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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Shenzhen Biolight Meditech Co., Ltd. V9 Patient Monitor. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the proposed device to a predicate and confirming compliance with relevant standards, rather than detailing the full scope of acceptance criteria and a specific study proving those criteria are met for this new device in the way a clinical trial report would.

However, I can extract the information that is present and highlight what is not present given the nature of a 510(k) summary.

Here's an analysis based on your request:

Acceptance Criteria and Study Details for Guangdong Biolight Meditech Co., Ltd. V9 Patient Monitor

The V9 Patient Monitor is intended for monitoring, displaying, storing, and alarming for multiple physiological parameters: Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2), and Temperature (Temp).

The primary method for demonstrating acceptance criteria is by showing Substantial Equivalence (SE) to a predicate device (V6 Vital Signs Monitor, K153135) and compliance with recognized national and international standards for medical electrical equipment. No new clinical studies were conducted for this submission (as stated in point 6). Instead, the manufacturer relies on the previous clearance of its individual modules and compliance with established performance standards for each physiological parameter.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) demonstrating substantial equivalence based on previously cleared modules and compliance with standards, specific performance metrics for the new combined device (V9 Patient Monitor) are not presented in a direct "acceptance criteria vs. performance" table in the way one might see for a novel device undergoing clinical trials. Instead, the "acceptance criteria" are compliance with specific IEC/ISO standards, and the "reported device performance" is the assurance that the device meets these standards.

Acceptance Criteria (Compliance with Standards)	Reported Device "Performance" (Confirmed Compliance)
General Safety and Performance
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012 (Basic safety and essential performance)	The nonclinical tests demonstrated the proposed device complies with this standard.
IEC 60601-1-2:2014 (Electromagnetic compatibility)	The nonclinical tests demonstrated the proposed device complies with this standard.
IEC 60601-1-8:2012 (Alarm systems)	The nonclinical tests demonstrated the proposed device complies with this standard.
Specific Physiological Parameters
IEC 80601-2-30:2013 (Automated non-invasive sphygmomanometers - NIBP)	The nonclinical tests demonstrated the proposed device complies with this standard. (Note: NIBP modules used were previously cleared under K153135 for BLT NIBP Module and K152552 for Suntech NIBP Module)
IEC 80601-2-61:2011 (Pulse oximeter equipment - SpO2)	The nonclinical tests demonstrated the proposed device complies with this standard. (Note: SpO2 modules used were previously cleared under K052186 for Nellcor SpO2 Module, K101896 for MASIMO SpO2 Module, and K153135 for BLT SpO2 Module)
ISO 80601-2-55:2011 (Respiratory gas monitors - CO2)	The nonclinical tests demonstrated the proposed device complies with this standard. (Note: CO2 module used was previously cleared under K153135)
ISO 80601-2-56:2009 (Clinical thermometers for body temperature measurement)	The nonclinical tests demonstrated the proposed device complies with this standard. (Note: Temperature module used was previously cleared under K153135)
Wireless Coexistence
ANSI C63.27-2017 (Evaluation of Wireless Coexistence)	The nonclinical tests demonstrated the proposed device complies with this standard.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of this 510(k). No new clinical data or human subject test sets were used. The "tests" referred to are non-clinical (engineering and performance assessment against standards) and rely on the prior clearances of the individual modules.
Data Provenance: Not applicable for the reasons above.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No "ground truth" established by experts for a test set for this new device. The compliance with standards is assessed through engineering tests.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is a patient monitor, not an AI-assisted diagnostic tool involving "human readers" or image interpretation. Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This device is a patient monitor, which relies on sensors and processing algorithms to measure and display physiological parameters. While it contains algorithms, the submission doesn't detail their standalone performance in terms of "algorithm only" studies as would be seen for a complex AI diagnostic system. The performance is assessed by the device's ability to accurately measure and display parameters according to established medical device standards. The "standalone" performance is integrated into the compliance testing against the IEC/ISO standards mentioned above.

7. The type of ground truth used

The "ground truth" in this context is defined by the established performance requirements and test methodologies outlined in the referenced IEC and ISO standards (e.g., accuracy requirements for NIBP, SpO2, CO2, Temp as defined in their respective standards). Compliance ensures the device's measurements are consistent with these industry-accepted benchmarks. For the previously cleared modules, their "ground truth" would have been established during their initial clearance process, likely through comparison to highly accurate reference methods or clinical data as appropriate for each module.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This document does not describe the development of a novel algorithm requiring a training set in the AI sense. The device integrates previously cleared modules.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable for the reasons mentioned above.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K181919

Device Name Patient Monitor Model: V9

Indications for Use (Describe)

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)

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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
1. 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

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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

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
------------------------------------	--	--

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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.

1. 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.
1. Identification of Predicate Device
  Predicate Device 510(k) Number: K153135 Product Name: V6 Vital Signs Monitor

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8. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate DeviceVital 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 beused for monitoring, displaying,reviewing, storing and alarming ofmultiple physiological parameters ofpatients, including Pulse OxygenSaturation (SpO2), Pulse Rate (PR),Non-invasive Blood Pressure (NIBP),Carbon dioxide (CO2) and Temperature(Temp).V9 Patient Monitor is used to monitorvital signals for patients and is intendedto be used in controlled, hospitalenvironments. It is applicable for adult,pediatric and neonatal patients. It is notintended for helicopter transport,hospital ambulance or home use.	The vital signs monitor is intended to beused for monitoring, displaying, reviewing,storing and alarming of multiplephysiological parameters of patients,including Pulse Oxygen Saturation (SpO2),Pulse Rate (PR), Non-invasive BloodPressure (NIBP), Carbon dioxide (CO2)and Temperature (Temp).This vital signs monitor is used to monitorvital signals for patients and is suitable foruse in hospital environments includingout-patient department, wards and NICU. Itis not intended for helicopter transport,hospital ambulance or home use. And it isapplicable for adult, pediatric and neonatalpatients.
Intended Population	The monitors are intended for adult,pediatric and neonatal.	The monitors are intended for adult,pediatric and neonatal.
IntendedEnvironment	The V9 Patient Monitor is used to beused in hospital environments includingout-patient outpatient departments,wards and NICU. It is not intended forhelicopter transport, hospital ambulanceor home use.	The vital signs monitor is used to be usedin hospital environments includingout-patient outpatient departments, wardsand NICU. It is not intended for helicoptertransport, hospital ambulance or home use.
Power Supply	The monitors can be supplied by ACpower.	The monitors can be supplied by ACpower.
Number of Patientbe monitored eachtime	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 MasimoComply with IEC 80601-2-61	BLT and NellcorComply with IEC 80601-2-61
	NIBP Module	BLT and SuntechComply 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 ContactAccessories	SpO2 Sensor, NIBP cuff, CO2 Sensorand Temp Sensor	SpO2 Sensor, NIBP cuff, CO2 Sensor andTemp Sensor
	Biocompatibility	All the patient contact accessories werepreviously cleared by FDA

Table 2 Substantially Equivalent Comparison

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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.

Regulation Number and Section

§ 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).