(183 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard patient monitoring parameters and hardware.
No
Explanation: The device is described as a multi-parameter patient monitor, which is used for monitoring various physiological parameters, not for providing therapy or treatment.
Yes
Explanation: The "Indications for Use" section states that "The CARESCAPE B450 is indicated for monitoring of: · hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement...)" and later mentions "The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias". This indicates its use goes beyond simple monitoring for alerts and includes diagnostic capabilities for ECG and arrhythmia detection.
No
The device description explicitly states that the CARESCAPE B450 includes hardware components such as a monitor with a built-in CPU, power unit, display, and batteries, in addition to the software.
Based on the provided text, the CARESCAPE B450 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 focuses on monitoring physiological parameters directly from the patient (hemodynamic, respiratory, neurophysiological).
- Device Description: The description details a patient monitoring system with sensors and modules that connect to the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CARESCAPE B450 does not perform these functions. It directly measures physiological signals from the patient's body.
Therefore, the CARESCAPE B450 falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, 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 B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources.
The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility
Product codes
MHX, BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, OEM, DOA, DOK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, DPZ, NHO, NHP, NHQ, OLT, OLW, ORT, OMC
Device Description
CARESCAPE B450 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software and one or two batteries. CARESCAPE B450 is equipped with an ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 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
The subject of this premarket submission, CARESCAPE B450 did not require clinical studies to support substantial equivalence.
Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B450, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental, WLAN, and usability.
Software testing included software design, development, verification, validation and traceability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 13, 2022
GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, Helsinki FI-00510 Finland
Re: K213363
Trade/Device Name: CARESCAPE B450, 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, OEM, DOA, DOK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, DPZ, NHO, NHP, NHQ, OLT, OLW, ORT, OMC 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) K213363
Device Name CARESCAPE B450
Indications for Use (Describe)
The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B450 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, 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 B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources.
The CARESCAPE B450 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility
Contraindications for using the monitor
The CARESCAPE B450 is not intended for use in a controlled MR environment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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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: | October 12, 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 B450 Common/Usual Name: Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms))
5
Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm) 21 CFR 868.1850 spirometer, monitoring (w/wo alarm) 21 CFR 868.1730 computer, oxygen-uptake 21 CFR 868.2375 monitor, breathing frequency 21 CFR 868.2600 monitor, airway pressure (includes gauge and/or alarm) 21 CFR 868.1500 analyzer, gas, enflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, desflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, sevoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, isoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1700 analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) 21 CFR 868.1620 analyzer, gas, halothane, gaseous-phase (anesthetic conc.) 21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-phase 21 CFR 868.1720 analyzer, gas, oxygen, gaseous-phase 21 CFR 870.2340 electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 computer, diagnostic, programmable 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) 21 CFR 870.1025 detector and alarm, arrhythmia 21 CFR 870.1100 alarm, blood-pressure 21 CFR 870.1110 computer, blood-pressure 21 CFR 870.1435 computer, diagnostic, pre-programmed, single-function 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 870.2910 thermometer, electronic, clinical 21 CFR 882.1900 stimulator, auditory, evoked response 21 CFR 882.1400 full-montage standard electroencephalograph 21 CFR 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) The primary predicate for this submission is K191249 CARESCAPE B450 (807.92(a)(3)):
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 B450 is a new version of a portable multiparameter patient monitoring system. The CARESCAPE B450 includes the monitor itself with built-in CPU, power unit, a 12 inch touch display, the CARESCAPE Software and one or two batteries. CARESCAPE B450 is equipped with an ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. CARESCAPE B450 is also equipped with one module slot where patient data acquisition modules (E-Modules), can be connected to perform patient monitoring. The CARESCAPE B450 includes features and subsystems that are optional or configurable.
Intended Use: (807.92(a)(5)):
Indications for Use (from labeling)
The CARESCAPE B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE B450 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
7
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE B450 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B450 also shows alarms from other ECG sources.
The CARESCAPE B450 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Contraindications for using the monitor
The CARESCAPE B450 is not intended for use in a controlled MR environment.
Technology (807.92(a)(6)): The CARESCAPE B450 incorporates updated software and minor modifications to the hardware.
The fundamental function and operation of the proposed CARESCAPE B450 monitor are unchanged compared to CARESCAPE B450 (K191249).
A summary of the main changes compared to the predicate are listed below in the comparison table.
8
| Specification | CARESCAPE B450
(K191249) | Proposed
CARESCAPE B450 | 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 | 290 x 310 x 160 mm
(11.4 x 12.2 x 6.3 in) (H x
W x D) and weight 4.7 kg
(10.4 lbs) with two
batteries inserted but
without modules inserted. | 290 x 310 x 160 mm
(11.4 x 12.2 x 6.3 in) (H x
W x D) and weight 4.7 kg
(10.4 lbs) with two
batteries inserted but
without modules inserted. | Identical |
| Module Housing | One E-module slot and
optional recorder. One
slide mount for
acquisition module. | One E-module slot and
optional recorder. One
slide mount for
acquisition module. | Identical |
| Display/screen | Integrated 12" TFTcolor
LCD Display | Integrated 12" TFTcolor
LCD Display | Identical |
| Waveforms and
parameter
windows | Standard view: Up to 6
individual waveforms and
up to 16 parameter
windows, if horizontal
parameter area turned on. | Standard view: Up to 6
individual waveforms and
up to 16 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 |
| 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, Bed Rail Hook,
BRH | Multiple GCX mounting
systems, roll stand, Bed
Rail Hook, BRH | Equivalent
Quick Mount is obsolete. |
| 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 B450, 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 B450 | |
| did not require clinical studies to support substantial equivalence. | |
| Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE B450 to be as safe, as |
| effective, and the performance to be substantially equivalent to | |
| the predicate device. |