Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard vital sign monitoring functionalities.

Therapeutic

No.
This device is for monitoring physiological parameters, not for treating or rehabilitating patients.

Diagnostic

No

Explanation: The device is described as a "vital signs monitor" intended for "monitoring, reviewing, storing and alarming of multiple physiological parameters." It does not provide a diagnosis or help determine the cause of a disease; its function is to track existing physiological states.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as an LCD/LED display, various measurement modules (SpO2, NIBP, CO2, Temp), and a built-in battery, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The vital signs monitor described measures physiological parameters directly from the patient's body (SpO2, PR, NIBP, CO2, Temp). It does not analyze samples taken from the body.
Intended Use: The intended use is for monitoring, reviewing, storing, and alarming of these physiological parameters, not for diagnostic testing of samples.

Therefore, this device falls under the category of a patient monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

MWI

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult, pediatric and neonatal patients.

Intended User / Care Setting

health care professionals.
hospital environments including out-patient department, wards and NICU.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K113833, K003313

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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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
1. Sponsor Identification

Establishment Registration Number: 3007305624

Contact Person: Jin Liang Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang j@blt.com.cn

1. 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: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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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)

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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

1. 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.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device(s) | Predicate Device(s)
Vital Signs Monitor V6
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
SpO2
CO2
Quick Temp | NIBP
SpO2
CO2
Infrared temp |
| Sterile | N/A | N/A |
| Single Use | N/A | N/A |
| Biocompatibility | ISO 10993-1 ISO 10993-5
ISO 10993-10 | ISO 10993-1 ISO 10993-5
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,
Predictive mode: ≤±0.1°C
Quick mode: ±0.2°C | Monitoring Mode and
Predictive mode: ±0.1°C
Quick Predictive Mode:
±0.3°C |
| Response time | Predictive Mode: ≤10 seconds
Monitoring Mode(all sites):
120180 seconds | Oral(Quick Predictive
Mode):35
seconds(non-fever temps);
810 seconds (fever temps)
Oral(Predictive Mode):610
seconds
Axillary:812 seconds
Rectal:1014 seconds
Monitoring Mode(all
sites):60~120 seconds |

Table 1 Comparison of Technology Characteristics(V6)

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Table 2 General Comparison to Filac Fast Temp

1. 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.