CMS-2000 Central Monitoring System

K172966 · Advanced Instumentations, Inc. · MHX · Dec 8, 2017 · Cardiovascular

Device Facts

• Record ID: K172966
• Device Name: CMS-2000 Central Monitoring System
• Applicant: Advanced Instumentations, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Dec 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CMS-2000 Central Monitoring System provides centralized monitoring and critical care management for patients monitored by bedside monitors. From the CMS-2000, clinicians can gain access to patient information for patients on the Network. The CMS-2000 displays waveforms, parameters and alarm status of bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.

Device Story

CMS-2000 Central Monitoring System; software-based platform running on Windows XP/7. Inputs: physiological waveforms, parameters, and alarm data from bedside monitors via network protocol. Operation: collects, displays, and archives patient data; enables bidirectional control of bedside monitors (alarm limits, NIBP measurements). Output: centralized display of up to 32-64 patients; printed reports; historical data review. Used in clinical settings by healthcare providers for critical care management. Benefits: enables remote oversight of multiple patients, facilitating timely clinical response to alarm status and parameter changes.

Clinical Evidence

No clinical data; bench testing only. Quality assurance included software testing, risk analysis, safety testing, and performance testing.

Technological Characteristics

Software-based system; PC platform (Windows XP/7). Connectivity: hospital LAN, HL7 support. Features: bidirectional control, multi-patient display (up to 64), trend/waveform/alarm storage. No specific hardware materials or sterilization required as it is a software-based monitoring system.

Indications for Use

Indicated for centralized monitoring and critical care management of patients connected to bedside monitors in a clinical network environment.

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

• EDAN Central Monitoring System, model MFM-CMS (K120727)

Submission Summary (Full Text)

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December 8, 2017

Advanced Instrumentations, Inc. Jorge Millan Regulatory Affairs Manager 6800 NW 77th. Ct. Miami. Florida 33166

Re: K172966

Trade/Device Name: CMS-2000 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: August 22, 2017 Received: September 26, 2017

Dear Jorge Millan:

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. Iisting 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 of medical device-related adverse events) (21 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.

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

M.A. Wilhelm

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K172966

Device Name

CMS-2000 Central Monitoring System

Indications for Use (Describe)

The CMS-2000 Central Monitoring System provides centralized monitoring and critical care management for patients monitored by bedside monitors. From the CMS-2000, clinicians can gain access to patient information for patients on the Network. The CMS-2000 displays waveforms, parameters and alarm status of bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.

본 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510K SUMMARY

CMS-2000 Central Monitoring System

ADVANCED INSTRUMENTATIONS, INC SUBMITTER 6800 NW 77th Ct, Miami, FL 33166 Phone: [phone]

US AGENT JORGE MILLAN, PHD REGULATORY AFFAIRS CORRESPONDENT Email: [e-mail] Web: https://www.sigmabiomedical.com

#### DEVICE NAME AND CLASSIFICATION

| TRADE NAME: | CMS-2000 Central Monitoring System |
|-------------------------------------------|-----------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | 870.1025 monitor, physiological, patient (with arrhythmia<br>detection or alarms) |
| | Product Code: MHX |
| REGULATORY CLASS:<br>PANEL IDENTIFICATION | Class II<br>Cardiovascular |

#### DEVICE DESCRIPTION

The CMS-2000 Central Monitoring System is a software production, which runs on a PC platform running under the Microsoft Windows XP or Windows 7 operating system. Through specified protocol, one CMS-2000 can connect with multi-monitors from ADVANCED INSTRUMENTATIONS to collect patients' information and monitoring data such as physiological waveforms, physiological parameters and alarms. The CMS-2000 can also send bidirectional control instruction to bedside monitors to change patients' information, alarm limits and conduct NIBP measurements. The bedside Patient Physiological Monitors have been cleared by the FDA under K123048 separately. The monitoring information collected by the CMS-2000 can be saved and printed. At the same time, the old records can be searched conveniently and quickly.

Indications for Use: The CMS-2000 Central Monitoring System provides centralized monitoring and critical care management for patients monitored by bedside monitors. From the CMS-2000, clinicians can gain access to patient information for patients on the Network. The CMS-2000 displays waveforms, parameters and alarm status of bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.

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Predicate Devices: The CMS-2000 Central Monitoring System is equivalent to the EDAN Central Monitoring System, model MFM-CMS cleared under K120727.

#### Comparison with the Predicate Devices [21 CFR 807.92(a) (6)]

The CMS-2000 Central Monitoring System is comparable with and substantially equivalent to the EDAN Central Monitoring System, model MFM-CMS cleared under K120727. Compared with the MFM-CMS the Subject Device CMS-2000 has the same intended uses and functionality.

# Technical Characteristics Comparison:

The basic and main technical features of the subject device CMS-2000 are the same as the predicated device MFM-CMS including Design, Operation Controls, Display Modes and performance results. Table 1 provides the comparison of features and functionality:

| ITEM | PROPOSED DEVICE | PREDICATE DEVICE |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CMS-2000<br>K# TBD | MFM-CMS<br>K120727 |
| PRODUCT CODE | MHX | MHX |
| REGULATION NO. | 870.1025 | 870.1025 |
| CLASS | II | II |
| INTENDED USE | The CMS-2000 Central<br>Monitoring System provides<br>centralized monitoring and<br>critical care management for<br>patients monitored by<br>bedside monitors. From the<br>CMS-2000, clinicians can gain<br>access to patient information<br>for patients on the Network.<br>The CMS-2000 displays<br>waveforms, parameters and<br>alarm status of bedside<br>monitors for up to 32 patients<br>on a single screen or up to 64<br>patients using two screens. | The MFM-CMS Central<br>Monitoring System provides<br>centralized monitoring and<br>critical care management for<br>patients monitored by<br>bedside monitors. From the<br>MFM-CMS clinicians can gain<br>access to patient information<br>for patients on the Network.<br>The MFM-CMS displays<br>waveforms, parameters and<br>alarm status of bedside<br>monitors for up to 32<br>patients on a single screen<br>or up to 64 patients using<br>two screens. |
| WAVEFORMS | 2 ECG Waveforms<br>1 RESP waveform<br>1 PLETH waveform | 2 ECG Waveforms<br>1 RESP waveform<br>1 PLETH waveform |

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| | 8 IBP waveform | 8 IBP waveform | | | |
|-----------------|----------------------------------|--------------------------------|--|--|--|
| | 1 C02 waveform | 1 CO2 waveform | | | |
| | 4 AG waveforms for CO2, 02, | 4 AG waveforms for CO2, 02, | | | |
| | N20 and AA | N20 and AA | | | |
| PARAMETERS | ECG: HR, ST value, PVCs | ECG: HR, ST value, PVCs | | | |
| | RESP: RR | RESP: RR | | | |
| | NIBP: SYS, DIA, MAP | NIBP: SYS, DIA, MAP | | | |
| | SP02: SP02, PR | SP02: SP02, PR | | | |
| | IBP: ART, PA, CVP, RAP, ICP, | IBP: ART, PA, CVP, RAP, ICP, | | | |
| | LAP, P1, P2 (only IBP | LAP, P1, P2 (only IBP | | | |
| | supported by the monitor will | supported by the monitor | | | |
| | be displayed) | will be displayed) | | | |
| | CO2: EtCO2, FiCO2, AwRR | CO2: EtCO2, FiCO2, AwRR | | | |
| | TEMP: T1, T2, TD | TEMP: T1, T2, TD | | | |
| | AG: EtCO2, FiCO2, AwRR, | AG: EtCO2, FiCO2, AwRR, | | | |
| | Et02, FiO2, EtN20, FuN20, | Et02, Fi02, EtN20, FuN20, | | | |
| | HAL/ISO/ENF/SEV/DES: Et, | HAL/ISO/ENF/SEV/DES: Et, | | | |
| | Fi, MAC | Fi, MAC | | | |
| | C.O: C.O., TB | C.O. C.O., TB | | | |
| DISPLAY | The<br>Central<br>Monitoring | The Central<br>Monitoring | | | |
| | supports one or two displays. | supports one or two | | | |
| | It can display up to 32 | displays. It can display up to | | | |
| | bedside monitors on one | 32 bedside monitors on one | | | |
| | and 64<br>bedside<br>display - | display and 64 bedside | | | |
| | displays<br>monitors on two | monitors on two displays | | | |
| | simultaneously | simultaneously | | | |
| RECORD CAPACITY | 240-hour trend data, 72 hour | 240-hour trend<br>data,<br>72 | | | |
| | waveform, 720 alarm events, | hour waveform, 720 alarm | | | |
| | 1~2 hours short trend, 720 | events, 1~2 hours<br>short | | | |
| | group<br>NIBP measurement | 720 group<br>trend,<br>NIBP | | | |
| | for each bedside<br>review | measurement review<br>for | | | |
| | monitor | each bedside monitor | | | |
| CALCULATION | Drug calculation and titration | calculation<br>Drug<br>and | | | |
| | table | titration table | | | |
| REVIEW | information,<br>Print<br>patient | Print patient information, | | | |
| | wave review, alarm review, | wave review, alarm review, | | | |
| | trend review, NIBP review, | trend review, NIBP review, | | | |
| | and drug calculation result | and drug calculation result | | | |
| ALARMS | Audible and visible alarms | Audible and visible alarms | | | |

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| NETWORK/CONNECTIVITY | Web observation in the<br>hospital local area network<br>Bidirectional control<br>HL7 | Web observation in the<br>hospital local area network<br>Bidirectional control<br>HL7 |
|----------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
|----------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|

## Clinical Test:

Clinical testing is not required.

## Non-clinical Test:

The following quality assurance measures were applied to the development of the CMS-2000 System:

- . Software testing
- Risk analysis
- . Safety testing
- Performance test

# Substantially Equivalent Determination

The subject device has similar technology characteristics and has the same intended use, same design principle and same functionality as the predicate device. There are no differences between the devices. In accordance with the 21 CFR Part 807 and based on the information provided in this premarket notification, Advanced Instrumentations concludes that the CMS-2000 Central Monitoring System is substantially equivalent to the predicate device.