(205 days)
Not Found
No
The device description details standard oscillometric and ECG measurement techniques and mentions a simple threshold-based detection for irregular heartbeat, not complex AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
Yes.
The device measures blood pressure and provides ECG readings, which are used to measure and monitor physiological parameters related to health conditions, fulfilling the definition of a therapeutic device.
Yes
The device measures blood pressure and pulse rate, and it also measures single-channel ECG rhythms and provides "suggested symptoms such as regular beat, low HR and high HR." This falls under the definition of a diagnostic device as it intends to identify potential states or conditions (e.g., low HR, high HR) rather than solely providing a measurement.
No
The device description explicitly details hardware components such as an inflatable cuff, integral pump, electric valve, electrodes, microprocessor, pressure sensor, power on/off key, and battery. It is a physical device with integrated software, not a software-only 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. They are used to examine these samples outside of the body.
- Device Function: This device measures blood pressure and records ECG rhythms directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and ECG) in vivo (within the living body).
- Device Description: The description details the non-invasive methods used to obtain these measurements (cuff on the arm, electrodes on the fingers).
Therefore, while this is a medical device, it falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
BP measurement: Upper arm
ECG Recording: Right hand to left hand (Lead I), right hand to left abdomen (Lead II)
Indicated Patient Age Range
adult population
Intended User / Care Setting
Home Use
Healthcare facilities
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)
Blood Pressure Clinical Investigation:
Study Type: Clinical study
Sample Size: 85 patients (39 males and 46 females)
Data Source: Same arm sequential method with manual Mercury Sphygmomanometer as a reference device.
Key Results: The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2.
ECG Clinical Investigation:
Study Type: Clinical study
Sample Size: 35 patients (24 males and 11 females)
Data Source: Comprising with the cleared device was adopted during the clinical testing.
Key Results: ECG rhythm accuracy demonstrated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pressure: ± 3mmHg
Pulse: 2 bpm
HR: ± 2 bpm or 2%, whichever is greater
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
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
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/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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Liufang | |
| Road, Block 67, Xin'an Street, Baoan District, Shenzhen, 518101, | |
| Guangdong, China | |
| Manufacturer | |
| information | Contact person: Zhou Saixin |
| TEL: +86-0755-86638929 | |
| FAX: +86-0755-22649904 | |
| E-Mail: zhousaixin@viatomtech.com | |
| Submission | |
| Correspondent | Contact person: Miss Lucy. Yan |
| E-Mail: lucyyan75@163.com | |
| 4205-4210#, Shenzhen International Chamber of Commerce | |
| Tower, 163# Fuhua 3 Road, Futian District, Shenzhen, | |
| Guangdong, P.R.China. | |
| Establishment | |
| registration 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-Invasive | |
| Electrocardiograph | |
| Regulation Number: 870.1130, 870.2340 | |
| Device Class: II | |
| Product Code: DXN, DPS | |
| Type of 510(k) submission | Traditional |
3 Predicate Device Information
4
| 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 Blood | ||
| Pressure Monitor + EKG | NA | |||
| Device Model | BP2, BP2A | BP7900 | NA | |
| Manufacturer | Shenzhen Viatom | |||
| Technology Co., Ltd. | Omron Healthcare, Inc. | NA |
5
Product: BPM+ECG
Version: A/0
| Intended
Use/
Indication
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 | The device is indented to
measure blood pressure only,
electrocardiogram (ECG) only
or blood pressure and ECG
simultaneously.
The device is a digital monitor
intended for use in measuring
blood pressure and pulse rate
in adult population.
The device is intended to
record, store, and transfer
single-channel
electrocardiogram (ECG)
rhythms. The device also
displays ECG rhythms and
detects the presence of atrial
fibrillation,
bradycardia,
tachycardia and normal sinus
rhythm (when prescribed or
used under the care of a
physician). the device is | Similar
Note01 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | and high HR.
The ECG part of the device
is for Rx only, and the blood
pressure part is for OTC. | intended for use by healthcare
professionals, patients with
known or suspected heart
conditions, and health-
conscious, and health-
conscious individuals. The
device has not been tested
and it is not intended for
pediatric use. | |
| Intended
Population | Adult | Adult | Same |
| Intended
Anatomical site | BP measurement: Upper arm
ECG Recording: Right hand
to left hand (Lead I), right
hand to left abdomen (Lead
II) | BP measurement: Upper arm
ECG Recording: Right hand to
left hand (Lead I) | Different
Note02 |
| Contraindicatio
ns/Warnings/
Precautions | This device is
contraindicated for use in
ambulatory environments.
This device is
contraindicated for use on
aircraft. | Added contraindications (n=2)
against use in ambulatory
environments and aircraft. | SE |
| Environment of
Use | Home Use
Healthcare facilities | Home Use | Different
Note03 |
| Single Use | No. | No. | Same |
| Sterility | Non sterile | Non sterile | Same |
| Label
Information | Labeled for both OTC (Home
Use) and Rx (Prescription
Use) | Labeled for both OTC (Home
Use) and Rx (Prescription
Use) | Same |
6
VOL_005: 001_510(k) Summary
Version: A/0
| Working
Principle | Blood
Pressure
measurement: Oscillometric
method
ECG recording: The device
collects the ECG data
through the potential
difference of the body
surface based on the ECG
electrode, and obtains ECG
data after being amplified
and filtered, then displays
through the screen. | Blood Pressure measurement:
Oscillometric method
ECG recording: User
completes circuit with skin
contact and hardware
transmits audio signal to MCP
to convert and display ECG. | Similar
Note04 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Pressure
Sensor | Semiconductor pressure
sensor | Semiconductor pressure
sensor | Same |
| Internal Power
supply | Rechargeable lithium-
polymer battery | 4*AA alkaline Batteries | Different
Note05 |
| Cuff Size | 22-42cm | 17-22cm
22-42cm | Different
Note 06 |
| | Pressure: 0 to 300mmHg | Pressure: 0mmHg300mmHg | |40°C
| Measuring
range | Pulse: 40 to 200 beat/minute | Pulse: 40-199 beats/minute | Different
Note 07 |
| | Heart rate: 30 to 250 /min | Heart rate: 30 to 300
beats/minute | |
| Accuracy | Pressure: $\pm$ 3mmHg
Pulse: 2 bpm
HR: $\pm$ 2 bpm or 2%,
whichever is greater; | Pressure: Within $\pm$ 3mmHg or
2% of reading;
Pulse: Within 5% of HR
reading | Different
Note 08 |
| Irregular Heart
beat | Irregular beat, High HR, Low
HR were displayed in the
LCD. | Possible Atrial Fibrillation (or
AFib), Tachycardia,
Tachycardia, Unreadable or
Unclassified were analyse by
APP. | Different
Note 09 |
| Operating
Environment | 5°C ~ 45°C
10% to 95% RH | 10°C
15% to 90% RH | Different |
| Storage | -25°C60°C | -20°C60°C | Note 10 |
| Environment | 10% to 95% RH | 10% to 95% RH
BP measurement: | |
| Bluetooth
transmission | The device has wireless
Bluetooth LE transmission. | BP measurement:
Bluetooth
ECG recording:
Ultrasonic Acoustics acquired
by phone | Different
Note 11 |
| Body
Movement
Detection | No. | Yes, for BP measurement | Different
Note 12 |
| Data
Acquisition for
ECG recording: | The device displays ECG
rhythms and detects the
presence of regular beat and
irregular beat (Irregular beat,
High HR, Low HR). | The device displays ECG
rhythms and detects the
presence of atrial fibrillation,
bradycardia, tachycardia and
normal sinus rhythm. | Different
Note09 |
| Frequency
Response | 0.67 to 40 Hz | 0.67 - 40Hz | Same |
| ECG channels | Single Channel | Single Channel | Same |
| CMRR | >60 dB | >60 dB | Same |
| Input
Impedance | ≥10MΩ, 10Hz | ≥10MΩ, 10Hz | Same |
7
Product: BPM+ECG
Version: A/0
| Capacity | 100 BP readings can be
stored in the internal
memory.
ECG recording:
10 records 30s ECG data | 90 BP readings can be stored
in the internal memory.
ECG recording:
Essentially unlimited due to
real-time transmission to MCP
memory (size of ECG file is
miniscule – kilobytes
compared to device memory
capacity – gigabytes) | Note13 |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Display | BP measurement:
LCD (Liquid Crystal Display)
displays;
systolic blood pressure
diastolic blood pressure
pulse rate
ECG recording:
ECG rhythm
Heart Rate
Regular beat
Irregular beat
High HR
Low HR | BP measurement:
LCD (Liquid Crystal Display)
displays;
current cuff pressure
systolic blood pressure
diastolic blood pressure
pulse rate
error messages
ECG recording:
APP display
ECG rhythm
ECG detectors (Normal /
Possible Atrial Fibrillation /
Bradycardia / Tachycardia
Unclassified / Unreadable)
Past ECG recording in the
memory
Some other user convenient
information | Different
Note14 |
| Materials | Patient contact materials of
the cuff have been tested in
accordance with ISO 10993
tested in accordance with
accordance with ISO 10993
and FDA guidance | Patient contact materials of the
cuff have been tested in
accordance with ISO 10993
tested in accordance with
accordance with ISO 10993
and 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.
8
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
9
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).