(352 days)
K022834 Pro1000, K080251 APEXPRO TELEMETRY SYSTEM, K011000 TRAM module, K051367 DASH 3000/4000/5000 monitoring systems, K900598 TRAMSCOPE SYSTEM, K171580 B105/B125 monitor, K151063 Monitor B40, K110028 MASIMO RADICAL Y PULSE CO-OXIMETER, K172482 The Nellcor pulse oximetry monitor interface cable., K053174 LOFLO C5 CO2 SENSOR, K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
No
The summary describes a standard physiological patient monitor with various parameter acquisition modules. There is no mention of AI or ML in the intended use, device description, or performance studies. The algorithms mentioned (EK-Pro V14 and TruSignal V3) are described as updates to existing algorithms, not as incorporating AI/ML.
No.
The device is a physiological patient monitor, indicated for monitoring various physiological parameters. Its intended use is for monitoring, not for therapeutic intervention.
No
Explanation: The CARESCAPE ONE is described as a "multi-parameter physiological patient monitor" and its purpose is to acquire and monitor physiological parameters. While it collects data that can be used for diagnosis, its primary stated function is monitoring, not making a diagnosis itself.
No
The device description explicitly states it is a "new patient monitor device" and describes hardware components like "plug and play Active Cable Modules (ACM)", "medical grade USB ports", and a "built-in" NIBP measurement capability. It also mentions running on an "internal battery as well as AC power". The performance studies include "hardware bench testing". This clearly indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the CARESCAPE ONE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring of hemodynamic... and respiratory... physiological parameters." This involves measuring physiological signals directly from the patient's body.
- Device Description: The description details how the device acquires and displays physiological parameters like ECG, blood pressure, SpO2, temperature, respiration, and CO2. These are all measurements taken from the patient.
- Lack of In Vitro Activity: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The CARESCAPE ONE does not perform any analysis on such specimens. It directly monitors the patient's vital signs.
Therefore, the CARESCAPE ONE is a patient monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.
The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.
The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.
Contraindications for using CARESCAPE ONE:
The CARESCAPE ONE is not intended for use within a controlled MR environment.
Product codes
MHX, MLD, DSI, BZO, DXN, DOA, DPZ, DRT, DSJ, DSK, FLL, CCK
Device Description
CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).
CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).
CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.
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 the 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
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental (including Mechanical stress testing and Package Testing) and usability.
The CARESCAPE ONE has been found to be safe and effective for the intended users, uses and use environments. Extensive usability work has been completed for CARESCAPE ONE 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. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major" level of concern.
The CARESCAPE ONE monitor does not have direct contact with the patient. There are patient cables that can have unintended/intermittent intact skin contact with the patient and appropriate biocompatibility testing has been completed for those components.
Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE ONE including a Security Risk Assessment, Threat model and Penetration testing. 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 for all parameter performance characteristics, including applicable consensus standards for ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, and CO2. The algorithms with changes compared to the predicates, EK-Pro V14 arrhythmia and TruSignal V3 SPO2 were validated as described below.
For EK-Pro V14 performance values for the applicable characteristics as defined in the ANSI/AAMI EC57:1998 (R)2012 standard has been provided to support a comparison of the EC57 results for the EK-Pro V14 algorithm (the subject device) to the predicate version EK-Pro V13 (K132533). The comparison demonstrates that the EC57 results and performance values are substantially equivalent between the subject V14 and predicate V13 versions of EK-Pro.
The accuracy of the SpO2 parameter as measured with the U-TruSignal ACM medical device (with TruSignal V3) during motion and non-motion conditions as compared to CO-oximetry in a controlled desaturation study was completed using the method as set forth by ISO 80601-2-61:2011 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013.
Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K071073, K132533 CARESCAPE Monitor B450
Reference Device(s)
K022834 Pro1000, K080251 APEXPRO TELEMETRY SYSTEM, K011000 TRAM module, K051367 DASH 3000/4000/5000 monitoring systems, K900598 TRAMSCOPE SYSTEM, K171580 B105/B125 monitor, K151063 Monitor B40, K110028 MASIMO RADICAL Y PULSE CO-OXIMETER, K172482 The Nellcor pulse oximetry monitor interface cable., K053174 LOFLO C5 CO2 SENSOR, K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
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
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December 20, 2019
GE Healthcare Joel Kent Senior Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re: K190008
Trade/Device Name: CARESCAPE ONE 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. MLD. DSI. BZO. DXN. DOA. DPZ. DRT. DSJ. DSK. FLL. CCK Dated: November 15, 2019 Received: November 18, 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.
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
1
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 Jessica Paulsen Director 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) K190008
Device Name CARESCAPE ONE
Indications for Use (Describe)
The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.
The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.
The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.
Contraindications for using CARESCAPE ONE:
The CARESCAPE ONE is not intended for use within a controlled MR environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular border. The background is black, and the logo is white, creating a strong contrast. The design is simple, yet recognizable.
GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, Wisconsin 53223
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: | December 20, 2019 |
|---|---|
| Owner/Submitter: | GE Medical Systems Information Technologies, Inc. |
| 8200 West Tower Avenue | |
| Milwaukee, Wisconsin 53223 | |
| Primary Contact Person: | Joel Kent |
| Senior Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | Monica Morrison |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Phone: 608-515-3077 | |
| E-mail: monica.morrison@ge.com |
Device names (807.92(a)(2)):
Trade Name: CARESCAPE ONE Common/Usual Name: Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms)
4
Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including ST-
segment measurement and alarm)
21 CFR 868.2375 monitor, breathing frequency
21 CFR 868.1400 analyzer, gas, carbon-dioxide, 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 870.1130 system, measurement, blood-pressure, noninvasive
21 CFR 870.2910 thermometer, electronic, clinical
21 CFR 870.1025 monitor, st segment with alarm
Product Code: MHX
Subsequent Product Codes: BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, MLD
The primary predicate for this submission is K071073, Patient Predicate Device(s) (807.92(a)(3)): Data Module (PDM)
Additional predicates/reference devices: K132533 CARESCAPE Monitor B450 K022834 Pro1000 K080251 APEXPRO TELEMETRY SYSTEM K011000 TRAM module K051367 DASH 3000/4000/5000 monitoring systems K900598 TRAMSCOPE SYSTEM K171580 B105/B125 monitor K151063 Monitor B40 K110028 MASIMO RADICAL Y PULSE CO-OXIMETER K172482 The Nellcor pulse oximetry monitor interface cable. K053174 LOFLO C5 CO2 SENSOR K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
5
Device Description (807.92(a)(4)):
CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).
CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).
CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.
6
Intended Use: (807.92(a)(5)):
Indications (from labeling)
The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.
The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure. SpO2. pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.
The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.
Contraindications for using CARESCAPE ONE:
The CARESCAPE ONE is not intended for use within a controlled MR environment
The CARESCAPE ONE is a new multi-parameter monitor, Technology (807.92(a)(6)): introducing equivalent features and enhancements to existing features from two predicate devices. The primary predicate device is the PDM (K071073), and the main additional predicate used in this comparison is the CARESCAPE Monitor B450 with ESP V2 software (K132533).
The CARESCAPE ONE can be used as a full-standalone multiparameter monitor [equivalent to the CARESCAPE Monitor B450 (K132533) using the PDM (K071073)], providing the users the acquired display values, waveforms and alarms without the necessity of requiring a separate host monitor. The CARESCAPE ONE monitor's size is small and compact to support use in intra-hospital transport as well.
7
Some key features of the device are summarized below:
· The CARESCAPE ONE includes a touch screen display allowing the user to control the monitor's functions and display. · CARESCAPE ONE can be used as a stand-alone monitor This is equivalent to the functionality to the predicate CARESCAPE Monitor B450 using the PDM module. · The CARESCAPE ONE uses Active Cable Modules (also called Parameters) where the specific parameter electronics are encapsulated into the respective patient cables, allowing the monitor to be as compact as possible. In the PDM, the electronics related to a specific parameter, such as ECG, were contained within the PDM itself. In this case, the Active Cables Modules (ACMs) provide patient isolation, parameter data acquisition with signal conditioning, some signal processing, and USB communication back to the CARESCAPE ONE. The same technology to process and analyze the signals is maintained as compared to the predicate, and the equivalent functionality is maintained. However, the electronics are contained within the active cables themselves rather than inside the monitor. · Incorporates an alarm system that complies with IEC 60601-1-8:2012. Also adds additional flexibility for clinicians to tailor the alarms to their particular patient needs such as the ability to select/adjust the alarm priority levels for certain alarms and adjust time delays/alarm trigger delays. Alarms are displayed and alerted with visual alerts and audio directly on the CARESCAPE ONE Monitor.
· Uses a Common Software Platform (CSP) that is used for the user interface, service interface, operating system, parameter data processing, alarms, trends, security, power management, and battery control. The operating system and display use a similar lavout and look/feel as the CARESCAPE bedside monitors. This gives the user a similar experience across the various products.
· The CARESCAPE ONE incorporates the EK-Pro V14 arrhythmia detection algorithm into the monitor software. This is a slightly newer version of the EK-Pro algorithm that was utilized with the CARESCAPE Monitor B450 (EK-Pro v13), however it serves the same function and retains equivalent performance.
· The CARESCAPE ONE measures LoFlo Sidestream CO2. PDM did not measure CO2 on its own. The B450 does include the display of CO2 through associated parameter modules. The CARESCAPE ONE CO2 measurement technology has been
8
used by GE Healthcare in other existing bedside devices. The technology for this measurement has been cleared by its OEM developer, Respironics Novametrix LLC, with 510(k) K053174. This same technology was incorporated into GE Healthcare Solar and Dash bedside monitors with our Capnostat/Capnoflex CO2 System 510(k) K083750. • The CARESCAPE ONE and the PDM can measure SpO2 with technology supplied by OEM manufacturers Masimo and Nellcor. The CARESCAPE ONE can also measure SpO2 with the GE Trusignal technology. This technology is used in multiple FDA cleared GE devices including the B105/B125 monitor (K171580) and the Monitor B40 (K151063).
A summary of the main changes compared to the predicate are listed below in the comparison table.
| Specification | CARESCAPE B450
monitor with ESP
V2
(K132533) | PDM
(K071073) | CARESCAPE
ONE | Discussion of Differences
CARESCAPE ONE and Predicates |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------|
| Patient type | Adult, pediatric &
neonatal | 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) | Within a
professional
healthcare facility
(Not intended for
MRI) | Identical |
| Intrahospital
transport within
a professional
healthcare
facility. | Yes | Yes | Yes | Identical |
Product Comparison versus Predicate Main features
9
| Specification | CARESCAPE B450
monitor with ESP
V2
(K132533) | PDM
(K071073) | CARESCAPE
ONE | Discussion of Differences
CARESCAPE ONE and Predicates |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Monitored
Parameters | Parameters
monitored by B450
with ESP V2
include:
- hemodynamic
(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) - neurophysiological
status
(electroencephalog
raphy, Entropy,
Bispectral Index
(BIS), and
neuromuscular
transmission) | Parameters
monitored by PDM
include: - hemodynamic
(ECG, ST segment,
arrhythmia detection,
invasive pressures,
NIBP, temperature,
and pulse oximetry) - respiratory
(impedance
respiration) | Parameters
monitored by
CARESCAPE
ONE include: - hemodynamic
(ECG, ST
segment,
arrhythmia
detection, invasive
pressures, NIBP,
temperature, and
pulse oximetry) - respiratory
(impedance
respiration, CO2) | Equivalent. The CARESCAPE ONE monitors a
subset of the parameters included
for display on the B450.
CARESCAPE ONE includes the
same parameters for measurement
acquisition as the PDM, with the
addition of the LoFLo CO2
measurement. PDM does not
include the CO2 parameter. The
B450 does include the display of
CO2 through associated parameter
modules. The CARESCAPE ONE
CO2 measurement technology has
been used by GE Healthcare in
other existing bedside devices. The
technology for this measurement
has been cleared by its OEM
developer, Respironics Novametrix
LLC, with 510(k) K053174. This
same technology was incorporated
into GE Healthcare Solar and Dash
bedside monitors with our
Capnostat/Capnoflex CO2 System
510(k) K083750. The additional
parameters included in B450 which
are not included in CARESCAPE
ONE, such as anesthetic agents,
N2O, and BIS, are not necessary for
the function and use of the
CARESCAPE ONE monitor. These
changes do not affect the
determination of substantial
equivalence. |
| Specification | CARESCAPE B450
monitor with ESP | PDM
(K071073) | CARESCAPE
ONE | Discussion of Differences
CARESCAPE ONE and Predicates |
| | V2
(K132533) | | | |
| Parameters
Acquisition
Method | B450 connects to
multiple parameter
acquisition
modules, including
PDM (Masimo and
Nellcor), E-sCO.
E-sCOV, E-
sCAiO, E-
sCAiOV, E-miniC,
E-PSM, E-EEG, E-
BIS, E-COP, E-
ENTROPY, E-
MASIMO, E-
NMT, E-NSATX,
E-P, E-PP, and E-
PT for acquisition
of measured
parameters that are
displayed on the
B450. | The PDM is a
parameter
acquisition module,
which includes the
parameter
acquisition
electronics within
the frame of the
PDM. | The
CARESCAPE
ONE utilizes the
Active Cable
Modules (ACMs)
Or
PARAMETERS,
in which the
parameter
electronics are
encapsulated into
the respective
patient cables,
rather than inside
the main frame of
the monitor.
Only the NIBP
parameter is
integrated into the
CARESCAPE
ONE monitor.
Parameter/Active
Cable Modules:
CARESCAPE
TEMP -
Temperature
CARESCAPE
PRES - Invasive
Pressure
CARESCAPE
ECG - ECG
CARESCAPE
SPO2 - Trusignal
SPO2
CARESCAPE
SPO2 Nellcor -
Nellcor SPO2
CARESCAPE
SPO2 Masimo -
Masimo SPO2
CARESCAPE
CO2 - LoFlo | Equivalent
The same parameter acquisition
technology is utilized in the
CARESCAPE ONE as in the
predicate PDM, however, some of
the specific parameter electronics
are encapsulated into the respective
patient cables, allowing the monitor
to be as compact as possible. In the
PDM, the electronics related to a
specific parameter, such as ECG,
were contained within the PDM
itself. In this case, the Active Cables
Modules (ACMs) provide patient
isolation, parameter data acquisition
with signal conditioning, some
signal processing, and USB
communication back to the
CARESCAPE ONE. The same
technology to process and analyze
the signals is maintained as
compared to the predicate, and the
equivalent functionality is
maintained. However, the
electronics are contained within the
active cables themselves rather than
inside the monitor. The additional
measured parameter compared to
PDM is CO2 as summarized in the
line item above.
The measurement technology and
functionality remain equivalent to
the predicate. |
| EK-Pro
arrhythmia
detection
algorithm | EK-Pro V13 | EK-Pro v11 | EK-Pro V14 | The CARESCAPE ONE
incorporates the EK-Pro V14
arrhythmia detection algorithm into
the monitor software. This is a
slightly newer version of the EK-
Pro algorithm that was utilized with
the CARESCAPE Monitor B450
(EK-Pro v13), however it serves the
same function and retains
equivalent performance. |
| Specification | CARESCAPE B450
monitor with ESP
V2
(K132533) | PDM
(K071073) | CARESCAPE
ONE | Discussion of Differences
CARESCAPE ONE and Predicates |
| Size (H x W x
D) | 290 mm x 310 mm
x 160 mm
(11.4 in x 12.1 in x
6.2 in) | Height 6.4 cm (2.5
in.) maximum
Width 14.0 cm (5.5
in.) maximum
Depth 21.6 cm (8.5
in.) maximum | 155 mm x 270
mm x 65 mm (6.1
in x 10.6 in x 2.6
in)
Note: Excludes
dock | Equivalent.
The CARESCAPE ONE is a patient
monitor and performs the function
of both CARESCAPE PDM and
CARESCAPE B450 combined. As
a patient monitor, the CARESCAPE
ONE has reduced size making it
easier to transport and mount. This
improvement does not impact the
determination of substantial
equivalence since it is only a change
in the physical size of the device. |
| Weight | 4.7 kg (10.4 lbs)
with two batteries
but without
modules | 1.0 kg (2.2 lbs.)
without optional
battery
1.2 kg (2.6 lbs.) with
optional battery | 1.85 kg (4.1 lbs)
with battery | Equivalent.
The CARESCAPE ONE is a patient
monitor and performs the function
of both CARESCAPE PDM and
CARESCAPE B450 combined. As
a patient monitor, the CARESCAPE
ONE has reduced weight making it
easier to transport and mount. This
improvement does not affect the
determination of substantial
equivalence since it is only a change
in the weight of the of the device
making it lighter than the predicate
combination that performed similar
functions. |
| Battery Type | Lithium-Ion | Lithium-ion | Lithium-ion | Identical |
| Display size | 12.1 in | Not Applicable | 7 inch | Equivalent.
The smaller form factor of the
CARESCAPE ONE required a
smaller screen compared to the
B450. The PDM does not have a
display screen as it was used as a
parameter acquisition module to
communicate data to a patient
monitor, like B450. The smaller
screen is intended to make the
device more transportable. The
parameter data, waveforms, and
alarms adequately fit on the display.
This smaller screen does not affect
the determination of substantial
equivalence since it is only a change
in the screen size of the device with
specific design to display numerics
and waveforms as the predicate. |
| Specification | CARESCAPE B450
monitor with ESP
V2
(K132533) | PDM
(K071073) | CARESCAPE
ONE | Discussion of Differences
CARESCAPE ONE and Predicates |
| Display type | Active matrix color
TFT LCD | Not Applicable | Active matrix
color TFT LCD | Identical to B450. |
| Number of
traces
(waveforms) | Up to 6, or up to 12
if optional dual
display is used. | Not Applicable | Up to 8 with 4
available on 2nd
waveform page. | Equivalent.
The lower number of waveforms
shown at one time, 4 verses 6, and 8
verses 12, is due to having a smaller
screen and smaller set of available
parameters. These technical
differences are intentional to make
the CARESCAPE ONE more
transportable. The CARESCAPE
B450 patient monitor also supports
some specialized parameters which
includes more waveforms, and these
specialized parameters are not
available with the CARESCAPE
ONE. The CARESCAPE ONE can
show 8 waveforms with swiping to
a second page/screen while the
CARESCAPE B450 requires a
second physical display.
Waveforms for all parameters
supported by the CARESCAPE
ONE can be displayed at the same
time using the second waveform
page. The lower number of
waveforms shown does not affect
the determination of substantial
equivalence since the device
displays waveforms for the
parameters it specifies. |
| Operating
System | Linux Operating
System | Linux operating
system | Linux operating
system | Identical |
| Software
packages | 5 software
packages:
Emergency Care
(ED), Critical Care
(ICU), Operating
Room (OR), Post-
Anesthesia Care
(PACU), Neonatal
Care (NICU) | Not Applicable | 5 software
packages:
Emergency Care
(ED), Critical
Care (ICU),
Operating Room
(OR), Post-
Anesthesia Care
(PACU), Neonatal
Care (NICU) | Identical. |
| Specification | CARESCAPE B450
monitor with ESP
V2
(K132533) | PDM
(K071073) | CARESCAPE
ONE | Discussion of Differences
CARESCAPE ONE and Predicates |
| Patient Network
functionality | WLAN, LAN | Not Applicable | Not Applicable | CARESCAPE ONE is not a
networked monitor. Patient
monitors do not require connection
to a clinical network for safe and
effective use. Therefore, this change
does not affect the determination of
substantial equivalence since it has
been designed not to be directly
connected to the network. |
| Patient Network | Yes | Yes | No | Equivalent. |
| Ethernet port
connector
(RJ45-8-pin) | Three Ethernet
ports: Network
MC, Network IX,
Unity Network ID. | Powered Ethernet
TCP/IP and
USB | One Ethernet port
for service tools. | The Ethernet port on the
CARESCAPE ONE is intended for
access to service functions when
connected to the F0 Dock. This port
is not intended for nor will it
communicate on a clinical network.
CARESCAPE ONE is not a
networked monitor. Patient
monitors do not require connection
to a clinical network for safe and
effective use. Therefore, this change
does not affect the determination of
substantial equivalence since it is
only a change in the use of the
network connection for service use
since this device does not connect to
the patient network. |
| Defaults
available | User selectable
arrhythmia alarm
levels, Parameter
settings and alarm
levels, default
alarm limits,
display layout,
parameter priority,
catheters, drugs
and common
events defaults. Up
to 8 different pre-
configured or
custom defaults
available. Not all
parameters have
configurable alarm
priorities. | Not Applicable | User selectable
arrhythmia alarm
levels, Parameter
settings and alarm
levels, default
alarm limits,
display layout,
parameter priority
defaults. Up to 8
different pre-
configured or
custom defaults
available. Not all
parameters have
configurable
alarm priorities. | Equivalent.
The CARESCAPE ONE does not
support catheters, drugs and
common events. Other defaults
available are equivalent. Support for
these are features and not essential
to the use of the device, and
therefore this change does not affect
the determination of substantial
equivalence since it is only a change
due to the fact that the device
supports different parameters
compared to the predicate. |
| Alarm
Classification
(IEC) | Four levels –
High, Medium,
Low and
Informational | Not Applicable | Four levels –
High, Medium,
Low and
Informational | Identical to B450. The predicate
PDM is a parameter acquisition
module that provides data to the
host devices. PDM does not have a
display and does not provide
alarms; alarms are provided from
the host device. The CARESCAPE
ONE is a combination of the
parameter acquisition technology
and function from the PDM, and the |
| Specification | CARESCAPE B450 monitor with ESP V2 (K132533) | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates |
| Alarm Notification | Audible and visual | Not Applicable | Audible and visual | Identical |
| Technical alarms | System generated alarms to notify the user of special conditions. | Not Applicable | System generated alarms to notify the user of special conditions. | Identical |
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Determination of
(807.92(b)(1)):
Substantial Equivalence
Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
The hardware bench testing included electromagnetic compatibility, electrical safety, environmental (including Mechanical stress testing and Package Testing) and usability.
The CARESCAPE ONE has been found to be safe and effective for the intended users, uses and use environments. Extensive usability work has been completed for CARESCAPE ONE 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. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major" level of concern.
The CARESCAPE ONE monitor does not have direct contact with the patient. There are patient cables that can have unintended/intermittent intact skin contact with the patient and appropriate biocompatibility testing has been completed for those components.
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Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE ONE including a Security Risk Assessment, Threat model and Penetration testing. 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 for all parameter performance characteristics, including applicable consensus standards for ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, and CO2. The algorithms with changes compared to the predicates, EK-Pro V14 arrhythmia and TruSignal V3 SPO2 were validated as described below.
For EK-Pro V14 performance values for the applicable characteristics as defined in the ANSI/AAMI EC57:1998 (R)2012 standard has been provided to support a comparison of the EC57 results for the EK-Pro V14 algorithm (the subject device) to the predicate version EK-Pro V13 (K132533). The comparison demonstrates that the EC57 results and performance values are substantially equivalent between the subject V14 and predicate V13 versions of EK-Pro.
The accuracy of the SpO2 parameter as measured with the U-TruSignal ACM medical device (with TruSignal V3) during motion and non-motion conditions as compared to CO-oximetry in a controlled desaturation study was completed using the method as set forth by ISO 80601-2-61:2011 and the FDA guidance Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, March 2013.
Clinical (807.92(b)(2)): Summary of Clinical Tests:
Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence.
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Conclusion (807.92(b)(3)):
Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE ONE to be as safe, as effective, and the performance to be substantially equivalent to the predicate device.