(266 days)
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby.
It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
BW-BA1 Bluetooth Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method during inflating @ 3~8mmHg/second from about 30mmHg by inflating a cuff on the upper arm. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. An irregular heartbeat rhythm is defined as rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
BW-BA1 Bluetooth Blood Pressure Monitor without any display component achieves its function by integrating the device with a collateral device iPhone, iPad with a specific mobile app to constitute a complete blood pressure measurement system. And the new device connects the mobile platform with the mobile app through Bluetooth 4.0.
The operational principle is based on oscillometric and pressure sensor technology, it can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator according to the classification rule developed by WHO.
The BW-BA1 is powered by a rechargeable Lithium battery.
The device has an ON/START button for starting the measuring and stopping the measuring at any time when measuring.
The provided text describes the 510(k) premarket notification for the BW-BA1 Bluetooth Blood Pressure Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and device performance.
However, based on the information provided and the common requirements for blood pressure monitors, we can infer some details and highlight the missing information.
Here's an attempt to structure the answer based on your request, with a clear indication of what is not explicitly stated in the provided documents:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance for blood pressure measurement accuracy. However, it does state the device's accuracy claims and mentions adherence to ISO 81060-2, which dictates such criteria.
| Acceptance Criterion (Inferred from Predicate and Standards) | Reported Device Performance (As claimed and implied by equivalence) |
|---|---|
| Blood Pressure Accuracy: Pressure (Mean Difference) | $\pm$ 3 mmHg (Claimed, consistent with predicate and standard) |
| Blood Pressure Accuracy: Pulse (Mean Difference) | $\pm$ 5% of reading value (Claimed, consistent with predicate and standard) |
| Cuff pressure range | 0~299 mmHg (Claimed for proposed device) |
| Pulse rate range | 40~180 beat/min (Claimed for proposed device) |
| Irregular Heartbeat (IHB) detection | IHB warning signal if rhythm is 25% less or 25% more than average rhythm (Proposed device feature) |
| Arm circumference range | 8.7 inches (approx. 22 cm) to 16.5 inches (approx. 42 cm) (Claimed for proposed device) |
Important Note: The document explicitly states: "Clinical validation concerning the compliance of ISO 81060-2 has been performed that the device BW-BA1 is the same as the predicate except IHB adding for our device. And the fundamental scientific technology of the device is identical with the predicate and IHB adding does not raise new questions of safety and effectiveness. Therefore the performance of the device in terms of blood pressure measurement would be identical with performance of the predicate." This implies that the device's performance is expected to meet the same accuracy standards as the predicate device, which would have been demonstrated through its own ISO 81060-2 validation. However, the direct results of this "clinical validation" for the BW-BA1 are not provided in the text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the clinical validation or the data provenance. It only mentions that "Clinical validation concerning the compliance of ISO 81060-2 has been performed." For ISO 81060-2, a typical clinical validation would involve an appropriate number of participants (e.g., generally 85 subjects with specific age and blood pressure distributions as per the standard).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitor validation studies (like those following ISO 81060-2), ground truth is typically established by trained clinical professionals (e.g., physicians, nurses) using auscultatory methods with a mercury sphygmomanometer or validated reference device. The number and qualifications of these experts are usually specified in detailed study protocols, which are not included here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. For blood pressure validation studies, ground truth measurements often involve multiple observers taking readings to ensure accuracy and minimize bias, with methods for reconciling discrepant readings.
5. 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
This is not applicable to this device. The BW-BA1 is a medical device for measuring blood pressure, not an AI-assisted diagnostic tool that would involve human readers or image interpretation. Its primary function is to accurately measure blood pressure.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, implicit in the independent validation of a blood pressure monitor, the device's ability to measure blood pressure accurately standalone (i.e., its algorithm for oscillometric measurement) is evaluated against a reference standard. The document mentions "Clinical validation concerning the compliance of ISO 81060-2 has been performed," which is a standalone validation of the device's measurement accuracy. The output (blood pressure readings) is then displayed via a connected app.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For blood pressure monitors, the ground truth is typically established by simultaneous measurements taken by trained observers using a calibrated reference device, such as a mercury sphygmomanometer, via the auscultatory method. This involves multiple expert readings to ensure accuracy. The document does not explicitly state this, but it is the standard for ISO 81060-2 compliance.
8. The sample size for the training set
This is not applicable as the BW-BA1 is a traditional blood pressure monitor, not an AI/machine learning-based device that typically uses "training sets" in the same way. Its fundamental operational principle is based on oscillometric and pressure sensor technology.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8. The accuracy of oscillometric blood pressure monitors is based on their physical measurement principles and calibration, validated against established clinical methods.
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February 26, 2018
Visiomed Group SA % Dacheng Gong General Manager Shenzhen Kingyield Technology Co., Ltd. Section C2, Fuhai Industrial Zone Fuyong Town, Baoan District Shenzhen, 518000 China
Re: K171668
Trade/Device Name: BW-BA1 Bluetooth Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: January 18, 2018 Received: January 23, 2018
Dear Dacheng Gong:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Dacheng Gong
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Willemann
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171668
Device Name BW-BA1 Bluetooth blood pressure monitor
Indications for Use (Describe)
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby.
It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
| 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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BW-BA1 Premarket Notification 510(k)
510(k) Summary
Administrative Information I.
1.1 Submitter/Owner
Visiomed Group SA
Address: 112 Av. Kleber Paris, FRANCE 75116 Establishment Registration Number: 3012440774
1.2 Contact person
Authorized Contact Person: Dacheng Gong who works for the manufacturer Shenzhen Kingyield Technology Co., Ltd who manufactures BW-BA1 for Visiomed Group SA
Position: General Manager
Address: Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District, Shenzhen, 518103, China
Tel: 86 755 2737 1997 Fax: 86 755 2733 1856 Email: kingyield@kingyield.com
II. PROPOSED DEVICE
Device type by its common name: BW-BA1 Bluetooth Blood pressure monitor Regulation Number: 21CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II Panel: Cardiovascular Product Code: DXN
III. PREDICATE DEVICE
Device Name: Withings Blood Pressure Monitor, Upper Arm Type BP-801 Common/Usual Name: Blood Pressure Monitor, Upper Arm Type BP-801 510(k) Number: K133125 510(k) submitter/holder: Withings (VA HORNG Electronic Co., Ltd.)
IV. DEVICE DESCRIPTION
BW-BA1 Bluetooth Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method during inflating @ 3~8mmHg/second from about 30mmHg by inflating a cuff on the upper arm. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. An irregular heartbeat rhythm is defined as rhythm that is 25% less or 25% more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood
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BW-BA1 Premarket Notification 510(k)
pressure.
BW-BA1 Bluetooth Blood Pressure Monitor without any display component achieves its function by integrating the device with a collateral device iPhone, iPad with a specific mobile app to constitute a complete blood pressure measurement system. And the new device connects the mobile platform with the mobile app through Bluetooth 4.0.
The operational principle is based on oscillometric and pressure sensor technology, it can calculate the systolic and diastolic blood pressure, and the measurement results can be classified by the function of blood pressure classification indicator according to the classification rule developed by WHO.
The BW-BA1 is powered by a rechargeable Lithium battery.
The device has an ON/START button for starting the measuring and stopping the measuring at any time when measuring.
V. INDICATIONS FOR USE
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches to 16.5 inches (approx.22 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby.
lt cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.
| Comparison item | Proposed device | Predicate device |
|---|---|---|
| Applicant | Shenzhen Kingyield technology | Withings (VA HORNG Electronic Co., |
| Co., Ltd. | Ltd.) | |
| Model | BW-BA1 Bluetooth blood | Withings Blood Pressure Monitor, |
| pressure monitor | Upper Arm Type BP-801 | |
| 510k number | K133125 | |
| Collateral device | Same | The Withings BP-801 is a blood |
| The collateral device is iPhone, | pressure monitor achieves its | |
| iPad, but USB connection is | function by integrate the device | |
| deleted. | with an iPhone 4S. As it does not | |
| include a LCD or other display | ||
| components, it is necessary for the | ||
| new device to connect to an | ||
| iPhone 4S containing a supportsoftware to constitute a completeblood pressure measurementsystem. And the new deviceconnects iPhone 4S throughBluetooth or USB cable. | ||
| Intended use | Same | Intended to measure the systolicand diastolic blood pressures andpulse rate of an adult individual,over age 18, at home by using anoninvasive technique in which aninflatable cuff is wrapped aroundthe upper arm. The cuffcircumference is limited to be 9 to17 inches (22cm-42cm) for UpperArm type. |
| Measuring method | Same | Oscillometric |
| IHB | Rhythm that is 25% less or 25%more than the average rhythmdetected while the monitor ismeasuring the systolic anddiastolic blood pressure | No IHB function |
| Measuring range | Cuff pressure: 0 | Cuff pressure: 0 |
| Accuracy | Pressure: ± 3mmHgPulse: ± 5% reading value | Pressure:<200 mmHg ± 3mmHg or200mmHg±2%Pulse: ±5% of reading value |
| Inflation | Electric pump inflation | By air pump |
| Deflation | N/A | Automatic linear pressure deflationvalve |
| Pressure release | Pressure release valve | Automatic solenoid venting valve |
| Pressure sensor | Same | Semiconductor pressure sensor |
| Accessories | Same | Storage case, instruction manual |
| Operating Temp. &humidity | Temp.: 10 | Temp.: 10 |
| Storage Temp. &humidity | Temp.: -20 | -25 to 70°C,10 to 95%RH,Atmospheric 86kPa-106kPa,altitude: 2000m |
| Display | Same | Can display the measurement |
| result on the iPhone 4S | ||
| Battery | Li-ion Rechargeable batterywith 250 charging cycles | AAA alkaline battery x 4 pcs |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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BW-BA1 Premarket Notification 510(k)
VII.PERFORMANCE DATA
VII.I Performance Testing - Bench
Testing information demonstrating safety and effectiveness of BW-BA1 Bluetooth Blood Pressure Monitor in the intended environment of use is supported by testing that was conducted.
The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.
The following National and International Standards were utilized for testing the subject device.
a. EMC Test:
- IEC 60601-1-2:2014
General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
b. Safetv Test:
-IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare Environment
-IEC 62133:2012, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
c. Reliability Test:
-IEC 80601-2-30:2009+A1:2013 Medical electrical equipment-Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers, 2013
-EN 1060-3: 1995+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
d. Radio Frequency Wireless Test:
-EN 300 328, Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2.4 GHz
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BW-BA1 Premarket Notification 510(k)
ISM band and using wide band modulation techniques; Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive
-EN 301 489-1, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
-EN 301 489-17, Electromagnetic compatibility and Radio spectrum Matters (ERM); Electro Magnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems
d. FCC Test:
FCC 47 CFR Part 15, Subpart B & FCC 47 CFR Part 15, Subpart C
e. Biocompatibility Test:
-ISO 10993-1:2009, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
-ISO 10993-5:2009. Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
-ISO 10993-10:2010, Third Edition Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
f. Software Verification and Validation:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005
g. Usability Engineering:
-IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
-IEC 60601-1-6: 2010 +A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that BW-BA1 Bluetooth Blood Pressure Monitor tested met all relevant requirements of the aforementioned tests.
VII-II Performance Testing - Animal N/A
VII-III Performance Testing - Clinical
Clinical validation concerning the compliance of ISO 81060-2 has been performed that the device BW-BA1 is the same as the predicate except IHB adding for our device. And the fundamental scientific technology of the device is identical with the predicate and IHB adding does not raise new questions of safety and effectiveness. Therefore the performance of the device in terms of blood pressure measurement would be identical with performance of the
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BW-BA1 Premarket Notification 510(k)
୧ / ୧ Section 05
predicate.
VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION
The proposed device has been found to be substantially equivalent to the predicate. Differences between the proposed device and the predicate do not raise new questions of safety or 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).