Who is the manufacturer of CARESCAPE B650?

GE Healthcare Finland Oy filed the 510(k) submission for CARESCAPE B650 (K191149).

What is the FDA product code for CARESCAPE B650?

MHX. It is classified under 21 CFR 870.1025 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CARESCAPE B650?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CARESCAPE B650?

CARESCAPE Monitor B650 (K131223).

Who can help prepare an FDA 510(k) submission like CARESCAPE B650?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARESCAPE B650

K191149 · GE Healthcare Finland Oy · MHX · Jan 21, 2020 · Cardiovascular

Device Facts

Record ID	K191149
Device Name	CARESCAPE B650
Applicant	GE Healthcare Finland Oy
Product Code	MHX · Cardiovascular
Decision Date	Jan 21, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic 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 B650 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 B650 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 B650 also shows alarms from other ECG sources. The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B650 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.

Device Story

Multi-parameter patient monitor for professional healthcare facilities; monitors hemodynamic, respiratory, and neurophysiological signals via connected acquisition modules (PDM, CARESCAPE ONE, E-Modules). Transforms physiological inputs into real-time waveforms, numeric trends, and alarm notifications; utilizes EK-Pro V14 algorithm for arrhythmia detection. Operated by clinicians; provides visual/audible alerts and data for clinical decision-making. Supports stand-alone use or network integration for remote viewing and data management. Benefits include continuous patient status oversight and alarm management to reduce fatigue. Updated hardware (ARM Cortex-A9) and software platform (CSP V3) compared to predicate; includes USB support for remote alarm devices (CARESCAPE RAD).

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing, including software verification/validation, hardware performance, electromagnetic compatibility, electrical safety, and usability testing.

Technological Characteristics

15-inch TFT LCD display; ARM Cortex-A9 processor; rechargeable Li-ion battery. Supports wired (10/100baseT) and wireless (802.11abgn) networking with WPA2-Enterprise and IEEE 802.11r fast roaming. Modular design with E-module slots and ePort interface. Software-based arrhythmia detection (EK-Pro V14). Complies with IEC 60601-1-8 for alarm defaults.

Indications for Use

Indicated for monitoring adult, pediatric, and neonatal patients in professional healthcare facilities, including intra-hospital transport. Monitors hemodynamic, respiratory, and neurophysiological status. Contraindicated for use in controlled MR environments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

CARESCAPE Monitor B650 (K131223)

Related Devices

K191323 — Carescape B850 · GE Healthcare Finland Oy · Jan 29, 2020
K131223 — CARESCAPE MONITOR B650 · GE Healthcare Finland Oy · Aug 28, 2013
K102239 — CARESCAPE MONITOR B650 · GE Healthcare Finland Oy · Oct 18, 2010
K151063 — Monitor B40 · Ge Medical Systems China Co., Ltd. · Dec 15, 2015
K131414 — CARESCAPE MONITOR B850 · GE Healthcare Finland Oy · Aug 28, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. January 28, 2020 GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 00510 Helsinki Finland Re: K191149 Trade/Device Name: CARESCAPE B650 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 18, 2019 Received: December 20, 2019 Dear Joel Kent: This letter corrects our substantially equivalent letter of January 21, 2020. 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 W. Shih -S Jennifer Shih Assistant Director (Acting) 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191149 Device Name CARESCAPE B650 #### Indications for Use (Describe) The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic 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 B650 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 B650 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 B650 also shows alarms from other ECG sources. The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B650 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 B650 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. {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}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular border. The letters are stylized with curved lines, giving them a classic and elegant appearance. The logo is presented in black and white, with the letters and border in black against a white background. 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 B650 | | Common/Usual Name: | Multiparameter patient monitor (monitor, physiological, patient (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 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 {6}------------------------------------------------ 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): | K131223 CARESCAPE Monitor B650 | | Device Description (807.92(a)(4)): | CARESCAPE B650 V3 is a new version of a portable multi- parameter patient monitoring system. The CARESCAPE B650 V3 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software version 3 and the battery. CARESCAPE B650 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B650 V3 is also equipped with two module slots where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B650 V3 includes features and subsystems that are optional or configurable. | | Intended Use: (807.92(a)(5): | Indications (from labeling) The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 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 B650 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 B650 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 B650 also shows alarms from other ECG sources. The CARESCAPE B650 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B650 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 B650 is not intended for use in a controlled MR environment. Technology (807.92(a)(6)): CARESCAPE B650 with CARESCAPE Software version 3 incorporates updated hardware and a new software platform. > The fundamental function and operation of the proposed CARESCAPE B650 V3 monitor are unchanged compared to CARESCAPE Monitor B650 with ESP V2 software (K131223). There are no new types of monitored parameters introduced compared to the predicate B650 monitor. A summary of the main changes compared to the predicate are listed below in the comparison table. {8}------------------------------------------------ | Specification | CARESCAPE Monitor B650 with ESP V2 software (K131223) | CARESCAPE B650 with CSP software version V3 | Differences | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical | | | Use environments | Within a professional healthcare facility (Not intended for MRI) | Within a professional healthcare facility (Not intended for MRI) | Identical | | | Size (H x W x D) & Weight | 360 x 370 x 220 mm (14.2 x 14.6 x 8.7 in) and weight 9.2 kg (20.3 lbs) with battery but without modules | 360 x 370 x 220 mm (14.2 x 14.6 x 8.7 in) and weight 9.2 kg (20.3lbs) with battery but without modules. | Identical | | | Processor | Freescale PowerPC MPC8270 | Freescale ARM Cortex-A9 | Equivalent The CARESCAPE Bx50 V3 monitors have an updated common CPU platform. | | | Module Housing | Two optional E-module slots and optional recorder. One slide mount for acquisition module | Two optional E-module slots and optional recorder. One slide mount for acquisition module | Identical | | | Display/screen | 15" Active matrix color TFT LCD | 15" Active matrix color TFT LCD | Identical | | | Waveforms and parameter windows | Standard view: Up to 8 individual waveforms and up to 20 parameter windows, if horizontal parameter area turned on. | Standard view: Up to 8 individual waveforms and up to 20 parameter windows, if horizontal parameter area 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 | 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 | Equivalent Removed support for several legacy E/M multiparameter hemodynamic acquisition modules as many newer acquisition modules are included, covering the same parameters. Added support for CARESCAPE ONE and E-EEGX acquisition modules. Added support for E- sCAIOVX and E- sCOVX modules | | | Specification | CARESCAPE Monitor B650 with ESP V2 software (K131223) | CARESCAPE B650 with CSP software version V3 | Differences | | | Available parameters | 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, impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange, electroencephalography, Entropy, Bispectral Index (BIS), neuromuscular transmission. | 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, impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange, electroencephalography, Entropy, Bispectral Index (BIS), neuromuscular transmission. | Identical | | | EK-Pro arrhythmia detection algorithm | EK-Pro V13 | EK-Pro V14 | Equivalent CARESCAPE B650 V3 uses an EK-ProV14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors. | | | Graphical user interface | GE Healthcare Common User Interface (CUI) Requirements and Style Version 6 | GE Healthcare HDX | A new color scheme for the display and slight visual adjustments have been incorporated, in line with a GE Healthcare wide user interface design guideline. The overall user interface layout, structure, operations, and workflow remains the same as the predicate. | | | Printing | Built-in or central and networked laser printer Printings for waveforms, alarms waveforms, numeric trends | Built-in or central and networked laser printer Printings for waveforms, alarms waveforms, numeric trends | Identical | | | Specification | CARESCAPE Monitor B650 with ESP V2 software (K131223) | CARESCAPE B650 with CSP software version V3 | Differences | | | Mounting options | Multiple GCX mounting systems, Roll Stand, Quick Mount | Multiple GCX mounting systems, Roll Stand, Quick Mount | Identical | | | Alarms | Alarm management core functionalities: Classification and notification of alarms Adjustment of alarm settings Alarm On/Off functionality and audio silencing | Alarm management core functionalities: Classification and notification of alarms Adjustment of alarm settings Possibility to set critical alarm limits Alarm On/Off functionality and audio silencing | Equivalent The predicate already included the options to configure some alarm settings. In V3, more flexibility was added for the user to adjust alarm priorities and alarm criteria for additional parameter alarms, including additional alarm delay options, critical alarm options, alarm acknowledgement and latched alarm indicators, and a pause monitoring & central function. In general, options for tailored/specific alarm management schemes have been added supporting clinicians in their goals of reducing alarm fatigue while maintaining safety. Default setting are according to IEC 60601- 1-8. | | | Specification | CARESCAPE Monitor B650 with ESP V2 software (K131223) | CARESCAPE B650 with CSP software version V3 | Differences | | | Remote Alarm Device | Alarm Interface of ESP V2 SW was not utilized | Alarm Interface to the Remote Alarm Device, CARESCAPE RAD | Equivalent The predicate device did not support the connector type of the Remote Alarm Box with Remote Light (RAB RL). Therefore, the Alarm Interface of ESP V2 could not be utilized The CARESCAPE RAD is the new USB accessory for use with the CARESCAPE B650 V3. As the proposed CARESCAPE B650 V3 provides USB connection, now the Alarm Interface of the CARESCAPE B650 V3 is utilized for remote alarming. The CARESCAPE RAD is intended for relaying primary alarm signals from the host device to an external distributed alarm system, i.e. a nurse call system or a remote alarm light. The CARESCAPE B650 V3 alarm functionality is unaffected when using the CARESCAPE RAD as the new accessory simply receives data from the monitor (one- way communication) to indicate when an alarm is active or not. | | | | Intrahospital transport within a professional healthcare facility. | Yes | Yes | Identical | | | Battery operation | Rechargeable Lithium-Ion batteries | Rechargeable Lithium-Ion batteries | Identical | | | Specification | CARESCAPE Monitor B650 with ESP V2 software (K131223) | CARESCAPE B650 with CSP software version V3 | Differences | | | Networking capability | CARESCAPE Network LAN/VLAN Optional WLAN | CARESCAPE Network LAN/VLAN Single wire network configuration supported for CARESCAPE Networks Optional WLAN | Equivalent The single wire network configuration simplifies the installation and maintenance of CARESCAPE B650 V3 patient monitors. The single wire network configuration has no impact on clinical monitoring. | | | Network interface…