Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet).

The arrhythmia detection, ST segment analysis only applied to a single adult patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician.

It is not intended for helicopter transport, hospital ambulance, or home use.

Device Description

The Patient Monitors consist of two parts, which are host units and function modules.

The host units of Any View A Series Patient Monitors are available in four modules, which are Any View A3, AnyView A5, Any View A6 and AnyView A8, The units, themselves, did NOT collect any physiological data from the patient, which are collected by function modules and transmitted to the host unit. They shall be worked with the basic function module, EMS or MPS.

The host units of Q Series Patient Monitors are available in six modules, which are Q2, Q3, Q6 and Q7. These host units could complete the measurement of ECG, RESP, TEMP, SpO2, NIBP and IBP.

In addition, there are several extended function modules, which could be connected with the host units to complete the measurement functions, including TEMP, CO2 Mainstream, CO2 Sidestream, SpO2 Nellcor, SpO2 Masimo, AG Mainstream, AG Sidestream, ICG and CSM (CSI).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

Acceptance Criteria and Device Performance

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing specific performance metrics against pre-defined numerical clinical acceptance criteria. The acceptance criteria are primarily based on compliance with recognized medical device standards and qualitative comparison to a predicate device.

Acceptance Criteria Category	Reported Device Performance (Proposed Device)
Safety	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2
Performance - Cardiac Monitors	Complies with AAMI EC13
Performance - Sphygmomanometers	Complies with AAMI SP10
Performance - Pulse Oximeters	Complies with ISO 9919
Performance - Alarms	Complies with IEC 60601-1-8
Product Code	MWI
Regulation Number	870.2300
Subsequent Product Codes	DSI / MLD / DRT / DXN / DSK / FLL / DQA / CCK / CBQ / CBS / CBR / CCL / GWQ / DSB
Intended Use	Patient monitors for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG (3/5/12-lead), arrhythmia detection, ST segment analysis, HR, RESP, TEMP, SpO2, PR, NIBP, IBP, CO2, AG, ICG, CSI, BIS, SpHb, SpCO, SpMet. Arrhythmia detection and ST segment analysis for single adult patients only. For use in healthcare facilities by clinical physicians or appropriate medical staff under physician's direction. Not for helicopter transport, hospital ambulance, or home use.
Sterile	No
Single Use	No
Energy Source	AC Power / DC Power

"Study" Information (Non-Clinical Test Conclusion)

The document primarily describes non-clinical tests to verify compliance with design specifications and demonstrate substantial equivalence, rather than a clinical study with a test set of patient data and expert ground truth.

Sample size used for the test set and the data provenance: Not applicable in the context of a clinical study. The document refers to "non clinical tests" and compliance with standards. It does not mention a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set of patient data is not mentioned as the study is non-clinical.
Adjudication method for the test set: Not applicable. There is no mention of a test set requiring adjudication.
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 patient monitor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the traditional sense of an AI algorithm. The performance evaluation is based on the device's ability to accurately measure physiological parameters and comply with industry standards, which inherently means its "standalone" performance for collecting and displaying data.
The type of ground truth used:
- For safety and EMC: Compliance with international and national standards (IEC 60601-1, IEC 60601-1-2).
- For performance of specific physiological measurements: Compliance with specific standards like AAMI EC13 (cardiac monitors), AAMI SP10 (sphygmomanometers), and ISO 9919 (pulse oximeters). These standards typically define accuracy requirements against known calibration sources or reference methods.
The sample size for the training set: Not applicable. This document does not describe a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Overall Conclusion from the Document:

The proposed device (A Series / Q Series Patient Monitors) was determined to be Substantially Equivalent (SE) to the predicate devices based on non-clinical tests demonstrating compliance with recognized safety and performance standards. The comparison focused on intended use, technological characteristics, and principles of operation.

Summary

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FEB 1 8 2014

K131898; Page 1 of 5

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 Title 21, CFR Section 807.92.

The assigned 510(k) Number: _ K131898

l. Date of Submission: 12/30/2013
1. Sponsor Identification

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Ms. Liang, Jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang_j@blt.com.cn

1. Submission Correspondent
  Ms. Diana Hong& Mr. Lee Fu 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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K 131898; page 2 of 5

4. Proposed Device Identification

Proposed Device Name: Patient Monitors

Proposed Device Common Name: AnyView A8, AnyView A6, AnyView A5, AnyView A3, Q2, Q3, Q4, Q5, Q6 and Q7

Classification:

Regulation No.	Classification Name	Product Code	Device Class
Main Code
21 CFR 870.2300	Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)	MWI	Class II
Subsequent Product Codes
21 CFR 870.1025	Detector and Alarm, Arrhythmia	DSI	Class II
21 CFR 870.1025	Monitor, ST Segment with Alarm	MLD	Class II
21 CFR 870.2300	Cardiac monitor (including cardiotachometer and alarm)	DRT	Class II
21 CFR 870.1130	Non-invasive blood pressure measurement system	DXN	Class II
21 CFR 870.1113	Blood pressure computer	DSK	Class II
21 CFR 880.2910	Clinical Electronic Thermometers - Temperature Monitor with Probe	FLL	Class II
21 CFR 870.2700	Oximeter, Pulse	DQA	Class II
21 CFR 868.1400	Carbon Dioxide Gas Analyzer	CCK	Class II
21 CFR 868.1500	Enflurane gas analyzer	CBQ	Class II
21 CFR 868.1620	Halothane gas analyzer	CBS	Class II
21 CFR 868.1700	Nitrous Oxide gas analyzer	CBR	Class II
21 CFR 868.1720	Oxygen gas analyszer	CCL	Class II
21 CFR 882.1400	Electroencephalograph	GWQ	Class II
21 CFR 870.2770	Impedance plethysmograph	DSB	Class II

Intended Use Statement:

Patient monitors are intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG (3-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (RESP), Temperature (TESP), Temperature (TEMP), Pulse Oxygen Saturation (SpOz), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood

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K131898; page 3 of 5

Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO) and Methemoglobin(SpMet).

The arrhythmia detection, ST segment analysis only applied to a single adult patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

1. Predicate Device Identification
  Predicate Device 1 510(k) Number: K120193 Product Name: Any View Patient Monitors Manufacturer: Guangdong Biolight Meditech Co., Ltd

Predicate Device 2 510(k) Number: K072286 Product Name: Aspect Medical Systems BIS EEG VISTA Monitor System Manufacturer: Aspect Medical Systems, Inc.

1. Device Description
  The Patient Monitors consist of two parts, which are host units and function modules.

The host units of Q Series Patient Monitors are available in six modules, which are Q2, Q3, Q6 and Q7. These host units could complete the measurement of ECG, RESP, TEMP, SpO2, NIBP and IBP.

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K131898; page 4 of 5

7. 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, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; a) Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General Requirements for Safety b) Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
c) AAMI EC13:2002, Cardiac monitors, heart rate meters, and alarms;
AAMI SP10:2002/ A1:2003 (R) 2008, Manual, electronic or automated sphygmomanometers; d)
ISO 9919:2005, Medical electrical equipment Particular requirements for the basic safety and e) essential performance of pulse oximeter equipment for medical use;
Substantially Equivalent (SE) Conclusion 8.

The following table compares the A Series / Q Series Patient Monitors to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device(s)	Predicate Device(s)
Product Code	MWI	MWI
Regulation Number	870.2300	870.2300
Subsequent Product Code	DSI / MLD / DRT / DXN / DSK / FLL / DQA / CCK / CBQ / CBS / CBR / CCL / GWQ / DSB	DSI / MLD / DRT / DXN / DSK / FLL / DQA / CCK / CBQ / CBS / CBR / CCL/ GWQ / DSB
Intended Use	Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation(SpO2), Pulse Rate (PR), Non-invasive Blood Pressure	The AnyView series patient monitors including models AnyView A8, AnyView A6, AnyView A5 and AnyView A3 are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR)

Table 3-1 Comparison of Technology Characteristics

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(NIBP), Invasive Blood Pressure (IBP),Carbon dioxide (CO2), Anesthetic Gas(AG), Impedance Cardiograph (ICG),Cerebral State Index (CSI), BispectralIndex (BIS), Total Hemoglobin(SpHb),Carboxyhemoglobin (SpCO), andMethemoglobin(SpMet), The arrhythmiadetection, ST segment analysis is onlyapplied to a single adult patient.The monitors are to be used in healthcarefacilities by clinical physicians orappropriate medical staff under thedirection of physician. It is not intendedfor helicopter transport, hospitalambulance, or home use.	Respiration Rate (RESP), Temperature(TEMP), Pulse OxygenSaturation(SpO2), Pulse Rate (PR),Non-invasive Blood Pressure (NIBP),Invasive Blood Pressure (IBP), Carbondioxide (CO2), Anesthetic Gas (AG),Impedance Cardiograph (ICG) andCerebral State Index (CSI).The arrhythmia detection, ST segmentanalysis is only applied to a single adultpatient.The monitors are to be used inhealthcare facilities by clinicalphysicians or appropriate medical staffunder the direction of physician. It isnot intended for helicopter transport,hospital ambulance, or home use.
Sterile	No	No
Single Use	No	No
Energy Source	AC Power / DC Power	AC Power / DC Power
Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Performance	Comply with AAMI EC13Comply with AAMI SP10Comply with ISO 9919Comply with IEC 60601-1-8	Comply with AAMI EC13Comply with AAMI SP10Comply with ISO 9919Comply with IEC 60601-1-8

The proposed devices, A Series / Q Series Patient Monitors, AnyView A8, AnyView A6, AnyView A5, AnyView A3, Q2, Q3, Q4, Q5, Q6 and Q7, are determined to be Substantially Equivalent (SE) to the predicate devices, as identified above.

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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

February 18, 2014

Guangdong Biolight Meditech Co., Ltd. C/O Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai, 200120 CH

Re: K131898

Trade/Device Name: A series and O Series Patient Monitors Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (Without Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MWI Dated: January 3, 2014 Received: January 8, 2014

Dear Ms. 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.

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Page 2 - Ms. Diana Hong

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) (2) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Owen P. Earis -S

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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K131898 Page 1 of 1

Indications for Use

510(k) Number (if known):

Patient Monitors Device Name:

.. . . . . ....

Indications for Use: Patient monitors are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral State Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), and Methemoglobin(SpMet).

The arrhythmia detection, ST segment analysis only applied to a single adult patient.

The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician.

It is not intended for helicopter transport, hospital ambulance, or home use,

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

x Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use: (21 CFR 807 Subpart C)

Cwer Z.

Digitally signed by Owen P. e: 2014.02.18 13:29:35

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).