(30 days)
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.
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.
The provided text is a 510(k) Pre-Market Notification for the GE Healthcare CARESCAPE ONE device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (K190008, also CARESCAPE ONE).
However, the document does not describe a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML medical device (e.g., performance metrics like sensitivity, specificity, or AUC for an algorithm). Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device. The "study" mentioned is primarily focused on compliance with updated medical standards and the ability of the device to function as an acquisition module when connected to a host monitor, rather than a clinical performance study of a novel algorithm against pre-defined acceptance criteria.
Specifically, the document states:
- "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." (Page 14)
- The only "clinical study" mentioned ("U-TruSignal SpO2, Testing in Neonates") is related to a component (GE TruSignal sensors) and is described as an update to older data to ensure compliance with a specific FDA guidance for pulse oximeters, not a general performance study of the CARESCAPE ONE itself or its new features. It explicitly states 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)."
Therefore, based on the provided text, I cannot extract information regarding a study that proves the device meets acceptance criteria in terms of algorithmic performance against a defined ground truth using a test set, expert consensus, etc. The submission's focus is on demonstrating safety and effectiveness through substantial equivalence and compliance with relevant standards.
Therefore, many parts of your request cannot be answered directly from the provided text.
Here's what can be extracted and inferred, with limitations noted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for algorithmic performance, nor does it present "reported device performance" in terms of specific diagnostic or predictive metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this submission are focused on demonstrating substantial equivalence to a predicate device and compliance with updated industry standards.
The table on pages 8-9 compares the new CARESCAPE ONE to the predicate CARESCAPE ONE (K190008) across various specifications. The "Discussion of Differences" column implicitly reflects the "performance" relative to the predicate, often stating "Identical" or "Equivalent". For example, for "Medical Standards," the acceptance criterion would be compliance with the listed standards, and the reported performance is that it complies with newer editions. For "Monitored Parameters" and "EK-Pro arrhythmia detection algorithm," the performance is that they are "Identical" to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the context of an algorithmic performance test. The clinical study mentioned "U-TruSignal SpO2, Testing in Neonates" used "convenience samples collected in neonatal patients." The exact sample size is not stated in this document.
- Data Provenance: Not specified for the "U-TruSignal SpO2, Testing in Neonates" study. It's noted as a clinical study, implying prospective data collection, but no further details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving expert readers or establishing ground truth for an AI algorithm. The mentioned "clinical study" pertains to pulse oximetry sensor performance, which typically relies on arterial blood gas measurements for ground truth, not expert adjudication in the traditional sense of image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This type of MRMC study is not mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of a new AI algorithm. The device incorporates existing algorithms (like EK-Pro arrhythmia detection V14) which were part of the predicate device and are stated to be "identical." The type of "performance" testing done was bench testing and verification of compliance with updated standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "U-TruSignal SpO2, Testing in Neonates" study, the ground truth for pulse oximetry studies typically involves direct arterial blood gas measurements (SaO2), considered the "gold standard" for oxygen saturation. The document mentions compliance with "Pulse Oximeters - Premarket Notification Submissions [510(k)s], Guidance," which outlines the ground truth methodology for such devices.
8. The sample size for the training set
Not applicable. This submission is not about a new AI/ML algorithm that requires a training set. The device utilizes existing algorithms.
9. How the ground truth for the training set was established
Not applicable. As above, this document does not describe a new AI/ML algorithm requiring a training set with established ground truth.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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
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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
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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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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 border has decorative flourishes resembling water droplets or stylized leaves at the top, bottom, and sides of the circle.
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)
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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 |
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| Predicate Device(s)(807.92(a)(3)): | The primary predicate for this submission is K190008,CARESCAPE ONEAdditional predicates/reference devices:K071073, Patient Data Module (PDM)K191249, CARESCAPE B450K191149, CARESCAPE B650K191323, CARESCAPE B850 |
|---|---|
| Device Description(807.92(a)(4)): | CARESCAPE ONE, with CARESCAPE Software version 3belongs to the CARESCAPE V3 patient monitor family. Theconcept of the CARESCAPE ONE is to provide a flexiblebedside monitor that can also be used during intra-hospitaltransport. The flexibility of the CARESCAPE ONE allows theuser to configure the monitor's vital sign acquisition for only thparameters they require. This is achieved using plug and playActive Cable Modules (ACM) that connect via medical gradeUSB ports on the CARESCAPE ONE monitor. Note that theUSB ports are not compatible with commercial USB items onthe market due to a custom connector design. Each ACM isdedicated to measuring a particular vital sign, currently we haveECG/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 ACMsince the capability to measure NIBP is built-in to theCARESCAPE ONE monitor itself. CARESCAPE ONEprovides the users the acquired display values, waveforms,alarms and status messages in compact footprint monitor thatruns on an internal battery as well as AC power when connectedto the docking station.When connected to a compatible host monitor, CARESCAPEONE operates as an acquisition device. In this mode, theCARESCAPE ONE screen and user interface is effectivelydisabled and it transmits data received from the Active CableModules to the host monitor, which is responsible for managingclinical configuration settings, and displaying values,waveforms, alarms, and status messages. |
CARESCAPE ONE is compatible with the following 510(k) cleared host monitors:
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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.
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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.
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| 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 CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| The CARESCAPE ONE isindicated for use under thedirect supervision of alicensed healthcarepractitioner, or by personneltrained in the proper use of theequipment in a professionalhealthcare facility.Contraindications for usingCARESCAPE ONE:The CARESCAPE ONE isnot intended for use within acontrolled MR environment. | |||
| Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical |
| Useenvironments | Within a professionalhealthcare facility (Notintended for MRI) | Within a professionalhealthcare facility (Notintended for MRI) | Identical |
| Intrahospitaltransport withina professionalhealthcarefacility. | Yes | Yes | Identical |
| AcquisitionMode(accessory to acompatible hostmonitor) | N/A | Connects to a compatible"host" CARESCAPE PatientMonitor.The CARESCAPE ONEprovides parameteracquisition for the host patientMonitor. Visual and audiblealarms, user controls, and userinterface functions are notactive on the CARESCAPEONE and instead thosefunctions are provided by thehost CARESCAPE PatientMonitor. | Equivalent.The predicate device is standalonePatient Monitor, which includespatient signal acquisition andprocessing, patient data display, alarmsignal generation, and user inputfunctions.The new device includes thestandalone functionality and behavior,plus includes the ability to act as anacquisition device to a host monitor.This is equivalent to the referencedevice Patient Data Module (K071073)which acts as an acquisition module toa host device and was a predicate toK190008. This acquisition modeallows it to delegate alarm signalgeneration, patient data display, anduser input functions to a connected"host" CARESCAPE Patient Monitor.The CARESCAPE ONE can be usedboth as a standalone and a compatiblemodule for a host CARESCAPEMonitor. Verification ofinteroperability/compatibility wascompleted. Compatibility ofCARESCAPE ONE with the hostmonitors was also cleared in thefollowing submissions: CARESCAPEB650 K191149, CARESCAPE B450K191249 and CARESCAPE B850K191323. This change is substantiallyequivalent to the predicate device. |
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| MonitoredParameters | Parameters monitored byCARESCAPE ONE include:- hemodynamic (ECG, STsegment, arrhythmia detection,invasive pressures, NIBP,temperature, and pulseoximetry)- respiratory (impedancerespiration, CO2) | Parameters monitored byCARESCAPE ONE include:- hemodynamic (ECG, STsegment, arrhythmiadetection, invasive pressures,NIBP, temperature, and pulseoximetry)- respiratory (impedancerespiration, CO2) | Identical |
| MedicalStandards | IEC 60601-1:2005 + C1:2006+ C2:2007 + A1:2012IEC 60601-1-2:2007IEC 60601-1-2:2014-02 / EN60601-1-2:2015IEC 60601-1-6:2010 +A1:2013IEC 60601-1-8:2006 +A1:2012IEC 60601-2-27:2011IEC 80601-2-30:2013IEC 60601-2-34:2011IEC 60601-2-49:2011ISO 80601-2-55:2011ISO 80601-2-56:2009ISO 80601-2-61:2011IEC 62304:2006 + A1:2015IEC 62366:2017 + A1:2014ISO 10993-1:2009IEC 62133:2012 | IEC 60601-1:2005 + C1:2006+ C2:2007 + A1:2012IEC 60601-1-2:2007IEC 60601-1-2:2014-02 / EN60601-1-2:2015IEC 60601-1-6:2010 +A1:2013IEC 60601-1-8:2006 +A1:2012IEC 60601-2-27:2011IEC 80601-2-30:2018IEC 60601-2-34:2011IEC 80601-2-49:2018ISO 80601-2-55:2018ISO 80601-2-56:2017 +A1:2018ISO 80601-2-61:2017IEC 62304:2006 + A1:2015IEC 62366:2017 + A1:2014ISO 10993-1:2009IEC 62133-2:2017 | Equivalent.Both the predicate and the new devicecomply with the same standards,except the new device complies withthe more recent edition of theparticulars for the following standards:IEC 80601-2-30:2018IEC 80601-2-49:2018ISO 80601-2-55:2018ISO 80601-2-56:2017+A1 2018ISO 80601-2-61:2017The battery is identical to thepredicate, but we now comply with themost recent battery standard IEC62133-2:2017.Verification testing to showcompliance with the updated standardsare included in the submission. Inorder to meet the new standardrequirements we did not require anysoftware or hardware changescompared to the predicateCARESCAPE ONE (K190008). Wehave only changed our manuals to listthe new standards and our IP41 wateringress specification and label haschanged to a higher rating to complywith IEC 60601-2-61:2017. The newpulse oximetry standard requires IPx2instead of IPX1, but we tested to IP44 |
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| ParametersAcquisitionMethod | The CARESCAPE ONEutilizes the Active CableModules (ACMs) orPARAMETERS, in which theparameter electronics areencapsulated into therespective patient cables,rather than inside the mainframe of the monitor. Onlythe NIBP parameter isintegrated into theCARESCAPE ONE monitor.Parameter/Active CableModules:CARESCAPE TEMP -TemperatureCARESCAPE PRES –Invasive PressureCARESCAPE ECG - ECGCARESCAPE SPO2 -Trusignal SPO2CARESCAPE SPO2 Nellcor -Nellcor SPO2CARESCAPE SPO2 Masimo -Masimo SPO2CARESCAPE CO2 - LoFlo | The CARESCAPE ONEutilizes the Active CableModules (ACMs) orPARAMETERS, in which theparameter electronics areencapsulated into therespective patient cables,rather than inside the mainframe of the monitor. Onlythe NIBP parameter isintegrated into theCARESCAPE ONE monitor.Parameter/Active CableModules:CARESCAPE TEMP -TemperatureCARESCAPE PRES –Invasive PressureCARESCAPE ECG - ECGCARESCAPE SPO2 -Trusignal SPO2CARESCAPE SPO2 Nellcor -Nellcor SPO2CARESCAPE SPO2 Masimo -Masimo SPO2CARESCAPE CO2 - LoFlo | Identical |
| EK-Proarrhythmiadetectionalgorithm | EK-Pro V14 | EK-Pro V14 | Identical |
| Size (H x W xD) | 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 CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| Number oftraces(waveforms) | Up to 8 with 4 available on2nd waveform page. | Up to 8 with 4 available on2nd waveform page. | Identical |
| OperatingSystem | Linux Operating System | Linux operating system | Identical |
| Softwarepackages | 5 software packages:Emergency Care (ED), CriticalCare (ICU), Operating Room(OR), Post-Anesthesia Care(PACU), Neonatal Care(NICU) | 5 software packages:Emergency Care (ED),Critical Care (ICU), OperatingRoom (OR), Post-AnesthesiaCare (PACU), Neonatal Care(NICU) | Identical. |
| Patient Network | No | No | Identical |
| Ethernet portconnector(RJ45-8-pin) | One Ethernet port for servicetools. | One Ethernet port for servicetools. | Identical |
| Defaultsavailable | User selectable arrhythmiaalarm levels, Parametersettings and alarm levels,default alarm limits, displaylayout, parameter prioritydefaults. Up to 8 different pre-configured or custom defaultsavailable. Not all parametershave configurable alarmpriorities. | User selectable arrhythmiaalarm levels, Parametersettings and alarm levels,default alarm limits, displaylayout, parameter prioritydefaults. Up to 8 different pre-configured or custom defaultsavailable. Not all parametershave configurable alarmpriorities. | Identical |
| AlarmClassification(IEC) | Four levels - High, Medium,Low and Informational | Four levels - High, Medium,Low and Informational | Identical |
| AlarmNotification | Audible and visual | Audible and visual | Identical |
| Technicalalarms | System generated alarms tonotify the user of specialconditions. | System generated alarms tonotify the user of specialconditions. | Identical |
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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
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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.
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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.
§ 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.