CARESCAPE B450, E-musb

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. April 13, 2022 GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, Helsinki FI-00510 Finland Re: K213363 Trade/Device Name: CARESCAPE B450, 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, CBS, CCK, CCL, DPS, OEM, DOA, DOK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, DPZ, NHO, NHP, NHQ, OLT, OLW, ORT, OMC 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) K213363 Device Name CARESCAPE B450 #### Indications for Use (Describe) The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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, 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 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}------------------------------------------------ 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 12, 2021 | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Owner/Submitter: | GE Healthcare Finland Oy.<br>Kuortaneenkatu 2<br>00510 Helsinki<br>FINLAND<br>Phone: +358 10 39411 | | Primary Contact Person: | Joel Kent<br>Senior Regulatory Affairs Manager<br>GE Healthcare<br>Phone: 617-851-0943<br>E-mail: joel.kent@ge.com | | Secondary Contact Person: | Karin Mårtenson<br>Regulatory Affairs Leader<br>GE Healthcare Finland Oy<br>Kuortaneenkatu 2<br>00510 Helsinki<br>Finland<br>Phone: + 358 50 384 6646<br>E-mail: karin.martenson@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 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) The primary predicate for this submission is K191249 CARESCAPE B450 (807.92(a)(3)): > 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 B450 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software and one or two batteries. CARESCAPE B450 is equipped with an ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 includes features and subsystems that are optional or configurable. Intended Use: (807.92(a)(5)): ## Indications for Use (from labeling) The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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, 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 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 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. Technology (807.92(a)(6)): The CARESCAPE B450 incorporates updated software and minor modifications to the hardware. > The fundamental function and operation of the proposed CARESCAPE B450 monitor are unchanged compared to CARESCAPE B450 (K191249). A summary of the main changes compared to the predicate are listed below in the comparison table. {8}------------------------------------------------ | Specification | CARESCAPE B450<br>(K191249) | Proposed<br>CARESCAPE B450 | Differences | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient type | Adult, pediatric &<br>neonatal | Adult, pediatric &<br>neonatal | Identical | | Use<br>environments | Within a professional<br>healthcare facility (Not<br>intended for MRI) | Within a professional<br>healthcare facility (Not<br>intended for MRI) | Identical | | Intrahospital<br>transport | Intrahospital transport<br>within a professional<br>healthcare facility. | Intrahospital transport<br>within a professional<br>healthcare facility. | Identical | | Size (H x W x<br>D) & Weight | 290 x 310 x 160 mm<br>(11.4 x 12.2 x 6.3 in) (H x<br>W x D) and weight 4.7 kg<br>(10.4 lbs) with two<br>batteries inserted but<br>without modules inserted. | 290 x 310 x 160 mm<br>(11.4 x 12.2 x 6.3 in) (H x<br>W x D) and weight 4.7 kg<br>(10.4 lbs) with two<br>batteries inserted but<br>without modules inserted. | Identical | | Module Housing | One E-module slot and<br>optional recorder. One<br>slide mount for<br>acquisition module. | One E-module slot and<br>optional recorder. One<br>slide mount for<br>acquisition module. | Identical | | Display/screen | Integrated 12" TFTcolor<br>LCD Display | Integrated 12" TFTcolor<br>LCD Display | Identical | | Waveforms and<br>parameter<br>windows | Standard view: Up to 6<br>individual waveforms and<br>up to 16 parameter<br>windows, if horizontal<br>parameter area turned on. | Standard view: Up to 6<br>individual waveforms and<br>up to 16 parameter<br>windows, if horizontal<br>parameter area turned on. | Identical | | Modules | E-BIS, E-COP, E-<br>COPSv, E-PiCCO, E-<br>EEGX, E-Entropy, E-<br>Masimo, E-miniC, E-<br>NMT, E-NSATX, E-PP,<br>E-PT, E-sCAiO , E-<br>sCAiOV, E-sCAiOVX,<br>E-sCO, E-sCOV, E-<br>sCOVX, PDM,<br>CARESCAPE ONE | E-BIS, E-COP, E-<br>COPSv, E-PiCCO, E-<br>EEGX, E-Entropy, E-<br>Masimo, E-miniC, E-<br>NMT, E-NSATX, E-PP,<br>E-PT, E-sCAiO , E-<br>sCAiOV, E-sCAiOVX,<br>E-sCO, E-sCOV, E-<br>sCOVX, PDM,<br>CARESCAPE ONE | Identical | | Optional system<br>components | -Remote Control<br>-CARESCAPE D19KT<br>VER01 optional display<br>-CARESCAPE RAD,<br>Remote Alarm Device<br>-Keyboard<br>-Mouse<br>-Barcode scanner<br>-Laser Printer | -Remote Control<br>-CARESCAPE D19KT<br>VER01 optional display<br>-CARESCAPE RAD,<br>Remote Alarm Device<br>-Keyboard<br>-Mouse<br>-Barcode scanner<br>-Laser Printer<br>-E-musb Interface module | Equivalent<br>Added E-musb Interface module<br>that provides a communication path<br>for the OEM owned devices<br>CARESCAPE rSO2 – INVOS and<br>CARESCAPE CO2 – Microstream<br>to the CARESCAPE Bx50 host<br>monitors | | Available<br>measurement<br>parameters | ECG, ST segment,<br>arrhythmia detection,<br>ECG diagnostic analysis<br>and measurement,<br>invasive pressure, non-<br>invasive blood pressure,<br>pulse oximetry, cardiac<br>output (thermodilution<br>and pulse contour),<br>temperature, mixed<br>venous oxygen saturation,<br>and central venous<br>oxygen saturation,<br>impedance respiration,<br>airway gases (CO2, O2,<br>N2O, and anesthetic<br>agents), spirometry, gas<br>exchange,<br>electroencephalography,<br>Entropy, Bispectral Index<br>(BIS), neuromuscular<br>transmission. | ECG, ST segment,<br>arrhythmia detection,<br>ECG diagnostic analysis<br>and measurement,<br>invasive pressure, non-<br>invasive blood pressure,<br>pulse oximetry, <b>regional<br/>oxygen saturation, total<br/>hemoglobin<br/>concentration</b> , cardiac<br>output (thermodilution<br>and pulse contour),<br>temperature, mixed<br>venous oxygen saturation,<br>and central venous<br>oxygen saturation,<br>impedance respiration,<br>airway gases (CO2, O2,<br>N2O, and anesthetic<br>agents), spirometry, gas<br>exchange,<br>electroencephalography,<br>Entropy, Bispectral Index<br>(BIS), neuromuscular<br>transmission. | Equivalent | | EK-Pro<br>arrhythmia<br>detection<br>algorithm | EK-Pro V14 | EK-Pro V14 | Identical | | Printing | Built-in or central and<br>networked laser printer<br><br>Printings for waveforms,<br>alarms waveforms,<br>numeric trends. | Built-in or central and<br>networked laser printer<br><br>Printings for waveforms,<br>alarms waveforms,<br>numeric trends. | Identical | | Mounting<br>options | Multiple GCX mounting<br>systems, roll stand, Quick<br>Mount, Bed Rail Hook,<br>BRH | Multiple GCX mounting<br>systems, roll stand, Bed<br>Rail Hook, BRH | Equivalent<br><br>Quick Mount is obsolete. | | Alarms | Alarm management core<br>functionalities:<br>Classification and<br>notification of alarms<br>Adjustment of alarm<br>settings<br>Possibility to set critical<br>alarm limits<br>Alarm On/Off<br>functionality and audio<br>silencing | Alarm management core<br>functionalities:<br>Classification and<br>notification of alarms<br>Adjustment of alarm<br>settings<br>Possibility to set critical<br>alarm limits<br>Alarm On/Off<br>functionality and audio<br>silencing | Identical | | Battery operation | Rechargeable Lithium-<br>Ion batteries | Rechargeable Lithium-<br>Ion batteries | Identical | | Networking<br>capability | CARESCAPE Network<br>LAN/VLAN<br>Optional WLAN | CARESCAPE Network<br>LAN/VLAN<br>Optional WLAN | Identical | | Network<br>interface | 10baseT, 100baseT,<br>802.11 abgn, IEEE<br>802.11r fast roaming is<br>supported. | 10baseT, 100baseT,<br>802.11 abgn, IEEE<br>802.11r fast roaming is<br>supported. | Identical | Subject Device and Predicate Device Comparison {9}------------------------------------------------ {10}------------------------------------------------ | Determination of<br>Substantial Equivalence<br>(807.92(b)(1)): | Summary of Non-Clinical Tests: | |----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Bench testing related to software, hardware and performance<br>including applicable consensus standards was conducted on the<br>CARESCAPE B450, demonstrating the design meets the<br>specifications. | | | The hardware bench testing included electromagnetic<br>compatibility, electrical safety, environmental, WLAN, and<br>usability. | | | Software testing included software design, development,<br>verification, validation and traceability. | | Clinical (807.92(b)(2)): | Summary of Clinical Tests: | | | The subject of this premarket submission, CARESCAPE B450<br>did not require clinical studies to support substantial equivalence. | | Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE B450 to be as safe, as<br>effective, and the performance to be substantially equivalent to<br>the predicate device. |