(266 days)
K131223 CARESCAPE Monitor B650
Not Found
No
The document does not mention AI, ML, or related terms in the description of the device's functionality or technology. The focus is on standard physiological monitoring parameters and alarm detection based on predefined criteria.
No
The device is a multi-parameter patient monitor that gathers and displays patient data, performs analysis (like arrhythmia detection), and generates alarms; it does not provide treatment or therapy.
Yes
The device is a multi-parameter patient monitor that performs "ECG diagnostic analysis and measurement" and detects and generates alarms for "ECG arrhythmias," which are functions used to diagnose medical conditions.
No
The device description explicitly states that the CARESCAPE B650 V3 includes hardware components such as a monitor with built-in CPU, power unit, display, and battery, in addition to the software.
Based on the provided text, the CARESCAPE B650 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "multi-parameter patient monitor intended for use in multiple areas and intra hospital transport within a professional healthcare facility." It focuses on monitoring physiological parameters directly from the patient (hemodynamic, respiratory, neurophysiological status).
- Device Description: The description details a patient monitoring system with modules for acquiring patient data.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CARESCAPE B650 does not perform these functions. It directly measures and displays physiological signals from the patient.
Therefore, the CARESCAPE B650 is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MHX, 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
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, pediatric, and neonatal patients
Intended User / Care Setting
licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.
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.
Summary of Clinical Tests: The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K131223 CARESCAPE Monitor B650
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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.
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
2
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.
3
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4
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) |
5
Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm) 21 CFR 868.1850 spirometer, monitoring (w/wo alarm) 21 CFR 868.1730 computer, oxygen-uptake 21 CFR 868.2375 monitor, breathing frequency 21 CFR 868.2600 monitor, airway pressure (includes gauge and/or alarm) 21 CFR 868.1500 analyzer, gas, enflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, desflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, sevoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, isoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1700 analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) 21 CFR 868.1620 analyzer, gas, halothane, gaseous-phase (anesthetic conc.) 21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-phase 21 CFR 868.1720 analyzer, gas, oxygen, gaseous-phase 21 CFR 870.2340 electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 computer, diagnostic, programmable 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) 21 CFR 870.1025 detector and alarm, arrhythmia 21 CFR 870.1100 alarm, blood-pressure 21 CFR 870.1110 computer, blood-pressure 21 CFR 870.1435 computer, diagnostic, pre-programmed, single-function 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 870.2910 thermometer, electronic, clinical 21 CFR 882.1900 stimulator, auditory, evoked response 21 CFR 882.1400 full-montage standard electroencephalograph 21 CFR 868.2775 stimulator, nerve, peripheral, electric 21 CFR 870.1915 probe, thermodilution 21 CFR 870.1025 monitor, st segment with alarm 21 CFR 882.1400 non-normalizing quantitative electroencephalograph software 21 CFR 882.1400 index-generating electroencephalograph software 21 CFR 882.1400 reduced- montage standard electroencephalograph
6
21 CFR 882.1400 burst suppression detection software for electroencephalograph
| Product Code: | MHX |
|---|---|
| Subsequent Product Codes: | BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, |
| DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, | |
| GWJ, GWQ, KOI, KRB, MLD, NHO, NHP, NHQ, OLT, OLW, | |
| OMC, ORT | |
| Predicate Device(s) | |
| (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 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. | |
| Intended Use: (807.92(a)(5): | Indications (from labeling) |
| 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). |
7
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.
8
| Specification | CARESCAPE Monitor B650
with ESP V2 software
(K131223) | CARESCAPE B650 with
CSP software version V3 | Differences | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical | |
| Use environments | Within a professional
healthcare facility (Not
intended for MRI) | Within a professional
healthcare facility (Not
intended for MRI) | Identical | |
| Size (H x W x D)
& Weight | 360 x 370 x 220 mm (14.2 x
14.6 x 8.7 in) and weight 9.2
kg (20.3 lbs) with battery but
without modules | 360 x 370 x 220 mm (14.2 x
14.6 x 8.7 in) and weight 9.2
kg (20.3lbs) with battery but
without modules. | Identical | |
| Processor | Freescale PowerPC MPC8270 | Freescale ARM Cortex-A9 | Equivalent
The CARESCAPE
Bx50 V3 monitors have
an updated common
CPU platform. | |
| Module Housing | Two optional E-module slots
and optional recorder. One
slide mount for acquisition
module | Two optional E-module slots
and optional recorder. One
slide mount for acquisition
module | Identical | |
| Display/screen | 15" Active matrix color TFT
LCD | 15" Active matrix color TFT
LCD | Identical | |
| Waveforms and
parameter
windows | Standard view: Up to 8
individual waveforms and up
to 20 parameter windows, if
horizontal parameter area
turned on. | Standard view: Up to 8
individual waveforms and up
to 20 parameter windows, if
horizontal parameter area
turned 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 | Equivalent
Removed support for
several legacy E/M
multiparameter
hemodynamic
acquisition modules as
many newer acquisition
modules are included,
covering the same
parameters.
Added support for
CARESCAPE ONE and
E-EEGX acquisition
modules.
Added support for E-
sCAIOVX and E-
sCOVX modules | |
| Specification | CARESCAPE Monitor B650
with ESP V2 software
(K131223) | CARESCAPE B650 with
CSP software version V3 | Differences | |
| Available
parameters | ECG, ST segment, arrhythmia
detection, ECG diagnostic
analysis and measurement,
invasive pressure, non-
invasive blood pressure, pulse
oximetry, cardiac output
(thermodilution and pulse
contour), temperature, mixed
venous oxygen saturation, and
central venous oxygen
saturation, impedance
respiration, airway gases
(CO2, O2, N2O, and
anesthetic agents), spirometry,
gas exchange,
electroencephalography,
Entropy, Bispectral Index
(BIS), neuromuscular
transmission. | ECG, ST segment, arrhythmia
detection, ECG diagnostic
analysis and measurement,
invasive pressure, non-
invasive blood pressure, pulse
oximetry, 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. | Identical | |
| EK-Pro
arrhythmia
detection
algorithm | EK-Pro V13 | EK-Pro V14 | Equivalent
CARESCAPE B650 V3
uses an EK-ProV14
arrhythmia analysis
algorithm compared to
the EK-Pro V13 used in
the predicate monitors. | |
| Graphical user
interface | GE Healthcare Common User
Interface (CUI) Requirements
and Style Version 6 | GE Healthcare HDX | A new color scheme for
the display and slight
visual adjustments have
been incorporated, in
line with a GE
Healthcare wide user
interface design
guideline. The overall
user interface layout,
structure, operations,
and workflow remains
the same as the
predicate. | |
| Printing | Built-in or central and
networked laser printer
Printings for waveforms,
alarms waveforms, numeric
trends | Built-in or central and
networked laser printer
Printings for waveforms,
alarms waveforms, numeric
trends | Identical | |
| Specification | CARESCAPE Monitor B650
with ESP V2 software
(K131223) | CARESCAPE B650 with
CSP software version V3 | Differences | |
| Mounting options | Multiple GCX mounting
systems, Roll Stand, Quick
Mount | Multiple GCX mounting
systems, Roll Stand, Quick
Mount | Identical | |
| Alarms | Alarm management core
functionalities:
Classification and notification
of alarms
Adjustment of alarm settings
Alarm On/Off functionality
and audio silencing | Alarm management core
functionalities:
Classification and notification
of alarms
Adjustment of alarm settings
Possibility to set critical alarm
limits
Alarm On/Off functionality
and audio silencing | Equivalent
The predicate already
included the options to
configure some alarm
settings. In V3, more
flexibility was added for
the user to adjust alarm
priorities and alarm
criteria for additional
parameter alarms,
including additional
alarm delay options,
critical alarm options,
alarm acknowledgement
and latched alarm
indicators, and a pause
monitoring & central
function.
In general, options for
tailored/specific alarm
management schemes
have been added
supporting clinicians in
their goals of reducing
alarm fatigue while
maintaining safety.
Default setting are
according to IEC 60601-
1-8. | |
| Specification | CARESCAPE Monitor B650
with ESP V2 software
(K131223) | CARESCAPE B650 with
CSP software version V3 | Differences | |
| Remote Alarm
Device | Alarm Interface of ESP V2
SW was not utilized | Alarm Interface to the Remote
Alarm Device, CARESCAPE
RAD | Equivalent
The predicate device did
not 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 CARESCAPE B650
V3.
As the proposed
CARESCAPE B650 V3
provides USB
connection, now the
Alarm Interface of the
CARESCAPE B650 V3
is utilized for remote
alarming.
The CARESCAPE RAD
is intended for relaying
primary alarm signals
from the host device to
an external distributed
alarm system, i.e. a
nurse call system or a
remote alarm light. The
CARESCAPE B650 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
transport within a
professional
healthcare facility. | Yes | Yes | Identical |
| | Battery operation | Rechargeable Lithium-Ion
batteries | Rechargeable Lithium-Ion
batteries | Identical |
| | Specification | CARESCAPE Monitor B650
with ESP V2 software
(K131223) | CARESCAPE B650 with
CSP software version V3 | Differences |
| | Networking
capability | CARESCAPE Network
LAN/VLAN
Optional WLAN | CARESCAPE Network
LAN/VLAN
Single wire network
configuration supported for
CARESCAPE Networks
Optional WLAN | Equivalent
The single wire network
configuration simplifies
the installation and
maintenance of
CARESCAPE B650 V3
patient monitors. The
single wire network
configuration has no
impact on clinical
monitoring. |
| | Network interface | 10baseT, 100baseT, 802.11
abg
IEEE 802.11r fast roaming is
not supported. | 10baseT, 100baseT, 802.11
abgn
IEEE 802.11r fast roaming
supported. | Equivalent
V3 supports wireless
data transfer with
support for WPA2-
Enterprise security
mechanisms 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
9
10
11
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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. |
|---|---|
| --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The hardware bench testing included electromagnetic
compatibility, electrical safety, environmental, WLAN, and usability.
13
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).