(196 days)
No
The summary describes a standard multi-parameter patient monitor with various physiological monitoring capabilities and alarm functions. There is no mention of AI or ML in the intended use, device description, or performance studies. The arrhythmia detection is described as a standard feature, not explicitly using AI/ML.
No.
The device is a multi-parameter patient monitor intended for diagnostic monitoring of various physiological parameters and is not described as providing treatment or therapy.
Yes
The device "CARESCAPE B650" is intended for monitoring various patient parameters, including "ECG diagnostic and measurement," and is able to "detect and generate alarms for ECG arrhythmias." While monitoring is its primary function, the inclusion of "ECG diagnostic" capabilities indicates it can aid in identifying medical conditions.
No
The device description explicitly states that the CARESCAPE B650 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 intrahospital transport within a professional healthcare facility." It is used for monitoring various physiological parameters directly from the patient (hemodynamic, respiratory, neurophysiological status).
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Lack of Specimen Analysis: The description of the CARESCAPE B650 and its intended use does not mention the analysis of any biological specimens (blood, tissue, etc.) outside of the body. All monitoring is performed directly on the patient.
Therefore, the CARESCAPE B650 falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE 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 CARESCAPE B650:
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, DOA, DOK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QEM
Device Description
CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 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
professional healthcare facility, under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment
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 B650, demonstrating the design meets the specifications. The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability. Software testing included software design, development, verification, validation and traceability. 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.
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
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April 13, 2022
GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, FI-00510 Finland
Re: K213181
Trade/Device Name: CARESCAPE B650, E-musb Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DOA, DOK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QEM Dated: March 11, 2022 Received: March 14, 2022
Dear Joel Kent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name CARESCAPE B650
Indications for Use (Describe)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital 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, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE 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 CARESCAPE B650:
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
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: | September 27, 2021 |
|---|---|
| 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: | Karin Mårtenson |
| Regulatory Affairs Leader | |
| GE Healthcare Finland Oy | |
| Kuortaneenkatu 2 | |
| 00510 Helsinki | |
| Finland | |
| Phone: + 358 50 384 6646 | |
| E-mail: karin.martenson@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 870.2700 Oximeter, Tissue Saturation 21 CFR 868.2775 stimulator, nerve, peripheral, electric 21 CFR 870.1915 probe, thermodilution 21 CFR 870.1025 monitor, st segment with alarm 21 CFR 882.1400 non-normalizing quantitative electroencephalograph software 21 CFR 882.1400 index-generating electroencephalograph software 21 CFR 882.1400 reduced- montage standard electroencephalograph 21 CFR 882.1400 burst suppression detection software for electroencephalograph 21 CFR 870.2700 Cerebral Oximeter
6
Product Code: MHX
| Subsequent Product Codes: | BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QEM |
|---|---|
| Predicate Device(s) | |
| (807.92(a)(3)): | The primary predicate for this submission is K191149 |
| CARESCAPE B650 | |
| Additional predicates / reference devices: | |
| K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 | |
| Sensor | |
| K110028, MASIMO RADICAL Y PULSE CO-OXIMETER | |
| Device Description | |
| (807.92(a)(4)): | CARESCAPE B650 is a new version of a portable multi- |
| parameter patient monitoring system. The CARESCAPE B650 | |
| includes the monitor with built-in CPU, power unit, a 15 inch | |
| touch display, the CARESCAPE Software and the battery. | |
| CARESCAPE B650 is equipped with two module slots where | |
| patient data acquisition modules (E-Module type) can be | |
| connected to perform patient monitoring. CARESCAPE B650 is | |
| equipped with the ePort interface that supports use of PDM or | |
| CARESCAPE ONE patient data acquisition devices. In addition | |
| to the ePort interface the PDM module can be also connected | |
| directly to the CARESCAPE B650 via special slide mount | |
| connector which is in the back of the monitor. The | |
| CARESCAPE B650 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 intrahospital 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, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed
7
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.
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 incorporates updated software and minor modifications to the hardware.
The fundamental function and operation of the proposed CARESCAPE B650 monitor are unchanged compared to CARESCAPE B650 (K191149).
A summary of the main changes compared to the predicate are listed below in the comparison table.
8
| Specification | CARESCAPE B650
(K191149) | Proposed
CARESCAPE B650 | 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 |
| Intrahospital
transport | Intrahospital transport
within a professional
healthcare facility. | Intrahospital transport
within a professional
healthcare facility. | 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 |
| Module Housing | Two E-module slots for
two single-width E-
modules or one double-
width E-module and
optional recorder. One
slide mount for
acquisition module. | Two E-module slots for
two single-width E-
modules and optional
recorder. One slide mount
for acquisition module. | Equivalent
Added mechanical block to E-
module housing mechanics and
removed related electronic
components, to prevent use of
double-width legacy modules, that
are no longer supported. There is no
change to functionality of the E-
module frame itself, only preventing
users from connecting legacy E-
modules that CARESCAPE B650
does not support |
| Display/screen | 15" TFT color LCD | 15" TFT color 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-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 | 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 | Identical |
| Optional system
components | -Remote Control
-CARESCAPE D19KT
VER01 optional display
-CARESCAPE RAD,
Remote Alarm Device
-Keyboard
-Mouse
-Barcode scanner
-Laser Printer | -Remote Control
-CARESCAPE D19KT
VER01 optional display
-CARESCAPE RAD,
Remote Alarm Device
-Keyboard
-Mouse
-Barcode scanner
-Laser Printer
-E-musb Interface module | Equivalent
Added E-musb Interface module
that provides a communication path
for the OEM owned devices
CARESCAPE rSO2 – INVOS and
CARESCAPE CO2 – Microstream
to the CARESCAPE Bx50 host
monitors |
| Available
measurement
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, regional
oxygen saturation, total
hemoglobin
concentration, 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. | Equivalent
Added hemodynamic parameters (in
bold) that are previously cleared but
are new to the monitor:
regional oxygen saturation and total
hemoglobin concentration, often
referred to as rSO2 and SpHb. The
Indications for Use were updated
accordingly.
The CARESCAPE B650 does not
change the measurement or
algorithm of these parameters but
simply displays the values from the
OEM owned
CARESCAPE parameter devices
CARESCAPE SpO2 –Masimo and
CARESCAPE rSO2 –INVOS. |
| EK-Pro
arrhythmia
detection
algorithm | EK-Pro V14 | EK-Pro V14 | Identical |
| 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 |
| Mounting
options | Multiple GCX mounting
systems, Roll Stand,
Quick Mount | Multiple GCX mounting
systems, Roll Stand | Equivalent
Quick Mount is obsolete and not
sold anymore. |
| Alarms | 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 | 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 | Identical |
| Battery operation | Rechargeable Lithium-Ion
batteries | Rechargeable Lithium- Ion
batteries | Identical |
| Networking
capability | CARESCAPE Network
LAN/VLAN
Optional WLAN | CARESCAPE Network
LAN/VLAN
Optional WLAN | Identical |
| Network
interface | 10baseT, 100baseT,
802.11 abgn, IEEE
802.11r fast roaming is
supported. | 10baseT, 100baseT,
802.11 abgn, IEEE
802.11r fast roaming is
supported. | Identical |
Subject Device and Predicate Device Comparison
9
10
| 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. | ||
| Software testing included software design, development, | ||
| verification, validation and traceability. | ||
| 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. | ||
| Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE B650 to be as safe, as | |
| effective, and the performance to be substantially equivalent to | ||
| the predicate device. |