The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:

· hemodynamic (including ECC, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.

The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

Device Description

The CARESCAPE B850 is a new version of a modular multi-parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 V3 includes features and subsystems that are optional or configurable.

AI/ML Overview

The provided document, [K191323](https://510k.innolitics.com/search/K191323), is a 510(k) premarket notification for the GE Healthcare CARESCAPE B850 patient monitor. It describes the device and compares it to a predicate device ([K131414](https://510k.innolitics.com/search/K131414) CARESCAPE Monitor B850). This document outlines non-clinical testing and explicitly states that clinical studies were not required.

Therefore, I cannot fully answer your request for acceptance criteria and a study proving the device meets those criteria from this specific document, as it indicates clinical studies were not performed. The document focuses on demonstrating substantial equivalence through non-clinical bench testing, including software, hardware, and performance tests, and usability studies.

However, I can extract the information related to the device's performance and the types of tests conducted, even if they aren't presented as a structured "acceptance criteria" table with "reported device performance" against them in a clinical study context.

Here's a breakdown of what can be extracted and what cannot:

What Can Be Inferred/Extracted from the Document:

Device Performance (as demonstrated by non-clinical testing):
- The CARESCAPE B850's hardware, software, and overall performance met specifications through bench testing.
- The device demonstrated electromagnetic compatibility, electrical safety, environmental resilience, and usability.
- Software testing covered design, development, verification, validation, and traceability.
- The device addressed patient safety, security, and privacy risks, including cybersecurity measures.
- It can withstand network storm conditions without rebooting.
Test Set Description (for non-clinical testing):
- Data Provenance: Not explicitly stated for specific datasets, but testing was conducted on the aformentioned device, manufactured by GE Healthcare Finland Oy. This implies internal testing. The nature of "bench testing" suggests controlled environments rather than real-world patient data for performance validation against specific clinical thresholds.
- Retrospective/Prospective: Not specified. Bench testing is typically a controlled laboratory process.
Ground Truth (for non-clinical testing):
- The "ground truth" for the technical specifications and performance of the device (e.g., accuracy of parameter measurements, robust alarms) would have been established by engineering and quality standards, internal specifications, and applicable consensus standards (e.g., IEC 60601-1-8 for alarms).

What Cannot Be Answered From the Document (specifically regarding clinical studies/acceptance criteria as implied by clinical outcomes or human reader performance):

A table of acceptance criteria and the reported device performance (in a clinical context): The document explicitly states "CARESCAPE B850 did not require clinical studies to support substantial equivalence." Therefore, no clinical performance acceptance criteria or reported clinical performance is provided. The acceptance criteria for the non-clinical tests are implicit in the statement "demonstrating the design meets the specifications" for hardware, software, and performance.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for a clinical study: Not applicable, as no clinical study was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no clinical study was performed. Ground truth for technical performance would be against engineering benchmarks, not expert clinical assessment in a study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.
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 patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar. The "EK-Pro arrhythmia detection algorithm" is an internal algorithm, not a separate AI for human assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The EK-Pro V14 arrhythmia analysis algorithm operates within the device as a standalone component for its intended function. Its performance would have been validated against a set of ECG waveforms with established ground truth for arrhythmias, but details of such testing (like sample size or specific metrics) are not in this 510(k) summary. The document states "EK-Pro V14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors," implying internal validation of the updated algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the arrhythmia detection algorithm, the ground truth would typically be established by expert cardiologists reviewing ECG recordings. However, the details of how EK-Pro V14's ground truth was established are not provided in this 510(k). For general device performance, the ground truth is adherence to technical specifications and relevant standards.
The sample size for the training set: Not applicable, as this is a 510(k) submission for a patient monitor, not an AI/ML device requiring a training set in the typical sense. While the EK-Pro algorithm may have been "trained" or developed using data, the document does not mention details about this.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary Table of Available Information (based on non-clinical context):

Acceptance Criterion (Type of Test)	Reported Device Performance / Outcome (Non-Clinical)
Hardware Performance	Meets specifications. Includes electromagnetic compatibility, electrical safety, environmental, and usability testing.
Software Performance	Meets specifications. Includes software design, development, verification, validation, and traceability. The new EK-Pro V14 arrhythmia analysis algorithm is considered equivalent to the predicate's V13.
Usability	Extensive usability work completed, including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing, and summative testing. The overall user interface layout, structure, operations, and workflow remain the same as the predicate, with only a new color scheme and slight visual adjustments aligned with a new design guideline.
Cybersecurity / Risks	Patient safety, security, and privacy risks addressed through design and development, including a Security Risk Assessment and Threat model (system integrity controls, access controls, audit controls, network controls, remote service controls) mapping to FDA Guidance for Cybersecurity in Medical Devices (2014). The device can withstand network storm conditions without rebooting when connected by wire to specific networks.
Alarm Functionality	Alarm management core functionalities (classification, notification, adjustment of settings, On/Off, audio silencing) are implemented and equivalent to the predicate. Added flexibility for users to adjust alarm priorities, criteria for additional parameter alarms, alarm delay options, critical alarm options, alarm acknowledgement, and latched alarm indicators. Supports tailored/specific alarm management schemes to reduce alarm fatigue while maintaining safety. Default settings are according to IEC 60601-1-8. The CARESCAPE RAD (new accessory for remote alarms) replaces the prior Remote Alarm Box and communicates one-way, not affecting the B850's alarm functionality.
Networking Capability	Supports CARESCAPE Network LAN/VLAN. New single-wire network configuration supported, simplifying installation and maintenance without impact on clinical monitoring.
Processor	Updated from Intel Celeron-M 423 ULV to Freescale ARM Cortex-A9, considered equivalent.
Modules Supported	Equivalent. Supports newer acquisition modules, covering the same parameters as the predicate, with some legacy modules removed and new ones (e.g., CARESCAPE ONE, E-EEGX, E-sCAiOVX, E-sCOVX) added.
General Equivalence	"The fundamental function and operation of the proposed CARESCAPE B850 V3 monitor are unchanged compared to CARESCAPE Monitor B850 with ESP V2 software (K131414). There are no new types of monitored parameters introduced compared to the predicate B850 monitor." The device is found to be substantially equivalent to the predicate device(s) for the intended users, uses and use environments based on non-clinical testing.

Conclusion from Document:

The acceptance criteria for the CARESCAPE B850, as presented in this 510(k) submission, were met through extensive non-clinical bench testing, hardware and software verification/validation, and usability studies. The submission asserts the device's substantial equivalence to its predicate based on these non-clinical activities, stating explicitly that clinical studies were not required or performed.

Summary

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January 29, 2020

GE Healthcare Finland OY Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 00510 Helsinki Finland

Re: K191323

Trade/Device Name: CARESCAPE B850 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, BZK, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Dated: December 23, 2019 Received: December 26, 2019

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.

{1}------------------------------------------------

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.

Jennifer Shih Assistant Director (Acting) 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) K191323

Device Name CARESCAPE B850

Indications for Use (Describe)

The CARESCAPE B850 is a multi-parameter patient montor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki
Finland
T: +358 10 39411

510(k) Summary

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

Owner/Contact/Date (807.92(a)(1):

Date:	January 21, 2020
Owner/Submitter:	GE Healthcare Finland Oy. Kuortaneenkatu 2 00510 Helsinki FINLAND Phone: +358 10 39411
Primary Contact Person:	Joel Kent Senior Regulatory Affairs Manager GE Healthcare Phone: 617-851-0943
	E-mail: joel.kent@ge.com
Secondary Contact Person:	Anssi Ruokonen Regulatory Affairs Leader GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki Finland
	Phone: + 358 10 394 3686
	E-mail: Anssi.ruokonen@ge.com
Device names (807.92(a)(2)):
Trade Name:	CARESCAPE B850
Common/Usual Name:	Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms)

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Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm) 21 CFR 868.1850 spirometer, monitoring (w/wo alarm) 21 CFR 868.1730 computer, oxygen-uptake 21 CFR 868.2375 monitor, breathing frequency 21 CFR 868.2600 monitor, airway pressure (includes gauge and/or alarm) 21 CFR 868.1500 analyzer, gas, enflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, desflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, sevoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, isoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1700 analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) 21 CFR 868.1620 analyzer, gas, halothane, gaseous-phase (anesthetic conc.) 21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-phase 21 CFR 868.1720 analyzer, gas, oxygen, gaseous-phase 21 CFR 870.2340 electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 computer, diagnostic, programmable 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) 21 CFR 870.1025 detector and alarm, arrhythmia 21 CFR 870.1100 alarm, blood-pressure 21 CFR 870.1110 computer, blood-pressure 21 CFR 870.1435 computer, diagnostic, pre-programmed, single-function 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 870.2910 thermometer, electronic, clinical 21 CFR 882.1900 stimulator, auditory, evoked response 21 CFR 882.1400 full-montage standard electroencephalograph 21 CFR 868.2775 stimulator, nerve, peripheral, electric 21 CFR 870.1915 probe, thermodilution 21 CFR 870.1025 monitor, st segment with alarm 21 CFR 882.1400 non-normalizing quantitative electroencephalograph software 21 CFR 882.1400 index-generating electroencephalograph software 21 CFR 882.1400 reduced- montage standard electroencephalograph

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21 CFR 882.1400 burst suppression detection software for electroencephalograph

Product Code: MHX

Subsequent Product Codes: BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT

Predicate Device(s) (807.92(a)(3): K131414 CARESCAPE Monitor B850

CARESCAPE B850 V3 is a new version of a modular multi-Device Description (807.92(a)(4)): parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 V3 includes features and subsystems that are optional or configurable.

Intended Use: (807.92(a)(5):

Indications (from labeling)

The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE B850 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

{7}------------------------------------------------

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.

The CARESCAPE B850 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

CARESCAPE B850 with CARESCAPE Software version 3 Technology (807.92(a)(6)): incorporates updated hardware and a new software platform.

The fundamental function and operation of the proposed CARESCAPE B850 V3 monitor are unchanged compared to CARESCAPE Monitor B850 with ESP V2 software (K131414). There are no new types of monitored parameters introduced compared to the predicate B850 monitor.

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

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Specification	CARESCAPE Monitor B850with ESP V2 software(K131414)	CARESCAPE B850 withCSP software version V3	Differences
Patient type	Adult, pediatric & neonatal	Adult, pediatric & neonatal	Identical
Use environments	Within a professionalhealthcare facility (Notintended for MRI)	Within a professionalhealthcare facility (Notintended for MRI)	Identical
Size (H x W x D)& Weight	91 x 401 x 340 mm (3.6 x 15.8 x 13.5in) and weight 7.5 kg (16.5 lbs)	91 x 401 x 340 mm (3.6 x 15.8 x 13.5in) and weight 7.5 kg (16.5 lbs)	Identical
Processor	Intel Celeron-M 423 ULV1.06GHz	Freescale ARM Cortex-A9	EquivalentThe CARESCAPEBx50 V3 monitors havean updated commonCPU platform.
Module Housing	Up to 12 optional E-module slots withF5 and F7 Frames. One slidemount for acquisition module	Up to 12 optional E-module slots withF5 and F7 Frames. One slidemount for acquisition module	Identical
Display/screen	19" Active matrix color TFTLCD	19" Active matrix color TFTLCD	Identical
Waveforms andparameterwindows	Standard view: Up to 8individual waveforms and upto 20, if horizontal parameterarea turned on.	Standard view: Up to 8individual waveforms and upto 20, if horizontal parameterarea turned on.	Identical
Modules	E-PSM; E-PSMP, E-PRESTN,E-PRETN, E-RESTN, M-PRESTN, M-PRETN, M-RESTN, E-miniC, E-CO, E-CAiO, E-CAiOV, E-CAiOVX, E-COVX, E-COV,E-P, E-PP, E-PT, E-COP, E-COPSv, E-EEG, E-Entropy,E-NMT, E-BIS, E-NSAT, E-NSATX, E-Masimo,E-sCO,E-sCAiO, E-sCOV, and E-sCAiOV, E-PiCCO, PDM,TRAM	E-BIS, E-COP, E-COPSv, E-PiCCO, E-EEGX, E-Entropy,E-Masimo, E-miniC, E-NMT,E-NSATX, E-PP, E-PT, E-sCAiO, E-sCAiOE, E-sCAiOV, E-sCAiOVX, E-sCAiOVE, E-sCO, E-sCOV,E-sCOVX,PDM, CARESCAPE ONE	EquivalentRemoved support forseveral legacy E/Mmultiparameterhemodynamicacquisition modules asmany newer acquisitionmodules are included,covering the sameparameters.Added support forCARESCAPE ONE andE-EEGX acquisitionmodules.Added support for E-sCAiOVX and E-sCOVX modules(K150245).

Subject Device and Predicate Device Comparison

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Specification	CARESCAPE Monitor B850with ESP V2 software(K131414)	CARESCAPE B850 withCSP software version V3	Differences
Availableparameters	ECG, ST segment, arrhythmiadetection, ECG diagnosticanalysis and measurement,invasive pressure, non-invasive blood pressure, pulseoximetry, cardiac output(thermodilution and pulsecontour), temperature, mixedvenous oxygen saturation, andcentral venous oxygensaturation, impedancerespiration, airway gases(CO2, O2, N2O, andanesthetic agents), spirometry,gas exchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission.	ECG, ST segment, arrhythmiadetection, ECG diagnosticanalysis and measurement,invasive pressure, non-invasive blood pressure, pulseoximetry, cardiac output(thermodilution and pulsecontour), temperature, mixedvenous oxygen saturation, andcentral venous oxygensaturation, impedancerespiration, airway gases(CO2, O2, N2O, andanesthetic agents), spirometry,gas exchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission.	Identical
EK-Proarrhythmiadetectionalgorithm	EK-Pro V13	EK-Pro V14	EquivalentCARESCAPE B850 V3uses an EK-ProV14arrhythmia analysisalgorithm compared tothe EK-Pro V13 used inthe predicate monitors
Graphical userinterface	GE Healthcare Common UserInterface (CUI) Requirementsand Style Version 6	GE Healthcare HDX	A new color scheme forthe display and slightvisual adjustments havebeen incorporated, inline with a GEHealthcare wide userinterface designguideline. The overalluser interface layout,structure, operations,and workflow remainsthe same as thepredicate.
Printing	Local recorder/printer andnetworked laser printer.Printings for waveforms,alarms waveforms, numerictrends	Local recorder/printer andnetworked laser printer.Printings for waveforms,alarms waveforms, numerictrends	Identical

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Specification	CARESCAPE Monitor B850with ESP V2 software(K131414)	CARESCAPE B850 withCSP software version V3	Differences
Mounting options	Multiple GCX mountingsystems	Multiple GCX mountingsystems	Identical
Alarms	Alarm management corefunctionalities:Classification and notificationof alarmsAdjustment of alarm settingsAlarm On/Off functionalityand audio silencing	Alarm management corefunctionalities:Classification and notificationof alarmsAdjustment of alarm settingsPossibility to set critical alarmlimitsAlarm On/Off functionalityand audio silencing	EquivalentThe predicate alreadyincluded the options toconfigure some alarmsettings. In V3, moreflexibility was added forthe user to adjust alarmpriorities and alarmcriteria for additionalparameter alarms,including additionalalarm delay options,critical alarm options,alarm acknowledgementand latched alarmindicators, and a pausemonitoring & centralfunction.In general, options fortailored/specific alarmmanagement schemeshave been addedsupporting clinicians intheir goals of reducingalarm fatigue whilemaintaining safety.Default setting areaccording to IEC 606011-8.

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	(K131414)
Remote AlarmDevice	Alarm Interface to the RemoteAlarm Box with Remote Light(RAB RL).	Alarm Interface to the RemoteAlarm Device, CARESCAPERAD	EquivalentCARESCAPE RADreplaces the RemoteAlarm Box with RemoteLight (RAB RL) device.The CARESCAPE RADis the new accessory foruse with theCARESCAPE Bx50 V3The proposed accessorycommunicates with theCARESCAPE Bx50 V3via a standard USBconnection. TheCARESCAPE RAD isintended for relayingprimary alarm signalsfrom the host device toan external distributedalarm system, i.e. anurse call system or aremote alarm light. TheCARESCAPE Bx50 V3alarm functionality isunaffected when usingthe CARESCAPE RADas the new accessorysimply receives datafrom the monitor (one-way communication) toindicate when an alarmis active or not.
Networkingcapability	CARESCAPE NetworkLAN/VLAN	CARESCAPE NetworkLAN/VLANSingle wire networkconfiguration supported forCARESCAPE Networks	EquivalentThe single wire networkconfiguration simplifiesthe installation andmaintenance ofCARESCAPE Bx50 V3patient monitors. Thesingle wire networkconfiguration has noimpact on clinicalmonitoring.
Network interface	10baseT, 100baseT	10baseT, 100baseT	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

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CARESCAPE B850, demonstrating the design meets the specifications.

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

The CARESCAPE B850 has been found to substantially equivalent to the predicate device(s) for the intended users, uses and use environments. Extensive usability work has been completed for CARESCAPE B850 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.

Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE B850 including a Security Risk Assessment and Threat model. This includes system integrity controls, access controls, audit controls, network controls, and remote service 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 Guidance for Industry and Food and Drug Administration Staff Document issued on October 2, 2014.

Testing was completed on CARESCAPE B850 to show the device can withstand network storm, i.e. continue to monitor patients without rebooting when connected by wire to either MC, IX, or both networks which suffer broadcast storm traffic.

Clinical (807.92(b)(2)): Summary of Clinical Tests:

The subject of this premarket submission, CARESCAPE B850 did not require clinical studies to support substantial equivalence.

GE Healthcare considers the CARESCAPE B850 to be Conclusion (807.92(b)(3)): substantially equivalent to the predicate device(s).

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.