VITAL SIGNS MONITOR

K113833 · Guangdong Biolight Meditech Co., Ltd. · MWI · May 1, 2012 · Cardiovascular

Device Facts

• Record ID: K113833
• Device Name: VITAL SIGNS MONITOR
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: MWI · Cardiovascular
• Decision Date: May 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department. The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp). It is intended to be used 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.

Device Story

Vital Signs Monitors M900 and V6 are bedside devices for continuous monitoring of physiological parameters. Inputs include SpO2, PR, NIBP, Temp, and for V6, additional CO2, SpCO, SpMet, and SpHb. Devices process signals to display, store, and trigger physiological, technical, or general alarms. Operated by healthcare professionals in hospitals and clinics. Output provides real-time patient status to clinicians, facilitating clinical decision-making and patient monitoring. Each monitor is restricted to single-patient use.

Clinical Evidence

Clinical testing was conducted for the V6 model specifically for the infrared thermometer function, following ASTM E1965-98 standards at People's Hospital in Zhuhai. All other performance verification was based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Monitors physiological parameters via sensors for SpO2, NIBP, Temp, and CO2. Materials comply with ISO 10993-5/10. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ASTM E1965-98 (thermometry). Connectivity is standalone. Power source is electrical. Form factor is bedside monitor.

Indications for Use

Indicated for patients requiring continuous monitoring of physiological parameters including SpO2, PR, NIBP, Temp (M900/V6) and SpCO, SpMet, SpHb, CO2 (V6 only). Intended for use in clinical settings (hospitals, clinics); 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 - VSM 6000 Series (K101445)
• LoFlo C5 CO2 sensor (K053174)
• Infrared Ear Thermometer (K103097)
• M66 Patient Monitor (K100046)

Submission Summary (Full Text)

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# 1 2012

## Exhibit #1 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K113833

- 1. Date of Submission: March 2, 2012
- 2. Sponsor

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast, Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Mr. Tianbao Li Position: Chief Engineer Tel: [phone] Fax: [phone] Email: li [e-mail]

- 3. Submission Correspondent Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- Proposed Device Identification 4.

Proposed Device Name: Vital Signs Monitor Proposed Device Model: M900

Classification: Class II

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K 113833 pg. 2ofs

Product Code: MWI Regulation Number: 21 CFR 870.2300 Review Panel: Cardiovascular Subsequent Product Code:

| Product<br>Code | Regulation<br>Number | Classification Name | Panel |
|-----------------|----------------------|---------------------------------------------------|------------------|
| DXN | 870.1130 | System, Measurement, Blood-pressure, Non-invasive | Cardiovascular |
| DQA | 870.2700 | Oximeter | Anesthesiology |
| FLL | 880.2910 | Thermometer, Electronic, Clinical | General Hospital |

Intended Use Statement:

The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.

Proposed Device Name: Vital Signs Monitor Proposed Device Model: V6

Classification: Class II Product Code: MWI Regulation Number: 21 CFR 870.2300 Review Panel: Cardiovascular Subsequent Product Code:

| Product<br>Code | Regulation<br>Number | Classification Name | Panel |
|-----------------|----------------------|---------------------------------------------------|------------------|
| DXN | 870.1130 | System, Measurement, Blood-pressure, Non-invasive | Cardiovascular |
| DQA | 870.2700 | Oximeter | Anesthesiology |
| CCK | 868.1400 | Analyzer, Gas, Carbon-Dioxide, Gaseous-phase | Anesthesiology |
| FLL | 880.2910 | Thermometer, Electronic, Clinical | General Hospital |

Intended Use Statement:

The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2)

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and Temperature (Temp).

It is intended to be used 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.

- ડ. Predicate Device Identification
510(k) Number: K101445 Product Name: Vital Signs Monitor - VSM 6000 Series Manufacturer: Welch Allyn, Inc.

510(k) Number: K053174 Product Name: LoFlo C5 CO2 sensor Manufacturer: Respironics Novametrix, LLC

510(k) Number: K103097 Product Name: Infrared Ear Thermometer Manufacturer: Radiant Innovation Inc.

510(k) Number: K100046 Product Name: M66 Patient Monitor Manufacturer: Guangdong Biolight Meditech Co., Ltd

- Device Description Q.
#### M900

The proposed device, Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as SpO2, PR, NIBP and TEMP continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.

The feature of the M900 is described as following:

#### Number of Patient for Use

Each monitor can only be used for single patient.

Alarming

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There are three kinds of alarming, which are physiological alarming, technical alarming and general alarming.

### V6

The proposed device, Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

The Vital Signs Monitor V6 is intended to be used in outpatients 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 feature of the V6 is described as following:

#### Number of Patient for Use

Each monitor can only be used for single patient.

### Alarming

There are three kinds of alarming, which are physiological alarming, technical alarming and prompt messages.

- Non-Clinical Test Conclusion 7.
Bench 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: 1988 +A1:1991+A2:1995, Medical Electrical Equipment Part 1: General A requirements for safety.
- IEC 60601-1-2: 2007, Medical Electrical Equipment Part 1-2: General requirements for basic A safety and essential performance - Collateral Standard: Electromagnetic compatibility -Requirements and tests.
- ASTM E1965-98(reapproved 2009), Standard Specification for Infrared Thermometers for V Intermittent Determination of Patient Temperature.

I-4

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- ♪ ISO 10993-5: 1999, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.
- > ISO 10993-10: 2002, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- 8. Clinical Test Conclusion

.

The clinical test of proposed device Vital Signs Monitor V6 was conducted in People's Hospital in Zhuhai, per ASTM E1965-98(reapproved 2009), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

- 9. Substantially Equivalent Conclusion
The proposed devices, Vital Signs Monitor, are determined to be Substantially Equivalent (SE) to the predicate device, Vital Signs Monitor - VSM 6000 Series (K101445), in respect of safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol in black, with three curved lines representing the body and wings. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

> MAY 1 2017

Guangdong Biolight Meditech Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 237-023 Shanghai 200237 -CHINA

K113833 Re:

Trade/Device Name: Vital Signs Monitors, M900 and V6

Regulatory Number: 21 CFR 870.2300

Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two)

Product Code: 74 MWI

Dated: April 5, 2012

Received: April 12, 2012

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave roviewed your over 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 conmisers that have been reclassified in accordance with the provisions of the Federal Food, DNAA 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 1 ou may, merelors, manel 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.

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### Page 2 - Ms. Diana Hong

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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Premarket Notification 510(k) Submission

Exhibit #2 Indications for Use Project #: M0292011Ba

# Exhibit #2 Indications for Use

510(k) Number: K113833 Device Name: Vital Signs Monitor M900

Indications for Use:

The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.

## ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

## OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

liovascular Devices

510(k) Number K113833

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# Exhibit #2 Indications for Use

510(k) Number: K113833 Device Name: Vital Signs Monitor V6

Indications for 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 Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

It is intended to be used 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.

APRESCRIPTION USE (Part 21 CFR 801 Subpart D) ]OVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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rdiovascular Devices

**510(k) Number**: K113833