(259 days)
No
The document does not mention AI, ML, or related concepts like deep learning or neural networks. The description focuses on standard patient monitoring functionalities and hardware.
No
The device is a multi-parameter patient monitor that gathers and displays physiological data; it does not provide any therapy or treatment.
Yes
The device is a multi-parameter patient monitor that performs "ECG diagnostic analysis and measurement" and detects and generates alarms for "ECG arrhythmias". These functions go beyond simple monitoring and provide information used for diagnosis.
No
The device description explicitly states it includes hardware components such as a separate touchscreen display, central processing unit, and module frames. It also mentions hardware bench testing.
Based on the provided text, the CARESCAPE B850 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 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 system for acquiring and displaying patient data through modules connected to the patient.
- Lack of IVD Characteristics: The text does not mention any analysis of samples taken from the body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This is the core function of an IVD.
Therefore, the CARESCAPE B850 is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The CARESCAPE B850 is a multi-parameter patient montor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:
· hemodynamic (including ECC, ST segment, arthythmia 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 B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.
The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using the monitor
The CARESCAPE B850 is not intended for use in a controlled MR environment.
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 B850 V3 is a new version of a modular multi-parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 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)
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B850, demonstrating the design meets the specifications. The hardware bench testing included electromagnetic compatibility, electrical safety, environmental and usability. Software testing included software design, development, verification, validation and traceability. Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE B850 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 B850 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. No clinical studies were required.
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.
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.
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
January 29, 2020
GE Healthcare Finland OY Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 00510 Helsinki Finland
Re: K191323
Trade/Device Name: CARESCAPE B850 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 23, 2019 Received: December 26, 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 (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 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) K191323
Device Name CARESCAPE B850
Indications for Use (Describe)
The CARESCAPE B850 is a multi-parameter patient montor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:
· hemodynamic (including ECC, ST segment, arthythmia 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 B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.
The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using the monitor
The CARESCAPE B850 is not intended for use in a controlled MR environment.
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
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 B850 |
| 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): K131414 CARESCAPE Monitor B850
CARESCAPE B850 V3 is a new version of a modular multi-Device Description (807.92(a)(4)): parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU) and the module frame F5 or F7. CARESCAPE B850 V3 is equipped with an "ePort" interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 V3 includes features and subsystems that are optional or configurable.
Intended Use: (807.92(a)(5):
Indications (from labeling)
The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE B850 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, 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 B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.
The CARESCAPE B850 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using the monitor
The CARESCAPE B850 is not intended for use in a controlled MR environment.
CARESCAPE B850 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 B850 V3 monitor are unchanged compared to CARESCAPE Monitor B850 with ESP V2 software (K131414). There are no new types of monitored parameters introduced compared to the predicate B850 monitor.
A summary of the main changes compared to the predicate are listed below in the comparison table.
8
| Specification | CARESCAPE Monitor B850
with ESP V2 software
(K131414) | CARESCAPE B850 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 | 91 x 401 x 340 mm (3.6 x 15.8 x 13.5
in) and weight 7.5 kg (16.5 lbs) | 91 x 401 x 340 mm (3.6 x 15.8 x 13.5
in) and weight 7.5 kg (16.5 lbs) | Identical |
| Processor | Intel Celeron-M 423 ULV
1.06GHz | Freescale ARM Cortex-A9 | Equivalent
The CARESCAPE
Bx50 V3 monitors have
an updated common
CPU platform. |
| Module Housing | Up to 12 optional E-module slots with
F5 and F7 Frames. One slide
mount for acquisition module | Up to 12 optional E-module slots with
F5 and F7 Frames. One slide
mount for acquisition module | Identical |
| Display/screen | 19" Active matrix color TFT
LCD | 19" Active matrix color TFT
LCD | Identical |
| Waveforms and
parameter
windows | Standard view: Up to 8
individual waveforms and up
to 20, if horizontal parameter
area turned on. | Standard view: Up to 8
individual waveforms and up
to 20, if horizontal parameter
area turned on. | Identical |
| Modules | E-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,
TRAM | 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 | 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
(K150245). |
Subject Device and Predicate Device Comparison
9
| Specification | CARESCAPE Monitor B850
with ESP V2 software
(K131414) | CARESCAPE B850 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 B850 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 | Local recorder/printer and
networked laser printer.
Printings for waveforms,
alarms waveforms, numeric
trends | Local recorder/printer and
networked laser printer.
Printings for waveforms,
alarms waveforms, numeric
trends | Identical |
10
| Specification | CARESCAPE Monitor B850
with ESP V2 software
(K131414) | CARESCAPE B850 with
CSP software version V3 | Differences |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mounting options | Multiple GCX mounting
systems | Multiple GCX mounting
systems | Identical |
| Alarms | Alarm management core
functionalities:
Classification and notification
of alarms
Adjustment of alarm settings
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. |
11
| (K131414) | |||
|---|---|---|---|
| Remote Alarm | |||
| Device | Alarm Interface to the Remote | ||
| Alarm Box with Remote Light | |||
| (RAB RL). | Alarm Interface to the Remote | ||
| Alarm Device, CARESCAPE | |||
| RAD | Equivalent | ||
| CARESCAPE RAD | |||
| replaces the Remote | |||
| Alarm Box with Remote | |||
| Light (RAB RL) device. | |||
| The CARESCAPE RAD | |||
| is the new accessory for | |||
| use with the | |||
| CARESCAPE Bx50 V3 | |||
| The proposed accessory | |||
| communicates with the | |||
| CARESCAPE Bx50 V3 | |||
| via a standard USB | |||
| connection. 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 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. | |||
| Networking | |||
| capability | CARESCAPE Network | ||
| LAN/VLAN | CARESCAPE Network | ||
| LAN/VLAN | |||
| Single wire network | |||
| configuration supported for | |||
| CARESCAPE Networks | Equivalent | ||
| The single wire network | |||
| configuration simplifies | |||
| the installation and | |||
| maintenance of | |||
| CARESCAPE Bx50 V3 | |||
| patient monitors. The | |||
| single wire network | |||
| configuration has no | |||
| impact on clinical | |||
| monitoring. | |||
| Network interface | 10baseT, 100baseT | 10baseT, 100baseT | Identical |
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
12
CARESCAPE B850, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental and usability.
The CARESCAPE B850 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 B850 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 B850 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 B850 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 B850 did not require clinical studies to support substantial equivalence.
GE Healthcare considers the CARESCAPE B850 to be Conclusion (807.92(b)(3)): substantially equivalent to the predicate device(s).