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, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, 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

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), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the 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 includes features and subsystems that are optional or configurable.

AI/ML Overview

This looks like a 510(k) summary for the GE Healthcare CARESCAPE B850 patient monitor. I will extract information related to the acceptance criteria and study that proves the device meets them.

Based on the provided text, the CARESCAPE B850 is a multi-parameter patient monitor. The 510(k) submission is for a new version with updated software and minor hardware modifications. The submission refers to a primary predicate device, also named CARESCAPE B850 (K191323), and additional predicate/reference devices for specific parameters (INVOS PM7100 and MASIMO RADICAL Y PULSE CO-OXIMETER).

The key takeaway is that the device did not require clinical studies to support substantial equivalence because it is a modified version of an already cleared device and incorporates previously cleared parameters. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the new CARESCAPE B850 compared to a specific threshold. Instead, it relies on the concept of substantial equivalence to a predicate device.

The "acceptance criteria" are implied to be that the performance of the new device is "as safe, as effective, and the performance to be substantially equivalent to the predicate device." The reported "device performance" is primarily that it passed various non-clinical tests.

Implied Acceptance Criteria (based on substantial equivalence concept):

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Software	Meets specifications and validated as per design requirements.	Bench testing related to software design, development, verification, validation and traceability was conducted.
Hardware	Meets specifications, including safety and compatibility.	Bench testing related to electromagnetic compatibility, electrical safety, environmental, and usability was conducted.
Overall Safety & Effectiveness	As safe and effective as the predicate device (K191323).	The device is considered as safe, as effective, and its performance is substantially equivalent to the predicate device.

Note: The document states that the fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to its predicate (K191323), except for the addition of an E-musb Interface module and the capability to display previously cleared hemodynamic parameters from OEM devices (regional oxygen saturation and total hemoglobin concentration).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing related to software, hardware and performance." This typically involves testing prototypes or production units, but a "sample size" in the context of patient data is not applicable here as no clinical studies were performed for this submission.
Data Provenance: Not applicable, as no external data (e.g., patient data from a specific country, retrospective or prospective) was used for this 510(k) submission to demonstrate substantial equivalence. The testing was internal bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. For bench testing of hardware and software, "ground truth" is typically established by engineering specifications, validated test protocols, and adherence to consensus standards, rather than expert clinical consensus on patient data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept applies to clinical studies where discrepancies in observations or diagnoses need to be resolved. For bench testing, test results are typically compared against predefined specifications.

5. 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

MRMC Study: No. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The new version mostly focuses on software updates, minor hardware changes, and display of previously cleared parameters from other OEM devices.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: The core functionality of the device (e.g., ECG, arrhythmia detection, various physiological measurements) operates in a "standalone" fashion in that the algorithms process patient data collected by the sensors. The document doesn't detail specific "algorithm-only" performance metrics as would be seen for a novel AI algorithm. Instead, it relies on the previous clearance of the predicate device and the fact that the algorithms (like EK-Pro arrhythmia detection algorithm V14) are identical. The newly added parameters (regional oxygen saturation and total hemoglobin concentration) are sourced from OEM devices that would have their own standalone performance data from their original clearances.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical bench testing, the ground truth would be the engineering specifications of the device and adherence to relevant consensus standards (e.g., for electromagnetic compatibility, electrical safety, environmental performance). For the physiological parameters, the "ground truth" for the algorithms (e.g., arrhythmia detection) was established during the development and clearance of the predicate device (K191323) and the OEM devices for rSO2 and SpHb.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. As this is not an AI/ML device that requires a distinct "training set" for model development for this 510(k) submission, this information is not relevant here. The update involves existing algorithms and integration of existing cleared parameters.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 13, 2022

GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, FI-00510 Finland

Re: K213336

Trade/Device Name: Carescape B850, E-musb 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, BZL, BZQ, CAP, CBQ, CBR, CCK, CCL, DPS, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, DPZ, NHO, NHP, NHQ, OLT, QEM, OLW, OMC, ORT Dated: March 11, 2022 Received: March 14, 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.

{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.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213336

Device Name CARESCAPE B850

Indications for Use (Describe)

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, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, 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 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.

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.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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:	October 5, 2021
Owner/Submitter:	GE Healthcare Finland Oy.Kuortaneenkatu 200510 HelsinkiFINLANDPhone: +358 10 39411
Primary Contact Person:	Joel KentSenior Regulatory Affairs ManagerGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com
Secondary Contact Person:	Karin MårtensonRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 50 384 6646E-mail: karin.martenson@ge.com
Device names (807.92(a)(2)):

CARESCAPE B850 Trade Name: Multiparameter patient monitor (monitor, physiological, patient Common/Usual Name: (with arrhythmia detection or alarms)

{5}------------------------------------------------

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 870.2700 Oximeter, Tissue Saturation 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 21 CFR 882.1400 burst suppression detection software for electroencephalograph 21 CFR 870.2700 Cerebral Oximeter

{6}------------------------------------------------

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, MUD, NHO, NHP, NHQ, OLT,OLW, OMC, ORT, QEM
Predicate Device(s)(807.92(a)(3)):	The primary predicate for this submission is K191323CARESCAPE B850Additional predicates / reference devices:K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2SensorK110028, MASIMO RADICAL Y PULSE CO-OXIMETER
Device Description(807.92(a)(4)):	CARESCAPE B850 is a new version of a modular multi-parameter patient monitoring system. The monitor includes aseparate 19-inch touchscreen display, the central processing unit(also called CPU), the CARESCAPE Software, and a moduleframe F5 or F7. CARESCAPE B850 is equipped with the ePortinterface that supports use of PDM or CARESCAPE ONEpatient data acquisition modules for patient monitoring. Inaddition, the F5 module frame has five module slots, and the F7module frame has seven module slots where patient dataacquisition modules (E-Module type), can be connected toperform patient monitoring. The CARESCAPE B850 includesfeatures and subsystems that are optional or configurable.
Intended Use:(807.92(a)(5)):	Indications (from labeling)The CARESCAPE B850 is a multi-parameter patient monitorintended for use in multiple areas within a professionalhealthcare 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, arrhythmiadetection, ECG diagnostic analysis and measurement, invasivepressure, non-invasive blood pressure, pulse oximetry, regionaloxygen saturation, total hemoglobin concentration, cardiacoutput (thermodilution and pulse contour), temperature, mixedvenous oxygen saturation, and central venous oxygensaturation)

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

· 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, 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.

Technology (807.92(a)(6)): The CARESCAPE B850 incorporates incorporates updated software and minor modifications to the hardware.

The fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to CARESCAPE B850 (K191323).

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

{8}------------------------------------------------

Subject Device and Predicate Device Comparison

{9}------------------------------------------------

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

Summary of Non-Clinical Tests:

{10}------------------------------------------------

Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B850, demonstrating the design meets the specifications. The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, and usability. Software testing included software design, development, verification, validation and traceability. 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. Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE B850 to be as safe, as effective, and the performance to be 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.

Specification	CARESCAPE B850(K191323)	ProposedCARESCAPE B850	Differences
Patient type	Adult, pediatric &neonatal	Adult, pediatric &neonatal	Identical
Useenvironments	Within a professionalhealthcare facility (Notintended for MRI)	Within a professionalhealthcare facility (Notintended for MRI)	Identical
Size (H x W xD) & Weight	91 mm x 401 mm x 340mm(3.6 in x 15.8 in x 13.4 in)and weight 7.5 kg (16.5lbs)	91 mm x 401 mm x 340mm(3.6 in x 15.8 in x 13.4 in)and weight 7.5 kg (16.5lbs)	Identical
Module Housing	Up to 12 optional E-module slots with F5 andF7 Frames. One slidemount for acquisitionmodule	Up to 12 optional E-module slots with F5 andF7 Frames. One slidemount for acquisitionmodule	Identical
Display/screen	19" Active matrix colorTFT LCD	19" Active matrix colorTFT LCD	Identical
Waveforms andparameterwindows	Standard view: Up to 8individual waveforms andup to 20, if horizontalparameter area turned on.	Standard view: Up to 8individual waveforms andup to 20, if horizontalparameter area turned on.	Identical
Modules	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-sCAIOV, E-sCAIOVX,E-sCO, E-SCOV, E-sCOVX, PDM,CARESCAPE ONE	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-SCAIOV, E-sCAIOVX,E-sCO, E-SCOV, E-sCOVX, PDM,CARESCAPE ONE	Identical
Optional systemcomponents	-Remote Control-CARESCAPE D19KTVER01 display-CARESCAPE RAD,Remote Alarm Device-Keyboard-Mouse-Barcode scanner-Laser Printer	-Remote Control-CARESCAPE D19KTVER01 display-CARESCAPE RAD,Remote Alarm Device-Keyboard-Mouse-Barcode scanner-Laser Printer-E-musb Interface module	EquivalentAdded E-musb Interface modulethat provides a communication pathfor the OEM owned devicesCARESCAPE rSO2 – INVOS andCARESCAPE CO2 – Microstreamto the CARESCAPE Bx50 hostmonitors
Availablemeasurementparameters
	ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, cardiacoutput (thermodilutionand pulse contour),temperature, mixedvenous oxygen saturation,and central venousoxygen saturation,impedance respiration,airway gases (CO2, O2,N2O, and anestheticagents), spirometry, gasexchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission.	ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, regionaloxygen saturation, totalhemoglobinconcentration, cardiacoutput (thermodilutionand pulse contour),temperature, mixedvenous oxygen saturation,and central venousoxygen saturation,impedance respiration,airway gases (CO2, O2,N2O, and anestheticagents), spirometry, gasexchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission.	EquivalentAdded hemodynamic parameters (inbold) that are previously cleared butare new to the monitor:regional oxygen saturation and totalhemoglobin concentration, oftenreferred to as rSO2 and SpHb. TheIndications for Use were updatedaccordingly.The CARESCAPE B850 does notchange the measurement oralgorithm of these parameters butsimply displays the values from theOEM ownedCARESCAPE parameter devicesCARESCAPE SpO2 –Masimo andCARESCAPE rSO2 –INVOS.
EK-Proarrhythmiadetectionalgorithm	EK-Pro V14	EK-Pro V14	Identical
Printing	Local recorder/printer andnetworked laser printer.Printings for waveforms,alarms waveforms,numeric trends.	Local recorder/printer andnetworked laser printer.Printings for waveforms,alarms waveforms,numeric trends.	Identical
Mountingoptions	Multiple GCX mountingsystems	Multiple GCX mountingsystems	Identical
Alarms	Alarm management corefunctionalities:Classification and notification ofalarmsAdjustment of alarm settingsPossibility to set critical alarmlimitsAlarm On/Off functionality andaudio silencing	Alarm management corefunctionalities:Classification and notification ofalarmsAdjustment of alarm settingsPossibility to set critical alarmlimitsAlarm On/Off functionality andaudio silencing	Identical
Networkingcapability	CARESCAPE NetworkLAN/VLAN	CARESCAPE NetworkLAN/VLAN	Identical
Networkinterface	10baseT, 100baseT	10baseT, 100baseT	Identical