Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The 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). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

Device Description

The Central Monitoring System Software-only device that is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors connected by a wired or wireless network. The Central Monitoring System consists of two models: M6000C and Truscope CNS. Both models provide functions including collecting, storing, displaying, and alarming (e.g. when the monitored data exceeds a set value, the device will alarm to alert medical personnel) the information which is received from the bedside monitor(s). Multiple patients can be monitored simultaneously. Parameters monitored include ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria related to a numerical performance target (e.g., sensitivity, specificity, accuracy) for the Central Monitoring System Software, nor does it describe a study that proves the device meets such criteria in terms of clinical performance.

Instead, the document focuses on non-clinical testing to demonstrate:

Compatibility with various bedside monitors.
Acceptable data latency rates for the clinical environment.
Software verification and validation testing, following FDA guidance.
Compliance with voluntary standards (IEC 62366:2007 and IEC 62304:2006).

Therefore, I cannot populate a table of acceptance criteria and reported device performance directly from this text in the way that would typically be done for a diagnostic AI device requiring performance metrics. The information needed for almost all of your specific questions (sample size, data provenance, number of experts, etc.) is also not present because the study described is not a clinical performance study with defined ground truth.

Here's a breakdown based on the information available in the document:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (as implied by document)	Reported Device Performance (as summarized by document)
Software Functionality	Compliance with design specifications.	Met all design specifications.
Compatibility	Compatible with various bedside monitors.	Performance testing confirmed compatibility.
Data Latency	Acceptable data latency rates for the clinical environment.	Performance testing confirmed acceptable data latency rates.
Software Validation	Adherence to FDA guidance for software contained in medical devices.	Software verification and validation testing completed as recommended.
Standards Compliance	Compliance with IEC 62366:2007 (Usability Engineering), IEC 62304:2006 (Software Life Cycle Process).	Tests demonstrated compliance with these standards.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The performance testing mentioned is non-clinical and focuses on system functionality and compatibility rather than clinical data performance.
Data Provenance: Not applicable, as there is no mention of clinical data or patient-specific test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable.
Qualifications: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable.

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

No, an MRMC comparative effectiveness study was not done. The device is a "Central Monitoring System Software" for displaying and alarming vital sign data, not an AI diagnostic tool designed to assist human readers in interpretation.

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

The described tests are for the standalone functionality of the software system (e.g., collecting, storing, displaying, alarming data) and its compatibility, not for an "algorithm only" in the sense of an AI diagnostic prediction. Its function is to operate independently of real-time human interpretation, presenting data from other devices.

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

Type of Ground Truth: For the non-clinical tests, the "ground truth" would be the expected functional behavior and performance defined by the design specifications and relevant standards. For example, for data latency, the ground truth would be the maximum acceptable delay. For compatibility, it would be successful data exchange with target bedside monitors. No clinical ground truth (e.g., pathology, expert consensus on a diagnosis) is relevant or mentioned.

8. The sample size for the training set

Sample Size: Not applicable. There is no mention of a machine learning or AI model being trained, so no training set is described.

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

How Ground Truth Established: Not applicable, as there is no training set described.

In summary: This 510(k) summary focuses on the functional and technical performance of software that collects, displays, and alarms vital sign data from other monitors. It is not an AI diagnostic device that requires clinical performance metrics like sensitivity or specificity derived from interpreting medical images or complex data, and therefore, the types of studies and ground truth requested in questions 2-9 are not applicable to the information provided.

Summary

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

September 7, 2016

Guangdong Biolight Meditech Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200237 CHINA

Re: K153580

Trade/Device Name: Central Monitoring System Software Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: August 5, 2016 Received: August 8, 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

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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 (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.

Douglas Silverstein -S For Division 2016.09.07 15:26:22 -04'00' Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153580

Device Name Central Monitoring System Software

Indications for Use (Describe)

Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECCG), 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). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

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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510(k) Summary

K153580

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation: 09/06/2016
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

Designated Submission Correspondent 3. Ms. Diana Hong (Primary 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 Software Common Name: Central Monitoring System Software Model(s): Truscope CNS/ M6000C

Regulatory Information

Classification Name: Perinatal monitoring system and accessories Classification: Class II Product Code: HGM, system, monitoring, perinatal Regulation Number: 21 CFR 884.2740 Review Panel: Obstetrics/Gynecology

1. Identification of Predicate Device(s)
  510(k) Number: K103172 Product Name: Obstetrical Data Management and Monitoring Software Application Model Name: CIV-OB (PLUS)
Device Description 6.
The Central Monitoring System Software-only device that is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors connected by a wired or wireless network. The Central Monitoring System consists of

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two models: M6000C and Truscope CNS. Both models provide functions including collecting, storing, displaying, and alarming (e.g. when the monitored data exceeds a set value, the device will alarm to alert medical personnel) the information which is received from the bedside monitor(s). Multiple patients can be monitored simultaneously. Parameters monitored include ECG/HR, RESP, SpO2, PULSE, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO and FM.

1. Indications for Use
  Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women's vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The 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). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

8.	Predicate Comparison
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Item	Proposed Device(s)	Predicate Device(s)
Product Code	HGM	HGM
Regulation Number	21 CFR 884.2740	21 CFR 884.2740
Intended Use	Central Monitoring System Software isintended to conduct centralizedantepartum and intrapartummonitoring of pregnant women's vitalsign information from compatiblebedside monitors. The softwarecollects, stores, displays and alarms theinformation provided on the bedsidemonitor. The monitoring parametersinclude Electrocardiogram(ECG),Heart Rate(HR), Respiration(RESP),Pulse Oxygen Saturation(SpO2), PulseRate(PR), Non-invasive BloodPressure (NIBP), Invasive BloodPressure(IBP), ImpedanceCardiograph(ICG),TEMP(Temperature), Carbon dioxide(CO2), Anesthetic Gas (AG), FetalHeart Rate (FHR), Uterine contraction(TOCO) and Fetal Movement (FM). Itis intended to be used in the hospital ormedical institutions, and it is notintended for home use.	The CIVNET CIV-obTM (plus) isa clinical data managing softwareapplication and is indicated forantepartumn and intrapartumnmonitoring of pregnant women in ahealthcare setting.The CIVNET CIV-obT* (plus) isindented to manage perinatalmonitoring data acquired frombedside monitors or manual inputsfor viewing at the central nursingstation. The system also producesan electronic medical record.The CIYNET CIV-ob1~" (plus)has display fields for the followingobstetric data:Monitoring site details Patient demographics, Provider notes, fetal heart rate (FHR), uterine activity(viatocodynamometry or IUP) Head Decent Cervix Dilation
Sterile	Not applicable	Not applicable

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Single Use	Not applicable	Not applicable
Biocompatibility	Not applicable	Not applicable
Networkconnecting tobedside monitor	Wired and Wireless	Wired
Display	Fetal heart rate, TOCO, maternal vitalsigns, patient demographic data, andnotes.Providing the means to displaymultiple beds simultaneously.	Fetal heart rate, TOCO, maternalvital signs, patient demographicdata, and notes.Providing the means to displaymultiple beds simultaneously.
Print	Print (locally or remotely) CTG,patient record	Print (locally or remotely) CTG,patient records s, and CIV-ob TM(plus) data base definition (e.g.item names).
Archive	CTG and maternal vital signs.Providing the ability to archive filesto a secondary or tertiary storagemedium (i.e. optical disk).Providing automatic archiving of thedata.	CTG and maternal vital signs.Providing the ability to archivefiles to a secondary or tertiarystorage medium (i.e. optical disk).Saving data automatically.
Alarm	Visual alerts of fetal/maternal monitorsuch as out-of-limit heart rate or poorsignal quality.	Visual alerts of fetal/maternalmonitor such as out-of-limit heartrate or poor signal quality.
Electronic patientrecord	Easy interfacing with any IT patientrecord system for data acquisition,viewing and storage of electronicpatient record.	Easy interfacing with any ITpatient record system for dataacquisition, viewing and storage ofelectronic patient record.
Notes	Providing the user the ability to entercomments and specific data.	Providing the user the ability toenter comments and specific data.
Remote Access	Review fetal/maternal monitor data	Review fetal/maternal monitor data

Central Monitoring System Software and the predicate device do not have identical indication for use statements; however, they have the same intended use (centralized antepartum and intrapartum monitoring of pregnant women's vital sign information).

In addition, there are differences in the device technological characteristics. The predicate device uses a wired network to connect to the bedside units, while the subject device gives the option of a wired or wireless network. Wireless networks are widely used for various applications. There are also differences in the parameters that the subject device and predicate collect, store, display and alarm. These differences do not raise different questions of safety as compared to the predicate device.

1. Non-Clinical Testing
  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:

IEC 62366: 2007 Medical Devices Application of Usability Engineering to Medical Devices A
IEC 62304: 2006 Medical Device Software Software Life Cycle Process >

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

A Performance testing was conducted to verify that the Central Monitoring System Software is compatible with various bedside monitors.
A Performance testing was conducted to verify that the data latency rates were acceptable for the clinical environment.
A 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)
1. Substantially Equivalent (SE) Conclusion

Based on the comparison and performance data described above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).