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 Description

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 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 Sathemoglobin 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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Standard Reference)	Reported Device Performance (Vital Signs Monitor V6)
Temperature Measurement	ASTM E1965-98 (reapproved 2009)	Device complies with ASTM E1965-98

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not explicitly state the specific sample size used for the clinical test of the Vital Signs Monitor V6. It only mentions that the clinical test was conducted "per ASTM E1965-98(reapproved 2009)."
Data Provenance: The clinical test was conducted in People's Hospital in Zhuhai, indicating the data is from China. The document does not specify whether the data was retrospective or prospective, but clinical tests are typically prospective studies.

3. Number of Experts and their Qualifications for Ground Truth

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the temperature measurement test. For a clinical study following ASTM E1965-98, ground truth usually relies on highly accurate reference thermometers used by trained clinical personnel, but specific details are not provided here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device performance against a standard, not on human reader improvement with AI.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done for the temperature measurement of the Vital Signs Monitor V6. The clinical test evaluated the device's performance against the ASTM E1965-98 standard. This standard typically defines the accuracy requirements for infrared thermometers, meaning the device's temperature measurement algorithm and hardware were tested as a standalone system.

7. Type of Ground Truth Used

The ground truth for the temperature measurement test would have been established by comparing the device's readings to those of a highly accurate reference thermometer as mandated by the ASTM E1965-98 standard. This is a form of empirical measurement comparison against a validated reference.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of device (vital signs monitor for temperature) typically undergoes calibration and validation against standards rather than machine learning-style training using a distinct training set.

9. How Ground Truth for the Training Set Was Established

As no training set is described, there is no information on how its ground truth was established.

Summary

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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
1. 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: +86-756-3399963 Fax: +86-756-3399989 Email: li tb@blt.com.cn

1. Submission Correspondent Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
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:

ProductCode	RegulationNumber	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:

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:

ProductCode	RegulationNumber	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:

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and Temperature (Temp).

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 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 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.
1. 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.

1. 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 (800) 638-2041 or (301) 796-7100 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:

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

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

Page 1 of 2

(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:

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)

Page 2 of 2

rdiovascular Devices

510(k) Number: K113833

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).