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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "CMS-2000 Central Monitoring System." This document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (EDAN Central Monitoring System, model MFM-CMS, K120727).

Therefore, the provided document DOES NOT contain the information needed to answer many of the questions regarding acceptance criteria, study design, and performance for a device that relies on novel AI/ML capabilities.

The CMS-2000 is described as a software product that collects and displays physiological data from bedside monitors. It is a Central Monitoring System, which implies it aggregates and visualizes data rather than performing complex analytical or diagnostic functions that would typically require extensive clinical validation studies with ground truth. The submission explicitly states "Clinical testing is not required." and emphasizes "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." This means the FDA cleared the device based on its similarity to a previously cleared product, not on novel performance claims that would necessitate rigorous testing against specific acceptance criteria.

However, based on the information provided, here's what can be inferred or directly stated:

Acceptance Criteria and Device Performance (Limited Information based on the provided text):

As this submission is for a device establishing substantial equivalence to a predicate, the "acceptance criteria" are implicitly met by demonstrating comparable technical characteristics and intended use. There are no performance metrics provided in the format of a typical AI/ML device study.

Acceptance Criterion (Inferred from Substantial Equivalence)	Reported Device Performance (as stated in the document)
Intended Use Equivalence: The CMS-2000 must perform the same intended use as the predicate device.	"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." (Identical to predicate)
Technical Characteristic Equivalence: The CMS-2000 must have similar technical features, design, operation, and display modes.	Waveforms: 2 ECG, 1 RESP, 1 PLETH, 8 IBP, 1 CO2, 4 AG. (Identical to predicate)
	Parameters: ECG (HR, ST, PVCs), RESP (RR), NIBP (SYS, DIA, MAP), SpO2 (SpO2, PR), IBP (ART, PA, CVP, RAP, ICP, LAP, P1, P2), CO2 (EtCO2, FiCO2, AwRR), TEMP (T1, T2, TD), AG (EtCO2, FiCO2, AwRR, EtO2, FiO2, EtN20, FuN20, HAL/ISO/ENF/SEV/DES: Et, Fi, MAC), C.O. (C.O., TB). (Identical to predicate)
	Display: Supports one or two displays, up to 32 bedside monitors on one, 64 on two. (Identical to predicate)
	Record Capacity: 240-hour trend data, 72 hour waveform, 720 alarm events, 1-2 hours short trend, 720 group NIBP measurement review. (Identical to predicate)
	Calculation: Drug calculation and titration table. (Identical to predicate)
	Review: Print patient information, wave review, alarm review, trend review, NIBP review, drug calculation result. (Identical to predicate)
	Alarms: Audible and visible alarms. (Identical to predicate)
	Network/Connectivity: Web observation in hospital LAN, Bidirectional control, HL7. (Identical to predicate)
Safety and Performance Standards: The device must meet general safety and performance requirements.	Non-clinical tests were applied: Software testing, Risk analysis, Safety testing, Performance test. (No specific numerical results or benchmarks are provided for these tests in the excerpt).

Detailed Study Information (Based on the provided text, many fields are "Not applicable" or "Not provided" as it's a 510(k) based on substantial equivalence, not a de novo AI/ML device):

Sample sizes used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. The document states "Clinical testing is not required." The evaluation was based on comparison to a predicate device's specifications, not a clinical test set.
- Data Provenance: Not applicable. No patient data or clinical test set was described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth was established from experts for a test set, as no clinical testing was deemed necessary for this type of device and submission pathway.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication was used.
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 central monitoring system for displaying already acquired physiological data and alarms from bedside monitors. It is not an AI/ML-driven diagnostic or interpretative tool designed to assist human readers or improve their performance. The submission explicitly highlights that its functionality and intended use are identical to the predicate device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device's "performance" is based on its ability to accurately reflect and transmit data from connected bedside monitors as per its technical specifications, which are compared to the predicate. It does not have a standalone "algorithm" with a specific output requiring a performance study in this context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this 510(k) submission is effectively the technical specifications and performance claims of the legally marketed predicate device. The CMS-2000 demonstrated its functionality matched the predicate's without requiring independent clinical ground truth.
The sample size for the training set:
- Not applicable. This device is described as a "software production" running on a PC, connecting to monitors. It is not presented as an AI/ML device that requires a training set in the contemporary sense of deep learning or machine learning models. Its functionality is explicitly stated as being "the same" as the predicate based on fixed design principles.
How the ground truth for the training set was established:
- Not applicable. As no training set for an AI/ML model was described, no ground truth collection for such a set was needed.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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: (305) 477-6331

US AGENT JORGE MILLAN, PHD REGULATORY AFFAIRS CORRESPONDENT Email: regulatory@advanced-inst.com Web: https://www.sigmabiomedical.com

DEVICE NAME AND CLASSIFICATION

TRADE NAME:	CMS-2000 Central Monitoring System
CLASSIFICATION NAME:	870.1025 monitor, physiological, patient (with arrhythmiadetection or alarms)
	Product Code: MHX
REGULATORY CLASS:PANEL IDENTIFICATION	Class IICardiovascular

DEVICE DESCRIPTION

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-2000K# TBD	MFM-CMSK120727
PRODUCT CODE	MHX	MHX
REGULATION NO.	870.1025	870.1025
CLASS	II	II
INTENDED USE	The CMS-2000 CentralMonitoring System providescentralized monitoring andcritical care management forpatients monitored bybedside monitors. From theCMS-2000, clinicians can gainaccess to patient informationfor patients on the Network.The CMS-2000 displayswaveforms, parameters andalarm status of bedsidemonitors for up to 32 patientson a single screen or up to 64patients using two screens.	The MFM-CMS CentralMonitoring System providescentralized monitoring andcritical care management forpatients monitored bybedside monitors. From theMFM-CMS clinicians can gainaccess to patient informationfor patients on the Network.The MFM-CMS displayswaveforms, parameters andalarm status of bedsidemonitors for up to 32patients on a single screenor up to 64 patients usingtwo screens.
WAVEFORMS	2 ECG Waveforms1 RESP waveform1 PLETH waveform	2 ECG Waveforms1 RESP waveform1 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	TheCentralMonitoring	The CentralMonitoring
	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 64bedsidedisplay -	display and 64 bedside
	displaysmonitors on two	monitors on two displays
	simultaneously	simultaneously
RECORD CAPACITY	240-hour trend data, 72 hour	240-hour trenddata,72
	waveform, 720 alarm events,	hour waveform, 720 alarm
	1~2 hours short trend, 720	events, 1~2 hoursshort
	groupNIBP measurement	720 grouptrend,NIBP
	for each bedsidereview	measurement reviewfor
	monitor	each bedside monitor
CALCULATION	Drug calculation and titration	calculationDrugand
	table	titration table
REVIEW	information,Printpatient	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 thehospital local area networkBidirectional controlHL7	Web observation in thehospital local area networkBidirectional controlHL7
----------------------	---------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------

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.

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.