(71 days)
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.
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.
The provided text describes the submission of a 510(k) premarket notification for a "Bluetooth Blood Pressure Monitor, BPW1" and its substantial equivalence to a predicate device. It details various performance tests conducted, including safety, EMC, reliability, and biocompatibility. However, it does not contain the specific acceptance criteria for the device's performance (e.g., blood pressure accuracy in mmHg or pulse accuracy in bpm), nor does it provide the detailed study results that prove the device meets these criteria in a quantitative manner.
Instead, the document states that the device was tested according to relevant standards (e.g., IEC 80601-2-30, ISO81060-2:2013) and that it "met all relevant requirements" or "achieved the requirements." It also states "The evaluation of these results present no new issues related to safety or effectiveness." This indicates that the study was performed, and the results were deemed acceptable, but the specific numerical performance data and detailed acceptance thresholds are not included in this summary.
Therefore, for aspects requiring quantitative data (like specific accuracy tolerances and achieved performance), the information is implicitly covered by conformance to standards, but not explicitly stated.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria (Implied by Standard) | Reported Device Performance (Summary Statement) |
|---|---|---|
| Accuracy (Static Pressure) | ± 3mmHg (from comparison table) | Met requirements of IEC 80601-2-30 |
| Accuracy (Pulse) | ± 5% reading value (from comparison table) | Met requirements of IEC 80601-2-30 |
| Safety | Conformance to IEC 60601-1, IEC 60601-1-11, IEC 62133 | Met all relevant requirements |
| EMC | Conformance to IEC 60601-1-2 | Met all relevant requirements |
| Reliability | Conformance to IEC 80601-2-30, EN 1060-3 | Met all relevant requirements |
| Radio Frequency Wireless Performance | Conformance to EN 300 328, EN 301 489-1, EN 301 489-17 | Met all relevant requirements |
| FCC Compliance | Conformance to FCC 47 CFR Part 15 Subpart B/C, 1.1307, 2.1093 | Met all relevant requirements |
| Biocompatibility | Conformance to ISO 10993-1, -5, -10 | Met all relevant requirements |
| Clinical Validation (Accuracy) | Conformance to ISO81060-2:2013 | Achieved the requirements of ISO81060-2:2013 |
| Cybersecurity Risk | Acceptable residual risk per FDA guidance | Overall residual risk is acceptable |
Note: The "Accuracy" values (Static Pressure: ± 3mmHg, Pulse: ± 5% reading value) are explicitly stated in the "Comparison of Technological Characteristics" table under the "Accuracy" row for both the predicate and modified device. This implies they are the expected performance standard and likely the acceptance criteria for those specific parameters. The broader "Reported Device Performance" for other categories is a general statement of compliance with standards, as detailed numerical results are not included.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The text clearly mentions "Clinical Validation: ISO81060-2:2013 Non-invasive sphygmomanometers —Part 2: Clinical validation of automated measurement type." This standard specifies requirements for the number of subjects and measurements for clinical validation. While the exact number of subjects is not stated in this document, it implies that the sample size adhered to the ISO 81060-2:2013 standard. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a blood pressure monitor, the ground truth for clinical validation is typically established by trained observers using a reference measurement method (e.g., auscultation with a sphygmomanometer). The ISO 81060-2 standard outlines requirements for such observers, but the specific details are not in this text.
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 clinical validation, ground truth primarily relates to the reference measurement method (e.g., mercury sphygmomanometer with trained observers), rather than expert adjudication of AI output.
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 device is a blood pressure monitor, not an AI-based imaging diagnostic tool that typically involves human readers. Therefore, an MRMC study is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the clinical validation study conducted per ISO 81060-2:2013 is a standalone performance test of the device (its algorithm) against a reference standard. The document states, "The device has achieved the requirements of ISO18060-2:2013," which indicates its standalone performance against a clinical reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the clinical validation of the blood pressure monitor, the ground truth would be established through simultaneous or closely sequential measurements using a validated reference method, typically auscultation by trained observers with a mercury sphygmomanometer or another precisely calibrated and validated reference device, as specified by ISO 81060-2:2013. This is implicitly the "ground truth" against which the device's measurements are compared.
8. The sample size for the training set:
This device is a traditional oscillometric blood pressure monitor, not a machine learning/AI device requiring a separate "training set" in the conventional sense of AI model development. Therefore, this concept is not applicable in the context presented. The "training" for such devices is inherent in their design and calibration processes, not a distinct data set for algorithm training.
9. How the ground truth for the training set was established:
As explained in point 8, the concept of a separate "training set" with established ground truth as used in AI/ML is not applicable to this type of medical device based on the information provided.
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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
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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
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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
| Comparisonitem | Predicate/unmodifieddevice | Modified device | Explanation of thedifferences |
|---|---|---|---|
| The trade name | BP210 Wrist BloodPressure Monitor | Bluetooth blood pressuremonitor, BPW1 | |
| 510(k) Number | K112042 | ||
| Applicant | Shenzhen Kingyieldtechnology Co., Ltd. | Shenzhen Kingyieldtechnology Co., Ltd. | Identical |
| Recommendedclassificationregulation | 21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem | 21CFR 870.1130,Noninvasive Blood PressureMeasurement System | Identical |
| RegulatoryClass | II | II | Identical |
| Panel | Cardiovascular | Cardiovascular | Identical |
| Product Code | DXN | DXN | Identical |
| Intended use | BP210 Wrist BloodPressure Monitor isintended to be used tomeasure blood pressure(systolic and diastolic)and heart rate from thewrist by using theoscillometric method.The device is intended | This blood pressure monitor isintended to be used to measureblood pressure (systolic anddiastolic) and heart rate fromthe wrist by using theoscillometric method. Thedevice detects the appearanceof irregular heartbeats duringmeasurement and gives a | Identicalthough the wording isadjusted |
| population, not appliedto the other populationssuch as neonatal baby.It can't be used whilethe wrist (arm) hasbleeding or wound toavoid the blood flowingfrom the wound inpressurizing.The wrist circumferenceis limited to 13.5cm -21.5cm. | The device is intended forusing in only adult population,not applied 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. | ||
| Measuringprinciple | Oscillometric method | Oscillometric method | Identical |
| Measuringrange | Cuff pressure: 0 | Cuff pressure: 0 | Identical |
| Max cuffpressure | 300mmHg | 300mmHg | Identical |
| Accuracy | Static Pressure: ± 3mmHgPulse: ± 5% reading value | Static Pressure: ± 3mmHgPulse: ± 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 |
| DimensionalSpecifications | Body: 776234Body with cuff: 776284 | Body: 414717.7Body with bladder &wristband: 270.124117.7 | EquivalentThe changes are testedaccording to therequirements of thestandards IEC 60601-1, IEC60601-1-2, IEC 62133, EN1060-3,IEC 80601-2-30,60601-1-11, EN 300 328,EN 301 489-1, EN 301489-17, FCC 47 CFR Part15, Subpart B & FCC 47CFR Part 15 Subpart C, IEC62366-1, IEC 60601-1-6,and ISO81060-2.The changes in dimensionalspecifications are |
| Bladder andCuff | Cuff containing bladder | Bladder + wristband | documented; do not affectthe intended use or thefundamental scientifictechnology.EquivalentThe changes are testedaccording to therequirements IS081060-2:2013, ISO 10993-1, ISO10993-5, and ISO 10993-10.The changes in thespecifications aredocumented; do not affectthe intended use or thefundamental scientifictechnology. |
| Event marking | By pressing theSTART/STOP button | By pressing theSTART/STOP button;By click "START/STOP" onAPP | EquivalentThe change in thespecification is documented,the cybersecurity risk hasbeen considered and theoverall residual risk isacceptable.The change does not affectthe intended use or thefundamental scientifictechnology. |
| By pressing the MEMbutton | By pressing the MEM button | Equivalent | |
| Display | Device LCD | Device LCD;LCD on collateral devicewhile connecting | EquivalentThe changes of the userinterface are documented,do not affect the intendeduse or the fundamentalscientific technology.. |
| OperatingTemp. &humidity | Temp.: 10 | Temp.: 10 | EquivalentThe environmentalconditions changes aretested according to therequirements of thestandards IEC 60601-2-30 |
| Storage Temp.& humidity | Temp.: -20 | Temp.: -20 | EquivalentThe environmentalconditions changes aretested according to therequirements of thestandards IEC 80601-2-30and IEC 60601-1-11. Thesechanges do not affect theintended use. |
| Communication | USB cable---The memory data can betransferred to the PC byconnecting the device withthe PC via USB cable | Bluetooth | EquivalentThe changes are testedaccording to therequirements of thestandards IEC 80601-2-30and 60601-1-11.The changes in thespecifications aredocumented; do not affectthe intended use or thefundamental scientifictechnology. |
| IHB function | IHB function | IHB function | Identical |
| Memoryfunction | 90*2 | 30 | EquivalentThe change in thespecification is documentedand tested, does not affectthe intended use or thefundamental scientifictechnology. |
| Automaticpower-off | In 2 minutes | No automatic power-offfunction, adding clockfunction instead. | EquivalentThe change in thespecification is documentedand tested, does not affectthe intended use or thefundamental scientifictechnology. |
| Clock function | No clock | Yes | Equivalent |
| Material | PC and ABS for the caseand plastic foil for thelabels of the device.Biocompatible materialsare used for the appliedparts (Cuff containingbladder). | Zinc alloy for the case of thedevice and ABS for Button.Biocompatible materials areused for the applied parts(Bladder + wristband). | specification is documentedand tested, does not affectthe intended use or thefundamental scientifictechnology. |
| Energy source | AAA alkaline battery x 2pcs | Li-ion Rechargeable batterywith 250 charging cycles | EquivalentThe change in thespecification is documentedand tested, does not affectthe intended use or thefundamental scientifictechnology. |
| Sterilization | Not applicable | Not applicable | Identical |
| Expiration date | Not applicable | The rechargeable batteryinstalled in the device willself-discharge | EquivalentInstruction Manual isrevised to add "The device'sbattery should be rechargedperiodically, even duringstorage since therechargeable batteryinstalled in the device willself-discharge, leading to anunacceptably low voltage,thus damaging the battery."The change in thespecification is documented,does not affect the intendeduse or the fundamentalscientific technology. |
| Accessories | Instruction manual | Instruction manual which isrevised according to thechanges made | EquivalentThe change in thespecification is documented,does not affect the intendeduse or the fundamentalscientific technology. |
| Soft rule | Equivalent | ||
| The adding of the soft rulethat increases the measuringaccuracy of the device isdocumented | |||
| BP-management softwareon Personal Computer | A mobile medical app onAndroid | EquivalentThe change in thespecification is documented,the cybersecurity risk hasbeen considered and theoverall residual risk isacceptable.The change does not affectthe intended use or thefundamental scientifictechnology. |
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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.
§ 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).