(447 days)
Not Found
No
The summary describes a standard vital signs monitoring system with data storage and transmission capabilities. There is no mention of AI, ML, or any advanced analytical techniques that would suggest the use of such technologies.
No
The device is described as a "VitalSigns Monitoring System" intended to "monitor the patient's physical indexes." Its primary functions are collecting, storing, and transmitting patient vital signs data (ECG, SpO2, NIBP, TEMP, pulse rate), not providing therapy or treatment.
Yes
The device is intended to monitor patient's physical indexes (ECG, SpO2, NIBP, TEMP, pulse rate) and collect, store, and transmit this general patient health information and vital signs data. This process of monitoring and data collection to assess health status is a form of diagnosis.
No
The device description explicitly states it is a "handheld, smart and wireless connected medical device" that "incorporates an embedded system" and integrates hardware modules for Temp, ECG, NIBP, and SpO2. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the BW-X07HD Handheld VitalSigns Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the BW-X07HD monitors physical indexes directly from the patient's body (ECG, SpO2, NIBP, TEMP, pulse rate). It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor the patient's physical indexes and collect, store, and transmit this data. This is a direct physiological measurement, not an in vitro analysis.
Therefore, the BW-X07HD Handheld VitalSigns Monitoring System falls under the category of a physiological monitoring device, not an IVD.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DRT, DXN, DQA, FLL
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
For ECG and SpO2: adult
For NIBP: adult and pediatric aged more than 3 years old
For TEMP: all types of people including newborn, pediatric and adult
Intended User / Care Setting
Qualified healthcare personnel. Used in hospital, clinic, homecare, home and other medical settings where patient care is offered.
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)
Clinical tests were performed for NIBP, Oximeter, and Thermometer parts of the subject device.
The clinical results met the requirements described in ISO 80601-2-61:2011 for Oximeter, ISO 81060-2:2013 for NIBP, and ISO 80601-2-56:2009 for Thermometer. No AE or side-effect occurred during the clinical investigations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue and white.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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 | |
| information | Submitter's Name: Visiomed Technology Co.,Ltd |
| Address: 2 Floor of No.1 Building, Jia An Technological | |
| Industial Park, 67 Distric, | |
| Bao An, Shenzhen, | |
| Guangdong, | |
| China | |
| Contact person: Chen XiaoFeng | |
| TEL: 0755-29481701-103 | |
| FAX: 0755-29481705 | |
| E-Mail: jay@visiomed-tech.com | |
| Submission | |
| Correspondent | |
| Image: Logo | |
| Establishment | |
| 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 |
| Subsequent Product Codes: DRT, DXN, DQA, FLL | |
| Device Class: | 2 |
| Regulation Number: | 870.2300 |
4
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
BW-X07HD | Predicate Device
K150361 | Remark | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-------------------|
| Intended
Use/Indication
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 | The ViSi Mobile Monitoring System is
lintended for use by clinicians and
medically qualified personnel for single
or multi-parameter vital
sians
monitoring of adult patients (18 years or
older). It is indicated for ECG (3 or 5
lead-wire), respiration rate (RESP),
heart rate (HR), noninvasive blood
(NIBP),
pressure
noninvasive blood pressure (cNIBP),
Inoninvasive monitoring of functional
oxygen saturation
of arterial
hemoglobin (SpO2), pulse rate (PR),
and skin temperature (TEMP) in
hospital-based facilities; including,
medical-surgical
general
floors.
lintermediate care floors,
and
emergency departments. The ViSi
Mobile Monitoring System may be used
as standalone devices or networked to | Similar (Note 01) | |
| Item | Subject Device
BW-X07HD | Predicate Device
K150361 | Remark | |
| | patient vital signs data between the patient
and a health care professional. | ViSi Mobile Remote Viewers through
wireless 802.11 communications. | | |
| Product Code | MWI, DRT, DXN, FLL, DQA | MWI, DRT, DXN, FLL, DQA | Same | |
| Patient
population | The intended patient population for
measuring Temp is all types of people
including newborn, pediatric and adult,
whereas, for measuring NIBP is both
pediatric and adult, for measuring ECG is
adult and SpO2 is adult. | Adults ≥ 18 years | Different (Note
02) | |
| Usage
Environment | home and hospital | Hospital-based facility including
emergency departments, general
medical-surgical and intermediate care
floors. | Similar (Note 03) | |
| Power Supply | | | | |
| Internal
supply | Type
Rechargeable Li-polymer
battery | Rechargeable Li-polymer battery | | |
| | Capacity
3.7V/2500mAh | 3.7 V/2000 mAh | Similar (Note 04) | |
| | Performance
capacity
4 hours | > 12 hours | | |
| AC-DC Power
supply | Line Voltage
100Vac to 240Vac | 100Vac to 240Vac | | |
| | Current
less than 0.5A rms. at 90Vac
input and maximum load | / | SE | |
| | Frequency
50Hz or 60Hz | 50Hz or 60Hz | | |
| ECG Function | | | | |
| | | 3-wire: II | | |
| | Measuring Mode
5 Electrodes, 7-Lead ECG | 5-wire: I, II, III, AVL, AVR, AVF, V | | |
| | DC offset Voltage Range
±300mV | ±300mV | SE | |
| | Differential Voltage
Measurement Range
±5mV | ±5mV | | |
| | Resolution
1bpm | 1bpm | Same | |
| NIBP Function: | | | | |
| | Principle of
Operation | oscillation | Same | |
| Blood
Pressure | Measurement
Range
Adult & Pediatric:
0-295mmHg (0-39.3kPa) | Systolic Range: 60 to 240 mmHg
Diastolic Range: 40 to 160 mmHg | | |
| | Accuracy
±3mmHg (±0.4kPa) | Mean error of less than ± 5 mmHg
and a std. dev. of ≤ 8 mmHg | Similar (Note 05) | |
| | Pressure
Resolution
1mmHg | 1mmHg | | |
| Pulse Rate | Measuring
Range
40 bpm to 180 bpm | 30 to 240 BPM | | |
| | Accuracy
±3 bpm | ±3 BPM | | |
| | Resolution
1 bpm | 1 BPM | | |
| SpO2 Function | | | | |
| | Principle of Operation
Lambert Beer Law | | Same | |
| SpO2 | Measuremen
t Range
0100% | 49 to 100% | Similar (Note 06) | |43.0°C / 89°F
| Item | Subject Device
BW-X07HD | Predicate Device
K150361 | Remark | |
| Pulse Rate | Accuracy | Adult ±2 %
(70% to 100% SpO2),
Undefined (0 to 69% SpO2); | ≤ 2% from 70-100% (no motion)
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 | | Infrared red | | Same |
| Measurement Range | Body temperature: 32.0°C109.4°F50°C / 32°F
Room temperature: 0°C122°F90°C / 32°F~194°F | 0 ~ 19.9 (32 ~ 67.9 ) ±0.3 (±0.5 )
Surface temperature: 0°C
20 ~ 24.9 (68 ~ 76.9 ) ±0.3 (±0.5 )
25 ~ 35.9 (77 ~ 96.7 ) ±0.2 (±0.3 )
36 ~ 39.9 (96.8 ~ 103.9 )
±0.1 (±0.2 )
40 41.9 (104 ~ 107.5 )2s |
±0.2 (±0.3 )
42 ~ 50.0 (107.6 ~ 122 )
±0.3 (±0.5 ) | | |
| Accuracy (not including sensor) | +/- 0.2°C (35°C-42°C) / +/- 0.2°F (95°F-107.6°F) in body temperature
+/-0.3°C (32°C-34.9°C, 42.1°C-43°C) / +/- 0.3°F (89.6°F-93.2°F, 107.6°F-109.4°F) in body temperature.
+/- 0.2°C (22°C-40°C) / +/- 0.2°F (71,6°F-104°F);
Others +/-2°C / +/-2°F in surface temperature. | | | Similar (Note 07) |
| Resolution | 0.1°C / 0.1°F | 0.1°C / 0.1°F | | |
| Average Time Constant | 1