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.

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

AI/ML Overview

The document describes a 510(k) premarket notification for the V6 Vital Signs Monitor. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of AI/ML devices.

Therefore, many of the requested categories for acceptance criteria and study details for an AI-powered device are not applicable to this submission. This document describes a traditional medical device (vital signs monitor) which is evaluated based on its compliance with established electrical safety, EMC, and performance standards for each physiological parameter.

Here's an analysis based on the provided document, highlighting applicable information and noting where information for AI/ML performance would typically be found but isn't present here:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of the proposed device (Vital Signs Monitor V6) and its predicate devices, especially regarding technical specifications and compliance with standards. It does not present specific "accepted criteria" in terms of performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/ML diagnostic or assistive device. Instead, it demonstrates compliance with recognized medical device standards and equivalence to a predicate.

For the newly added F3000 Temperature Module, a "Clinical Electronic Thermometers testing" was conducted pursuant to guidance. The table below focuses on the reported accuracy of the temperature measurement, which can be interpreted as a performance metric for that specific function.

Parameter	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed Device)
Temperature (Accuracy)
Monitor mode	±0.1°C	≤±0.1°C
Predictive mode	±0.1°C	≤±0.1°C
Quick mode	±0.3°C (Quick Predictive Mode)	±0.2°C
Temperature (Response Time)
Predictive Mode	Oral (Predictive Mode): 6~10 seconds	≤10 seconds
Monitoring Mode (all sites)	Monitoring Mode (all sites): 60~120 seconds	120~180 seconds
General	Compliance with specified standards	Compliance with specified standards (IEC 60601-1, IEC 60601-1-2, etc.)
Measurement range	30 to 42°C	30 to 42°C
Resolution	0.1°C	0.1°C
Unit	°C, °F	°C
Update time	Every 1s	Every 1s
Self-checking	Every 3s	Every 3s

Note: The "acceptance criteria" here are largely derived from the predicate device's performance or standard requirements that both devices are expected to meet. For NIBP, SpO2, and CO2, the document only states that compliance with relevant IEC standards (IEC80601-2-30 for NIBP, IEC80601-2-61 for pulse oximeter) was demonstrated, but does not provide specific accuracy ranges within the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "No clinical study is included in this submission." This implies that for the substantial equivalence claim, the manufacturer relied on non-clinical testing and comparison to the predicate device, rather than a clinical study with a dedicated test set on human subjects to evaluate performance like sensitivity or specificity. For the temperature module, it mentions "Clinical Electronic Thermometers testing" but does not detail sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no clinical study data presented for expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. There is no clinical study data presented requiring adjudication.

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

Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers.

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

The device is a standalone vital signs monitor. Its "performance" is evaluated by its ability to accurately measure physiological parameters and comply with relevant international standards. The non-clinical tests mentioned demonstrate the device's standalone performance in meeting design specifications and standard requirements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests and equivalence claims of the vital signs monitor, the "ground truth" would be established by:

Reference instruments and calibration standards for objective measurements (e.g., for SpO2, NIBP, temperature).
Compliance with the technical requirements and performance specifications outlined in international standards (e.g., IEC 60601 series, IEC80601 series).

For the temperature module, "Clinical Electronic Thermometers testing" likely involved comparison to highly accurate reference thermometers in a controlled clinical setting, but specific details are not provided.

8. The sample size for the training set

Not applicable. This device does not appear to involve an AI/ML algorithm that would require a "training set" in the conventional sense for a diagnostic product. Its functionality is based on established hardware and software algorithms for physiological parameter measurement rather than machine learning on a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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

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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)

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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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 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 V6K113833
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	NIBPSpO2CO2Quick Temp	NIBPSpO2CO2Infrared temp
Sterile	N/A	N/A
Single Use	N/A	N/A
Biocompatibility	ISO 10993-1 ISO 10993-5ISO 10993-10	ISO 10993-1 ISO 10993-5ISO 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°CQuick mode: ±0.2°C	Monitoring Mode andPredictive mode: ±0.1°CQuick Predictive Mode:±0.3°C
Response time	Predictive Mode: ≤10 secondsMonitoring Mode(all sites):120~180 seconds	Oral(Quick PredictiveMode):3~~5seconds(non-fever temps);8~~10 seconds (fever temps)Oral(Predictive Mode):6~~10secondsAxillary:8~~12 secondsRectal:10~~14 secondsMonitoring Mode(allsites):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.

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).