(30 days)
No
The summary describes a standard physiological patient monitor and its accessories, focusing on parameter acquisition and display. There is no mention of AI, ML, or any advanced analytical capabilities that would typically involve these technologies. The performance studies mentioned are related to hardware, software, and sensor performance, not algorithmic learning or prediction.
No
Explanation: The device is described as a "multi-parameter physiological patient monitor" and an "accessory to a multi-parameter patient monitor" which is "indicated for the monitoring of hemodynamic and respiratory physiological parameters." Its function is solely to acquire and display vital signs and parameters, not to treat or provide therapy.
Yes
The device is described as a multi-parameter physiological patient monitor that measures various physiological parameters, including ECG, blood pressure, SpO2, and temperature, which are used to assess a patient's health status. This falls under the definition of a diagnostic device as it collects information to aid in the diagnosis or monitoring of medical conditions.
No
The device description explicitly states it is a "compact footprint monitor" that runs on an internal battery and AC power, and it utilizes "plug and play Active Cable Modules (ACM)" for vital sign acquisition, indicating it is a hardware device with integrated software.
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 physiological parameters directly from the patient. This includes things like ECG, blood pressure, SpO2, temperature, and respiratory parameters. IVD devices, on the other hand, are intended for the examination of specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details how the device acquires physiological signals from the patient via sensors and cables. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of reagents, specimen handling, laboratory analysis, or any other typical characteristics of an IVD device.
The CARESCAPE ONE is a patient monitoring device that measures physiological signals directly from the patient's body.
N/A
Intended Use / Indications for Use
The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital 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 can be used as a standalone monitor. In this mode of operation, 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 can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, 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. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode.
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 (comma separated list FDA assigned to the subject device)
MHX, BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXN, FLL, MLD
Device Description
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 vital sign, currently we have 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. 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.
When connected to a compatible host monitor, CARESCAPE ONE operates as an acquisition device. In this mode, the CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received from the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.
CARESCAPE ONE is compatible with the following 510(k) cleared host monitors:
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
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
There is no change in the electromagnetic compatibility, electrical safety, environmental (including Mechanical stress testing and Package Testing) and usability compared to the predicate.
Software testing was completed for minor software updates for maintenance/bug fixes only. This included software design, development, verification, validation and traceability. There were no changes to function, operation, parameters monitored, or algorithms. 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 is considered as a "Major" level of concern.
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 address 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.
CARESCAPE ONE has introduced and verified one new hardware component which is additional configuration of the CARESCAPE PRES parameter module, which contains a new connector type (cable connector) that was not included in the predicate CARESCAPE ONE (K190008).
Both the predicate and the new device comply with the same standards, except the new device complies with the more recent edition of the particulars for the following standards:
- . IEC 80601-2-30:2018
- . IEC 80601-2-49:2018
- . ISO 80601-2-55:2018
- ISO 80601-2-56:2017+A1 2018 .
- . ISO 80601-2-61:2017
The battery is identical to the predicate, but we now comply with the most recent battery standard IEC 62133-2:2017.
Verification evidence to show compliance with the updated standards are included in the submission. In order to meet the new standard requirements, we did not require any software or hardware changes compared to the predicate.
Summary of Clinical Tests:
Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence.
A clinical study was conducted on the related GE TruSignal sensors, to provide an update to older data from previous predicated. There is no change to the GE TruSignal Parameter active cable module in hardware, software or pulse oximetry algorithm, or in the sensors used compared to the predicate CARESCAPE ONE (K190008).
We have attached an updated Clinical Research Study Final Report: U-TruSignal SpO2, Testing in Neonates. This report continues to demonstrate compliance with the FDA guidance "Pulse Oximeters - Premarket Notification Submissions [510(k)s], Guidance for Industry and Food and Drug Administration Staff, March 4, 2013" where convenience samples were collected in neonatal patients to demonstrate clinical performance.
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.
K190008, K191249, K191149, K191323
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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March 29, 2020
GE Healthcare Joel Kent Senior Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re: K200494
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, BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSI, DSK, DXN, FLL, MLD Dated: February 25, 2020 Received: February 28, 2020
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
1
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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200494
Device Name CARESCAPE ONE
Indications for Use (Describe)
The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital 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 can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arthythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.
The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, 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. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode.
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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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: | March 10, 2020 |
|---|---|
| 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 Carbon dioxide gas analyzer
21 CFR 870.2340 Electrocardiograph
21 CFR 870.2710 oximeter, ear
21 CFR 870.2700 oximeter
21 CFR 870.1425 Programmable diagnostic computer
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 computers, blood-pressure
21 CFR 870.1130 system, measurement, blood-pressure, noninvasive
21 CFR 880.2910 Clinical electronic thermometer
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 |
5
| Predicate Device(s)
(807.92(a)(3)): | The primary predicate for this submission is K190008,
CARESCAPE ONE
Additional predicates/reference devices:
K071073, Patient Data Module (PDM)
K191249, CARESCAPE B450
K191149, CARESCAPE B650
K191323, CARESCAPE B850 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description
(807.92(a)(4)): | 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 th
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 vital sign, currently we have
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. 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.
When connected to a compatible host monitor, CARESCAPE
ONE operates as an acquisition device. In this mode, the
CARESCAPE ONE screen and user interface is effectively
disabled and it transmits data received from the Active Cable
Modules to the host monitor, which is responsible for managing
clinical configuration settings, and displaying values,
waveforms, alarms, and status messages. |
CARESCAPE ONE is compatible with the following 510(k) cleared host monitors:
6
Intended Use: (807.92(a)(5)):
Indications
The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital 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 can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, noninvasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.
The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, 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. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode.
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.
7
The CARESCAPE ONE that is the subject of this submission is Technology (807.92(a)(6)): based on the primary predicate CARESCAPE ONE (K190008).
The main differences with respect to the predicate discussed throughout the submission are summarized below:
-
Add the capability for CARESCAPE ONE to be utilized as an acquisition device when connected with host monitors (CARECSAPE Monitors). CARESCAPE ONE can be used as an acquisition module for compatible host devices, in addition to use as a stand-alone monitor. There are no changes to the device itself specifically to enable compatibility with the host monitors, as it was already built into the device design. The labeling and instructions have been updated to reflect the use with compatible host devices. Compatibility with CARESCAPE ONE was already cleared in the additional predicate devices CARESCAPE B650 K191149, CARESCAPE B450 K191249 and CARESCAPE B850 K191323. The acquisition module functionality in CARESCAPE ONE, as discussed in K190008, is substantially equivalent to the Patient Data Module (K071073). - Minor software updates for maintenance/bug fixes only. No changes to function, operation, parameters monitored, or algorithms.
-
Compliance demonstrated with newer versions of FDA recognized standards. No actual changes to the device were required to meet the updated standards, other than one update to the labeling for the water ingress protection level (IP44). - Minor updates to the compatible accessories list.
The CARESCAPE ONE remains substantially equivalent to the predicates and the device itself (software and hardware) remains nearly identical to the version cleared under K190008. There are no changes to the monitored parameters or algorithms.
A summary of the main changes compared to the predicate are listed below in the comparison table.
8
| Product Comparison versus Predicate Main features | |||
|---|---|---|---|
| Specification | PREDICATE CARESCAPE ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
|---|---|---|---|
| Indications for Use | The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intra-hospital 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. | The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital 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 can be used as a standalone monitor. In this mode of operation, 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 can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, 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. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode. | Equivalent.
The predicate device is standalone Patient Monitor, which includes patient signal acquisition and processing, patient data display, alarm signal generation, and user input functions.
The new device includes the standalone functionality and behavior, plus includes the ability to delegate alarm signal generation, patient data display, and user input functions to a connected "host" CARESCAPE Patient Monitor. The Patient Data Module (K071073) is a reference device which is similar to the CARESCAPE ONE used as an acquisition module since it connects to a CARESCAPE Monitor host and can also be used in patient transport and then reconnected to a host.
The changes have been made to clarify that the CARESCAPE ONE can be used both as a standalone monitor and a compatible module/accessory for a host CARESCAPE Monitor.
Verification of interoperability/ compatibility was completed. Compatibility of CARESCAPE ONE with the host monitors was also cleared in the following submissions: CARESCAPE B650 K191149, CARESCAPE B450 K191249 and CARESCAPE B850 K191323.
This change is substantially equivalent to the predicate device. |
| Contraindications for using CARESCAPE ONE: | The CARESCAPE ONE is not intended for use within a controlled MR environment. | The CARESCAPE ONE is | |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| | | 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. | |
| 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 within
a professional
healthcare
facility. | Yes | Yes | Identical |
| Acquisition
Mode
(accessory to a
compatible host
monitor) | N/A | Connects to a compatible
"host" CARESCAPE Patient
Monitor.
The CARESCAPE ONE
provides parameter
acquisition for the host patient
Monitor. Visual and audible
alarms, user controls, and user
interface functions are not
active on the CARESCAPE
ONE and instead those
functions are provided by the
host CARESCAPE Patient
Monitor. | Equivalent.
The predicate device is standalone
Patient Monitor, which includes
patient signal acquisition and
processing, patient data display, alarm
signal generation, and user input
functions.
The new device includes the
standalone functionality and behavior,
plus includes the ability to act as an
acquisition device to a host monitor.
This is equivalent to the reference
device Patient Data Module (K071073)
which acts as an acquisition module to
a host device and was a predicate to
K190008. This acquisition mode
allows it to delegate alarm signal
generation, patient data display, and
user input functions to a connected
"host" CARESCAPE Patient Monitor.
The CARESCAPE ONE can be used
both as a standalone and a compatible
module for a host CARESCAPE
Monitor. Verification of
interoperability/compatibility was
completed. Compatibility of
CARESCAPE ONE with the host
monitors was also cleared in the
following submissions: CARESCAPE
B650 K191149, CARESCAPE B450
K191249 and CARESCAPE B850
K191323. This change is substantially
equivalent to the predicate device. |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| Monitored
Parameters | Parameters monitored by
CARESCAPE ONE include:
- hemodynamic (ECG, ST
segment, arrhythmia detection,
invasive pressures, NIBP,
temperature, and pulse
oximetry) - respiratory (impedance
respiration, CO2) | Parameters monitored by
CARESCAPE ONE include: - hemodynamic (ECG, ST
segment, arrhythmia
detection, invasive pressures,
NIBP, temperature, and pulse
oximetry) - respiratory (impedance
respiration, CO2) | Identical |
| Medical
Standards | IEC 60601-1:2005 + C1:2006
- C2:2007 + A1:2012
IEC 60601-1-2:2007
IEC 60601-1-2:2014-02 / EN
60601-1-2:2015
IEC 60601-1-6:2010 +
A1:2013
IEC 60601-1-8:2006 +
A1:2012
IEC 60601-2-27:2011
IEC 80601-2-30:2013
IEC 60601-2-34:2011
IEC 60601-2-49:2011
ISO 80601-2-55:2011
ISO 80601-2-56:2009
ISO 80601-2-61:2011
IEC 62304:2006 + A1:2015
IEC 62366:2017 + A1:2014
ISO 10993-1:2009
IEC 62133:2012 | IEC 60601-1:2005 + C1:2006 - C2:2007 + A1:2012
IEC 60601-1-2:2007
IEC 60601-1-2:2014-02 / EN
60601-1-2:2015
IEC 60601-1-6:2010 +
A1:2013
IEC 60601-1-8:2006 +
A1:2012
IEC 60601-2-27:2011
IEC 80601-2-30:2018
IEC 60601-2-34:2011
IEC 80601-2-49:2018
ISO 80601-2-55:2018
ISO 80601-2-56:2017 +
A1:2018
ISO 80601-2-61:2017
IEC 62304:2006 + A1:2015
IEC 62366:2017 + A1:2014
ISO 10993-1:2009
IEC 62133-2:2017 | Equivalent.
Both the predicate and the new device
comply with the same standards,
except the new device complies with
the more recent edition of the
particulars for the following standards:
IEC 80601-2-30:2018
IEC 80601-2-49:2018
ISO 80601-2-55:2018
ISO 80601-2-56:2017+A1 2018
ISO 80601-2-61:2017
The battery is identical to the
predicate, but we now comply with the
most recent battery standard IEC
62133-2:2017.
Verification testing to show
compliance with the updated standards
are included in the submission. In
order to meet the new standard
requirements we did not require any
software or hardware changes
compared to the predicate
CARESCAPE ONE (K190008). We
have only changed our manuals to list
the new standards and our IP41 water
ingress specification and label has
changed to a higher rating to comply
with IEC 60601-2-61:2017. The new
pulse oximetry standard requires IPx2
instead of IPX1, but we tested to IP44 |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| Parameters
Acquisition
Method | 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 | 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 | Identical |
| EK-Pro
arrhythmia
detection
algorithm | EK-Pro V14 | EK-Pro V14 | Identical |
| Size (H x W x
D) | 155 mm x 270 mm x 65 mm
(6.1 in x 10.6 in x 2.6 in)
Note: Excludes dock | 155 mm x 270 mm x 65 mm
(6.1 in x 10.6 in x 2.6 in)
Note: Excludes dock | Identical |
| Weight | 1.85 kg (4.1 lbs) with battery | 1.85 kg (4.1 lbs) with battery | Identical |
| Battery Type | Lithium-Ion | Lithium-ion | Identical |
| Display size | 7 inch | 7 inch | Identical |
| Display type | Active matrix color TFT LCD | Active matrix color TFT LCD | Identical |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| Number of
traces
(waveforms) | Up to 8 with 4 available on
2nd waveform page. | Up to 8 with 4 available on
2nd waveform page. | Identical |
| 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) | 5 software packages:
Emergency Care (ED),
Critical Care (ICU), Operating
Room (OR), Post-Anesthesia
Care (PACU), Neonatal Care
(NICU) | Identical. |
| Patient Network | No | No | Identical |
| Ethernet port
connector
(RJ45-8-pin) | One Ethernet port for service
tools. | One Ethernet port for service
tools. | Identical |
| Defaults
available | 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. | 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. | Identical |
| Alarm
Classification
(IEC) | Four levels - High, Medium,
Low and Informational | Four levels - High, Medium,
Low and Informational | Identical |
| Alarm
Notification | Audible and visual | Audible and visual | Identical |
| Technical
alarms | System generated alarms to
notify the user of special
conditions. | System generated alarms to
notify the user of special
conditions. | Identical |
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10
11
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Determination of Substantial Equivalence (807.92(b)(1)):
Summary of Non-Clinical Tests:
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
There is no change in the electromagnetic compatibility, electrical safety, environmental (including Mechanical stress testing and
13
Package Testing) and usability compared to the predicate.
Software testing was completed for minor software updates for maintenance/bug fixes only. This included software design, development, verification, validation and traceability. There were no changes to function, operation, parameters monitored, or algorithms. 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 is considered as a "Major" level of concern.
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 address 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.
CARESCAPE ONE has introduced and verified one new hardware component which is additional configuration of the CARESCAPE PRES parameter module, which contains a new connector type (cable connector) that was not included in the predicate CARESCAPE ONE (K190008).
Both the predicate and the new device comply with the same standards, except the new device complies with the more recent edition of the particulars for the following standards:
- . IEC 80601-2-30:2018
- . IEC 80601-2-49:2018
- . ISO 80601-2-55:2018
- ISO 80601-2-56:2017+A1 2018 .
- . ISO 80601-2-61:2017
The battery is identical to the predicate, but we now comply with the most recent battery standard IEC 62133-2:2017.
Verification evidence to show compliance with the updated standards are included in the submission. In order to meet the new standard requirements, we did not require any software or hardware changes compared to the predicate.
14
Clinical (807.92(b)(2)): Summary of Clinical Tests:
Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence.
A clinical study was conducted on the related GE TruSignal sensors, to provide an update to older data from previous predicated. There is no change to the GE TruSignal Parameter active cable module in hardware, software or pulse oximetry algorithm, or in the sensors used compared to the predicate CARESCAPE ONE (K190008).
We have attached an updated Clinical Research Study Final Report: U-TruSignal SpO2, Testing in Neonates. This report continues to demonstrate compliance with the FDA guidance "Pulse Oximeters - Premarket Notification Submissions [510(k)s], Guidance for Industry and Food and Drug Administration Staff, March 4, 2013" where convenience samples were collected in neonatal patients to demonstrate clinical performance.
Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE ONE to be substantially equivalent to the predicate device.