(266 days)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility.
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:
• hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
• respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
• neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
CARESCAPE B650 V3 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 V3 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software version 3 and the battery. CARESCAPE B650 V3 is equipped with so called ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B650 V3 is also equipped with two module slots where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B650 V3 includes features and subsystems that are optional or configurable.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device meets those criteria, specifically concerning the CARESCAPE B650 medical monitor.
It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance against specific pre-defined acceptance criteria for a novel AI algorithm. The device here is a multi-parameter patient monitor with an updated arrhythmia detection algorithm (EK-Pro V14) as one of its changes. The document states that no clinical studies were required to support substantial equivalence, meaning the proof of meeting acceptance criteria for its functions comes from bench testing and comparison to the predicate, rather than a prospective clinical trial.
Therefore, the answers will reflect this context, particularly the lack of a traditional "AI algorithm" study with specific statistical performance metrics against a defined ground truth derived from expert consensus or pathology, as one might expect for a new AI diagnostic tool.
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way one might expect for a novel AI component. Instead, it demonstrates equivalence through:
- Identical specifications: Many features (patient type, use environments, size & weight, module housing, display/screen, waveforms/parameter windows, available parameters, printing, mounting options) are stated as "Identical" to the predicate. This implies that the performance for these aspects meets the original predicate's established performance, which implicitly acts as the "acceptance criteria."
- Equivalent specifications with justification: For changed components like the CPU, modules, EK-Pro arrhythmia algorithm, graphical user interface, alarms, remote alarm device, and networking capability, the document justifies the "equivalence" or improvement. The acceptance criteria here are implicitly that the new component performs at least as well as, or better than, the predicate, without introducing new safety or effectiveness concerns.
| Feature (Related to Acceptance Criteria) | Reported Device Performance / Status (CARESCAPE B650 V3) | Nature of "Acceptance" / Justification |
|---|---|---|
| Arrhythmia Detection Algorithm | Uses EK-Pro V14 (Predicate used EK-Pro V13) | Equivalent: This is a key change. Although not explicitly detailing sensitivity/specificity percentages, the clearance implies that the performance of V14 is considered equivalent or improved, and has passed internal verification and validation testing to ensure it meets the necessary standards for arrhythmia detection. |
| Overall Performance | Demonstrated design meets specifications. | Bench testing: Software, hardware, and performance testing, including applicable consensus standards. This is the primary method of "proving" it meets acceptance criteria without clinical data. |
| New Features (e.g., Alarms, Modules, Networking) | New functionalities and hardware, such as enhanced alarm flexibility, new acquisition modules (E-EEGX, CARESCAPE ONE, E-sCAIOVX, E-sCOVX), and faster wireless data transfer (IEEE 802.11n, 802.11r). | Equivalent/Improved: These changes are described as providing more flexibility, covering the same parameters, simplifying installation, enhancing security, and improving functionality, all while maintaining the fundamental function and safety of the device. Default alarm settings comply with IEC 60601-1-8. |
| Safety, Security, Privacy Risks | Addressed in design and development (Security Risk Assessment, Threat model, integral controls). Withstands network storm. | Compliance: Meets FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Demonstrated resilience in specific network conditions. |
2. Sample sized used for the test set and the data provenance
The document does not specify a "test set" in the context of a dataset for validating an AI algorithm's performance on clinical data. Since no clinical studies were required or conducted for this 510(k) submission, there is no mention of sample sizes of patient data for a test set.
The testing involved:
- Bench testing: "software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications."
- Usability testing: Formative and summative usability testing.
- Network testing: "Testing was completed on CARESCAPE B650 to show the device can withstand network storm..."
The data provenance for these internal engineering and usability tests would be the manufacturer's own internal testing environment. No information on country of origin or retrospective/prospective nature of data is provided because it's not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical "test set" from patient data was used against which the device's diagnostic performance (e.g., AI algorithm accuracy) was measured by external experts, there is no mention of experts establishing ground truth for such a set. The "ground truth" for demonstrating substantial equivalence primarily lies in adherence to performance specifications validated through engineering bench testing and comparison to the predicate device's established performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as #3. No external "test set" requiring expert adjudication was utilized to demonstrate the device's performance characteristics.
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
No. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was performed, and no effect size on human reader improvement with AI assistance is provided. The device integrates an EK-Pro arrhythmia detection algorithm, but the submission focuses on its equivalence to the previous version and the monitor's overall functionality, not on its assistance to human readers via a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The EK-Pro V14 arrhythmia detection algorithm is a component of the multi-parameter patient monitor. The submission states that the EK-ProV14 arrhythmia analysis algorithm is a change from the predicate's EK-Pro V13. The "standalone" performance of such internal algorithms is typically validated through internal testing against standardized datasets (e.g., annotated ECG databases for arrhythmia detection), which would fall under "Summary of Non-Clinical Tests: Bench testing related to software...". While the specific details of this internal algorithmic validation are not provided in the summary, the clearance implies it met the necessary performance and safety standards in a standalone manner as an embedded function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the arrhythmia detection algorithm, the ground truth would typically be established by:
- Expert consensus: Review of ECG waveforms by cardiologists or electrophysiologists.
- Annotated databases: Use of publicly available or proprietary ECG databases with expertly adjudicated arrhythmia annotations.
However, since this is a 510(k) for substantial equivalence and not a de novo submission requiring extensive clinical validation, the specific ground truth methodology for the EK-Pro V14 algorithm's development or internal testing is not detailed in this public summary. The "ground truth" implicitly aligns with the performance established by the predicate device and relevant industry standards.
For the overall device, the "ground truth" for demonstrating equivalence relies on:
- Predicate device performance: The previously cleared CARESCAPE Monitor B650 with ESP V2 software (K131223) serves as the benchmark.
- Design specifications: The device is manufactured to meet predefined internal design specifications, which are validated through rigorous bench testing.
- Applicable consensus standards: Compliance with relevant international and national standards for medical devices (e.g., electrical safety, EMC, usability).
8. The sample size for the training set
The document does not mention the sample size for a training set. This is not a submission for a de novo AI device where such details for machine learning model training would be critical. The EK-Pro algorithm is likely a rule-based or traditional signal processing algorithm, or at least one iterated and improved over time, for which a distinct "training set" in the deep learning sense might not be explicitly defined or described in this type of regulatory document.
9. How the ground truth for the training set was established
Not applicable. As no training set is described or required for this type of 510(k) (which primarily relies on substantial equivalence and bench testing), the method for establishing its ground truth is not provided. If the EK-Pro V14 algorithm did indeed involve machine learning, its ground truth for training would have been established internally by GE Healthcare, likely through methods similar to those described in point 7 (expert annotations on ECG data), but these details are not part of the publicly available 510(k) summary.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 28, 2020
GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 00510 Helsinki Finland
Re: K191149
Trade/Device Name: CARESCAPE B650 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, BZK, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Dated: December 18, 2019 Received: December 20, 2019
Dear Joel Kent:
This letter corrects our substantially equivalent letter of January 21, 2020.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer W. Shih -S
Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191149
Device Name CARESCAPE B650
Indications for Use (Describe)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility.
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using the monitor
The CARESCAPE B650 is not intended for use in a controlled MR environment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined within a circular border. The letters are stylized with curved lines, giving them a classic and elegant appearance. The logo is presented in black and white, with the letters and border in black against a white background.
GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki
Finland
T: +358 10 39411
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1):
| Date: | January 21, 2020 |
|---|---|
| Owner/Submitter: | GE Healthcare Finland Oy. |
| Kuortaneenkatu 2 | |
| 00510 Helsinki | |
| FINLAND | |
| Phone: +358 10 39411 | |
| Primary Contact Person: | Joel Kent |
| Senior Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | Anssi Ruokonen |
| Regulatory Affairs Leader | |
| GE Healthcare Finland Oy | |
| Kuortaneenkatu 2 | |
| 00510 Helsinki | |
| Finland | |
| Phone: + 358 10 394 3686 | |
| E-mail: Anssi.ruokonen@ge.com | |
| Device names (807.92(a)(2)): | |
| Trade Name: | CARESCAPE B650 |
| Common/Usual Name: | Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms) |
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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
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21 CFR 882.1400 burst suppression detection software for electroencephalograph
| Product Code: | MHX |
|---|---|
| Subsequent Product Codes: | BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS,DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL,GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW,OMC, ORT |
| Predicate Device(s)(807.92(a)(3): | K131223 CARESCAPE Monitor B650 |
| Device Description(807.92(a)(4)): | CARESCAPE B650 V3 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650V3 includes the monitor with built-in CPU, power unit, a 15 inchtouch display, the CARESCAPE Software version 3 and thebattery. CARESCAPE B650 V3 is equipped with so called ePortinterface that supports use of PDM or CARESCAPE ONEpatient data acquisition modules for patient monitoring.CARESCAPE B650 V3 is also equipped with two module slotswhere patient data acquisition modules (E-Modules), can beconnected to perform patient monitoring. The CARESCAPEB650 V3 includes features and subsystems that are optional orconfigurable. |
| Intended Use: (807.92(a)(5): | Indications (from labeling)The CARESCAPE B650 is a multi-parameter patient monitorintended for use in multiple areas and intra hospital transportwithin a professional healthcare facility.The CARESCAPE B650 is intended for use on adult, pediatric,and neonatal patients and on one patient at a time.The CARESCAPE B650 is indicated for monitoring of:• hemodynamic (including ECG, ST segment, arrhythmiadetection, ECG diagnostic analysis and measurement, invasivepressure, non-invasive blood pressure, pulse oximetry, cardiacoutput (thermodilution and pulse contour), temperature, mixedvenous oxygen saturation, and central venous oxygensaturation),• respiratory (impedance respiration, airway gases (CO2, O2,N2O, and anesthetic agents), spirometry, gas exchange), and• neurophysiological status (including electroencephalography,Entropy, Bispectral Index (BIS), and neuromusculartransmission). |
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The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using the monitor
The CARESCAPE B650 is not intended for use in a controlled MR environment.
Technology (807.92(a)(6)): CARESCAPE B650 with CARESCAPE Software version 3 incorporates updated hardware and a new software platform.
The fundamental function and operation of the proposed CARESCAPE B650 V3 monitor are unchanged compared to CARESCAPE Monitor B650 with ESP V2 software (K131223). There are no new types of monitored parameters introduced compared to the predicate B650 monitor.
A summary of the main changes compared to the predicate are listed below in the comparison table.
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| Specification | CARESCAPE Monitor B650with ESP V2 software(K131223) | CARESCAPE B650 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 | 360 x 370 x 220 mm (14.2 x14.6 x 8.7 in) and weight 9.2kg (20.3 lbs) with battery butwithout modules | 360 x 370 x 220 mm (14.2 x14.6 x 8.7 in) and weight 9.2kg (20.3lbs) with battery butwithout modules. | Identical | |
| Processor | Freescale PowerPC MPC8270 | Freescale ARM Cortex-A9 | EquivalentThe CARESCAPEBx50 V3 monitors havean updated commonCPU platform. | |
| Module Housing | Two optional E-module slotsand optional recorder. Oneslide mount for acquisitionmodule | Two optional E-module slotsand optional recorder. Oneslide mount for acquisitionmodule | Identical | |
| Display/screen | 15" Active matrix color TFTLCD | 15" Active matrix color TFTLCD | Identical | |
| Waveforms andparameterwindows | Standard view: Up to 8individual waveforms and upto 20 parameter windows, ifhorizontal parameter areaturned on. | Standard view: Up to 8individual waveforms and upto 20 parameter windows, ifhorizontal parameter areaturned on. | Identical | |
| Modules | E-PSM; E-PSMP, E-PRESTN,E-PRETN, E-RESTN, M-PRESTN, M-PRETN, M-RESTN, E-miniC, E-CO, E-CAIO, E-CAIOV, E-CAIOVX, E-COVX, E-COV,E-P, E-PP, E-PT, E-COP, E-COPSv, E-EEG, E-Entropy,E-NMT, E-BIS, E-NSAT, E-NSATX, E-Masimo, E-sCO,E-sCAIO, E-sCOV, and E-sCAIOV, E-PiCCO, PDM | E-BIS, E-COP, E-COPSv, E-PiCCO, E-EEGX, E-Entropy,E-Masimo, E-miniC, E-NMT,E-NSATX, E-PP, E-PT, E-sCAIO, E-sCAIOV, E-sCAIOVX, E-sCO, E-sCOV,E-sCOVX, PDM,CARESCAPE ONE | EquivalentRemoved support forseveral legacy E/Mmultiparameterhemodynamicacquisition modules asmany newer acquisitionmodules are included,covering the sameparameters.Added support forCARESCAPE ONE andE-EEGX acquisitionmodules.Added support for E-sCAIOVX and E-sCOVX modules | |
| Specification | CARESCAPE Monitor B650with ESP V2 software(K131223) | CARESCAPE B650 withCSP software version V3 | Differences | |
| Availableparameters | ECG, ST segment, arrhythmiadetection, ECG diagnosticanalysis and measurement,invasive pressure, non-invasive blood pressure, pulseoximetry, cardiac output(thermodilution and pulsecontour), temperature, mixedvenous oxygen saturation, andcentral venous oxygensaturation, impedancerespiration, airway gases(CO2, O2, N2O, andanesthetic agents), spirometry,gas exchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission. | ECG, ST segment, arrhythmiadetection, ECG diagnosticanalysis and measurement,invasive pressure, non-invasive blood pressure, pulseoximetry, cardiac output(thermodilution and pulsecontour), temperature, mixedvenous oxygen saturation, andcentral venous oxygensaturation, impedancerespiration, airway gases(CO2, O2, N2O, andanesthetic agents), spirometry,gas exchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission. | Identical | |
| EK-Proarrhythmiadetectionalgorithm | EK-Pro V13 | EK-Pro V14 | EquivalentCARESCAPE B650 V3uses an EK-ProV14arrhythmia analysisalgorithm compared tothe EK-Pro V13 used inthe predicate monitors. | |
| Graphical userinterface | GE Healthcare Common UserInterface (CUI) Requirementsand Style Version 6 | GE Healthcare HDX | A new color scheme forthe display and slightvisual adjustments havebeen incorporated, inline with a GEHealthcare wide userinterface designguideline. The overalluser interface layout,structure, operations,and workflow remainsthe 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, numerictrends | Identical | |
| Specification | CARESCAPE Monitor B650with ESP V2 software(K131223) | CARESCAPE B650 withCSP software version V3 | Differences | |
| Mounting options | Multiple GCX mountingsystems, Roll Stand, QuickMount | Multiple GCX mountingsystems, Roll Stand, QuickMount | Identical | |
| Alarms | Alarm management corefunctionalities:Classification and notificationof alarmsAdjustment of alarm settingsAlarm On/Off functionalityand audio silencing | Alarm management corefunctionalities:Classification and notificationof alarmsAdjustment of alarm settingsPossibility to set critical alarmlimitsAlarm On/Off functionalityand audio silencing | EquivalentThe predicate alreadyincluded the options toconfigure some alarmsettings. In V3, moreflexibility was added forthe user to adjust alarmpriorities and alarmcriteria for additionalparameter alarms,including additionalalarm delay options,critical alarm options,alarm acknowledgementand latched alarmindicators, and a pausemonitoring & centralfunction.In general, options fortailored/specific alarmmanagement schemeshave been addedsupporting clinicians intheir goals of reducingalarm fatigue whilemaintaining safety.Default setting areaccording to IEC 60601-1-8. | |
| Specification | CARESCAPE Monitor B650with ESP V2 software(K131223) | CARESCAPE B650 withCSP software version V3 | Differences | |
| Remote AlarmDevice | Alarm Interface of ESP V2SW was not utilized | Alarm Interface to the RemoteAlarm Device, CARESCAPERAD | EquivalentThe predicate device didnot support theconnector type of theRemote Alarm Box withRemote Light (RABRL). Therefore, theAlarm Interface of ESPV2 could not be utilizedThe CARESCAPE RADis the new USBaccessory for use withthe CARESCAPE B650V3.As the proposedCARESCAPE B650 V3provides USBconnection, now theAlarm Interface of theCARESCAPE B650 V3is utilized for remotealarming.The CARESCAPE RADis intended for relayingprimary alarm signalsfrom the host device toan external distributedalarm system, i.e. anurse call system or aremote alarm light. TheCARESCAPE B650 V3alarm functionality isunaffected when usingthe CARESCAPE RADas the new accessorysimply receives datafrom the monitor (one-way communication) toindicate when an alarmis active or not. | |
| Intrahospitaltransport within aprofessionalhealthcare facility. | Yes | Yes | Identical | |
| Battery operation | Rechargeable Lithium-Ionbatteries | Rechargeable Lithium-Ionbatteries | Identical | |
| Specification | CARESCAPE Monitor B650with ESP V2 software(K131223) | CARESCAPE B650 withCSP software version V3 | Differences | |
| Networkingcapability | CARESCAPE NetworkLAN/VLANOptional WLAN | CARESCAPE NetworkLAN/VLANSingle wire networkconfiguration supported forCARESCAPE NetworksOptional WLAN | EquivalentThe single wire networkconfiguration simplifiesthe installation andmaintenance ofCARESCAPE B650 V3patient monitors. Thesingle wire networkconfiguration has noimpact on clinicalmonitoring. | |
| Network interface | 10baseT, 100baseT, 802.11abgIEEE 802.11r fast roaming isnot supported. | 10baseT, 100baseT, 802.11abgnIEEE 802.11r fast roamingsupported. | EquivalentV3 supports wirelessdata transfer withsupport for WPA2-Enterprise securitymechanisms forenhanced security, andsupport the IEEE802.11n protocol forfaster wireless datatransfer, and the IEEE802.11r fast roamingstandard for fast andsecure handoffs fromone access point toanother during intra-hospital transport. |
Subject Device and Predicate Device Comparison
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| Determination of Substantial Equivalence (807.92(b)(1): | Summary of Non-Clinical Tests: Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications. |
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The hardware bench testing included electromagnetic
compatibility, electrical safety, environmental, WLAN, and usability.
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The CARESCAPE B650 has been found to substantially equivalent to the predicate device(s) for the intended users, uses and use environment. Extensive usability work has been completed for CARESCAPE B650 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 B650 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.
Testing was completed on CARESCAPE B650 to show the device can withstand network storm, i.e. continue to monitor patients 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 B650 did not require clinical studies to support substantial equivalence.
GE Healthcare considers the CARESCAPE B650 to be Conclusion (807.92(b)(3)): substantially 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.