Handheld VitalSigns Monitoring System

K172965 · Visiomed Technology Co.,Ltd · MWI · Dec 17, 2018 · Cardiovascular

Device Facts

• Record ID: K172965
• Device Name: Handheld VitalSigns Monitoring System
• Applicant: Visiomed Technology Co.,Ltd
• Product Code: MWI · Cardiovascular
• Decision Date: Dec 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient's physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate. For measuring ECG, SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intent population is all types of people including newborn, pediatric and adult. The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

Device Story

Handheld, wireless-connected vital signs monitor; measures ECG, SpO2, NIBP, TEMP, and pulse rate. Inputs: physiological sensors for ECG, SpO2, NIBP, and temperature. Device integrates embedded system with Android application; stores data locally; transmits via WiFi, 3G, or 4G. Includes HD video conferencing for communication between patient and healthcare professional. Used in hospitals, clinics, and home settings by healthcare personnel or patients. Output: vital signs data displayed on device and transmitted to healthcare professionals for clinical decision-making. Benefits: enables remote monitoring and data collection for patient health management.

Clinical Evidence

Clinical reports provided for NIBP, SpO2, and Thermometer functions. NIBP validation performed per ISO 81060-2:2013; SpO2 validation per ISO 80601-2-61:2011; Thermometer validation per ISO 80601-2-56:2009. Studies included adult and pediatric populations (NIBP >3 years; TEMP all ages). No adverse events or side effects reported.

Technological Characteristics

Handheld device with embedded system and Android application. Sensors: ECG, NIBP, SpO2, and infrared temperature. Power: 3.7V/2500mAh Li-polymer battery, AC-DC 100-240Vac. Connectivity: WiFi, 3G, 4G. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, IEC 60601-2-27, IEC 80601-2-30, ISO 81060-2, ISO 80601-2-61, ISO 80601-2-56, ISO 10993-5/10.

Indications for Use

Indicated for monitoring ECG, SpO2, NIBP, TEMP, and pulse rate. ECG/SpO2: adults. NIBP: adults and pediatric patients >3 years. TEMP: all populations including newborns, pediatric, and adults. Intended for use in hospital, clinic, and home settings by qualified healthcare personnel.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• ViSi Mobile Monitoring System (K150361)

Submission Summary (Full Text)

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December 17, 2018

Visiomed Technology Co., Ltd. % Filed Fu Consultant Shenzhen Joyantech Consulting Co., Ltd 1122#, International Mayor Communication Center, Baishizhong Road 55# Nanshan District, Shenzhen, 518000 CN

Re: K172965

Trade/Device Name: Handheld Vital Signs Monitoring System, Model: BW-X07HD Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI, DRT, DXN, DOA, FLL Dated: January 2, 2018 Received: January 19, 2018

Dear Filed Fu:

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/cfpmp/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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Stephen C. Browning -S5

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) K172965

Device Name

Handheld VitalSigns Monitoring System, Model: BW-X07HD

Indications for Use (Describe)

The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient's physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate.

For measuring ECG, SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intent population is all types of people including newborn, pediatric and adult.

The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 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 | 2017-12-24 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>information | Submitter's Name: Visiomed Technology Co.,Ltd<br>Address: 2 Floor of No.1 Building, Jia An Technological<br>Industial Park, 67 Distric,<br>Bao An, Shenzhen,<br>Guangdong,<br>China<br>Contact person: Chen XiaoFeng<br>TEL: [phone]<br>FAX: [phone]<br>E-Mail: [e-mail] |
| | Submission<br>Correspondent |
| Image: Logo | |
| | |
| Establishment<br>registration number | 3012429388 |

## 2. Device Information

| Type of 510(k) submission: | Traditional |
|----------------------------|----------------------------------------------------------------------|
| Trade Name: | Handheld VitalSigns Monitoring System |
| Model: | BW-X07HD |
| Classification name: | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Review Panel: | Cardiovascular |
| Product Code: | Product Code: MWI<br>Subsequent Product Codes: DRT, DXN, DQA, FLL |
| Device Class: | 2 |
| Regulation Number: | 870.2300 |

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### 3. Predicate Device Information

Sotera Wireless, Inc. Sponsor: Device: ViSi Mobile Monitoring System K150361 510(K) Number:

#### 4. Device Description

The BW-X07HD Handheld VitalSigns Monitoring System is a handheld, smart and wireless connected medical device. The device can be easily used by healthcare professional personnel, ordinary users or patients, to monitor multiple physiological indexes, including TEMP, ECG, NIBP and SpO2 as well as the pulse rate. Medical data can be stored locally and can be sent through WiFi, 3G or 4G network.

The device incorporates an embedded system and an Android application. The embedded system integrates the Temp module, the ECG, NIBP, SpO2 module and the wireless module together. The device allows users to communicate through an HD video conferencing system but cannot be used as phone (only IP connection, Micro SIM card for data transmission).

## 5. Intended Use/Indications for Use

The BW-X07HD Handheld VitalSigns Monitoring System is intended to be used in hospital, clinic, homecare, home and other medical settings where patient care is offered by qualified healthcare personnel who can use the device to monitor the patient's physical indexes, including ECG, SpO2, NIBP and TEMP as well as the pulse rate.

For measuring ECG, SPO2 the intended patient population is adult, for measuring SpO2 the intended patient population is adult, for measuring NIBP the intended patient population is both adult and pediatric aged more than 3 years old, whereas for measuring TEMP the intended patient population is all types of people including newborn, pediatric and adult.

The device is used to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional.

| Item | Subject Device<br>BW-X07HD | Predicate Device<br>K150361 | Remark | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-------------------|
| Intended<br>Use/Indication<br>for Use | The<br>BW-X07HD Handheld VitalSigns<br>Monitoring System is intended to be used in<br>hospital, clinic, homecare, home and other<br>medical settings where patient care is<br>offered by qualified healthcare personnel<br>who can use the device to monitor the<br>patient's physical indexes, including ECG,<br>SpO2, NIBP and TEMP as well as the pulse<br>rate.<br>For measuring ECG, SpO2 the intended<br>patient population is adult, for measuring<br>SpO2 the intended patient population is<br>adult, for measuring NIBP the intended<br>patient population is both adult and<br>pediatric aged more than 3 years old,<br>whereas for measuring TEMP the intended<br>patient population is all types of people<br>including newborn, pediatric and adult. The<br>device is used to collect, store, and transmit<br>general patient health information and | The ViSi Mobile Monitoring System is<br>lintended for use by clinicians and<br>medically qualified personnel for single<br>or multi-parameter vital<br>sians<br>monitoring of adult patients (18 years or<br>older). It is indicated for ECG (3 or 5<br>lead-wire), respiration rate (RESP),<br>heart rate (HR), noninvasive blood<br>(NIBP),<br>pressure<br>noninvasive blood pressure (cNIBP),<br>Inoninvasive monitoring of functional<br>oxygen saturation<br>of arterial<br>hemoglobin (SpO2), pulse rate (PR),<br>and skin temperature (TEMP) in<br>hospital-based facilities; including,<br>medical-surgical<br>general<br>floors.<br>lintermediate care floors,<br>and<br>emergency departments. The ViSi<br>Mobile Monitoring System may be used<br>as standalone devices or networked to | Similar (Note 01) | |
| Item | Subject Device<br>BW-X07HD | Predicate Device<br>K150361 | Remark | |
| | patient vital signs data between the patient<br>and a health care professional. | ViSi Mobile Remote Viewers through<br>wireless 802.11 communications. | | |
| Product Code | MWI, DRT, DXN, FLL, DQA | MWI, DRT, DXN, FLL, DQA | Same | |
| Patient<br>population | The intended patient population for<br>measuring Temp is all types of people<br>including newborn, pediatric and adult,<br>whereas, for measuring NIBP is both<br>pediatric and adult, for measuring ECG is<br>adult and SpO2 is adult. | Adults ≥ 18 years | Different (Note<br>02) | |
| Usage<br>Environment | home and hospital | Hospital-based facility including<br>emergency departments, general<br>medical-surgical and intermediate care<br>floors. | Similar (Note 03) | |
| Power Supply | | | | |
| Internal<br>supply | Type<br>Rechargeable Li-polymer<br>battery | Rechargeable Li-polymer battery | | |
| | Capacity<br>3.7V/2500mAh | 3.7 V/2000 mAh | Similar (Note 04) | |
| | Performance<br>capacity<br>4 hours | > 12 hours | | |
| AC-DC Power<br>supply | Line Voltage<br>100Vac to 240Vac | 100Vac to 240Vac | | |
| | Current<br>less than 0.5A rms. at 90Vac<br>input and maximum load | / | SE | |
| | Frequency<br>50Hz or 60Hz | 50Hz or 60Hz | | |
| ECG Function | | | | |
| | | 3-wire: II | | |
| | Measuring Mode<br>5 Electrodes, 7-Lead ECG | 5-wire: I, II, III, AVL, AVR, AVF, V | | |
| | DC offset Voltage Range<br>±300mV | ±300mV | SE | |
| | Differential Voltage<br>Measurement Range<br>±5mV | ±5mV | | |
| | Resolution<br>1bpm | 1bpm | Same | |
| NIBP Function: | | | | |
| | Principle of<br>Operation | oscillation | Same | |
| Blood<br>Pressure | Measurement<br>Range<br>Adult & Pediatric:<br>0-295mmHg (0-39.3kPa) | Systolic Range: 60 to 240 mmHg<br>Diastolic Range: 40 to 160 mmHg | | |
| | Accuracy<br>±3mmHg (±0.4kPa) | Mean error of less than ± 5 mmHg<br>and a std. dev. of ≤ 8 mmHg | Similar (Note 05) | |
| | Pressure<br>Resolution<br>1mmHg | 1mmHg | | |
| Pulse Rate | Measuring<br>Range<br>40 bpm to 180 bpm | 30 to 240 BPM | | |
| | Accuracy<br>±3 bpm | ±3 BPM | | |
| | Resolution<br>1 bpm | 1 BPM | | |
| SpO2 Function | | | | |
| | Principle of Operation<br>Lambert Beer Law | | Same | |
| SpO2 | Measuremen<br>t Range<br>0~100% | 49 to 100% | Similar (Note 06) | |
| Item | Subject Device<br>BW-X07HD | Predicate Device<br>K150361 | Remark | |
| Pulse Rate | Accuracy | Adult ±2 %<br>(70% to 100% SpO2),<br>Undefined (0 to 69% SpO2); | ≤ 2% from 70-100% (no motion)<br>Unspecified from 49-69% | |
| | Resolution | 1% | 1% | |
| | Measuring Range | 25 bpm to 250 bpm | 30 to 240 BPM | |
| | Accuracy | ±3 bpm | ≤ 3 BPM | |
| | Resolution | 1 bpm | 1 BPM | |
| Temperature Function | | | | |
| Principle of Operation |…