The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric noninvasive blood pressure (systolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).

The monitor B105M, B125M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

Device Description

The proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors that were developed based on predicate Monitor B125/B105(K201941) to provide additional monitored parameter: neuromuscular transmission (NMT), by supporting additional optional modules previously cleared by FDA: E-NMT module (K051635) with existing interface rack and/or second frame (B1X5-F2).

In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements:

Support 12-lead ECG measurement mode;
Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation;
Enabled the Impedance Respiration measurement from lead RL-LL:
Display Pulse Rate (PR) from NIBP when performing NIBP determination;
Display real-time GE SpO2 Perfusion Index (PI) value; .
Adoption of TruSignal V3 SpO2 algorithm;
Additional optimizing IBP waveform scale function;
Additional connectivity capabilities within GE CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA);
Additional remote service function:
Additional cybersecurity enhancements.

The proposed monitors B105M, B125M, B155M, B105P and B125P include improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate Monitor B125/B105(K201941) while maintaining the same primary function and operation.

The five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options.

As with the predicate Monitor B125/B105 (K201941), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters whic include CO2 and Gases parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardic Output parameter provided by the E-COP module (K052976), and thermal recorder B1X5-REC.

In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P)

Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification for a patient monitor. It does not describe a study involving an AI-driven device or an equivalent. Therefore, I cannot extract the information required to answer your prompt, as the prompt is geared towards AI/ML-based medical devices with specific performance metrics and validation studies.

The document focuses on demonstrating substantial equivalence of the new monitor models (B105M, B125M, B155M, B105P, B125P) to existing predicate devices (Monitor B125/B105, CARESCAPE B450, CARESCAPE VC150, CARESCAPE ONE). The changes primarily involve physical design, software enhancements (display modes, calculation additions, connectivity), and support for an additional, previously cleared, NMT measurement module. The document explicitly states:

"The subject of this premarket submission, the proposed monitors B105M, B125M, B155M, B105P and B125P did not require clinical studies to support substantial equivalence." (Page 16)

This indicates that the device's performance was evaluated through bench testing, cybersecurity assessments, and verification of software and hardware changes against established standards, rather than through comparative effectiveness studies with human readers or standalone algorithm performance studies typical for AI/ML devices. Therefore, a table of acceptance criteria and proven performance for an AI/ML component, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable or present in this document.

Summary

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April 1, 2022

GE Medical Systems Information Technologies, Inc. Joel Kent Director, Regulatory Affairs Strategy 9900 Innovation Drive Wauwatosa, Wisconsin 53226

Re: K213490

Trade/Device Name: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX, BZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSJ, DSK, GWQ, FLL, NHO, NHP, NHQ, DPZ, DQK, DSI, KRB, MLD, OLT, OLW, OMC, ORT, KOI Dated: February 28, 2022 Received: March 2, 2022

Dear Joel Kent:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213490

Device Name

Monitor B105M, Monitor B125M, Monitor B155M,Monitor B105P, Monitor B125P

Indications for Use (Describe)

The monitor B105M, B125M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The monitor B105M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric noninvasive blood pressure (systolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/ Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT).

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)

|__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

In accordance with 21 CFR 807.92(c) the following summary of information is provided:

Owner/Contact/Date (807.92(a)(1):
Date:	February 28, 2022
Submitter:	GE Medical Systems Information Technologies, Inc.9900 Innovation DriveWauwatosa, WI 53226USA
Primary Contact Person:	Joel KentDirector, Regulatory Affairs StrategyGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com
Secondary Contact Person:	William JungRegulatory Affairs DirectorGE HealthcarePhone: 571-396-1558E-mail: William.Jung@ge.comSun YanliRegulatory Affairs Program ManagerGE HealthcarePhone: +86-18051597363E-mail: yanli.sun@ge.com
Device names (807.92(a)(2):
Trade Name:	Monitor B105M, Monitor B125M, Monitor B155M,Monitor B105P, Monitor B125P
Common/Usual Name:	Multiparameter patient monitor (monitor, physiological, patient(with arrhythmia detection or alarms)

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Classification Names:	21 C.F.R. §868.1400 Carbon dioxide gas analyzer.21 C.F.R. §868.1500 Enflurane gas analyzer.21 C.F.R. §868.1620 Halothane gas analyzer.21 C.F.R. §868.1700 Nitrous oxide gas analyzer.21 C.F.R. §868.1720 Oxygen gas analyzer.21 C.F.R. §868.2375 Breathing frequency monitor.21 C.F.R. §870.1025 Arrhythmia detector and alarm (includingST-segment measurement and alarm).21 C.F.R. §870.1110 Blood pressure computer.21 C.F.R. §870.1130 Noninvasive blood pressure measurementsystem.21 C.F.R. §870.1425 Programmable diagnostic computer.21 C.F.R. §870.1915 Thermodilution probe.21 C.F.R. §870.2300 Cardiac monitor (includingcardiotachometer and rate alarm).21 C.F.R. §870.2700 Oximeter21 C.F.R. §870.2710 Ear oximeter.21 C.F.R. §880.2910 Clinical electronic thermometer.21 C.F.R. §882.1400 Electroencephalograph21 C.F.R. §870.1100 alarm, blood-pressure21 C.F.R. §868.2775 Electrical peripheral nerve stimulator
Product Code:Subsequent ProductCode:	MHXBZQ, CBR, CBS, CBQ, CCK, CCL, DXN, DQA, DRT, DSJ,DSK, GWQ, FLL, NHO, NHP, NHQ, DPZ, DQK, DSI, DSJ,KRB, MLD, OLT, OLW, OMC, ORT, KOI
Predicate Device(s)(807.92(a)(3)):	Primary Predicate: K201941 Monitor B125/B105Additional Predicate Devices:K191249 CARESCAPE B450K133810 CARESCAPE VC150K200494 CARESCAPE ONE
Device Description(807.92(a)(4)):	The proposed monitors B105M, B125M, B155M, B105P andB125P are multi-parameter patient monitors that were developedbased on predicate Monitor B125/B105(K201941) to provideadditional monitored parameter: neuromuscular transmission(NMT), by supporting additional optional modules previouslycleared by FDA: E-NMT module (K051635) with existinginterface rack and/or second frame (B1X5-F2).

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In addition to the added parameter, the proposed monitors B105M, B125M, B155M, B105P and B125P offer several software enhancements:

Support 12-lead ECG measurement mode; ●
Additional SPV (Systolic Pressure Variation) and PPV (Pulse Pressure Variation) values calculation;
Enabled the Impedance Respiration measurement from lead RL-LL:
Display Pulse Rate (PR) from NIBP when performing NIBP determination;
Display real-time GE SpO2 Perfusion Index (PI) value; .
Adoption of TruSignal V3 SpO2 algorithm; ●
Additional optimizing IBP waveform scale function; ●
Additional connectivity capabilities within GE ● CARESCAPE network (K032582) including Bed-to-Bed View and Automatic View on Alarm (AVOA);
Additional remote service function: ●
Additional cybersecurity enhancements. ●

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Indications for Use(807.92(a)(5)):	In addition, the predicate Monitor B125/B105 (K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P consists of the same interface to a variety of existing central station systems via a cabled or wireless network interface which implemented with identical integrated WIFI module. (WIFI feature is disabled in B125P/B105P)Moreover, both the predicate Monitor B125/B105(K201941) and the proposed monitors B105M, B125M, B155M, B105P and B125P can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
	The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
	The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.
	The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.
	The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.
	The monitor B105M, B125M, B155M, B105P and B125P monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoringEsophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/ Core/Surface temperature, impedance respiration, respiration rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and

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respiratory rate), Cardiac output (C.O.) and Entropy and neuromuscular transmission (NMT).

The monitors B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

Contraindications for using the monitor

The monitors B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

Technology (807.92(a)(6)): The monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors. The hardware functionality is unchanged compared to the predicate Monitor B125/B105(K201941), however this 510(k) introduces monitoring of additional (previously cleared) parameter through an existing cleared and marketed measurement module, enhancements of several software features and additional cybersecurity enhancements.

The fundamental technology of the proposed monitors B105M, B125M, B155M, B105P and B125P are the same as the predicate devices.

The proposed monitors B105M, B125M, B155M, B105P and B125P are substantially equivalent to the predicate devices.

A summary of the main changes compared to the predicate are listed below in the comparison table.

Product Comparison versus Predicate Main Features:

The proposed monitors B105M, B155M, B105P and B125P share identical indications for use, intended use patient populations, and functional features as the predicate devices. The monitors B105M, B125M, B155M, B105P and B125P consist of improvements and optional features outlined below that are substantially equivalent to the primary predicate device B125/B105 (K201941).

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Specification	Predicate monitorsB125/B105 (K201941)	Proposed monitorsB105M/B125M/B155M/B105P	Differences
Size (H x W x D)	Physical size withoutextension rack andmodules:B105: 270 mm x 290 mmx 150 mmB125: 280 mm x 317 mmx 150 mm	Physical size withoutextension rack andmodules:B105P/B105M: 275 mm x265 mm x 175 mmB125P/B125M: 280 mm x312 mm x 175 mmB155M: 305 mm x 405mm x 175 mm	Equivalent to predicate.Slight change in physical size for 10 inch and12-inch devices as the proposed deviceimproved Industrial Design for more portableand compact design than the predicate devices.The proposed device also introduced a 15-inchscreen version to meet customer requests.Regardless of the display size, all monitorshave the same functionality and options. Thechange doesn't impact the safety oreffectiveness.
Weight	Weight with battery,without extension rack andmodules:B105: $≤$ 3.9 kgB125: $≤$ 4.3 kg	Weight with battery,without extension rack andmodules:B105P/B105M: $≤$ 3.8 kgB125P/B125M: $≤$ 4.2 kgB155M: $≤$ 5.2 kg	Equivalent to predicate.Decrease in display size for B105 and B125have resulted in decreased weight. B155M is alarger monitor with higher weight.B155M has the same functionality and optionsas B125M and B105M except different displaysize.The change doesn't impact the safety oreffectiveness.
Hard keys	three functional hard keyson front panel: AlarmAudio Pause, TakeSnapshot and ManualNIBP	No functional hard keyson front panel	Equivalent to predicateThe proposed device removed the threefunctional hard keys for better cleaning.Instead, the proposed device provides threesoft keys with same functionality.The change doesn't impact the safety oreffectiveness.
Battery Type	Rechargeable Lithium-Ionbattery	Rechargeable Lithium-Ion battery	Equivalent to predicateThe predicate monitor supports one standardLithium-Ion battery. The proposed deviceprovides two different capacity Lithium-Ionbattery options to meet different customerneeds, however only one battery can beselected/installed in each device.The change doesn't impact the safety oreffectiveness.
Waveforms andparameter windows	Up to 6 waveformsUp to 10 parameterwindows	Up to 12 waveformsUp to 10 parameterwindows	Equivalent to predicateThe proposed device can display morewaveforms on the screen simultaneously to letthe clinician to view more information on onescreen.The change doesn't impact the safety oreffectiveness.
E-Modules	E-MiniCE-sCOE-sCAiON-CAiOE-ENTROPYE-COP	E-MiniCE-sCOE-sCAiON-CAiOE-ENTROPYE-COPE-NMT	Equivalent to predicate.Support added for additional parametermeasurement module E-NMT (K051635).The E-NMT module is cleared and availableon the market. This change solely adds thecapability to display these additionalparameters on the proposed device's display,similar to the other displayed parameters.The change doesn't impact the safety or
Maximum E-Modules Maximum three E-Support	Modules can be supported Maximum three E-at the same time:One through module rack,two through externalSecond Frame B1X5-F2.	B1x5M:Modules can be supportedat the same time:One through module rack,two through externalSecond Frame B1X5-F2.B1x5P:Maximum one E-Modulecan be support throughthe module rack.	effectiveness.Equivalent to predicateIdentical for the proposed monitors B1x5M.The Second Frame B1X5-F2 is not availablefor the proposed monitors B1x5P per differentcustomer needs so only one E-module may beconnected for those devices.The change doesn't impact the safety oreffectiveness.
Available parameters	ECG, ST segment,arrhythmia detection, ECGdiagnostic analysis andmeasurement, invasivepressure, heart/pulse rate,non-invasive bloodpressure, pulse oximetry,temperature, impedancerespiration, airway gases(CO2, O2, N2O, andanesthetic agents),Entropy,cardiac output.	ECG, ST segment,arrhythmia detection, ECGdiagnostic analysis andmeasurement, invasivepressure, heart/pulse rate,non-invasive bloodpressure, pulse oximetry,temperature, impedancerespiration, airway gases(CO2, O2, N2O, andanesthetic agents),Entropy,cardiac output,neuromusculartransmission (NMT).	Equivalent to predicate.The NMT parameter has been added and canbe displayed on the screen through thecompatibility/support for the E-NMT module(K051635).This change solely adds the capability todisplay these additional parameters on theproposed device's display, similar to the otherdisplayed parameters.The change doesn't impact the safety oreffectiveness.
ECG MeasurementMode	3-lead and 5-lead	3-lead, 5-lead and 12-lead	Equivalent to predicate.The proposed monitor adds the additionaloption for a 12-lead ECG mode measurementand display. This is equivalent to the 12-leadECG measurement and display alreadyimplemented in the predicate device B450 V3(K191249).

SPV and PPV valuescalculation	Not supported	Support SPV (SystolicPressure Variation) andPPV (Pulse PressureVariation) values calculationfrom arterial Invasive BloodPressure (IBP) monitoring	The change doesn't impact the safety oreffectiveness.Equivalent to predicate.SPV (Systolic Pressure Variation) and PPV(Pulse Pressure Variation) values arecalculated based on existing arterial InvasiveBlood Pressure (IBP) monitoring already in thepredicate. SPV and PPV values can support anassessment of the patient's arterial pressurevariation and reflect patient's respiratorychanges in arterial pressure during positivepressure ventilation. This feature is alreadypredicate monitor CARESCAPE MonitorB450 V3 (K191249).The change doesn't impact the safety oreffectiveness.
Impedancerespiration sourcelead	I, II and III	I, II and RL-LL	Equivalent to predicate.The proposed device no longer providesImpedance respiration measurement from ECGlead III, but provide additional Impedancerespiration source from ECG lead RL-LL.The Impedance respiration from ECG lead RLLL is equivalent to ECG lead I and II.Impedance respiration measurement from leadRL-LL is already implemented in theequivalent way in the predicate deviceCARESCAPE Monitor B450 V3 (K191249).The change doesn't impact the safety oreffectiveness.
NIBP measurement	Systolic pressure,Diastolic pressure andMean pressure	Systolic pressure, Diastolicpressure, Mean pressureand Pulse Rate	Equivalent to predicate.The proposed device uses the identical NIBPdesign as the predicate monitor B125/B105(K201941). The only difference is thepredicate Monitor B125/B105 (K201941) doesnot offer Pulse Rate (PR) display on thescreen, although PR is already calculated bythe algorithm when performing NIBPmeasurement. The proposed device nowdisplays the PR value on screen. There is nochange to the NIBP measurement algorithm orcalculations.The PR monitoring from NIBP measurementhas been implemented in an equivalent way inthe CARESCAPE VC150 (K133810).The change doesn't impact the safety oreffectiveness.
Perfusion Index (PI) for GE TruSignal SpO2	Monitors PI and saves PI in trend as "Pleth"	Monitors PI and saves PI in trend as “PI” and displays real-time PI value in digit field.	Equivalent to predicate.
TruSignal SpO2 algorithm	TruSignal V2	TruSignal V3	Equivalent to predicate.The TruSignal V3 algorithm was cleared with CARESCAPE ONE in K200494. This cleared algorithm provides equivalent functionality.The change doesn't impact the safety or effectiveness.
IBP waveform scale adjustment	Manual adjustment	Manual adjustment and automatic optimizing scale.	Equivalent to predicate.The proposed device provides an automatic optimizing scale feature.Optimizing IBP waveform scale is the function of adjusting the "Scale" menu selection automatically to let the current IBP waveform fully utilize the IBP waveform area, to avoid waveform too small or too large.It is an option the user can select and is not required. It does not change the data displayed only the scaling and use of the space on the screen. This is a workflow enhancement.Optimizing IBP waveform scale has been implemented in an equivalent way in the predicate device CARESCAPE Monitor B450 V3 (K191249).
Bed-to-Bed View and Automatic View on Alarm (AVOA)	Not supported	Bed-to-Bed View and AVOA is supported	Bed-to-Bed View and AVOA share a feature to allow the monitor to display a view of another patient monitor (for another bed) that is on the same GE CARESCAPE network.The AVOA allows configurable prioritization of displaying highest to lowest risk alarms.Bed-to-Bed view and AVOA functionality has been implemented in an equivalent way in the predicate device CARESCAPE Monitor B450 V3 (K191249).The change doesn't impact the safety or effectiveness.
Remote Service	Not supported	Remote Service is supported	With this feature, when the proposed device is connected to network, authorized service personnel can transfer the service log from the proposed device to GE Healthcare server via HTTPS for remote trouble shooting and support. The service log does not include patient information and the log files are encrypted before transmitting.
			The remote service feature is password protected and for service-use only.
			The service log does not include any patient information and the log files are encrypted before transmitting.
			This remote service functionality has been implemented in an equivalent way in the predicate device CARESCAPE Monitor B450 V3 (K191249).
			The change doesn't impact the safety or effectiveness.
Operating System	Linux(Rev 4.4)	Linux(Rev 4.19)	Equivalent to predicate.
			The two versions of the Operation System use the same technology. Since the 4.4 version Linux is going end of life, the updated version of Linux allows better technical support and cybersecurity while maintaining the same functionality, operation and performance. The change doesn't impact the safety or effectiveness.

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The proposed monitors B105M, B155M, B155M, B105P and B125P consist of improvements and optional features outlined below that are substantially equivalent to the additional predicate device CARESCAPE B450(K191249).

Specification	Predicate monitorCARESCAPE B450(K191249)	Proposed monitorsB105M/B125M/B155M/B105P	Differences
NMT measurementmodule	E-NMT module(K051635)	E-NMT module(K051635)	Identical
ECG MeasurementMode	3-lead, 5-lead, 12-lead,6-lead and 12RL	3-lead, 5-lead and 12-lead	Equivalent to predicate.Although the proposed device only supports 3-lead, 5-lead and 12-lead ECG mode thosemodes are identical to those used inCARESCAPE B450 (K191249).The change has been verified and validatedand does not affect safety or effectiveness.

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SPV and PPV valuescalculation	Support SPV (SystolicPressure Variation) andPPV (Pulse PressureVariation) valuescalculation from arterialInvasive Blood Pressure(IBP) monitoring	Support SPV (SystolicPressure Variation) andPPV (Pulse PressureVariation) valuescalculation from arterialInvasive Blood Pressure(IBP) monitoring	Identical
Impedancerespiration sourcelead	I, II and RL-LL	I, II and RL-LL	Identical
IBP waveform scaleadjustment	Manual adjustment andautomatic optimizingscale.	Manual adjustment andautomatic optimizingscale.	Identical
Bed-to-Bed View andAutomatic View onAlarm (AVOA)	Bed-to-Bed View andAVOA are supported	Bed-to-Bed View andAVOA are supported	Identical
Remote Servicefunctionalities	Transfer service logConfigure the deviceUpdate device software	Transfer service log	Equivalent to predicate.The proposed device limits the supportedremote service functionality to transferring theservice log only. That functionality isequivalent to the predicate and has beenimplemented with the equivalent securitycontrols and verification, including encryption.The change doesn't impact the safety oreffectiveness.

Specification	Predicate monitorCARESCAPE VC150(K133810)	Proposed monitorsB105M/B125M/B155M/B105P	Differences
NIBP measurement	Systolic pressure,Diastolic pressure, Meanpressure and Pulse Rate	Systolic pressure, Diastolicpressure, Mean pressureand Pulse Rate	Identical

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Specification	Predicate monitorCARESCAPE ONE(K200494)	Proposed monitorsB105M/B125M/B155M/B105P	Differences
TruSignal SpO2algorithm	TruSignal V3	TruSignal V3	Identical

Determination of Substantial Equivalence (807.92(b)(1):

Summary of Non-Clinical Tests:

Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the proposed monitors B105M, B125M, B155M, B105P and B125P, demonstrating the design meets the specifications.

The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.

The proposed monitors B105M, B125M, B155M, B105P and B125P have been found to be equivalent to the predicate devices for the intended users, functionality, and use environments. Usability evaluation has been completed for the proposed monitor and the predicate devices including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing and summative testing, among other activities.

Software testing included software design, development, verification, validation and traceability. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered "Major" level of concern, the same as the predicate.

The proposed monitors B105M, B125M, B155M, B105P and B125P have introduced and verified one additional battery optional. The battery is equivalent to the predicate and tested to comply with UL 2054 2nd Edition, UL1642 5th Edition and IEC 62133-2:2017 standards. Integration of the battery management has been successfully verified the functionality of proposed monitors can respond to certain battery and power management conditions as specified And also tested as part of system EMC testing.

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Patient safety, security, and privacy risks have been addressed in the design and development of the proposed B1x5M/B1x5P including a Security Risk Assessment and Threat model. This includes system integrity controls, access, controls audit controls and network controls which map to the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued on October 18, 2018. The proposed monitors B1x5M/B1x5P have been subjected to rigorous testing for cybersecurity vulnerability including penetration testing via an independent firm has been completed with acceptable conclusion, security controls verification testing including network port scan, vulnerability scan and virus scan were conducted, the results demonstrated that the potential cybersecurity risks are appropriately mitigated in the proposed devices and the cybersecurity protections are at least substantially equivalent to the predicate.

Testing was completed to show the device can withstand network storm, i.e. continue to monitor patients without rebooting when connected by wire to GE Unity networks which suffer broadcast storm traffic.

Clinical (807.92(b)(2)):	Summary of Clinical Tests:
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The subject of this premarket submission, the proposed monitors B105M, B125M, B155M, B105P and B125P did not require clinical studies to support substantial equivalence.

Conclusion (807.92(b)(3)): GE Healthcare considers the proposed monitors B105M/B125M/B155M/B105P/B125P to be substantially equivalent 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.