VITAL SIGNS MONITOR

K153135 · Guangdong Biolight Meditech Co., Ltd. · MWI · Feb 25, 2016 · Cardiovascular

Device Facts

• Record ID: K153135
• Device Name: VITAL SIGNS MONITOR
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The vital signs monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). This vital signs monitor is used to monitor vital signals for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

Device Story

Portable vital signs monitor for healthcare professionals in hospital settings; inputs include SpO2 (Nellcor/Masimo/BLT modules), PR, NIBP, CO2, and temperature (infrared ear or fast temp module). Device processes physiological signals to display numeric and waveform data on LCD/LED screen; provides visual/audible alarms and nurse call functionality. Powered by built-in Lithium-ion battery. Clinicians use real-time data for patient assessment and monitoring; output supports clinical decision-making regarding patient status. Benefits include continuous, reliable monitoring of vital signs in clinical environments.

Clinical Evidence

Bench testing only. No clinical studies were performed. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-30, and IEC 80601-2-61 was verified. Temperature module performance was validated per FDA guidance for clinical electronic thermometers.

Technological Characteristics

Portable monitor with LCD/LED display; SpO2, PR, NIBP, CO2, and temperature measurement modules. Biocompatibility per ISO 10993-1, -5, -10. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Alarm functionality per IEC 60601-1-8. NIBP performance per IEC 80601-2-30; Pulse Oximetry per IEC 80601-2-61. Powered by internal Lithium-ion battery. Nurse call interface included.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in hospital environments (out-patient, wards, NICU) for monitoring, displaying, storing, and alarming of SpO2, PR, NIBP, CO2, and temperature. Not for home, ambulance, or helicopter use.

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

• Vital signs monitor (K113833)
• Filac Fast Temp (K003313)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2016

Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co. Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K153135

Trade/Device Name: V6 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: January 21, 2016 Received: January 27, 2016

Dear Diana Hong:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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) K153135

Device Name Vital Signs Monitor V6

#### Indications for Use (Describe)

The vital signs monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

This vital signs monitor is used to monitor vital signals for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

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

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-----------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

## 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 [e-mail]

"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}------------------------------------------------

# Exhibit#1 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

- 1. Date of Preparation: 01/21/2016
- 2. Sponsor Identification

Establishment Registration Number: 3007305624

Contact Person: Jin Liang Position: R&D Director Tel: [phone] Fax: [phone] Email: liang [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Lee Fu (Alternative Contact Person)

# Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

{4}------------------------------------------------

#### 4. Identification of Proposed Device

Trade Name: Vital Signs Monitor

Common Name: Vital Signs Monitor Model(s): V6

Regulatory Information Classification Name: Patient Monitor Classification: II Product Code:MWI Regulation Number: 21 CFR 870.2300 Review Panel:Cardiovascular

> Indication for use:The vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

> This vital signs monitor is used to monitor vital signals for patients and is suitable for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

### Device Description

The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

The following lists the detailed features of the subject device.

- LCD/LED display
- SpO2, Pulse Rate NIBPCO2 and TEMP measurement
- Infrared ear temp or fast temp module for Temp measurement
- Nellcor or Masimo or BLT SpO2 module
- Display numeric and waveform information simultaneously .
- Nurse call feature
- . Built-in Lithium-ion Battery
- Suitable for adult, pediatric and neonate patients .
- Visual and audible alarm
- న. Identification of Predicate Device(s)

{5}------------------------------------------------

Predicate Device 1

510(k) Number: K113833 Product Name: Vital signs monitor Model Name: V6

Predicate Device 2

510(k) Number: K003313 Product Name:Filac Fast Temp Model Name: F3000

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > IEC 60601-1 Electrical Safety
- > IEC 60601-1-2 Electromagnetic Compatibility
- > IEC60601-1-8 Requirements of alarm function
- > IEC80601-2-30 Requirements forbasic safety and essential performance of NIBP
- IEC80601-2-61 Requirements forbasic safety and essential performance of pulse oximeter A equipment
- > Clinical Electronic Thermometers testing for the newly added F3000 Temperature Module pursuant to the guidance on the Content of Premarket Notification [510(K)] Submission for Clinical Electronic Thermometers" dated Mar. 1993.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

{6}------------------------------------------------

#### Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device(s) | Predicate Device(s)<br>Vital Signs Monitor V6<br>K113833 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MWI | MWI |
| Regulation Number | 870.2300 | 870.2300 |
| Intended Use | The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The Vital Signs Monitor V6 is intended to be use in outpatient departments and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use. | The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). The Vital Signs Monitor V6 is intended to be use in outpatient departments and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use. |
| Configuration | NIBP<br>SpO2<br>CO2<br>Quick Temp | NIBP<br>SpO2<br>CO2<br>Infrared temp |
| Sterile | N/A | N/A |
| Single Use | N/A | N/A |
| Biocompatibility | ISO 10993-1 ISO 10993-5<br>ISO 10993-10 | ISO 10993-1 ISO 10993-5<br>ISO 10993-10 |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 |
| ITEM | Proposed Device | Predicate Device |
| Measurement range | 30 to 42°C | 30 to 42°C |
| Resolution | 0.1°C | 0.1°C |
| Unit | °C | °C, °F |
| Update time | Every 1s | Every 1s |
| Self-checking | Every 3s | Every 3s |
| Accuracy | Monitor mode,<br>Predictive mode: ≤±0.1°C<br>Quick mode: ±0.2°C | Monitoring Mode and<br>Predictive mode: ±0.1°C<br>Quick Predictive Mode:<br>±0.3°C |
| Response time | Predictive Mode: ≤10 seconds<br>Monitoring Mode(all sites):<br>120~180 seconds | Oral(Quick Predictive<br>Mode):3~5<br>seconds(non-fever temps);<br>8~10 seconds (fever temps)<br>Oral(Predictive Mode):6~10<br>seconds<br>Axillary:8~12 seconds<br>Rectal:10~14 seconds<br>Monitoring Mode(all<br>sites):60~120 seconds |

# Table 1 Comparison of Technology Characteristics(V6)

{7}------------------------------------------------

Table 2 General Comparison to Filac Fast Temp

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.