The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment.

Device Description

CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).

CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the CARESCAPE ONE device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a direct table of specific acceptance criteria with corresponding performance values for all features. However, it does highlight performance claims and comparisons for key components, specifically arrhythmia detection and SpO2.

Parameter/Feature	Acceptance Criteria (Implied by Predicate Equivalence & Standards)	Reported Device Performance (CARESCAPE ONE)
Arrhythmia Detection	Performance equivalent to EK-Pro V13 (predicate).	EK-Pro V14: Substantially equivalent EC57 results and performance values to EK-Pro V13.
SpO2 Accuracy	Performance as per ISO 80601-2-61:2011 and FDA guidance.	TruSignal V3 SpO2: Accuracy validated in controlled desaturation study during motion and non-motion conditions, compared to CO-oximetry.
Other Parameters	Equivalent performance to PDM (K071073) and B450 (K132533)	Same parameter acquisition technology as PDM, integrated differently. CO2 measurement technology previously cleared and used by GE Healthcare.
Electrical Safety	Compliance with applicable consensus standards.	Bench testing demonstrated compliance.
EMC	Compliance with applicable consensus standards.	Bench testing demonstrated compliance.
Environmental (Mech.)	Compliance with applicable consensus standards.	Bench testing demonstrated compliance.
Usability	Safe and effective for intended users/uses.	Extensive usability work, including critical task identification, formative, and summative testing.
Software Level of Concern	Major	Software design, development, verification, validation, and traceability provided.
Biocompatibility	Applicable for patient-contacting components.	Biocompatibility testing completed for patient cables with intermittent skin contact.
Cybersecurity	Compliance with FDA guidance for medical device cybersecurity.	Security Risk Assessment, Threat model, Penetration testing, system integrity, access, audit, network, and remote service controls.

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

Arrhythmia (EK-Pro V14): The document references ANSI/AAMI EC57:1998 (R)2012. This standard specifies databases (e.g., AHA, MIT-BIH) that are used for testing arrhythmia algorithms. The specific sample size from these databases used for EK-Pro V14 testing is not explicitly stated in this 510(k) summary, but it would be derived from the standard's requirements.
- Data Provenance: The databases mentioned in EC57 are typically retrospective, internationally recognized ECG databases. The exact country of origin for the data used for this specific EK-Pro V14 validation is not specified, but the standard's databases often compile data from various global sources.
SpO2 (TruSignal V3): The document states a "controlled desaturation study." The sample size is not explicitly stated in this summary.
- Data Provenance: A controlled desaturation study is a prospective clinical study designed to test pulse oximeter accuracy. The country of origin for this study is not specified.

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

Arrhythmia (EK-Pro V14): When using standard databases like those referenced by ANSI/AAMI EC57, the ground truth (arrhythmia annotations) is typically established by multiple, highly experienced cardiologists or cardiac electrophysiologists. The exact number and qualifications for the original annotation of the standard databases are not specified in this document, as the standard itself defines these.
SpO2 (TruSignal V3): For controlled desaturation studies, the "ground truth" for SpO2 is provided by a CO-oximeter measurement, which itself is a highly accurate laboratory method for oxygen saturation. This is an objective measurement rather than expert consensus. Therefore, "experts" in the traditional sense for establishing ground truth are not directly applicable here.

4. Adjudication Method for the Test Set

Arrhythmia (EK-Pro V14): For standard databases, ground truth annotation often involves multiple experts reviewing and adjudicating discrepancies, sometimes with a "majority rules" or senior expert decision process. The specific adjudication method for the creation of the databases referenced by EC57 is not detailed in this summary, but would adhere to the methodologies defined by the creators of those databases.
SpO2 (TruSignal V3): As the ground truth comes from CO-oximetry, an objective measurement, adjudication by experts is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This indicates that human-in-the-loop performance with or without AI assistance was not assessed in this submission for primary equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, standalone performance was assessed for key algorithms:
- EK-Pro V14 Arrhythmia Detection algorithm: Its performance was evaluated against the ANSI/AAMI EC57 standard, comparing it to the predicate's EK-Pro V13 algorithm. This is a standalone algorithm performance evaluation.
- TruSignal V3 SpO2 algorithm: Its accuracy was validated in a controlled desaturation study against CO-oximetry. This is also a standalone algorithm performance evaluation.

7. The Type of Ground Truth Used

Arrhythmia (EK-Pro V14): The ground truth would be expert consensus annotations of ECG waveforms from standard arrhythmia databases (e.g., those specified in ANSI/AAMI EC57).
SpO2 (TruSignal V3): The ground truth was objective laboratory measurement using CO-oximetry in a controlled study. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size used for training the EK-Pro V14 arrhythmia detection algorithm or the TruSignal V3 SpO2 algorithm. In 510(k) submissions, training set details (especially for existing, updated algorithms) are often not required to be as extensively disclosed as test set performance, particularly when demonstrating equivalence to a predicate.

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

The document does not explicitly state how the ground truth for the training sets of the EK-Pro V14 or TruSignal V3 SpO2 algorithms was established. For complex algorithms like these, training data is typically meticulously annotated by a combination of clinical experts (for arrhythmia) or using highly accurate reference methods (for SpO2) and then verified. Again, in a 510(k) for an updated algorithm or component, the full developmental history and training data specifics may not be detailed if the focus is on demonstrating equivalent performance post-modifications.

Summary

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December 20, 2019

GE Healthcare Joel Kent Senior Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, Wisconsin 53223

Re: K190008

Trade/Device Name: CARESCAPE ONE 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. MLD. DSI. BZO. DXN. DOA. DPZ. DRT. DSJ. DSK. FLL. CCK Dated: November 15, 2019 Received: November 18, 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.

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

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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 Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190008

Device Name CARESCAPE ONE

Indications for Use (Describe)

The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment.

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)

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Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular border. The background is black, and the logo is white, creating a strong contrast. The design is simple, yet recognizable.

GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, Wisconsin 53223

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:	December 20, 2019
Owner/Submitter:	GE Medical Systems Information Technologies, Inc.8200 West Tower AvenueMilwaukee, Wisconsin 53223
Primary Contact Person:	Joel KentSenior Regulatory Affairs ManagerGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com
Secondary Contact Person:	Monica MorrisonRegulatory Affairs DirectorGE HealthcarePhone: 608-515-3077E-mail: monica.morrison@ge.com

Device names (807.92(a)(2)):

Trade Name: CARESCAPE ONE 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 ST-

segment measurement and alarm)

21 CFR 868.2375 monitor, breathing frequency

21 CFR 868.1400 analyzer, gas, carbon-dioxide, 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 870.1130 system, measurement, blood-pressure, noninvasive

21 CFR 870.2910 thermometer, electronic, clinical

21 CFR 870.1025 monitor, st segment with alarm

Product Code: MHX

Subsequent Product Codes: BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, MLD

The primary predicate for this submission is K071073, Patient Predicate Device(s) (807.92(a)(3)): Data Module (PDM)

Additional predicates/reference devices: K132533 CARESCAPE Monitor B450 K022834 Pro1000 K080251 APEXPRO TELEMETRY SYSTEM K011000 TRAM module K051367 DASH 3000/4000/5000 monitoring systems K900598 TRAMSCOPE SYSTEM K171580 B105/B125 monitor K151063 Monitor B40 K110028 MASIMO RADICAL Y PULSE CO-OXIMETER K172482 The Nellcor pulse oximetry monitor interface cable. K053174 LOFLO C5 CO2 SENSOR K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM

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Device Description (807.92(a)(4)):

CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

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

Indications (from labeling)

The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure. SpO2. pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

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

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

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment

The CARESCAPE ONE is a new multi-parameter monitor, Technology (807.92(a)(6)): introducing equivalent features and enhancements to existing features from two predicate devices. The primary predicate device is the PDM (K071073), and the main additional predicate used in this comparison is the CARESCAPE Monitor B450 with ESP V2 software (K132533).

The CARESCAPE ONE can be used as a full-standalone multiparameter monitor [equivalent to the CARESCAPE Monitor B450 (K132533) using the PDM (K071073)], providing the users the acquired display values, waveforms and alarms without the necessity of requiring a separate host monitor. The CARESCAPE ONE monitor's size is small and compact to support use in intra-hospital transport as well.

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Some key features of the device are summarized below:

· The CARESCAPE ONE includes a touch screen display allowing the user to control the monitor's functions and display. · CARESCAPE ONE can be used as a stand-alone monitor This is equivalent to the functionality to the predicate CARESCAPE Monitor B450 using the PDM module. · The CARESCAPE ONE uses Active Cable Modules (also called Parameters) where the specific parameter electronics are encapsulated into the respective patient cables, allowing the monitor to be as compact as possible. In the PDM, the electronics related to a specific parameter, such as ECG, were contained within the PDM itself. In this case, the Active Cables Modules (ACMs) provide patient isolation, parameter data acquisition with signal conditioning, some signal processing, and USB communication back to the CARESCAPE ONE. The same technology to process and analyze the signals is maintained as compared to the predicate, and the equivalent functionality is maintained. However, the electronics are contained within the active cables themselves rather than inside the monitor. · Incorporates an alarm system that complies with IEC 60601-1-8:2012. Also adds additional flexibility for clinicians to tailor the alarms to their particular patient needs such as the ability to select/adjust the alarm priority levels for certain alarms and adjust time delays/alarm trigger delays. Alarms are displayed and alerted with visual alerts and audio directly on the CARESCAPE ONE Monitor.

· Uses a Common Software Platform (CSP) that is used for the user interface, service interface, operating system, parameter data processing, alarms, trends, security, power management, and battery control. The operating system and display use a similar lavout and look/feel as the CARESCAPE bedside monitors. This gives the user a similar experience across the various products.

· The CARESCAPE ONE incorporates the EK-Pro V14 arrhythmia detection algorithm into the monitor software. This is a slightly newer version of the EK-Pro algorithm that was utilized with the CARESCAPE Monitor B450 (EK-Pro v13), however it serves the same function and retains equivalent performance.

· The CARESCAPE ONE measures LoFlo Sidestream CO2. PDM did not measure CO2 on its own. The B450 does include the display of CO2 through associated parameter modules. The CARESCAPE ONE CO2 measurement technology has been

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used by GE Healthcare in other existing bedside devices. The technology for this measurement has been cleared by its OEM developer, Respironics Novametrix LLC, with 510(k) K053174. This same technology was incorporated into GE Healthcare Solar and Dash bedside monitors with our Capnostat/Capnoflex CO2 System 510(k) K083750. • The CARESCAPE ONE and the PDM can measure SpO2 with technology supplied by OEM manufacturers Masimo and Nellcor. The CARESCAPE ONE can also measure SpO2 with the GE Trusignal technology. This technology is used in multiple FDA cleared GE devices including the B105/B125 monitor (K171580) and the Monitor B40 (K151063).

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

Specification	CARESCAPE B450monitor with ESPV2(K132533)	PDM(K071073)	CARESCAPEONE	Discussion of DifferencesCARESCAPE ONE and Predicates
Patient type	Adult, pediatric &neonatal	Adult, pediatric &neonatal	Adult, pediatric &neonatal	Identical
Useenvironments	Within aprofessionalhealthcare facility(Not intended forMRI)	Within aprofessionalhealthcare facility(Not intended forMRI)	Within aprofessionalhealthcare facility(Not intended forMRI)	Identical
Intrahospitaltransport withina professionalhealthcarefacility.	Yes	Yes	Yes	Identical

Product Comparison versus Predicate Main features

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Specification	CARESCAPE B450monitor with ESPV2(K132533)	PDM(K071073)	CARESCAPEONE	Discussion of DifferencesCARESCAPE ONE and Predicates
MonitoredParameters	Parametersmonitored by B450with ESP V2include:- hemodynamic(ECG, ST segment,arrhythmiadetection, ECGdiagnostic analysisand measurement,invasive pressure,non-invasive bloodpressure, pulseoximetry, cardiacoutput(thermodilutionand pulse contour),temperature, mixedvenous oxygensaturation, andcentral venousoxygen saturation),- respiratory(impedancerespiration, airwaygases (CO2, O2,N2O, andanesthetic agents),spirometry, gasexchange)- neurophysiologicalstatus(electroencephalography, Entropy,Bispectral Index(BIS), andneuromusculartransmission)	Parametersmonitored by PDMinclude:- hemodynamic(ECG, ST segment,arrhythmia detection,invasive pressures,NIBP, temperature,and pulse oximetry)- respiratory(impedancerespiration)	Parametersmonitored byCARESCAPEONE include:- hemodynamic(ECG, STsegment,arrhythmiadetection, invasivepressures, NIBP,temperature, andpulse oximetry)- respiratory(impedancerespiration, CO2)	Equivalent. The CARESCAPE ONE monitors asubset of the parameters includedfor display on the B450.CARESCAPE ONE includes thesame parameters for measurementacquisition as the PDM, with theaddition of the LoFLo CO2measurement. PDM does notinclude the CO2 parameter. TheB450 does include the display ofCO2 through associated parametermodules. The CARESCAPE ONECO2 measurement technology hasbeen used by GE Healthcare inother existing bedside devices. Thetechnology for this measurementhas been cleared by its OEMdeveloper, Respironics NovametrixLLC, with 510(k) K053174. Thissame technology was incorporatedinto GE Healthcare Solar and Dashbedside monitors with ourCapnostat/Capnoflex CO2 System510(k) K083750. The additionalparameters included in B450 whichare not included in CARESCAPEONE, such as anesthetic agents,N2O, and BIS, are not necessary forthe function and use of theCARESCAPE ONE monitor. Thesechanges do not affect thedetermination of substantialequivalence.
Specification	CARESCAPE B450monitor with ESP	PDM(K071073)	CARESCAPEONE	Discussion of DifferencesCARESCAPE ONE and Predicates
	V2(K132533)
ParametersAcquisitionMethod	B450 connects tomultiple parameteracquisitionmodules, includingPDM (Masimo andNellcor), E-sCO.E-sCOV, E-sCAiO, E-sCAiOV, E-miniC,E-PSM, E-EEG, E-BIS, E-COP, E-ENTROPY, E-MASIMO, E-NMT, E-NSATX,E-P, E-PP, and E-PT for acquisitionof measuredparameters that aredisplayed on theB450.	The PDM is aparameteracquisition module,which includes theparameteracquisitionelectronics withinthe frame of thePDM.	TheCARESCAPEONE utilizes theActive CableModules (ACMs)OrPARAMETERS,in which theparameterelectronics areencapsulated intothe respectivepatient cables,rather than insidethe main frame ofthe monitor.Only the NIBPparameter isintegrated into theCARESCAPEONE monitor.Parameter/ActiveCable Modules:CARESCAPETEMP -TemperatureCARESCAPEPRES - InvasivePressureCARESCAPEECG - ECGCARESCAPESPO2 - TrusignalSPO2CARESCAPESPO2 Nellcor -Nellcor SPO2CARESCAPESPO2 Masimo -Masimo SPO2CARESCAPECO2 - LoFlo	EquivalentThe same parameter acquisitiontechnology is utilized in theCARESCAPE ONE as in thepredicate PDM, however, some ofthe specific parameter electronicsare encapsulated into the respectivepatient cables, allowing the monitorto be as compact as possible. In thePDM, the electronics related to aspecific parameter, such as ECG,were contained within the PDMitself. In this case, the Active CablesModules (ACMs) provide patientisolation, parameter data acquisitionwith signal conditioning, somesignal processing, and USBcommunication back to theCARESCAPE ONE. The sametechnology to process and analyzethe signals is maintained ascompared to the predicate, and theequivalent functionality ismaintained. However, theelectronics are contained within theactive cables themselves rather thaninside the monitor. The additionalmeasured parameter compared toPDM is CO2 as summarized in theline item above.The measurement technology andfunctionality remain equivalent tothe predicate.
EK-Proarrhythmiadetectionalgorithm	EK-Pro V13	EK-Pro v11	EK-Pro V14	The CARESCAPE ONEincorporates the EK-Pro V14arrhythmia detection algorithm intothe monitor software. This is aslightly newer version of the EK-Pro algorithm that was utilized withthe CARESCAPE Monitor B450(EK-Pro v13), however it serves thesame function and retainsequivalent performance.
Specification	CARESCAPE B450monitor with ESPV2(K132533)	PDM(K071073)	CARESCAPEONE	Discussion of DifferencesCARESCAPE ONE and Predicates
Size (H x W xD)	290 mm x 310 mmx 160 mm(11.4 in x 12.1 in x6.2 in)	Height 6.4 cm (2.5in.) maximumWidth 14.0 cm (5.5in.) maximumDepth 21.6 cm (8.5in.) maximum	155 mm x 270mm x 65 mm (6.1in x 10.6 in x 2.6in)Note: Excludesdock	Equivalent.The CARESCAPE ONE is a patientmonitor and performs the functionof both CARESCAPE PDM andCARESCAPE B450 combined. Asa patient monitor, the CARESCAPEONE has reduced size making iteasier to transport and mount. Thisimprovement does not impact thedetermination of substantialequivalence since it is only a changein the physical size of the device.
Weight	4.7 kg (10.4 lbs)with two batteriesbut withoutmodules	1.0 kg (2.2 lbs.)without optionalbattery1.2 kg (2.6 lbs.) withoptional battery	1.85 kg (4.1 lbs)with battery	Equivalent.The CARESCAPE ONE is a patientmonitor and performs the functionof both CARESCAPE PDM andCARESCAPE B450 combined. Asa patient monitor, the CARESCAPEONE has reduced weight making iteasier to transport and mount. Thisimprovement does not affect thedetermination of substantialequivalence since it is only a changein the weight of the of the devicemaking it lighter than the predicatecombination that performed similarfunctions.
Battery Type	Lithium-Ion	Lithium-ion	Lithium-ion	Identical
Display size	12.1 in	Not Applicable	7 inch	Equivalent.The smaller form factor of theCARESCAPE ONE required asmaller screen compared to theB450. The PDM does not have adisplay screen as it was used as aparameter acquisition module tocommunicate data to a patientmonitor, like B450. The smallerscreen is intended to make thedevice more transportable. Theparameter data, waveforms, andalarms adequately fit on the display.This smaller screen does not affectthe determination of substantialequivalence since it is only a changein the screen size of the device withspecific design to display numericsand waveforms as the predicate.
Specification	CARESCAPE B450monitor with ESPV2(K132533)	PDM(K071073)	CARESCAPEONE	Discussion of DifferencesCARESCAPE ONE and Predicates
Display type	Active matrix colorTFT LCD	Not Applicable	Active matrixcolor TFT LCD	Identical to B450.
Number oftraces(waveforms)	Up to 6, or up to 12if optional dualdisplay is used.	Not Applicable	Up to 8 with 4available on 2ndwaveform page.	Equivalent.The lower number of waveformsshown at one time, 4 verses 6, and 8verses 12, is due to having a smallerscreen and smaller set of availableparameters. These technicaldifferences are intentional to makethe CARESCAPE ONE moretransportable. The CARESCAPEB450 patient monitor also supportssome specialized parameters whichincludes more waveforms, and thesespecialized parameters are notavailable with the CARESCAPEONE. The CARESCAPE ONE canshow 8 waveforms with swiping toa second page/screen while theCARESCAPE B450 requires asecond physical display.Waveforms for all parameterssupported by the CARESCAPEONE can be displayed at the sametime using the second waveformpage. The lower number ofwaveforms shown does not affectthe determination of substantialequivalence since the devicedisplays waveforms for theparameters it specifies.
OperatingSystem	Linux OperatingSystem	Linux operatingsystem	Linux operatingsystem	Identical
Softwarepackages	5 softwarepackages:Emergency Care(ED), Critical Care(ICU), OperatingRoom (OR), Post-Anesthesia Care(PACU), NeonatalCare (NICU)	Not Applicable	5 softwarepackages:Emergency Care(ED), CriticalCare (ICU),Operating Room(OR), Post-Anesthesia Care(PACU), NeonatalCare (NICU)	Identical.
Specification	CARESCAPE B450monitor with ESPV2(K132533)	PDM(K071073)	CARESCAPEONE	Discussion of DifferencesCARESCAPE ONE and Predicates
Patient Networkfunctionality	WLAN, LAN	Not Applicable	Not Applicable	CARESCAPE ONE is not anetworked monitor. Patientmonitors do not require connectionto a clinical network for safe andeffective use. Therefore, this changedoes not affect the determination ofsubstantial equivalence since it hasbeen designed not to be directlyconnected to the network.
Patient Network	Yes	Yes	No	Equivalent.
Ethernet portconnector(RJ45-8-pin)	Three Ethernetports: NetworkMC, Network IX,Unity Network ID.	Powered EthernetTCP/IP andUSB	One Ethernet portfor service tools.	The Ethernet port on theCARESCAPE ONE is intended foraccess to service functions whenconnected to the F0 Dock. This portis not intended for nor will itcommunicate on a clinical network.CARESCAPE ONE is not anetworked monitor. Patientmonitors do not require connectionto a clinical network for safe andeffective use. Therefore, this changedoes not affect the determination ofsubstantial equivalence since it isonly a change in the use of thenetwork connection for service usesince this device does not connect tothe patient network.
Defaultsavailable	User selectablearrhythmia alarmlevels, Parametersettings and alarmlevels, defaultalarm limits,display layout,parameter priority,catheters, drugsand commonevents defaults. Upto 8 different pre-configured orcustom defaultsavailable. Not allparameters haveconfigurable alarmpriorities.	Not Applicable	User selectablearrhythmia alarmlevels, Parametersettings and alarmlevels, defaultalarm limits,display layout,parameter prioritydefaults. Up to 8different pre-configured orcustom defaultsavailable. Not allparameters haveconfigurablealarm priorities.	Equivalent.The CARESCAPE ONE does notsupport catheters, drugs andcommon events. Other defaultsavailable are equivalent. Support forthese are features and not essentialto the use of the device, andtherefore this change does not affectthe determination of substantialequivalence since it is only a changedue to the fact that the devicesupports different parameterscompared to the predicate.
AlarmClassification(IEC)	Four levels –High, Medium,Low andInformational	Not Applicable	Four levels –High, Medium,Low andInformational	Identical to B450. The predicatePDM is a parameter acquisitionmodule that provides data to thehost devices. PDM does not have adisplay and does not providealarms; alarms are provided fromthe host device. The CARESCAPEONE is a combination of theparameter acquisition technologyand function from the PDM, and the
Specification	CARESCAPE B450 monitor with ESP V2 (K132533)	PDM (K071073)	CARESCAPE ONE	Discussion of Differences CARESCAPE ONE and Predicates
Alarm Notification	Audible and visual	Not Applicable	Audible and visual	Identical
Technical alarms	System generated alarms to notify the user of special conditions.	Not Applicable	System generated alarms to notify the user of special conditions.	Identical

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Determination of

(807.92(b)(1)):

Substantial Equivalence

Summary of Non-Clinical Tests:

Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.

The hardware bench testing included electromagnetic compatibility, electrical safety, environmental (including Mechanical stress testing and Package Testing) and usability.

The CARESCAPE ONE has been found to be safe and effective for the intended users, uses and use environments. Extensive usability work has been completed for CARESCAPE ONE 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 was considered as a "Major" level of concern.

The CARESCAPE ONE monitor does not have direct contact with the patient. There are patient cables that can have unintended/intermittent intact skin contact with the patient and appropriate biocompatibility testing has been completed for those components.

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Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE ONE including a Security Risk Assessment, Threat model and Penetration testing. 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 for all parameter performance characteristics, including applicable consensus standards for ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, and CO2. The algorithms with changes compared to the predicates, EK-Pro V14 arrhythmia and TruSignal V3 SPO2 were validated as described below.

For EK-Pro V14 performance values for the applicable characteristics as defined in the ANSI/AAMI EC57:1998 (R)2012 standard has been provided to support a comparison of the EC57 results for the EK-Pro V14 algorithm (the subject device) to the predicate version EK-Pro V13 (K132533). The comparison demonstrates that the EC57 results and performance values are substantially equivalent between the subject V14 and predicate V13 versions of EK-Pro.

The accuracy of the SpO2 parameter as measured with the U-TruSignal ACM medical device (with TruSignal V3) during motion and non-motion conditions as compared to CO-oximetry in a controlled desaturation study was completed using the method as set forth by ISO 80601-2-61:2011 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013.

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

Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence.

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Conclusion (807.92(b)(3)):

Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE ONE 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.