(71 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and irregular heartbeat detection based on rhythm variation, with no mention of AI or ML algorithms.
No
It is a blood pressure monitor intended for measurement and detection, not for therapy.
No
Explanation: While the device measures blood pressure and heart rate and detects irregular heartbeats, this information is intended for monitoring and screening, not for making a definitive medical diagnosis. The "Indications for Use" section doesn't state that it diagnoses specific conditions; it measures parameters.
No
The device description explicitly states it is a "fully automatic non-invasive blood pressure monitor" that measures blood pressure and heart rate using the oscillometric method. It also mentions a "START/STOP button" and a "MEM button," indicating physical hardware components beyond just software. While it can connect to a mobile application via Bluetooth, the core measurement functionality is performed by the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a blood pressure monitor that measures blood pressure and heart rate non-invasively from the wrist using the oscillometric method. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and heart rate) directly from the body, not to perform tests on in vitro samples.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This blood pressure monitor is intended to be used to measure (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.
Product codes
DXN
Device Description
Bluetooth Blood Pressure Monitor, BPW1 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, including irregular heartbeats (IHB) from the wrist.
The device is powered by a rechargeable Lithium battery.
The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement.
The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0.
An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
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 population
Intended User / Care Setting
Over-The-Counter Use
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)
Performance Testing - Bench:
EMC Test: IEC 60601-1-2: 2014
Safety Test: IEC 60601-1:2005+A1:2012, IEC 60601-1-11:2015, IEC 62133:2012
Reliability Test: IEC 80601-2-30:2009+A1:2013, EN 1060-3: 1995+A2:2009
Radio Frequency Wireless Test: EN 300 328 V2.1.1, Draft EN 301 489-1 V2.2.0, Draft EN 301 489-17 V3.2.0
FCC Test: FCC 47 CFR Part 15, Subpart B, FCC 47 CFR Part 15, Subpart C, FCC 47 CFR Part 1.1307, FCC 47 CFR Part 2.1093
Biocompatibility Test: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010
Key Results: 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 Bluetooth Blood Pressure Monitor, BPW1 tested met all relevant requirements of the aforementioned tests. The evaluation of these results present no new issues related to safety or effectiveness of the testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices. The test methods used are the same as those submitted in the original submission.
Performance Testing - Clinical:
Clinical Validation: ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type
Key Results: The device has achieved the requirements of ISO18060-2:2013.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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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 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2018
Shenzhen Kingyield Technology Co., Ltd. Dacheng Gong General Manager Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District Shenzhen, 518000 Cn
Re: K182018
Trade/Device Name: Bluetooth Blood Pressure Monitor, BPW1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 5, 2018 Received: September 6, 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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 comprehensive regulatory information about medical devices and radiation-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,
Image /page/1/Picture/6 description: The image contains the text "Shawn W. Forrest -A". The text is arranged in two lines, with "Shawn W." on the first line and "Forrest -A" on the second line. The font is a simple, sans-serif typeface, and the text is black against a white background. There is a light blue design in the background.
12 19200300 100 1 1=130040
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182018
Device Name Bluetooth Blood Pressure Monitor, BPW1
Indications for Use (Describe)
This blood pressure monitor is intended to be used to measure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method. The device detects the appearance of irregular heasurement 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date the summary was prepared: September/05/2018
I. Administrative Information
1.1 Submitter/Owner
Name: Shenzhen Kingyield Technology Co., Ltd.
Address: Section C2, Fuhai Industrial Zone, Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Facility registration number: 3007420856
1.2 Contact person
Authorized Contact Person: Dacheng Gong 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. MODIFIED DEVICE
Device type by its common name: Bluetooth Blood Pressure Monitor, BPW1 Regulation Number: 21CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II Panel: Cardiovascular Product Code: DXN
III. PREDICATE/UNMODIFIED DEVICE
Device Name: BP210 Wrist Blood Pressure Monitor Common/Usual Name: Wrist Blood Pressure Monitor BP210 510(k) Number: K112042 510(k) submitter/holder: Shenzhen Kingyield Technology Co., Ltd.
IV. MODIFIED DEVICE DESCRIPTION
Bluetooth Blood Pressure Monitor, BPW1 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, including irregular heartbeats (IHB) from the wrist.
The device is powered by a rechargeable Lithium battery.
The device has an START/STOP button for starting the measurement and stopping the measurement at any time when measuring. The MEM button is for displaying the last measurement.
The device can also connect the mobile platform with an MMA (mobile medical application) as its accessory which can start/stop the device through Bluetooth 4.0.
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An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
V. INDICATIONS FOR USE
This blood pressure monitor is intended to be used to measure (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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE/UNMODIFIED DEVICE
| Comparison
item | Predicate/unmodified
device | Modified device | Explanation of the
differences |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The trade name | BP210 Wrist Blood
Pressure Monitor | Bluetooth blood pressure
monitor, BPW1 | |
| 510(k) Number | K112042 | | |
| Applicant | Shenzhen Kingyield
technology Co., Ltd. | Shenzhen Kingyield
technology Co., Ltd. | Identical |
| Recommended
classification
regulation | 21CFR 870.1130,
Noninvasive Blood
Pressure Measurement
System | 21CFR 870.1130,
Noninvasive Blood Pressure
Measurement System | Identical |
| Regulatory
Class | II | II | Identical |
| Panel | Cardiovascular | Cardiovascular | Identical |
| Product Code | DXN | DXN | Identical |
| Intended use | BP210 Wrist Blood
Pressure Monitor 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 is intended | This blood pressure monitor 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 | Identical
though the wording is
adjusted |
| | | | |
| | 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 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. | |
| Measuring
principle | Oscillometric method | Oscillometric method | Identical |
| Measuring
range | Cuff pressure: 0299180
mmHg Pulse : 40
beat/min | Cuff pressure: 0299 mmHg180 beat/min | Identical |
Pulse : 40
| Max cuff
pressure | 300mmHg | 300mmHg | Identical |
| Accuracy | Static Pressure: ± 3mmHg
Pulse: ± 5% reading value | Static Pressure: ± 3mmHg
Pulse: ± 5% reading value | Identical |
| Inflation | By air pump | By air pump | Identical |
| Deflation | Not Apply | Not apply | Identical |
| Pressure release | By automatic valve | By automatic valve | Identical |
| Dimensional
Specifications | Body: 776234
Body with cuff: 776284 | Body: 414717.7
Body with bladder &
wristband: 270.124117.7 | Equivalent
The changes are tested
according to the
requirements of the
standards IEC 60601-1, IEC
60601-1-2, IEC 62133, EN
1060-3,
IEC 80601-2-30,
60601-1-11, EN 300 328,
EN 301 489-1, EN 301
489-17, FCC 47 CFR Part
15, Subpart B & FCC 47
CFR Part 15 Subpart C, IEC
62366-1, IEC 60601-1-6,
and ISO81060-2.
The changes in dimensional
specifications are |
| | | | |
| Bladder and
Cuff | Cuff containing bladder | Bladder + wristband | documented; do not affect
the intended use or the
fundamental scientific
technology.
Equivalent
The changes are tested
according to the
requirements IS081060-
2:2013, ISO 10993-1, ISO
10993-5, and ISO 10993-10.
The changes in the
specifications are
documented; do not affect
the intended use or the
fundamental scientific
technology. |
| Event marking | By pressing the
START/STOP button | By pressing the
START/STOP button;
By click "START/STOP" on
APP | Equivalent
The change in the
specification is documented,
the cybersecurity risk has
been considered and the
overall residual risk is
acceptable.
The change does not affect
the intended use or the
fundamental scientific
technology. |
| | By pressing the MEM
button | By pressing the MEM button | Equivalent |
| Display | Device LCD | Device LCD;
LCD on collateral device
while connecting | Equivalent
The changes of the user
interface are documented,
do not affect the intended
use or the fundamental
scientific technology.. |
| Operating
Temp. &
humidity | Temp.: 1040°C90%RH
Humidity: 15
(noncondensing )
Atmospheric:
105kPa80kPa | Temp.: 1040°C Humidity:
1590%RH (noncondensing )80kPa | Equivalent
Atmospheric: 106kPa
The environmental
conditions changes are
tested according to the
requirements of the
standards IEC 60601-2-30 |
| | | | |
| Storage Temp.
& humidity | Temp.: -2055°C90%RH
Humidity: 10
(noncondensing ) | Temp.: -2055°C Humidity:95%RH (noncondensing ) | Equivalent
0
The environmental
conditions changes are
tested according to the
requirements of the
standards IEC 80601-2-30
and IEC 60601-1-11. These
changes do not affect the
intended use. |
| Communication | USB cable---
The memory data can be
transferred to the PC by
connecting the device with
the PC via USB cable | Bluetooth | Equivalent
The changes are tested
according to the
requirements of the
standards IEC 80601-2-30
and 60601-1-11.
The changes in the
specifications are
documented; do not affect
the intended use or the
fundamental scientific
technology. |
| IHB function | IHB function | IHB function | Identical |
| Memory
function | 90*2 | 30 | Equivalent
The change in the
specification is documented
and tested, does not affect
the intended use or the
fundamental scientific
technology. |
| Automatic
power-off | In 2 minutes | No automatic power-off
function, adding clock
function instead. | Equivalent
The change in the
specification is documented
and tested, does not affect
the intended use or the
fundamental scientific
technology. |
| Clock function | No clock | Yes | Equivalent |
| Material | PC and ABS for the case
and plastic foil for the
labels of the device.
Biocompatible materials
are used for the applied
parts (Cuff containing
bladder). | Zinc alloy for the case of the
device and ABS for Button.
Biocompatible materials are
used for the applied parts
(Bladder + wristband). | specification is documented
and tested, does not affect
the intended use or the
fundamental scientific
technology. |
| Energy source | AAA alkaline battery x 2
pcs | Li-ion Rechargeable battery
with 250 charging cycles | Equivalent
The change in the
specification is documented
and tested, does not affect
the intended use or the
fundamental scientific
technology. |
| Sterilization | Not applicable | Not applicable | Identical |
| Expiration date | Not applicable | The rechargeable battery
installed in the device will
self-discharge | Equivalent
Instruction Manual is
revised to add "The device's
battery should be recharged
periodically, even during
storage since the
rechargeable battery
installed in the device will
self-discharge, leading to an
unacceptably low voltage,
thus damaging the battery."
The change in the
specification is documented,
does not affect the intended
use or the fundamental
scientific technology. |
| Accessories | Instruction manual | Instruction manual which is
revised according to the
changes made | Equivalent
The change in the
specification is documented,
does not affect the intended
use or the fundamental
scientific technology. |
| | Soft rule | Equivalent | |
| | | The adding of the soft rule
that increases the measuring
accuracy of the device is
documented | |
| BP-management software
on Personal Computer | A mobile medical app on
Android | Equivalent
The change in the
specification is documented,
the cybersecurity risk has
been considered and the
overall residual risk is
acceptable.
The change does not affect
the intended use or the
fundamental scientific
technology. | |
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6
7
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VII.PERFORMANCE DATA
VII.I Performance Testing - Bench
Testing information demonstrating safety and effectiveness of 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. Safety Test:
-IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-11:2015, 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
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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 V2.1.1, Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques; Harmonised Standard covering the essential requirements of article 3.2 of Directive 2014/53/EU
-Draft EN 301 489-1 V2.2.0, ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU
-Draft EN 301 489-17 V3.2.0, ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Broadband Data Transmission Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU
e. FCC Test:
-FCC 47 CFR Part 15, Subpart B -FCC 47 CFR Part 15, Subpart C -FCC 47 CFR Part 1.1307 -FCC 47 CFR Part 2.1093
f. 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, Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
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 Bluetooth Blood Pressure Monitor, BPW1 tested met all relevant requirements of the aforementioned tests. The evaluation of these results present no new issues related to safety or effectiveness of the testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.
The test methods used are the same as those submitted in the original submission.
VII-II Performance Testing – Animal N/A
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VII-III Performance Testing - Clinical
Clinical Validation:
- ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type
The device has achieved the requirements of ISO18060-2:2013.
VII-IV Cybersecurity Risk Management
- FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014)
- FDA Post Market Management of Cybersecurity in Medical Devices (2016)
The overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan.
VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION
The modified device has been found to be substantially equivalent to the predicate/unmodified device. Differences between the modified device and the predicate/unmodified device do not raise new questions of safety or effectiveness.