(194 days)
No
The summary describes a standard multi-parameter physiological patient monitor and its accessories. There is no mention of AI or ML in the intended use, device description, or performance studies. The parameters monitored are standard physiological measurements.
No
The device is a multi-parameter physiological patient monitor, indicated for monitoring various physiological parameters. It does not provide therapeutic intervention.
No
This device is a multi-parameter physiological patient monitor that measures and displays various physiological parameters. While these measurements can inform diagnosis, the device itself does not make a diagnosis. It provides data for a healthcare practitioner to interpret.
No
The device description explicitly states that the CARESCAPE ONE is a "flexible bedside monitor" with "built-in" NIBP measurement capability and uses "Active Cable Modules" for other parameters. This indicates it is a hardware device with integrated software, not a software-only 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 CARESCAPE ONE is a "multi-parameter physiological patient monitor" and an "accessory to a multi-parameter patient monitor." It is used for "monitoring of hemodynamic and respiratory physiological parameters." These are measurements taken directly from the patient's body, not from samples of bodily fluids or tissues tested outside the body.
- Device Description: The description details how the device measures vital signs like ECG, pulse oximetry, blood pressure, temperature, and respiratory carbon dioxide. These are all in-vivo measurements.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
Therefore, the CARESCAPE ONE is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, functional oxygen saturation [SpO2]) - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]] - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Regional oxygen saturation (rSO2) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE. CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended 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, MUD, QEM
Device Description
CARESCAPE ONE belongs to the CARESCAPE 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 there are ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, CO2, and rSO2 (rSO2 monitoring is only supported when CARESCAPE ONE is operating as an acquisition device. rSO2 values are not displayed on CARESCAPE ONE). 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, CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received form the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain or other tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
Per the FDA guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff, Document issued on December 20, 2019", the following was verified:
- o Compatibility with new OEM CARESCAPE Parameter Modules
- o Extended support for Masimo parameters
- Updates to the list of accessories ●
- Updates to the user documentation
CARESCAPE ONE was tested and meets the EMC requirements described in IEC 60601-1-2 Edition 4.0 2014-02 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests".
Compliance according to the "Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Issued July 11, 2016" and "Electromagnetic Compatibility (EMC) of Medical Devices, issued on November 17,2020".
CARESCAPE ONE was tested and meets the electrical safety requirements of IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1".
The usability testing of the CARESCAPE ONE patient monitor is in compliance with the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K191149, K191323, K191249, K182868, K110028
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
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 26, 2022
GE Medical Systems Information Technologies, Inc. Joel Kent Sr. Manager Regulatory Affairs 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K213234
Trade/Device Name: CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 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, DSJ, DSK, DXN, FLL, MLD, MUD, QEM
Dear Joel Kent:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 12, 2022. Specifically, FDA is updating this SE Letter to add a missing product code as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih, OHT2: Office of Cardiovascular Devices, Jennifer.Shih(@fda.hhs.gov.
Sincerely,
Jennifer W. Shih -S
Jennifer Shih Assistant 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
1
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April 12, 2022
GE Medical Systems Information Technologies, Inc. Joel Kent Sr. Manager Regulatory Affairs 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K213234
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, DRT, DSI, DSK, DXN, FLL, MLD, MUD, OEM Dated: March 16, 2022 Received: March 17, 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.
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
2
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer W.Shih -S
Jennifer Shih Assistant 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
3
Indications for Use
510(k) Number (if known) K213234
Device Name CARESCAPE ONE
Indications for Use (Describe)
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. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters:
- · ECG (heart rate, ST segment, and arrhythmia detection)
- · Pulse oximetry (pulse rate, functional oxygen saturation [SpO2])
- · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
- · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
- · Temperature
- · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
- · Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor:
- · ECG (heart rate, ST segment, and arrhythmia detection)
- · Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]]
- · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
- · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
- · Regional oxygen saturation (rSO2)
- · Temperature
- · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
- · Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE.
CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states.
CARESCAPE ONE is intended 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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4
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GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226, USA
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: April 7, 2022 | |
|---|---|
| Owner/Submitter: | GE Medical Systems Information Technologies, Inc. |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226, USA | |
| Primary Contact Person: | Joel Kent |
| Director, Regulatory Affairs Strategy | |
| GE Healthcare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | Monica Morrison |
| Regulatory Affairs Executive | |
| GE Healthcare | |
| Phone: 608-515-3077 |
Device names (807.92(a)(2)):
Trade Name: CARESCAPE ONE Common/Usual Name: Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms)
E-mail: monica.morrison(@ge.com
6
Classification Names: 21 CFR 870.1025 monitor, physiological, patient (with
arrhythmia detection or alarms)
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
21 CFR 870.2700 Oximeter, Tissue Saturation
21 CFR 870.2700 Cerebral Oximeter
Product Code: MHX
| Subsequent Product Codes: | BZQ |
|---|---|
| CCK | |
| DPS | |
| DPZ | |
| DQA | |
| DQK | |
| DRT | |
| DSI | |
| DSJ | |
| DSK | |
| DXN | |
| FLL | |
| MLD | |
| MUD | |
| QEM |
7
The primary predicate for this submission is K200494, Predicate Device(s) (807.92(a)(3)): CARESCAPE ONE
Additional reference devices: K191149, CARESCAPE B650 K191323, CARESCAPE B850 K191249, CARESCAPE B450 K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor K110028, MASIMO RADICAL Y PULSE CO-OXIMETER
Device Description (807.92(a)(4)):
CARESCAPE ONE belongs to the CARESCAPE 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 there are ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, CO2, and rSO2 (rSO2 monitoring is only supported when CARESCAPE ONE is operating as an acquisition device. rSO2 values are not displayed on CARESCAPE ONE). 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, CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received form the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.
8
Intended Use: (807.92(a)(5)):
Indications
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.
CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters.
When the CARESCAPE ONE is operated as a standalone multiparameter physiological patient monitor, it provides the following physiological parameters:
·ECG (heart rate, ST segment, and arrhythmia detection)
·Pulse oximetry (pulse rate, functional oxygen saturation [SpO2])
·Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
·Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
·Temperature
•Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
·Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor:
·ECG (heart rate, ST segment, and arrhythmia detection)
•Pulse oximetry (pulse rate, functional oxygen saturation [SpO2], and total hemoglobin concentration [SpHb])
•Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
•Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
·Regional oxygen saturation (rSO2)
·Temperature
•Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
·Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE.
CARESCAPE ONE is intended for use on adult, pediatric, and
9
neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for noninvasive monitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended 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. Technology (807.92(a)(6)): The CARESCAPE ONE uses the same fundamental technology and functionality as the predicate CARESCAPE ONE (K200494). The main differences with respect to the predicate discussed throughout the submission are summarized below: - Compatibility with CARESCAPE Bx50 host monitors running the latest version of software - Compatibility with new OEM CARESCAPE Parameter Modules - Extended support for Masimo parameters - Updates to the Indications for Use (We have revised the Indications for Use statement from the predicate to reflect the changes that have been made for clarity and to reflect the inclusion of the acquisition of OEM parameter rSO2 with the CARESCAPE rSO2 – INVOS™ Parameter module and extended functionality with CARESCAPE SpO2 - Masimo measurement device - Continuous improvements in Cybersecurity - Workflow enhancements in the clinical software - Workflow enhancements in the monitor service and installation features - Updates to the list of accessories - Updates to the user documentation The CARESCAPE ONE remains substantially equivalent to the predicates and the device itself (software and hardware) remains nearly identical to the version cleared under K200494. There are no significant changes to the CARESCAPE ONE monitored parameters, and all measurement algorithms are identical to those that were included in K200494.
10
A summary of the main changes compared to the predicate are listed below in the comparison table.
Product Comparison versus Predicate Main features
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Equivalent
Added functionality to pass total
hemoglobin concentration [SpHb]
from CARESCAPE SpO2 – Masimo
(previously cleared K110028) and
regional oxygen saturation (rSO2)
from CARESCAPE rSO2 – INVOS |
| | The CARESCAPE ONE is
indicated for the monitoring of
hemodynamic (including
ECG, ST segment, arrhythmia
detection, invasive pressure,
non-invasive blood pressure, | CARESCAPE ONE is
indicated for the monitoring
of hemodynamic and
respiratory physiological
parameters. | (previously cleared K182868) through
to a host monitor. These parameters
are not displayed on the CARESCAPE
ONE. |
| | SpO2, pulse rate, and
temperature), and respiratory
(impedance respiration and
CO2 airway gas) physiological
parameters. | When the CARESCAPE
ONE is operated as a
standalone multi-parameter
physiological patient
monitor, it provides the | There were some minor text edits
made to improve clarity.
This change is substantially equivalent |
| | The CARESCAPE ONE can
be used as a standalone
monitor. In this mode of | following physiological
parameters: | to the predicate device. |
| | operation, the CARESCAPE
ONE provides ECG, ST
segment, arrhythmia detection, | • ECG (heart rate, ST
segment, and arrhythmia
detection) | |
| | invasive pressure, non-
invasive blood pressure, SpO2,
pulse rate, temperature,
impedance respiration, and
CO2 airway gas parameter | • Pulse oximetry (pulse rate,
functional oxygen saturation
[SpO2]) | |
| | acquisition and monitoring.
The CARESCAPE ONE can | •Non-invasive blood
pressure (systolic, diastolic,
and mean arterial | |
| | be connected as an accessory
to a compatible CARESCAPE | pressures) | |
| | monitor. In this mode of
operation, the CARESCAPE
ONE provides ECG, ST | • Invasive pressure (pulse
rate and systolic, diastolic,
and mean pressures) | |
| | segment, arrhythmia detection,
invasive pressure, non- | •Temperature | |
| | invasive blood pressure, SpO2,
pulse rate, temperature,
impedance respiration, and
CO2 airway gas parameter
acquisition. | •Respiratory carbon dioxide
(EtCO2, FiCO2, and
respiration rate)
•Impedance respiration | |
| | Visual and audible alarms,
user controls, and user
interface on the CARESCAPE
ONE are not active in this
mode. | When the CARESCAPE
ONE is connected as an
accessory to a compatible
host monitor, it provides the | |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| | 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 | following physiological
parameters to the host
monitor:
•ECG (heart rate, ST
segment, and arrhythmia
detection)
•Pulse oximetry (pulse rate,
functional oxygen saturation
[SpO2], and total
hemoglobin concentration
[SpHb])
•Non-invasive blood | |
| | CARESCAPE ONE:
The CARESCAPE ONE is not
intended for use within a
controlled MR environment. | pressure (systolic, diastolic,
and mean arterial
pressures) | |
| | | •Invasive pressure (pulse
rate and systolic, diastolic,
and mean pressures) | |
| | | •Regional oxygen saturation
(rSO2) | |
| | | •Temperature | |
| | | •Respiratory carbon dioxide
(EtCO2, FiCO2, and
respiration rate) | |
| | | •Impedance respiration | |
| | | When the CARESCAPE
ONE is connected as an
accessory to a compatible
host monitor, visual and
audible alarms, user
controls, and user interface
are provided on the
compatible host monitor
and not on CARESCAPE
ONE. | |
| | | CARESCAPE ONE is
indicated for use on adult,
pediatric, and neonatal
patients and on one patient at
a time. | |
| | | Regional oxygen saturation
(rSO2) is an adjunct
parameter for noninvasive
monitoring of
cerebral/somatic regional
oximetry of blood in the
brain or other tissue
beneath the sensor. It is | |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| | | intended to be used on
patients greater than 40 kg
(88 lbs) at risk for reduced-
flow or no-flow ischemic
states. | |
| | | CARESCAPE ONE is
intended 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) | 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. | 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.
CARESCAPE ONE is
compatible with host monitors
running the latest software
versions. | Equivalent
The basic functionality, data transfer
mechanisms, and physical connection
mechanism between the CARESCAPE
ONE and compatible host monitors is
identical to the predicate
CARESCAPE ONE (K200494).
However, due to enhancements in
functionality (i.e., compatibility with
new CARESCAPE Parameters) that
are not available in older versions of
host monitors, CARESCAPE ONE is
compatible with host monitors running
the latest software versions.
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 80601-2-30:2018
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 62366:2007+ A1:2014
IEC 62366-1:2015
ISO 10993-1:2009
IEC 62133-2:2017
UL 2054:2004
UL 1642:2012
AIM 7351731:2017 | IEC 60601-1:2005 + C1:2006 - C2:2007 + A1:2012
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 62366:2007+ A1:2014
IEC 62366-1:2015
ISO 10993-1:2009
IEC 62133-2:2017
UL 2054:2004
UL 1642:2012
AIM 7351731:2017 | Equivalent
CARESCAPE ONE no longer claims
compliance to IEC 60601-1-2:2007
because it has been superseded by IEC
60601-1-2:2014-02 / EN 60601-1-
2:2015. CARESCAPE ONE complies
with the FDA recognized standards in
scope of the device and its intended
use. This change is substantially
equivalent to the predicate device. |
| 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 Temperature
CARESCAPE Pressure
CARESCAPE ECG (Includes
impedance respiration)
CARESCAPE SPO2
(TruSignal)
OEM CARESCAPE SPO2 -
Nellcor SPO2
OEM CARESCAPE SPO2 -
Masimo SPO2
OEM CARESCAPE CO2 -
LoFlo (Philips Respironics
LoFlo CO2) | 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 Temperature
CARESCAPE Pressure
CARESCAPE ECG (Includes
impedance respiration)
CARESCAPE SPO2
(TruSignal)
OEM CARESCAPE SPO2 -
Nellcor SPO2
OEM CARESCAPE SPO2 -
Masimo SPO2
OEM CARESCAPE CO2 -
LoFlo (Philips Respironics
LoFlo CO2)
OEM CARESCAPE CO2 –
Microstream (Medtronic)
OEM CARESCAPE rSO2 -
INVOS (Medtronic) | Equivalent
Added OEM CARESCAPE CO2 –
Microstream and OEM CARESCAPE
rSO2 - INVOS parameters.
These two parameter cables can be
plugged into any of the eight parameter
acquisition ports on the CARESCAPE
ONE.
This change is substantially equivalent
to the predicate device. |
| 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)
excluding dock and excluding
any host CARESCAPE Patient
monitor. | 155 mm x 270 mm x 65 mm
(6.1 in x 10.6 in x 2.6 in)
excluding dock and excluding
any host CARESCAPE
Patient monitor. | Identical |
| Weight | 1.85 kg (4.1 lbs.) with battery
and excluding dock and
excluding any host
CARESCAPE Patient monitor. | 1.85 kg (4.1 lbs.) with battery
and excluding dock and
excluding any host
CARESCAPE Patient
monitor. | Identical |
| Battery Type | Lithium-Ion | Lithium-ion | Identical |
| Display size | 7 inch | 7 inch | Identical |
| Specification | PREDICATE CARESCAPE
ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| Display type | Active matrix color TFT LCD | Active matrix color TFT LCD | Identical |
| Number of
traces
(waveforms) | Up to 8 with 4 available on
2nd waveform page. | Up to 12 total with 4 available
on 1st page, 4 available on 2nd
page, and 4 available on 3rd
page. | Equivalent
Support for a third page with four
additional parameter windows and
waveforms was added in this release.
The third page is used to display any
parameter windows and waveforms
that are available but haven't been
configured to be shown on either the
first or second page. This functionality
guarantees that all possible parameter
windows and waveforms can be
displayed on the screen. This
functionality was expanded from two
pages to three pages, due to the two
additional invasive pressure channels
that can now be monitored in this
release.This change is substantially
equivalent to the predicate device. |
| 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 |
11
12
13
14
15
16
Summary of Non-Clinical Tests:
Determination of Substantial Equivalence (807.92(b)(1)):
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
This section addresses the Non-Clinical testing for CARESAPE ONE modifications with respect to the predicate CARESCAPE ONE (K200494) that are the subject of this 510(k) submission.
Per the FDA guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff, Document issued on December 20, 2019", the following was verified:
- o Compatibility with new OEM CARESCAPE Parameter Modules
- o Extended support for Masimo parameters
- Updates to the list of accessories ●
- Updates to the user documentation
The CARESCAPE ONE hardware design and environmental requirements have not changed since CARESCAPE ONE (K200494) and none of the other design changes required any new environmental testing.
CARESCAPE ONE was tested and meets the EMC requirements described in IEC 60601-1-2 Edition 4.0 2014-02 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests".
Compliance according to the "Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Issued July 11, 2016" and "Electromagnetic Compatibility (EMC) of Medical Devices, issued on November 17,2020"
CARESCAPE ONE was tested and meets the electrical safety requirements of IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1".
17
Due to the software changes and addition of compatibility with new OEM CARESCAPE Parameters and accessories that is included in this submission. CARESCAPE ONE received updated CB reports demonstrating compliance with the FDA recognized standards in scope for the product.
The usability testing of the CARESCAPE ONE patient monitor is in compliance with the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).
The main differences with respect to the predicate (related to software) are listed below:
• Compatibility with CARESCAPE Bx50 host monitors running the latest version of software
- Compatibility with new OEM CARESCAPE Parameter Modules
· Extended support for Masimo parameters
·Continuous improvements in Cybersecurity
· Workflow enhancements in the clinical software
· Workflow enhancements in the monitor service and installation features
There are no changes to algorithms within CARESCAPE ONE, or any changes to any of the software within the CARESCAPE Parameters created by GE other than correction of minor anomalies in the CARESCAPE ECG parameter device. Testing was conducted and 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
18
Industry and Food and Drug Administration Staff Document issued on October 2, 2014 (and is in-line with the draft Guidance issue October 2018).
| Clinical (807.92(b)(2)): | Summary of Clinical Tests:
Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE ONE to be substantially equivalent to the predicate device. |