(205 days)
The Blood Pressure Monitor is indented to measure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults' single-channel ECG rhythms and gives some suggested symptoms such as regular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure, pulse rate and ECG of an individual intended for home use. By using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm, the device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which deternines pulse rate, as well as systolic and diastolic blood pressure, which is a well-known technique in the market called the "oscillometric method". In addition to the BP measurement, the device also incorporates electrodes capable of gathering ECG data from the user. This can be done as a separate function. To initiate the ECG, the user places one or more fingers in contact with the electrodes on the right and left side of the device. The electrodes measure a single-lead ECG between left and right fingers. The single-lead ECG data is displayed on the LCD. The main components of the Blood Pressure Monitor are the main unit, cuff unit and ECG unit (only for BP2). The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Nylon and polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the pump, exhaust valve, bluetooth transmission, cuff and ECG circuit including the electrodes. The subiect devices are powered by Li-ion Polymer Battery. The device has Irreqular beat: If the change speed of heart rate exceeds a certain threshold during measurement, is judged as irreqular heartbeat. The subject device includes bluetooth transmission which can transfer data to other device through the bluetooth connection such as smart phone.
Here's a breakdown of the acceptance criteria and study information for the Shenzhen Viatom Technology Co., Ltd. Blood Pressure Monitor (K193348), based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
Blood Pressure Measurement (based on ISO 81060-2)
| Acceptance Criteria (Overall) | Reported Device Performance |
|---|---|
| Mean difference and standard deviation between device and reference. | "The accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2" |
| Individual difference distribution (e.g., within 5, 10, and 15 mmHg). | Implied as passing ISO 81060-2 |
ECG Measurement (based on IEC 60601-2-47)
| Acceptance Criteria (Overall) | Reported Device Performance |
|---|---|
| Validation of ECG function (Lead I and Lead II). | "All the performance of ECG function (Lead I and Lead II) were validated and the results is Pass." |
| Accuracy of irregular beat, High HR, and Low HR detection. | "The ECG performance of the subject device is tested by bench test including the irregular beat High HR and Low HR and has been verified by the required accuracy." |
| Accuracy within full claimed range for operating/storage temperature. | "The subject devices have been validated all the full claimed range according to the IEC 60601-1, IEC 80601-2-30, IEC 60601-2-47 and IEC 60601-1-11." |
| Functional performance and evaluation of high-frequency use, cleaning/disinfection for healthcare facilities. | "The high-frequencyuse performance of the product life and cleaning /disinfection is evaluated and passed, the device can meet the requirements of healthcare facilities." |
Specific Accuracy Parameters (from Comparison Table)
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | Within $\pm$ 3mmHg or 2% of reading (for predicate) | $\pm$ 3mmHg (for subject device) |
| Pulse Accuracy | Within 5% of HR reading (for predicate) | 2 bpm (for subject device) |
| HR Accuracy | No specific value for predicate, but for device: 30 to 300 bpm | $\pm$ 2 bpm or 2%, whichever is greater; (for subject device) |
2. Sample Size Used for the Test Set and Data Provenance
-
Blood Pressure Clinical Investigation:
- Sample Size: 85 patients (39 males and 46 females).
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a prospective clinical study conducted by the manufacturer for this submission. The "same arm sequential method" was adopted.
-
ECG Clinical Investigation:
- Sample Size: 35 patients (24 males and 11 females).
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a prospective clinical study conducted by the manufacturer for this submission. "Comprising with the cleared device" was adopted during the clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing the ground truth for either the blood pressure or ECG test sets.
- Blood Pressure: The ground truth was established using a "manual Mercury Sphygmomanometer" as a reference device. It's implied that trained personnel would operate this for comparison, but their specific qualifications are not detailed.
- ECG: The ground truth for the ECG investigation was established by "comprising with the cleared device," suggesting comparison against an existing, cleared ECG device. There is no mention of expert review of the ECG waveforms themselves for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for resolving discrepancies in either the blood pressure or ECG test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or described in the provided document. The clinical studies focused on comparing the device to a reference (for BP) or a cleared device (for ECG).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance (algorithm only) was evaluated for both the blood pressure and ECG functionalities.
- Blood Pressure: The device's automated oscillometric method was compared directly to a manual mercury sphygmomanometer.
- ECG: The device's ability to measure, display, store, and detect suggested symptoms (regular beat, irregular beat, low HR, high HR) was tested against a cleared device and bench tests for accuracy. The note states, "The ECG performance of the subject device is tested by bench test including the irregular beat High HR and Low HR and has been verified by the required accuracy." This indicates standalone algorithmic evaluation.
7. The Type of Ground Truth Used
- Blood Pressure: The ground truth used was comparison to a manual Mercury Sphygmomanometer.
- ECG: The ground truth used was comparison to a cleared device and bench test verification for specific parameters like irregular beat, high HR, and low HR.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This submission focuses on the performance evaluation of the final product, implying that any internal development/training would have occurred prior to these validation studies.
9. How the Ground Truth for the Training Set Was Established
Since no information on a training set is provided, there is no information on how its ground truth would have been established.
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June 25, 2020
Shenzhen Viatom Technology Co., Ltd. c/o Lucy Yan, Consultant 4205-4210#, Shenzhen international Chamber of Commerce Tower 168#. Fuhua 3 Road. Futian District Shenzhen, 518048 CHINA
Re: K193348
Trade/Device Name: Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DPS Dated: April 24, 2020 Received: May 26, 2020
Dear Lucy Yan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 (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,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193348
Device Name Blood Pressure Monitor
Indications for Use (Describe)
The Blood Pressure Monitor is indented to measure or electrocardiogram (ECG) in home or healthcare facilities environment. The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population. The device is intended to measure, display, store and review adults' single-channel ECG rhythms and gives some suggested symptoms such as regular beat, low HR and high HR. The ECG part of the device is for Rx only, and the blood pressure part is for OTC.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| X Over-The-Counter Use (21 CFR 801 Subpart C) |
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Product: BPM+ECG
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Submission Date | Nov. 25, 2019 |
|---|---|
| Submitter's Name: Shenzhen Viatom Technology Co., Ltd.Address: 4E, Building 3, Tingwei Industrial Park, No.6 LiufangRoad, Block 67, Xin'an Street, Baoan District, Shenzhen, 518101,Guangdong, China | |
| Manufacturerinformation | Contact person: Zhou SaixinTEL: +86-0755-86638929FAX: +86-0755-22649904E-Mail: zhousaixin@viatomtech.com |
| SubmissionCorrespondent | Contact person: Miss Lucy. YanE-Mail: lucyyan75@163.com |
| 4205-4210#, Shenzhen International Chamber of CommerceTower, 163# Fuhua 3 Road, Futian District, Shenzhen,Guangdong, P.R.China. | |
| Establishmentregistration number | NA |
2 Device Information
| Common name of the device | System, Measurement, Blood-Pressure, Non-Invasive |
|---|---|
| Trade name of the device | Blood Pressure Monitor |
| Type/Model of the device | BP2, BP2A |
| Classification information | Classification panel: Cardiovascular |
| Classification name: System, Measurement, Blood-Pressure, Non-InvasiveElectrocardiograph | |
| Regulation Number: 870.1130, 870.2340 | |
| Device Class: II | |
| Product Code: DXN, DPS | |
| Type of 510(k) submission | Traditional |
3 Predicate Device Information
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| Sponsor: | Omron Healthcare, Inc. |
|---|---|
| Device: | Omron Model BP7900 Blood Pressure Monitor + EKG |
| 510(K) Number: | K182579 |
4 Device Descriptions
Product: BPM+ECG
Viatom Blood Pressure Monitor are designed to measure the systolic and diastolic blood pressure, pulse rate and ECG of an individual intended for home use.
By using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm, the device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which deternines pulse rate, as well as systolic and diastolic blood pressure, which is a well-known technique in the market called the "oscillometric method".
In addition to the BP measurement, the device also incorporates electrodes capable of gathering ECG data from the user. This can be done as a separate function. To initiate the ECG, the user places one or more fingers in contact with the electrodes on the right and left side of the device. The electrodes measure a single-lead ECG between left and right fingers. The single-lead ECG data is displayed on the LCD.
The main components of the Blood Pressure Monitor are the main unit, cuff unit and ECG unit (only for BP2). The preformed cuff unit, which is applicable to arm circumference approximately between 220 and 420 mm, includes the inflatable bladder and Nylon and polyester shell. All models of the arm blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the power on/off key, the pump, exhaust valve, bluetooth transmission, cuff and ECG circuit including the electrodes. The subiect devices are powered by Li-ion Polymer Battery.
The device has Irreqular beat: If the change speed of heart rate exceeds a certain threshold during measurement, is judged as irreqular heartbeat.
The subject device includes bluetooth transmission which can transfer data to other device through the bluetooth connection such as smart phone.
5 Intended Use/Indications for Use
The subject device is indented to measure blood pressure or electrocardiogram (ECG) in home or healthcare facilities environment.
The device is a blood pressure monitor intended for use in measuring blood pressure and pulse rate in adult population.
The device is intended to measure, display, store and review adults' single-channel ECG rhythms and gives some suggested symptoms such as regular beat, irregular beat, low HR and high HR.
The ECG part of the device is for Rx only, and the blood pressure part is for OTC. 6 SE Comparisons
| Characteristics | Subject device | Predicate device (K182579) | Remark | |
|---|---|---|---|---|
| Device Name | Blood Pressure Monitor | Omron Model BP7900 BloodPressure Monitor + EKG | NA | |
| Device Model | BP2, BP2A | BP7900 | NA | |
| Manufacturer | Shenzhen ViatomTechnology Co., Ltd. | Omron Healthcare, Inc. | NA |
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Product: BPM+ECG
Version: A/0
| IntendedUse/IndicationforUse | The subject deviceisindented to measure bloodpressureorelectrocardiogram (ECG) inhome or healthcare facilitiesenvironment.The device is a bloodpressure monitor intended foruse in measuring bloodpressure and pulse rate inadult population.The device is intended tomeasure, display, store andreview adults' single-channel ECG rhythms andgives some suggestedsymptoms such as regularbeat, irregular beat, low HR | The device is indented tomeasure blood pressure only,electrocardiogram (ECG) onlyor blood pressure and ECGsimultaneously.The device is a digital monitorintended for use in measuringblood pressure and pulse ratein adult population.The device is intended torecord, store, and transfersingle-channelelectrocardiogram (ECG)rhythms. The device alsodisplays ECG rhythms anddetects the presence of atrialfibrillation,bradycardia,tachycardia and normal sinusrhythm (when prescribed orused under the care of aphysician). the device is | SimilarNote01 |
|---|---|---|---|
| and high HR.The ECG part of the deviceis for Rx only, and the bloodpressure part is for OTC. | intended for use by healthcareprofessionals, patients withknown or suspected heartconditions, and health-conscious, and health-conscious individuals. Thedevice has not been testedand it is not intended forpediatric use. | ||
| IntendedPopulation | Adult | Adult | Same |
| IntendedAnatomical site | BP measurement: Upper armECG Recording: Right handto left hand (Lead I), righthand to left abdomen (LeadII) | BP measurement: Upper armECG Recording: Right hand toleft hand (Lead I) | DifferentNote02 |
| Contraindications/Warnings/Precautions | This device iscontraindicated for use inambulatory environments.This device iscontraindicated for use onaircraft. | Added contraindications (n=2)against use in ambulatoryenvironments and aircraft. | SE |
| Environment ofUse | Home UseHealthcare facilities | Home Use | DifferentNote03 |
| Single Use | No. | No. | Same |
| Sterility | Non sterile | Non sterile | Same |
| LabelInformation | Labeled for both OTC (HomeUse) and Rx (PrescriptionUse) | Labeled for both OTC (HomeUse) and Rx (PrescriptionUse) | Same |
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VOL_005: 001_510(k) Summary
Version: A/0
| WorkingPrinciple | BloodPressuremeasurement: OscillometricmethodECG recording: The devicecollects the ECG datathrough the potentialdifference of the bodysurface based on the ECGelectrode, and obtains ECGdata after being amplifiedand filtered, then displaysthrough the screen. | Blood Pressure measurement:Oscillometric methodECG recording: Usercompletes circuit with skincontact and hardwaretransmits audio signal to MCPto convert and display ECG. | SimilarNote04 |
|---|---|---|---|
| PressureSensor | Semiconductor pressuresensor | Semiconductor pressuresensor | Same |
| Internal Powersupply | Rechargeable lithium-polymer battery | 4*AA alkaline Batteries | DifferentNote05 |
| Cuff Size | 22-42cm | 17-22cm22-42cm | DifferentNote 06 |
| Pressure: 0 to 300mmHg | Pressure: 0mmHg~300mmHg | ||
| Measuringrange | Pulse: 40 to 200 beat/minute | Pulse: 40-199 beats/minute | DifferentNote 07 |
| Heart rate: 30 to 250 /min | Heart rate: 30 to 300beats/minute | ||
| Accuracy | Pressure: $\pm$ 3mmHgPulse: 2 bpmHR: $\pm$ 2 bpm or 2%,whichever is greater; | Pressure: Within $\pm$ 3mmHg or2% of reading;Pulse: Within 5% of HRreading | DifferentNote 08 |
| Irregular Heartbeat | Irregular beat, High HR, LowHR were displayed in theLCD. | Possible Atrial Fibrillation (orAFib), Tachycardia,Tachycardia, Unreadable orUnclassified were analyse byAPP. | DifferentNote 09 |
| OperatingEnvironment | 5°C ~ 45°C10% to 95% RH | 10°C~40°C15% to 90% RH | Different |
| Storage | -25°C~60°C | -20°C~60°C | Note 10 |
| Environment | 10% to 95% RH | 10% to 95% RHBP measurement: | |
| Bluetoothtransmission | The device has wirelessBluetooth LE transmission. | BP measurement:BluetoothECG recording:Ultrasonic Acoustics acquiredby phone | DifferentNote 11 |
| BodyMovementDetection | No. | Yes, for BP measurement | DifferentNote 12 |
| DataAcquisition forECG recording: | The device displays ECGrhythms and detects thepresence of regular beat andirregular beat (Irregular beat,High HR, Low HR). | The device displays ECGrhythms and detects thepresence of atrial fibrillation,bradycardia, tachycardia andnormal sinus rhythm. | DifferentNote09 |
| FrequencyResponse | 0.67 to 40 Hz | 0.67 - 40Hz | Same |
| ECG channels | Single Channel | Single Channel | Same |
| CMRR | >60 dB | >60 dB | Same |
| InputImpedance | ≥10MΩ, 10Hz | ≥10MΩ, 10Hz | Same |
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Product: BPM+ECG
Version: A/0
| Capacity | 100 BP readings can bestored in the internalmemory.ECG recording:10 records 30s ECG data | 90 BP readings can be storedin the internal memory.ECG recording:Essentially unlimited due toreal-time transmission to MCPmemory (size of ECG file isminiscule – kilobytescompared to device memorycapacity – gigabytes) | Note13 |
|---|---|---|---|
| Display | BP measurement:LCD (Liquid Crystal Display)displays;systolic blood pressurediastolic blood pressurepulse rateECG recording:ECG rhythmHeart RateRegular beatIrregular beatHigh HRLow HR | BP measurement:LCD (Liquid Crystal Display)displays;current cuff pressuresystolic blood pressurediastolic blood pressurepulse rateerror messagesECG recording:APP displayECG rhythmECG detectors (Normal /Possible Atrial Fibrillation /Bradycardia / TachycardiaUnclassified / Unreadable)Past ECG recording in thememorySome other user convenientinformation | DifferentNote14 |
| Materials | Patient contact materials ofthe cuff have been tested inaccordance with ISO 10993tested in accordance withaccordance with ISO 10993and FDA guidance | Patient contact materials of thecuff have been tested inaccordance with ISO 10993tested in accordance withaccordance with ISO 10993and FDA guidance | Same |
Note01: The subject devices have the smaller clinic use range than predicate device. The predicate device is indented to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously. But the subject devices can not be indented to measure blood pressure and ECG simultaneously. Moreover, the subject device can detect regular beat, irregular beat High HR and Low HR but can not identify the presence of atrial fibrillation, bradycardia and normal sinus rhythm as the predicate device. The subject device may produce very less risk of fault diagnosis. The subject devices have been passed the test of bench test, ISO 81060-2, IEC 80601-2-30 and IEC 60601-2-47.
Note02: The Intended Anatomical site of the subject device is different from the predicated device on the ECG measurement. The subject device can measure ECG by Lead I and Lead II, but the predicated device only used Lead I. The subject devices have been passed the test of IEC 60601-2-47. Moreover, All the performance of ECG function (Lead I and Lead II) were validated and the results is Pass.
Note03: The Environment of Use of the subject device is different from the predicated device on the ECG measurement. The subject device can be used not only in home but also in healthcare facilities. The accuracy is validated and passed. The high-frequencyuse performance of the product life and cleaning /disinfection is evaluated and passed, the device can meet the requirements of healthcare facilities.
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Product: BPM+ECG
Note04: The ECG display principle of the subject device is different from the predicate device. The subject device is integrated of the ECG circuit and display the ECG rhythm on the LCD. But the predicate device transmits audio signal to MCP then display in the smartphone. The subject device may reduce the risk of data transmission error attacked by auto noise interfere. It passed the test of IEC 60601-2-47.
Note05: The power supply of the subject device is different from the predicate device. The subject device is powered by rechargeable lithium-polymer battery which can be charged. The rechargeable lithium-polymer battery has been verified by the IEC62133 standard. It passed the tests.
Note06: The subject devices have the smaller cuff circumference than predicate device, but the subject devices have been passed the test of ISO 81060-2 and IEC 80601-2-30.
Note07: The HR measuring range is different from the predicate device. The subject device is tested by bench test. The subject device has been verified by the required accuracy.
Note08: The pulse accuracy and the HR accuracy are different from the predicate device. The subject device is tested by bench test. The subject device has been verified by the required accuracy.
Note09: The subject device can detect regular beat, irregular beat High HR Low HR but can not identify the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm as the predicate device which may produce very less risk of fault diagnosis. The subject devices have been passed the test of ISO 81060-2, IEC 80601-2-30 and IEC 60601-2-47. The ECG performance of the subject device is tested by bench test including the irregular beat High HR and Low HR and has been verified by the required accuracy.
Note10: The subject device has a wider measuring range of operating temperature and larger measuring range of storage temperature than predicate device, but the subject devices have been validated all the full claimed range according to the IEC 60601-1, IEC 80601-2-30, IEC 60601-2-47 and IEC 60601-1-11.
Note11: For data transmission, the subject device has bluetooth function but the predicated device uses auto signal to transmit ECG data. FCC test and wireless coexistence especially the cybersecurity evaluation about the wireless performance have been validated.
Note12: The subject device has no body movement detection function but the clinical function is accurate enough and passed the ISO 81060-2.
Note13: The memory capacity is different from the predicate device. The subject device has been verified the capacity in product software verification and validation. It passed the tests.
Note14: The display is different from the predicate device. The subject device has been verified the display in product software verification and validation. It passed the tests.
The subject device is as same as predicate device in basic function (blood pressure and ECG measurement), intended patient population, measuring pressure accuracy. Only the intended clinic use(refer to Note01), intended application site(refer to Note02), use environment (refer to Note03), the work principle (only on the data transmission refer to Note04), power supply(refer to Note05), the cuff size(refer to Note06), the HR measuring range (refer to Note07), the pulse accuracy (refer to Note08), Irregular Heartbeat(refer to Note09), Note10), " operating/storage environment(refer to the wireless
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Product: BPM+ECG
transmission(refer to Notel1), the body movement detection(refer to Note12), the ECG rhythm identification(refer to Note09), the memory capacity(refer to Note13) and the display contents(refer to Notel4) are different which had been However, the differences would not raise any validated. safety or effectiveness issue based on tests in this submission.
Thus, the subject device is Substantially Equivalent (SE) to the predicate device which is legally marketed in US.
7 Brief discussions of the non-clinical tests
The subject device conforms to the following guidances and standards:
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance ゃ
- ◆ ANSI AAMI ES60601-1:2005+A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance:
- ゃ IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
- IEC 60601-111: 2015 Medical Electrical Equipment Part 1-11: General Requirements ゃ for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in The Home Healthcare Environment;
- ゃ ISO 10993-5: 2009 /(R)2014 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity:
- ゃ ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
- ゃ 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
- � IEC 80601-2-47: 2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
- ゃ 47 CFR FCC PART 15. Subpart C Unintentional Radiators/ Miscellaneous Wireless Commutations Service
8 Brief discussions of clinical tests
- ISO 81060-2:2018 Non-invasive sphygmomanometers Part 2: Clinical validation of ゃ automated measurement type;
In the blood pressure clinical investigation, 85 patients (39 males and 46 females) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference
{10}------------------------------------------------
device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect.
In the ECG clinical investigation, 35 patients (24 males and 11 females) participated in the clinical study. Comprising with the cleared device was adopted during the clinical testing. All the subjects were volunteer to take part in the clinical study, the participants completed the clinical study without any AE or side-effect.
The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2 and ECG rhythm.
9 Other information (such as required by FDA guidance)
No other information.
10 Conclusions
The subject device:
Blood Pressure Monitor, manufactured by Shenzhen Viatom Technology Co., Ltd. is respectively substantially equivalent to the predicate device (Omron Model BP7900 Blood Pressure Monitor + EKG) manufactured by Omron Healthcare, Inc. (K182579).
§ 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).