Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

Device Description

M6000C central monitoring system software, the risk management object, can central monitor significant vital sign parameters of multi-patients, including ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM. It is connected by network with bedside units and receives data from bedside units. Then, the data are displayed on the screen or recorded or printed as per needs. When the monitored data exceed a set value, the central monitoring system software will start alarm system and gives out alarm to remind doctors and nurses for attention.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct comparison of the device's performance against such criteria. Instead, it focuses on non-clinical testing to verify design specifications and compliance with voluntary standards. The "Performance testing" mentioned is general and doesn't provide specific numerical results or target metrics.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Compatibility	N/A (implied by testing)	Compatible with various bedside monitors
Data Latency	N/A (implied by testing)	Acceptable for the clinical environment
Software Verification	N/A (implied by testing)	Verified and Validated
Risk Management	Compliance with EN ISO 14971:2012	Complies with EN ISO 14971:2012
Usability Engineering	Compliance with IEC 62366:2007	Complies with IEC 62366:2007
Software Lifecycle	Compliance with IEC 62304	Complies with IEC 62304

Detailed Study Information:

A table of acceptance criteria and the reported device performance:
(See table above)
Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "Performance testing" but does not detail the number of test cases, patient data, or scenarios used in these tests.
- Data Provenance: Not specified. It's unclear if the tests used simulated data, existing patient data, or newly acquired data. The country of origin is also not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document describes non-clinical performance and software verification testing, which typically do not involve expert-established ground truth in the same way clinical studies or diagnostic AI algorithms do. The "performance testing" seems to focus on functional verification rather than accuracy against a clinical reference standard.
Adjudication method for the test set:
Not applicable, as no external experts or adjudication process against a ground truth is described for the functional and performance testing.
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:
No. The submission explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in a sense. The described "Performance testing" and "Software verification and validation testing" are evaluations of the device (software) itself, without direct human-in-the-loop involvement in the performance assessment against a clinical outcome. These tests confirm the software's functionality, compatibility, and data processing capabilities, rather than its diagnostic or interpretative accuracy in a clinical context.
The type of ground truth used:
Not explicitly stated as "ground truth" in the diagnostic sense. For the functional and performance tests, the "ground truth" would be the expected behavior or output of the software and system based on its design specifications and standard requirements. For example, for data latency, the ground truth would be the defined acceptable latency rate. For compatibility, it would be successful communication with specified bedside monitors.
The sample size for the training set:
Not applicable. This device is a Central Monitoring System, which collects, stores, displays, and alarms vital sign information. It is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. It performs rule-based monitoring and alarm generation.
How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of monitoring system.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

Re: K170514

Trade/Device Name: M6000C Central Monitoring System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX Dated: February 14, 2017 Received: February 21, 2017

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.

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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 devicerelated 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,

M.A. Hillemann

for

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) K170514

Device Name M6000C Central Monitoring System

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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Tab #6 510(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: K170514

1. Date of Preparation: 05/04/2017
1. Sponsor Identification Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technology Innovation Coast, Hi-Tech Zone, Zhuhai, Guangdong, 519085, P.R. China

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) Ms. Cindy Wang (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
1. Identification of Proposed Device Trade Name: Central Monitoring System Common Name: Central Monitoring System Model(s): M6000C Regulatory Information Classification Name: Perinatal monitoring system and accessories Classification: II; Product Code: MHX; Regulation Number: 21 CFR 870.1025; Review Panel: Cardiovascular;

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Intended Use Statement:

Central Monitoring System Software is intended to conduct centralized monitoring of adult, pediatrics and neonatal patient's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. Rate(HR), The monitoring parameters include Electrocardiogram(ECG), Heart Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood (NIBP), Pressure Invasive -Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM) etc. It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

Device Description:

ર. Identification of Predicate Device and Reference Device
Predicate Device 510(k) Number: K120727 Product Name: Central monitoring system Model Name: MFM-CMS

Reference Device 510(k) Number: K153580 Product Name: Central monitoring system Model Name: M6000C

6. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The Central Monitoring System also complies with voluntary standards for medical devices.

The test results demonstrated that the proposed device complies with the following standards:

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EN ISO 14971: 2012 Medical Device Risk Management A
A IEC 62366: 2007 Medical Devices - Application of Usability Engineering to Medical Devices

The following data were provided to support the substantial equivalence determination:

≫ Performance testing was conducted to verify that the Central Monitoring System Software is compatible with various bedside monitors.
Performance testing was conducted to verify that the data latency rates were acceptable for the clinical environment.
≫ Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005)

Please note that the subject is a software only product, EMC and Electrical Safety Evaluation are not required.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

ITEM	Proposed DeviceCentral Monitoring SystemTruscope CNS	Predicate Device
ProductCode	MHX	MHX
RegulationNo.	870.1025	870.1025
Class	II	II
IntendedUse	Central Monitoring SystemSoftware is intended to conductcentralized monitoring of adult,pediatrics and neonatal patient'svital sign information fromcompatible bedside monitors. Thesoftware collects, stores, displaysand alarms the informationprovided on the bedside monitor.The monitoring parameters includeElectrocardiogram(ECG), HeartRate(HR), Respiration(RESP),	MFM-CMS provided centralizedmonitoring and critical caremanagement for patientsmonitored by EDAN bedsidemonitors, From MFM-CMS,clinicians can gain access topatient information from patientson the Network. MFM-CMSdisplay waveforms , parametersand alarm status of EDAN bedsidemonitors for up to 32 patients on asingle screen or up to 64 patients

	Pulse Oxygen Saturation(SpO2),Pulse Rate(PR), Non-invasiveBlood Pressure (NIBP), InvasiveBlood Pressure(IBP), ImpedanceCardiograph(ICG),TEMP(Temperature), Carbondioxide (CO2), Anesthetic Gas(AG), Fetal Heart Rate (FHR),Uterine contraction (TOCO) andFetal Movement (FM) etc. It isintended to be used in the hospitalor medical institutions, and it is notintended for home use.	using two screens
Network	Wired and Wireless	Wired and wireless
Display	Patient demography data, andnotes.Providing the means to displaymultiple beds simultaneously.	Waveforms and notesProviding the means to displaymultiple beds simultaneously
Print	Print Patient's monitoring records	Print Patient's monitoring records
Archive	Providing the ability to archivefiles to a secondary or tertiarystorage medium (i.e. optical disk).Providing automatic archiving ofthe data.	Providing the ability to archivefiles to a secondary or tertiarystorage medium (i.e. optical disk).Providing automatic archiving ofthe data.
Alarm	Visual alerts of out-of-limit data	Visual alerts of out-of-limit data
Electronicpatientrecord	Easy interfacing with any ITpatient record system for dataacquisition, viewing and storage ofelectronic patient record.	Easy interfacing with any ITpatient record system for dataacquisition, viewing and storage ofelectronic patient record.
Notes	Providing the user the ability toenter comments and specific data.	Providing the user the ability toenter comments and specific data.
CompliedStandard	IEC 62304	IEC 62304

Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison of Technology Characteristics

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9. 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

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.