wrist to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy.
The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor.
The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x120 sets of measurement values can be stored automatically. The unit also calculates an average reading based on the values of the latest 3 times measurement.
This blood pressure monitor has the function of blood pressure classification according to WHO recommendation, which is convenient for you to judge whether your blood pressure is normal or not.
This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips.
The device detects an Irregular Heart Beat (IHB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values.
The device features a built-in "Bluetooth Data Transmission" function, which enables
{5}------------------------------------------------
the device automatically transmit measuring results through Bluetooth LE4.2 to paired Bluetooth-enabled device (FC-BP200, FC-BP210, FC-BP220 and FC-BP221 applied).
There is a maximum pressure safety setting at 300 mmHg, when the pressure is more than 300mmHg, the device will exhaust fast automatically.
No operation for 2 minute the device will shut down automatically.
The device includes model FC-BP200, FC-BP201, FC-BP210, FC-BP211, FC-BP220, FC-BP221. Six models are identical in terms of software design, cuff type and measurement range. The schematic circuit diagram are identical in all models except for model FC-BP220. Six models PCB layout are different because of different appearance (such as structure, buttons layout, etc.) and function.
6.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 &
A2:2010/(R)2012(Cons. Text) [Incl. AMD2:2021] - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-
1:2005, MOD) [Including Amendment 2 (2021)]
IEC 60601-1-2:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2020, 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.
EN 300328:2019 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques.
301489-1:2019 ElectroMagnetic Compatibility (EMC)standard for radio EN equipment and services;Part 1:Common technical requirements.
EN 301489-17:2020 Electromagnetic compatibility and Radio spectrum Matters
(ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems.
EN 62479:2010 Assessment of the compliance of low power electronic and electrical equipment with the basic restrictions related to human exposure to electromagnetic
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fields (10 MHZ to 300 GHZ )
IEC 62304:2015 standard and FDA Guidance for the Content of Pre-Market Submission for Software Contained in Medical Devices standard.
7.0 Clinical Test Conclusion
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use.
The clinical trials for the Wrist Electronic Blood Pressure Monitor were performed according the standard of ISO 81060-2:2018, Non-Invasive Sphygmomanometers -Part 2: Clinical Validation of Automated Measurement Type, and relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement.
There were 130 subjects been selected to participate in the trial, and Auscultation applied as gold standard with the qualified calibrated mercurial was was was and sphygmomanometer used as control group for comparison with the subject device. The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg.And the subject device comply with the standard requirements and the accuracy the manufacture declared.
8.0 Technological Characteristic Comparison Table
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| Item | Subject DeviceK231367 | Predicate DeviceK182018 | Remark |
|---|---|---|---|
| Manufacturer | Shenzhen Finicare Co., Ltd. | Shenzhen Kingyieldtechnology Co., Ltd | / |
| Product Name | Wrist Electronic Blood PressureMonitorFC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220,FC-BP221 | Bluetooth blood pressuremonitor, BPW1 | / |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| IntendedUse/Indicationfor Use | This blood pressure monitor(Model: FC-BP200, FC-BP201,FC-BP210, FC-BP211, FC-BP220, FC-BP221) is intended tobe used to measure bloodpressure (systolic and diastolic)and heart rate from the wrist byusing the oscillometric method.The device detects theappearance of irregularheartbeats during measurementand gives a symbol with reading.The device is intended for usingin only adult population, notapplied to the other populationssuch as neonatal baby. It can't beused while the wrist (arm) hasbleeding or wound to avoid theblood flowing from the wound inpressurizing. The wristcircumference is limited to 13.5cm- 21.5cm. | This blood pressure monitor isintended to be used tomeasure blood pressure(systolic and diastolic) andheart rate from the wrist byusing the oscillometric method.The device detects theappearance of irregularheartbeats duringmeasurement and gives asymbol with reading. Thedevice is intended for using inonly adult population, notapplied to the otherpopulations such as neonatalbaby. It can't be used while thewrist (arm) has bleeding orwound to avoid the bloodflowing from the wound inpressurizing. The wristcircumference is limited to13.5cm - 21.5cm | Same |
| Application Site | Wrist | Wrist | Same |
| WristCircumference | 13.5cm - 21.5cm | 13.5cm - 21.5cm | Same |
| PatientsContactingMaterials | Patient contact materials of thecuff: Brushed FabricAccording to ISO-10993 | Zinc alloy for the case of thedevice and ABS for Button.Biocompatible materials areused for the applied parts(Bladder + wristband)According to ISO-10993 | Different |
| PatientPopulation | Adult | Adult | Same |
| MeasurementsItem | SYS,DYS,Pulse | SYS,DYS,Pulse | Same |
| Display | LCD Digital Display | LCD | Same |
| Item | Subject Device | Predicate DeviceK182018 | Remark |
| Max Cuffpressure | 300 mmHg | 300mmHg | Same |
| BP Range | 0-299 mmHg | 0 ~ 299 mmHg | Same |
| BP Accuracy | ±3 mmHg | ±3 mmHg | Same |
| PR Range | 40-180 beats/min | 40 ~ 180 beats/min | Same |
| Pulse Accuracy | ±5% of readingvalue | ±5% of readingvalue | Same |
| Irregularheartbeatdetection | More than ±25% to themean interval of pulseintervals. | More than ±25% to themean interval of pulseintervals. | Same |
| InflationMethod | Automatic inflation by pump | By air pump | Same |
| DeflationMethod | Automatic rapid deflation | Not apply | Different |
| Memory Size | 2x120 set of data | 30 set | Different |
| OperationCondition | 10 | 10 | Different |
| StorageCondition | -20~60 °CHumidity: 10 to 95% RH | -20°C~ 55°C,0~95%RH (noncondensing ) | Different |
| Power Supply | 2 AAA alkaline batteries, DC3V | Li-ion Rechargeable batterywith 250 charging cycles | Different |
| PerformanceStandard | Comply with IEC 80601-2-30 | Comply with IEC 80601-2-30 | Same |
Table1-General Comparison
Analysis:
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The material of the wrist cuff of the subject device is different with that of the predicate device. Biocompatibility testing was carried out and the test results shown the materials of both devices are complied with the requirements of ISO 10993-1.
Table 2 Performance Comparison
Analysis:
The subject and predicate device have same general intended use, similar design features and performance specifications.
The differences in Memory Size do not raise different questions of safety or effectiveness since the device complied with the requirement of IEC 80601-2-30. The differences in Operation Condition and Storage Condition between both devices are insignificant in terms of safety and effectiveness. Also, the little difference in power supply according to the Electrical Safety and EMC test result, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. So we think the subject device is substantially equivalent to the predicate device.
Table 3 Safety Comparison
| Item | Proposed Device | Predicate DeviceK182018 | Remark |
|---|---|---|---|
| ------ | ----------------- | ----------------------------- | -------- |
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| Electrical Safety | Comply with ANSI AAMIES60601-1 | Comply with IEC 60601-1 | Same |
|---|---|---|---|
| Home Use | Comply with IEC 60601-1-11 | Comply with IEC 60601-1-11 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| FCC conformity | FCC 47 part 15 subject BFCC 47 CFR Part 15,Subpart C | FCC 47 CFR part 15,Subject BFCC 47 CFR Part 15, Subpart CFCC 47 CFR Part 1.1307FCC 47 CFR Part 2.1093 | Same |
| ERM conformity | EN 301489-1:2017;EN301489-17:2017 | EN 301489-1:2017;EN 301489-17:2017 | Same |
| RF conformity | EN300328:2016 | EN300328:2016 | Same |
| Health | EN62479:2010 | EN62479:2010 | Same |
| Biocompatibility | Comply with ISO 10993-1,FDA Guidance | Comply with ISO 10993-1, FDAGuidance | Same |
9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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).