Who is the manufacturer of Carescape B850, E-musb?

GE Healthcare Finland Oy filed the 510(k) submission for Carescape B850, E-musb (K213336).

What is the FDA product code for Carescape B850, E-musb?

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 B850, E-musb?

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

Who can help prepare an FDA 510(k) submission like Carescape B850, E-musb?

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 B850, E-musb

K213336 · GE Healthcare Finland Oy · MHX · Apr 13, 2022 · Cardiovascular

Device Facts

Record ID	K213336
Device Name	Carescape B850, E-musb
Applicant	GE Healthcare Finland Oy
Product Code	MHX · Cardiovascular
Decision Date	Apr 13, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), • respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and • neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources. The CARESCAPE B850 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Device Story

Modular multi-parameter patient monitor; includes 19-inch touchscreen, CPU, software, and module frames (F5/F7). Inputs: physiological signals via connected modules (ECG, pressure, pulse oximetry, gas, EEG, etc.). Transforms inputs into real-time waveforms, numeric values, trends, and alarms. Used in professional healthcare facilities by clinicians. Features E-musb interface for communication with OEM devices (e.g., INVOS rSO2, Microstream CO2). Displays data from Masimo SpO2 and INVOS rSO2 sensors. Provides arrhythmia detection (EK-Pro V14 algorithm). Output: visual/audible alarms, waveform displays, and data transmission to networked monitors/management software. Benefits: continuous patient status monitoring, early detection of physiological changes, and centralized data management for clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Modular system with 19-inch TFT LCD. Connectivity: CARESCAPE Network (LAN/VLAN), 10baseT/100baseT. Software: EK-Pro V14 arrhythmia algorithm. Hardware: F5/F7 module frames, E-musb interface. Sterilization: N/A (non-sterile).

Indications for Use

Indicated for monitoring adult, pediatric, and neonatal patients in professional healthcare facilities. 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 B850 (K191323)

Reference Devices

INVOS PM7100 Patient Monitor (K182868)
MASIMO RADICAL Y PULSE CO-OXIMETER (K110028)

Related Devices

K191323 — Carescape B850 · GE Healthcare Finland Oy · Jan 29, 2020
K102239 — CARESCAPE MONITOR B650 · GE Healthcare Finland Oy · Oct 18, 2010
K071020 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE · GE Healthcare · Jun 18, 2007
K131223 — CARESCAPE MONITOR B650 · GE Healthcare Finland Oy · Aug 28, 2013
K191249 — CARESCAPE B450 · GE Healthcare Finland Oy · Jan 24, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 13, 2022 GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, FI-00510 Finland Re: K213336 Trade/Device Name: Carescape B850, E-musb Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, BZK, BZL, BZQ, CAP, CBQ, CBR, CCK, CCL, DPS, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, DPZ, NHO, NHP, NHQ, OLT, QEM, OLW, OMC, ORT Dated: March 11, 2022 Received: March 14, 2022 Dear Joel Kent: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213336 Device Name CARESCAPE B850 #### Indications for Use (Describe) The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of: - · hemodynamic (including ECG, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), - · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and - · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources. The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. Contraindications for using the monitor The CARESCAPE B850 is not intended for use in a controlled MR environment. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki Finland T: +358 10 39411 ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: Owner/Contact/Date (807.92(a)(1)): | Date: | October 5, 2021 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner/Submitter: | GE Healthcare Finland Oy. Kuortaneenkatu 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: | Karin Mårtenson Regulatory Affairs Leader GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki Finland Phone: + 358 50 384 6646 E-mail: karin.martenson@ge.com | | Device names (807.92(a)(2)): | | CARESCAPE B850 Trade Name: Multiparameter patient monitor (monitor, physiological, patient Common/Usual Name: (with arrhythmia detection or alarms) {5}------------------------------------------------ Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm) 21 CFR 868.1850 spirometer, monitoring (w/wo alarm) 21 CFR 868.1730 computer, oxygen-uptake 21 CFR 868.2375 monitor, breathing frequency 21 CFR 868.2600 monitor, airway pressure (includes gauge and/or alarm) 21 CFR 868.1500 analyzer, gas, enflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, desflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, sevoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, isoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1700 analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) 21 CFR 868.1620 analyzer, gas, halothane, gaseous-phase (anesthetic conc.) 21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-phase 21 CFR 868.1720 analyzer, gas, oxygen, gaseous-phase 21 CFR 870.2340 electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 computer, diagnostic, programmable 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) 21 CFR 870.1025 detector and alarm, arrhythmia 21 CFR 870.1100 alarm, blood-pressure 21 CFR 870.1110 computer, blood-pressure 21 CFR 870.1435 computer, diagnostic, pre-programmed, single-function 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 870.2910 thermometer, electronic, clinical 21 CFR 882.1900 stimulator, auditory, evoked response 21 CFR 882.1400 full-montage standard electroencephalograph 21 CFR 870.2700 Oximeter, Tissue Saturation 21 CFR 868.2775 stimulator, nerve, peripheral, electric 21 CFR 870.1915 probe, thermodilution 21 CFR 870.1025 monitor, st segment with alarm 21 CFR 882.1400 non-normalizing quantitative electroencephalograph software 21 CFR 882.1400 index-generating electroencephalograph software 21 CFR 882.1400 reduced- montage standard electroencephalograph 21 CFR 882.1400 burst suppression detection software for electroencephalograph 21 CFR 870.2700 Cerebral Oximeter {6}------------------------------------------------ Product Code: MHX | Subsequent Product Codes: | BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QEM | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device(s) (807.92(a)(3)): | The primary predicate for this submission is K191323 CARESCAPE B850 Additional predicates / reference devices: K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor K110028, MASIMO RADICAL Y PULSE CO-OXIMETER | | Device Description (807.92(a)(4)): | CARESCAPE B850 is a new version of a modular multi- parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 includes features and subsystems that are optional or configurable. | | Intended Use: (807.92(a)(5)): | Indications (from labeling) The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of: • hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation) | {7}------------------------------------------------ · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission). The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources. The CARESCAPE B850 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices. The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. ### Contraindications for using the monitor The CARESCAPE B850 is not intended for use in a controlled MR environment. Technology (807.92(a)(6)): The CARESCAPE B850 incorporates incorporates updated software and minor modifications to the hardware. > The fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to CARESCAPE B850 (K191323). A summary of the main changes compared to the predicate are listed below in the comparison table. {8}------------------------------------------------ | Specification | CARESCAPE B850 (K191323) | Proposed CARESCAPE B850 | 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 | 91 mm x 401 mm x 340 mm (3.6 in x 15.8 in x 13.4 in) and weight 7.5 kg (16.5 lbs) | 91 mm x 401 mm x 340 mm (3.6 in x 15.8 in x 13.4 in) and weight 7.5 kg (16.5 lbs) | Identical | | Module Housing | Up to 12 optional E- module slots with F5 and F7 Frames. One slide mount for acquisition module | Up to 12 optional E- module slots with F5 and F7 Frames. One slide mount for acquisition module | Identical | | Display/screen | 19" Active matrix color TFT LCD | 19" Active matrix color TFT LCD | Identical | | Waveforms and parameter windows | Standard view: Up to 8 individual waveforms and up to 20, if horizontal parameter area turned on. | Standard view: Up to 8 individual waveforms and up to 20, if horizontal parameter area turned on. | Identical | | Modules | E-BIS, E-COP, E- COPSv, E-PiCCO, E- EEGX, E-Entropy, E- Masimo, E-miniC, E- NMT, E-NSATX, E-PP, E-PT, E-sCAIO , E- sCAIOV, E-sCAIOVX, E-sCO, E-SCOV, E- sCOVX, PDM, CARESCAPE ONE | E-BIS, E-COP, E- COPSv, E-PiCCO, E- EEGX, E-Entropy, E- Masimo, E-miniC, E- NMT, E-NSATX, E-PP, E-PT, E-sCAIO , E- SCAIOV, E-sCAIOVX, E-sCO, E-SCOV, E- sCOVX, PDM, CARESCAPE ONE | Identical | | Optional system components | -Remote Control -CARESCAPE D19KT VER01 display -CARESCAPE RAD, Remote Alarm Device -Keyboard -Mouse -Barcode scanner -Laser Printer | -Remote Control -CARESCAPE D19KT VER01 display -CARESCAPE RAD, Remote Alarm Device -Keyboard -Mouse -Barcode scanner -Laser Printer -E-musb Interface module | Equivalent Added E-musb Interface module that provides a communication path for the OEM owned devices CARESCAPE rSO2 – INVOS and CARESCAPE CO2 – Microstream to the CARESCAPE Bx50 host monitors | | Available measurement 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, regional oxygen saturation, total hemoglobin concentration, 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. | Equivalent Added hemodynamic parameters (in bold) that are previously cleared but are new to the monitor: regional oxygen saturation and total hemoglobin concentration, often referred to as rSO2 and SpHb. The Indications for Use were updated accordingly. The CARESCAPE B850 does not change the measurement or algorithm of these parameters but simply displays the values from the OEM owned CARESCAPE parameter devices CARESCAPE SpO2 –Masimo and CARESCAPE rSO2 –INVOS. | | EK-Pro arrhythmia detection algorithm | EK-Pro V14 | EK-Pro V14 | Identical | | Printing | Local recorder/printer and networked laser printer. Printings for waveforms, alarms waveforms, numeric trends. | Local recorder/printer and networked laser printer. Printings for waveforms, alarms waveforms, numeric trends. | Identical | | Mounting options | Multiple GCX mounting systems | Multiple GCX mounting systems | Identical | | Alarms | 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 | 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 | Identical | | Networking capability | CARESCAPE Network LAN/VLAN | CARESCAPE Network LAN/VLAN | Identical | | Network interface | 10baseT, 100baseT | 10baseT, 100baseT | Identical | Subject Device and Predicate Device Comparison {9}------------------------------------------------ Determination of Substantial Equivalence (807.92(b)(1): Summary of Non-Clinical Tests: {10}------------------------------------------------ Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B850, demonstrating the design meets the specifications. The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, and usability. Software testing included software design, development, verification, validation and traceability. Clinical (807.92(b)(2)): Summary of Clinical Tests: The subject of this premarket submission, CARESCAPE B850 did not require clinical studies to support substantial equivalence. Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE B850 to be as safe, as effective, and the performance to be substantially equivalent to the predicate device.