(260 days)
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.
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.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the CARESCAPE B450, based on the information provided in the 510(k) summary.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with specific acceptance criteria and performance metrics for the novel aspects. Therefore, much of the requested information (like specific quantitative acceptance criteria or detailed study methodologies for new features) is not explicitly present. The summary explicitly states that no clinical studies were required to support substantial equivalence for this particular submission.
Acceptance Criteria and Device Performance for CARESCAPE B450
Given that this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance outlined refers to the device's ability to maintain existing functionalities and integrate new ones without compromising safety or efficacy, primarily through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit, quantitative acceptance criteria for each individual parameter for this 510(k) are not provided in the document (as it's a "substantial equivalence" claim based on existing technology), the table below reflects what can be inferred. The "acceptance criteria" here are largely implicit: that the new device performs equivalently or better than the predicate, or that new features function as intended and safely.
| Feature/Parameter | Acceptance Criteria (Inferred from Substantial Equivalence and Bench Testing) | Reported Device Performance (from K191249 Summary) |
|---|---|---|
| Arrhythmia Detection (EK-Pro) | Performance of EK-Pro V14 algorithm to be equivalent or improved compared to EK-Pro V13 in the predicate devices while ensuring clinical safety and accuracy for detected arrhythmias (e.g., atrial fibrillation, asystole, bradycardia, V-fib/V-tach, etc.). This would typically involve meeting sensitivity and specificity targets compared to an expert-annotated ground truth. | Equivalent: "CARESCAPE B450 V3 uses an EK-ProV14 arrhythmia analysis algorithm compared to the EK-Pro V13 used in the predicate monitors." (Implies it meets or exceeds V13 performance, which was already cleared.) The document does not provide specific performance metrics for sensitivity/specificity of EK-Pro V14 itself, but rather states it's an "equivalent" change. |
| Gas Exchange Parameters (VO2, VCO2, EE, RQ) | Accurate and reliable measurement of O2 consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ) when utilizing the E-sCOVX or E-sCAIOVX modules. Performance should be equivalent to existing cleared devices (B850, B650) that support these parameters. | Added support for gas exchange parameters: "The gas exchange parameters and calculations are identical to the predicate CARESCAPE Monitor B850 (K131414) and CARESCAPE Monitor B650 (K131223) monitors." These modules were previously cleared (K150245); the B450 V3 now supports their integration. |
| Hardware Components (Processor, Modules) | New hardware (Freescale ARM Cortex-A9 processor) and updated module support (e.g., CARESCAPE ONE, E-EEGX, E-sCAIOVX) should maintain or improve overall system performance, reliability, and safety compared to the predicate device, without introducing new hazards. Functionality of all supported modules must be verified within the new system. | Equivalent: "The CARESCAPE Bx50 V3 monitors have an updated common CPU platform." "Removed support for several legacy... as many newer acquisition modules are included... Added support for CARESCAPE ONE and E-EEGX acquisition modules. Added support for E-sCAIOVX and E-sCOVX modules (K150245)." Implies functional equivalence or improvement. |
| Alarm Management | Enhanced flexibility in alarm settings (priorities, criteria, delays, critical alarm options, acknowledgment, latched indicators, pause monitoring) must reduce alarm fatigue while maintaining patient safety. Default settings must conform to IEC 60601-1-8. Functionality including remote alarm integration via CARESCAPE RAD must be reliable. | Equivalent: "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." "Default setting are according to IEC 60601-1-8." Remote alarm functionality is "utilized for remote alarming" and "the CARESCAPE Bx50 V3 alarm functionality is unaffected." |
| Network Capability (WLAN) | Ability to support new wireless standards (IEEE 802.11n, 802.11r fast roaming, WPA2-Enterprise security) while ensuring secure, fast, and reliable data transfer during intra-hospital transport, and without impacting clinical monitoring. The device must withstand network storms without rebooting. | Equivalent: "Support wireless data transfer with support for WPA2-Enterprise security mechanisms... and support the IEEE 802.11n protocol for faster wireless data transfer, and the IEEE 802.11r fast roaming standard for fast and secure handoffs... without rebooting when connected by wire to either MC, IX, or both networks which suffer broadcast storm traffic." Testing confirmed the device can withstand network storms. |
| Overall Performance & Safety | The device must meet all specified performance requirements for its intended use (monitoring hemodynamic, respiratory, and neurophysiological status for adult, pediatric, and neonatal patients) and maintain safety and effectiveness as outlined by applicable consensus standards and regulatory requirements. | "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B450, demonstrating the design meets the specifications." "Found to be substantially equivalent to the predicate device(s) for the intended users, uses and use environments." |
| Usability | Usability of the device, particularly with the new graphical user interface (HDX) and revised alarm management, must be maintained or improved, ensuring that critical tasks can be performed safely and effectively. | "Extensive usability work has been completed for CARESCAPE B450 and the predicate devices including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing and summative testing, among other activities." The new GUI is a "new color scheme" and "slight visual adjustments," but the "overall user interface layout, structure, operations, and workflow remains the same as the predicate," ensuring equivalence. |
| Cybersecurity | Security risks related to system integrity, access control, audit control, network control, and remote services must be addressed in accordance with FDA guidance. | "Patient safety, security, and privacy risks have been addressed... including a Security Risk Assessment and Threat model. This includes system integrity controls, access controls, audit controls, network controls, and remote service controls which map to the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the 510(k) summary for specific performance tests. The review relies on "bench testing" and "extensive usability work" without providing specific numbers of test cases, patients, or data points.
- Data Provenance: Not explicitly stated. The nature of "bench testing" suggests a controlled, laboratory environment. For usability, it would involve participants, but their origin is not specified. The arrhythmia algorithm (EK-Pro V14) likely draws from large, existing ECG databases typically used in device development, but this is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: Not specified in the provided text. For arrhythmia algorithms (EK-Pro), ground truth is typically established by multiple cardiologists or electrophysiologists. However, for this 510(k), since the EK-Pro V14 is considered "equivalent" to a previously cleared version, the detailed ground truth establishment for it is likely from prior submissions or internal development, not explicitly reported here.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. For tasks like arrhythmia detection, typically multiple experts review and label data, and disagreements are resolved through consensus, majority vote, or a super-reader.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The document explicitly states: "The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence." This means no clinical MRMC studies were conducted for this submission. The device is a patient monitor, not primarily an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: The document does not explicitly present a standalone performance study for the EK-Pro V14 arrhythmia algorithm. It states that EK-Pro V14 is an update to V13 and is "equivalent." Implied is that internal validation of the algorithm's performance against ground truth would have occurred during its development, but the results are not detailed in this 510(k) summary. The gas exchange parameters are also noted as "identical" in calculation to previously cleared predicate devices, implying their standalone performance is already established.
7. The Type of Ground Truth Used:
- Ground Truth Type: Not explicitly stated for any of the tested features within this document.
- For Arrhythmia Detection (EK-Pro V14): Typically, expert-annotated ECG waveforms (clinical data) serve as ground truth.
- For Gas Exchange Parameters: Likely derived from high-precision laboratory measurements or established physiological models.
- For Hardware/Software Functional Testing: System specifications and expected behavior as defined during development serve as ground truth.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not specified. Training sets are primarily relevant for machine learning algorithms. While the EK-Pro algorithm may have some adaptive or learning components from its development, the document doesn't detail its training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment for Training Set: Not specified. As mentioned above, for arrhythmia detection, this would typically involve expert cardiological review and annotation of large datasets.
{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 200510 HelsinkiFINLANDPhone: +358 10 39411 |
| Primary Contact Person: | Joel KentSenior Regulatory Affairs ManagerGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com |
| Secondary Contact Person: | Anssi RuokonenRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 10 394 3686E-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
{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 MonitorB450 with ESP V2software (K132533) | CARESCAPE B450 withCSP software version V3 | Differences |
|---|---|---|---|
| Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical |
| Use environments | Within a professionalhealthcare facility (Notintended for MRI) | Within a professionalhealthcare facility (Notintended for MRI) | Identical |
| Size (H x W x D)& Weight | 290 x 310 x 160 mm (11.4 x12.1 x 6.2 in) and 4.7 kg (10.4lbs) with batteries but withoutmodules | 290 x 310 x 160 mm (11.4 x12.1 x 6.2 in) and weight 4.7kg (10.4 lbs) with batteriesbut without modules | Identical |
| Processor | Intel Atom Z510 1,1GHz | Freescale ARM Cortex-A9 | EquivalentThe CARESCAPE Bx50 V3monitors have an updatedcommon CPU platform. |
| Module Housing | One optional E-module slotsand optional recorder. Oneslide mount for acquisition module | One optional E-module slotsand optional recorder. Oneslide mount for acquisitionmodule | Identical |
| Display/screen | 12" Active matrix color TFTLCD | 12" Active matrix color TFTLCD | Identical |
| Waveforms andparameterwindows | Standard view: Up to 6individual waveforms and up to16 parameter windows, ifhorizontal parameter areaturned on | Standard view: Up to 6individual waveforms and upto 16 parameter windows, ifhorizontal parameter areaturned 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 | EquivalentRemoved support for severallegacy E/M multiparameterhemodynamic acquisition modulesas many newer acquisitionmodules are included, covering thesame parameters. Added supportfor CARESCAPE ONE and E-EEGX acquisition modules.Added support for E-sCAIOVXand E-sCOVX modules(K150245). |
| Specification | CARESCAPE MonitorB450 with ESP V2software (K132533) | CARESCAPE B450 with DifferencesCSP software version V3 | |
| Availableparameters | 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 MonitorB450 with ESP V2software (K132533) | CARESCAPE B450 with DifferencesCSP software version V3 | |
| EK-Proarrhythmiadetectionalgorithm | EK-Pro V13 | EK-Pro V14 | EquivalentCARESCAPE B450 V3 usesan EK-ProV14 arrhythmiaanalysis algorithm compared tothe EK-Pro V13 used in thepredicate monitors |
| Graphical userinterface | GE Healthcare CommonUser Interface (CUI)Requirements and StyleVersio 6 | GE Healthcare HDX | A new color scheme for thedisplay and slight visualadjustments have beenincorporated, in line with a GEHealthcare wide user interfacedesign guideline. The overalluser interface layout, structure,operations, and workflowremains the same as thepredicate. |
| Printing | Built-in or central andnetworked laser printerPrintings for waveforms,alarms waveforms, numerictrends | Built-in or central andnetworked laser printerPrintings for waveforms,alarms waveforms,numeric trends | Identical |
| Mounting options | Multiple GCX mountingsystems, Roll Stand, QuickMount, Bed Rail Hooks | Multiple GCX mountingsystems, Roll Stand,Quick Mount, Bed RailHooks | Identical |
| Alarms | Alarm management corefunctionalities:Classification and notificationof alarmsAdjustment of alarm settingsAlarm On/Off functionality and Possibility to set criticalaudio silencing | Alarm management corefunctionalities:Classification andnotification of alarmsAdjustment of alarm settingsalarm limitsAlarm On/Off functionalityand audio silencing | EquivalentThe predicate already included theoptions to configure some alarmsettings. In V3, more flexibilitywas added for the user to adjustalarm priorities and alarm criteriafor additional parameter alarms,including additional alarm delayoptions, critical alarm options,alarm acknowledgement andlatched alarm indicators, and apause monitoring & centralfunction.In general, options fortailored/specific alarmmanagement schemes have beenadded supporting clinicians intheir goals of reducing alarmfatigue while maintaining safety.Default setting are according toIEC 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 | |||
| for use with the CARESCAPEBx50 V3. | |||
| As the proposed CARESCAPE | |||
| B450 V3 provides USB | |||
| connection, now the Alarm | |||
| Interface of the CARESCAPE | |||
| Bx50 V3 is utilized for remote | |||
| alarming. | |||
| The CARESCAPE RAD is | |||
| intended for relaying primary | |||
| alarm signals from the host device | |||
| to an external distributed alarmsystem, i.e. a nurse call system or | |||
| a remote alarm light. The | |||
| CARESCAPE Bx50 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 | Yes | Yes | Identical |
| transport within a | |||
| professional | |||
| healthcare facility. | |||
| Battery operation | Rechargeable Lithium-Ionbatteries | Rechargeable Lithium-Ionbatteries | Identical |
| Networking | CARESCAPE Network | CARESCAPE Network | Equivalent |
| capability | LAN/VLAN | LAN/VLAN | The single wire network |
| Optional WLAN | Single wire network | configuration simplifies the | |
| configuration supported for | installation and maintenance of | ||
| CARESCAPE Networks | CARESCAPE Bx50 V3 patient | ||
| Optional WLAN | monitors. The single wire networkconfiguration has no impact on | ||
| clinical monitoring. | |||
| Network interface 10baseT, 100baseT, 802.11 abg 10baseT, 802.11 | Equivalent | ||
| IEEE 802.11r fast roaming is | abgn | Support wireless data transfer with | |
| not supported. | IEEE 802.11r fast roaming | support for WPA2-Enterprise | |
| supported. | security mechanisms using | ||
| advanced authentication and dataencryption for enhanced security, | |||
| and support the IEEE 802.11n | |||
| protocol for faster wireless data | |||
| transfer, and the IEEE 802.11r fast | |||
| roaming standard for fast and | |||
| secure handoffs from one access | |||
| point to another during intra- | |||
| hospital transport. |
Subject Device and Predicate Device Comparison
{10}------------------------------------------------
{11}------------------------------------------------
{12}------------------------------------------------
{13}------------------------------------------------
Determination of Substantial Equivalence (807.92(b)(1):
Summary of Non-Clinical Tests: Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B450, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, battery and usability.
The CARESCAPE B450 has been found to substantially equivalent to the predicate device(s) for the intended users, uses and use environments. Extensive usability work has been completed for CARESCAPE B450 and the predicate devices including critical task identification through use-based hazard analysis, multiple rounds of formative usability testing and summative testing, among other activities.
Software testing included software design, development, verification, validation and traceability.
Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE B450 including a Security Risk Assessment and Threat model. This includes system integrity controls, access controls, audit controls, network controls, and remote service controls which map to the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on October 2, 2014.
The CARESCAPE B450 battery has been investigated by UL in accordance with the Standard for Safety of Household and commercial Batteries. UL 2054 and Standard for Safety of Information Technology Equipment-Safety-Part1: General Requirements, CAN/CSA-C22.2 No. 60950-1-07, and UL 60950-
{14}------------------------------------------------
| 1. The battery has been tested by UL and found to be inconformity with IEC 62133 ed.2. Secondary cells and batteriescontaining alkaline or other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells, and for batteriesmade from them, for use in portable applications. Integration ofthe battery management with the new design has beensuccessfully tested and concluded to be operating as specified | |
|---|---|
| Testing was completed on CARESCAPE B450 to show thedevice can withstand network storm, i.e. continue to monitorpatients without rebooting when connected by wire to either MC,IX, or both networks which suffer broadcast storm traffic. | |
| Clinical (807.92(b)(2)): | Summary of Clinical Tests: |
| The subject of this premarket submission, CARESCAPE B450did not require clinical studies to support substantial equivalence. | |
| Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE B450 to besubstantially equivalent to the predicate device(s). |
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.