Who is the manufacturer of Patient Monitor?

Guangdong Biolight Meditech Co., Ltd. filed the 510(k) submission for Patient Monitor (K181919).

What is the FDA product code for Patient Monitor?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Patient Monitor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Patient Monitor?

V6 Vital Signs Monitor (K153135).

Who can help prepare an FDA 510(k) submission like Patient Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Patient Monitor

K181919 · Guangdong Biolight Meditech Co., Ltd. · MWI · Apr 5, 2019 · Cardiovascular

Device Facts

Record ID	K181919
Device Name	Patient Monitor
Applicant	Guangdong Biolight Meditech Co., Ltd.
Product Code	MWI · Cardiovascular
Decision Date	Apr 5, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

Intended Use

V9 Patient 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). V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patients. It is not intended for helicopter transport, hospital ambulance or home use.

Device Story

Portable patient monitor; inputs physiological signals via NIBP cuff, temperature sensor, CO2 sensor, and SpO2 sensor; processes signals using integrated modules (BLT, Suntech, Nellcor, or Masimo) to display, store, and alarm on vital signs; used in hospital environments (out-patient departments, wards, NICU) by clinicians; output provides real-time vital sign data to assist clinical decision-making; benefits patient through continuous monitoring of physiological status.

Clinical Evidence

Bench testing only. No clinical studies were performed. Substantial equivalence is supported by the use of previously FDA-cleared physiological monitoring modules and verification of design specifications against international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-30, IEC 80601-2-61, ISO 80601-2-55, ISO 80601-2-56).

Technological Characteristics

Portable patient monitor; AC-powered; modular design supporting various SpO2, NIBP, CO2, and temperature sensors. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), IEC 80601-2-30 (NIBP), IEC 80601-2-61 (SpO2), ISO 80601-2-55 (CO2), and ISO 80601-2-56 (temperature).

Indications for Use

Indicated for monitoring, displaying, reviewing, storing, and alarming physiological parameters (SpO2, PR, NIBP, CO2, Temp) in adult, pediatric, and neonatal patients within controlled hospital environments.

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

V6 Vital Signs Monitor (K153135)

Reference Devices

BLT NIBP Module (K153135)
Suntech NIBP Module (K152552)
Nellcor SpO2 Module (K052186)
MASIMO SpO2 Module (K101896)
BLT SpO2 Module (K153135)
Temperature Module (K153135)
CO2 Module (K153135)

Related Devices

K153135 — VITAL SIGNS MONITOR · Guangdong Biolight Meditech Co., Ltd. · Feb 25, 2016
K014255 — DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 · Ge Medical Systems Information Technologies · Jul 2, 2002
K093802 — ULTRAVIEW DM3 MONITOR · Zoe Medical, Inc. · Apr 9, 2010
K971910 — MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) · Hewlett-Packard GmbH · Mar 23, 1998
K131818 — VITAL SIGNS MONITOR · Edan Instruments, Inc. · Aug 30, 2013

Submission Summary (Full Text)

{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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 5, 2019 Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn Re: K181919 Trade/Device Name: Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: February 19, 2019 Received: February 26, 2019 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. 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/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, 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) K181919 Device Name Patient Monitor Model: V9 ### Indications for Use (Describe) V9 Patient Monitor is intended to be used for monitoring, displaying, 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). V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patiented for helicopter transport, hospital ambulance or home use. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------------------------| | ☐ 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}------------------------------------------------ # 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: K181919 - 1. Date of Preparation: 4/5/2019 - 2. Sponsor Identification ## Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technical Innovation Coast Hi-Tech Zone, Zhuhai, 519085, Guangdong, China. Establishment Registration Number: 3007305624 Contact Person: Dan Hou Position: Manager Tel: +86-0756-3399971 Fax: +86-0756-3399989 Email: hou d@blt.com.cn ### 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person) # Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850 Fax: 001-3609253199 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Patient Monitor Model: V9 Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Classification: II Product Code: MWI Regulation Number: 21 CFR 870.2300 Review Panel: Cardiovascular Indications for Use: V9 Patient 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). V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patients. It is not intended for helicopter transport, hospital ambulance or home use. ## Device Description The V9 Patient Monitor can 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 V9 Patient Monitor is a portable device, consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor. It consists of main unit and accessories, including NIBP cuff, Temperature sensor, CO2 sensor and SpO2 sensor. All modules, boards and accessories used in V9 Patient Monitor has already been cleared by FDA, referring to Table 1. In which, two NIBP and three SpO2 modules are optional for proposed device. | Module | | 510(k) Number | |-------------|---------------------|---------------| | NIBP | BLT NIBP Module | K153135 | | | Suntech NIBP Module | K152552 | | SpO2 | Nellcor SpO2 Module | K052186 | | | MASIMO SpO2 Module | K101896 | | | BLT SpO2 Module | K153135 | | Temperature | Temperature Module | K153135 | | CO2 | CO2 Module | K153135 | | Table 1. List of 510(k) of Modules | | | |------------------------------------|--|--| |------------------------------------|--|--| {5}------------------------------------------------ #### 5. 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 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance - > IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - > IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - > IEC 80601-2-30:2013 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers - > IEC 80601-2-61:2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment - ISO 80601-2-55:2011 Medical electrical equipment Part 2-55: Particular requirements for the > basic safety and essential performance of respiratory gas monitors - A ISO 80601-2-56: 2009 Medical electrical equipment - Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. - > ANSI C63.27-2017 American National Standard For Evaluation Of Wireless Coexistence The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device predicate. - 6. Clinical Test Conclusion No clinical study is included in this submission, because all modules have been previously cleared by FDA. The K Number of each module is listed in Table 1 of this document. - 7. Identification of Predicate Device Predicate Device 510(k) Number: K153135 Product Name: V6 Vital Signs Monitor {6}------------------------------------------------ ### 8. Substantially Equivalent (SE) Comparison | ITEM | Proposed Device | Predicate Device Vital Signs Monitor V6, K153135 | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | MWI | MWI | | Regulation Number | 21 CFR 870.2300 | 21 CFR 870.2300 | | Class | II | II | | Indications for Use | V9 Patient 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). V9 Patient Monitor is used to monitor vital signals for patients and is intended to be used in controlled, hospital environments. It is applicable for adult, pediatric and neonatal patients. It is not intended for helicopter transport, hospital ambulance or home 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. | | Intended Population | The monitors are intended for adult, pediatric and neonatal. | The monitors are intended for adult, pediatric and neonatal. | | Intended Environment | The V9 Patient Monitor is used to be used in hospital environments including out-patient outpatient departments, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. | The vital signs monitor is used to be used in hospital environments including out-patient outpatient departments, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. | | Power Supply | The monitors can be supplied by AC power. | The monitors can be supplied by AC power. | | Number of Patient be monitored each time | Single patient each time | Single patient each time | | Sterile | No | No | | Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | | EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | | Alarm Function | Comply with IEC60601-1-8 | Comply with IEC60601-1-8 | | SpO2 Module | BLT, Nellcor and Masimo Comply with IEC 80601-2-61 | BLT and Nellcor Comply with IEC 80601-2-61 | | | NIBP Module | BLT and Suntech Comply with IEC 80601-2-30 | | CO2 Module | Comply with ISO 80601-2-55 | Comply with ISO 80601-2-55 | | Temp Module | Comply with ISO 80601-2-56 | Comply with ISO 80601-2-56 | | Patient Contact Accessories | SpO2 Sensor, NIBP cuff, CO2 Sensor and Temp Sensor | SpO2 Sensor, NIBP cuff, CO2 Sensor and Temp Sensor | | | Biocompatibility | All the patient contact accessories were previously cleared by FDA | # Table 2 Substantially Equivalent Comparison {7}------------------------------------------------ The SpO2 and NIBP module of proposed device and predicate device is different. Masimo SpO2 and Suntech NIBP are not included in predicate device, however, the Masimo SpO2 and Suntech NIBP have been cleared by FDA under K131898 and K152552. Therefore, this difference is considered not to affect the substantially equivalency (SE) between the proposed and predicate device. ### 9. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.