Who is the manufacturer of CARESCAPE B450?

GE Healthcare Finland Oy filed the 510(k) submission for CARESCAPE B450 (K191249).

What is the FDA product code for CARESCAPE B450?

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 B450?

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

What are the predicate devices for CARESCAPE B450?

CARESCAPE Monitor B450 (K132533); CARESCAPE Monitor B850 (K131414); CARESCAPE Monitor B650 (K131223).

Who can help prepare an FDA 510(k) submission like CARESCAPE B450?

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 B450

K191249 · GE Healthcare Finland Oy · MHX · Jan 24, 2020 · Cardiovascular

Device Facts

Record ID	K191249
Device Name	CARESCAPE B450
Applicant	GE Healthcare Finland Oy
Product Code	MHX · Cardiovascular
Decision Date	Jan 24, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 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 B450 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 B450 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 B450 also shows alarms from other ECG sources. The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B450 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; supports adult, pediatric, and neonatal patients. Inputs: ECG, invasive/non-invasive pressure, pulse oximetry, cardiac output, temperature, gas exchange, EEG, Entropy, BIS, neuromuscular transmission. Operation: processes physiological signals via internal CPU; displays waveforms/numerics on 12-inch touch screen; generates alarms for arrhythmias and parameter thresholds. Connectivity: network-enabled for remote viewing/data management; supports USB accessories (e.g., Remote Alarm Device). Clinicians use output for real-time patient assessment and decision-making. Benefits: continuous monitoring, early detection of physiological changes, and alarm management to reduce fatigue.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing, including hardware (EMC, electrical safety, environmental, battery) and software verification/validation. Usability testing (formative and summative) performed to validate user interface and alarm management.

Technological Characteristics

12-inch TFT LCD monitor; Freescale ARM Cortex-A9 CPU; rechargeable Li-ion batteries. Connectivity: LAN/VLAN, WLAN (802.11abgn, 802.11r fast roaming, WPA2-Enterprise). Sterilization: N/A. Software: CARESCAPE Software V3. Standards: IEC 60601-1-8 (alarms), IEC 62133 (batteries), UL 2054, UL 60950-1.

Indications for Use

Indicated for monitoring adult, pediatric, and neonatal patients in professional healthcare facilities and during 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 B450 (K132533)
CARESCAPE Monitor B850 (K131414)
CARESCAPE Monitor B650 (K131223)

Reference Devices

CARESCAPE Respiratory Modules, EsCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX (K150245)

Related Devices

K102239 — CARESCAPE MONITOR B650 · GE Healthcare Finland Oy · Oct 18, 2010
K131414 — CARESCAPE MONITOR B850 · GE Healthcare Finland Oy · Aug 28, 2013
K191323 — Carescape B850 · GE Healthcare Finland Oy · Jan 29, 2020
K092027 — CARESCAPE MONITOR B850 · Ge Medical Systems Information Technologies · Aug 28, 2009
K171901 — uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 15, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 24, 2020 GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 00510 Helsinki Finland Re: K191249 Trade/Device Name: CARESCAPE B450 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 20, 2019 Received: December 23, 2019 Dear Joel Kent: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191249 Device Name CARESCAPE B450 #### Indications for Use (Describe) The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 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 B450 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 B450 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 B450 also shows alarms from other ECG sources. The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B450 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 B450 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. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circle. The background of the circle is black, while the letters and the decorative flourishes around them are white, creating a high-contrast design. 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, 2019 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 B450 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) Primary predicate: (807.92(a)(3): K132533 CARESCAPE Monitor B450 Additional predicates: K131414 CARESCAPE Monitor B850 K131223 CARESCAPE Monitor B650 {7}------------------------------------------------ ## Device Description (807.92(a)(4)): CARESCAPE B450 V3 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 V3 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software version 3 and one or two batteries. CARESCAPE B450 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 V3 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 V3 includes features and subsystems that are optional or configurable. ### Intended Use: (807.92(a)(5): Indications (from labeling) The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility. The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 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). The CARESCAPE B450 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 B450 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 {8}------------------------------------------------ tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources. The CARESCAPE B450 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B450 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 B450 is not intended for use in a controlled MR environment. The CARESCAPE B450 with CARESCAPE Software version 3 Technology (807.92(a)(6)): incorporates updated hardware and a new software platform. > The fundamental function and operation of the proposed CARESCAPE B450 V3 monitor is unchanged compared to CARESCAPE Monitor B450 with ESP V2 software (K132533). All monitored parameters are identical compared to the predicate except now we have added support for gas exchange parameters in the CARESCAPE B450 V3 indications for use. In 2015 the single-width gas module that includes gas exchange parameters received clearance in CARESCAPE Respiratory Modules, EsCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX (K150245). As a result, when using the E-sCOVX or EsCAiOVX modules with gas exchange option and the CARESCAPE B450 V3 we can enable monitoring of O2 consumption (VO2), CO2 production (VCO2), energy expenditure (EE) and respiratory quotient (RQ). These gas exchange parameters are not new to our product line as they are present already in both the predicate CARESCAPE Monitor B850 (K131414) and CARESCAPE Monitor B650 (K131223). A summary of the main changes compared to the predicate are listed below in the comparison table. {9}------------------------------------------------ | Specification | CARESCAPE Monitor B450 with ESP V2 software (K132533) | CARESCAPE B450 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 | 290 x 310 x 160 mm (11.4 x 12.1 x 6.2 in) and 4.7 kg (10.4 lbs) with batteries but without modules | 290 x 310 x 160 mm (11.4 x 12.1 x 6.2 in) and weight 4.7 kg (10.4 lbs) with batteries but without modules | Identical | | Processor | Intel Atom Z510 1,1GHz | Freescale ARM Cortex-A9 | Equivalent The CARESCAPE Bx50 V3 monitors have an updated common CPU platform. | | Module Housing | One optional E-module slots and optional recorder. One slide mount for acquisition module | One optional E-module slots and optional recorder. One slide mount for acquisition module | Identical | | Display/screen | 12" Active matrix color TFT LCD | 12" Active matrix color TFT LCD | Identical | | Waveforms and parameter windows | Standard view: Up to 6 individual waveforms and up to 16 parameter windows, if horizontal parameter area turned on | Standard view: Up to 6 individual waveforms and up to 16 parameter windows, if horizontal parameter area turned on | Identical | | Modules | E-PSM; E-PSMP, E-miniC, 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, 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-sCAIOE, E- sCAIOV, E-sCAIOVX, E- sCAIOVE, 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 (K150245). | | Specification | CARESCAPE Monitor B450 with ESP V2 software (K132533) | CARESCAPE B450 with Differences CSP software version V3 | | | 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, 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. | Added support for gas exchange parameters in the CARESCAPE B450 V3 indications for use. These gas exchange parameters are not new to our product line as they are present already in both the predicate CARESCAPE Monitor B850 (K131414) and CARESCAPE Monitor B650 (K131223). The reason for not including these in the predicate CARESCAPE Monitor B450 (K132533) was simply a limitation because at the time (2013) the older gas modules that allowed gas-exchange were double-width size and these size modules only fit in the predicate B650 and B850 monitors but not in the predicate B450 which only has a single-width E-module slot. In 2015 the single-width gas module that includes gas exchange parameters received clearance in CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAIO, E-SCAIOV, E-SCAIOVX (K150245). As a result when using the E-sCOVX or E-sCAIOVX modules with gas exchange option and the CARESCAPE B450 V3 we can enable monitoring of O2 consumption (VO2), CO2 production (VCO2), energy expenditure (EE) and respiratory quotient (RQ). The gas exchange parameters and calculations are identical to the predicate CARESCAPE Monitor B850 (K131414) and CARESCAPE Monitor B650 (K131223) monitors. | | Specification | CARESCAPE Monitor B450 with ESP V2 software (K132533) | CARESCAPE B450 with Differences CSP software version V3 | | | EK-Pro arrhythmia detection algorithm | EK-Pro V13 | EK-Pro V14 | Equivalent CARESCAPE B450 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 Versio 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 | | Mounting options | Multiple GCX mounting systems, Roll Stand, Quick Mount, Bed Rail Hooks | Multiple GCX mounting systems, Roll Stand, Quick Mount, Bed Rail Hooks | Identical | | Alarms | Alarm management core functionalities: Classification and notification of alarms Adjustment of alarm settings Alarm On/Off functionality and Possibility to set critical audio silencing | Alarm management core functionalities: Classification and notification of alarms Adjustment of alarm settings 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 | CARESCAPE B450 with Differences | | | | B450 with ESP V2 | CSP software version V3 | | | | software (K132533) | | | | Remote Alarm | Alarm Interface of ESP V2 SW Alarm Interface to the | | Equivalent | | Device | was not utilized | Remote Alarm Device, | The predicate device did not | | | | CARESCAPE RAD | 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…