Central Monitoring System

K170514 · Guangdong Biolight Meditech Co., Ltd. · MHX · May 24, 2017 · Cardiovascular

Device Facts

• Record ID: K170514
• Device Name: Central Monitoring System
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: MHX · Cardiovascular
• Decision Date: May 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

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 Story

M6000C Central Monitoring System is software-only device for centralized patient monitoring; collects, stores, displays, and alarms vital sign data received via network from compatible bedside monitors. Inputs include ECG/HR, RESP, SpO2, PR, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO, and FM. System displays waveforms and parameters for multiple patients simultaneously; triggers visual/audible alarms when data exceeds set thresholds. Used in hospitals/medical institutions by clinicians (doctors/nurses) to facilitate patient management. Output allows clinicians to view real-time patient status, review historical records, and enter notes. Benefits include centralized oversight of multiple patients, enabling timely clinical intervention for out-of-limit vital signs.

Clinical Evidence

No clinical study is included in this submission. Evidence consists of bench testing, including performance testing for compatibility with various bedside monitors and data latency verification, and software verification and validation testing per FDA guidance.

Technological Characteristics

Software-only device; operates on networked hardware. Connectivity via wired and wireless networks. Complies with IEC 62304 (software lifecycle), EN ISO 14971 (risk management), and IEC 62366 (usability). Features include multi-patient display, alarm management, data archiving, and electronic patient record interfacing.

Indications for Use

Indicated for centralized monitoring of vital signs in adult, pediatric, and neonatal patients in hospital or medical institutional settings. Parameters include ECG, HR, RESP, SpO2, PR, NIBP, IBP, ICG, TEMP, CO2, AG, FHR, TOCO, and FM. Not for home use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MFM-CMS (K120727)

Reference Devices

• M6000C (K153580)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone], Fax: [phone] Email: [e-mail]

- 4. 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:

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.

- 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.

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

| ITEM | Proposed Device<br>Central Monitoring System<br>Truscope CNS | Predicate Device |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | MHX | MHX |
| Regulation<br>No. | 870.1025 | 870.1025 |
| Class | II | II |
| Intended<br>Use | Central Monitoring System<br>Software is intended to conduct<br>centralized monitoring of adult,<br>pediatrics and neonatal patient's<br>vital sign information from<br>compatible bedside monitors. The<br>software collects, stores, displays<br>and alarms the information<br>provided on the bedside monitor.<br>The monitoring parameters include<br>Electrocardiogram(ECG), Heart<br>Rate(HR), Respiration(RESP), | MFM-CMS provided centralized<br>monitoring and critical care<br>management for patients<br>monitored by EDAN bedside<br>monitors, From MFM-CMS,<br>clinicians can gain access to<br>patient information from patients<br>on the Network. MFM-CMS<br>display waveforms , parameters<br>and alarm status of EDAN bedside<br>monitors for up to 32 patients on a<br>single screen or up to 64 patients |
| | | |
| | Pulse Oxygen Saturation(SpO2),<br>Pulse Rate(PR), Non-invasive<br>Blood Pressure (NIBP), Invasive<br>Blood Pressure(IBP), Impedance<br>Cardiograph(ICG),<br>TEMP(Temperature), Carbon<br>dioxide (CO2), Anesthetic Gas<br>(AG), Fetal Heart Rate (FHR),<br>Uterine contraction (TOCO) and<br>Fetal Movement (FM) etc. It is<br>intended to be used in the hospital<br>or medical institutions, and it is not<br>intended for home use. | using two screens |
| Network | Wired and Wireless | Wired and wireless |
| Display | Patient demography data, and<br>notes.<br>Providing the means to display<br>multiple beds simultaneously. | Waveforms and notes<br>Providing the means to display<br>multiple beds simultaneously |
| Print | Print Patient's monitoring records | Print Patient's monitoring records |
| Archive | Providing the ability to archive<br>files to a secondary or tertiary<br>storage medium (i.e. optical disk).<br>Providing automatic archiving of<br>the data. | Providing the ability to archive<br>files to a secondary or tertiary<br>storage medium (i.e. optical disk).<br>Providing automatic archiving of<br>the data. |
| Alarm | Visual alerts of out-of-limit data | Visual alerts of out-of-limit data |
| Electronic<br>patient<br>record | Easy interfacing with any IT<br>patient record system for data<br>acquisition, viewing and storage of<br>electronic patient record. | Easy interfacing with any IT<br>patient record system for data<br>acquisition, viewing and storage of<br>electronic patient record. |
| Notes | Providing the user the ability to<br>enter comments and specific data. | Providing the user the ability to<br>enter comments and specific data. |
| Complied<br>Standard | 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.