(134 days)
K213336 CARESCAPE B850 V3.2
No
The summary describes a standard multi-parameter patient monitoring system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on traditional physiological monitoring and alarm systems.
No.
The device is a patient monitor, which is used for monitoring various physiological parameters, not for providing therapy or treatment.
Yes
The device is explicitly indicated for "ECG diagnostic analysis and measurement" and "arrhythmia detection," which are diagnostic functions.
No
The device description explicitly states that the submission includes hardware components (CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame) in addition to software. The performance studies also detail extensive hardware bench testing and compliance with hardware-related standards.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame are multi-parameter patient monitors used for monitoring physiological parameters of patients (hemodynamic, respiratory, neurophysiological status).
- Device Description: The device description reinforces that these are patient monitoring systems and associated components (display, module frame).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The device directly measures physiological signals from the patient.
Therefore, the device falls under the category of a patient monitor, which is not an IVD.
N/A
Intended Use / Indications for Use
The following devices are covered in this submission: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01).
Indications for Use for CARESCAPE Canvas 1000:
CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas 1000 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.
CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
CARESCAPE Canvas 1000 is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas Smart Display:
CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas Smart Display is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and
· respiratory (impedance respiration, airway gases (CO2)
CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.
CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events. CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas D19:
CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.
CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.
Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.
Indications for Use for F2 Frame; F2-01:
The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.
The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.
The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Product codes (comma separated list FDA assigned to the subject device)
MHX, BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, KRB, MLD, MUD, QEM, BZK, BZL, CAP, CBQ, CBR, CBS, CCL, GWJ, GWQ, KOI, NHO, NHP, NHQ, OLT, OLW, OMC, ORT
Device Description
Hardware and software modifications carried out on the legally marketed predicate device CARESCAPE B850 V3.2, resulted in new products CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display, along with the CARESCAPE Canvas D19 and F2 Frame (F2-01) all of which are the subject of this submission.
CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new modular multi-parameter patient monitoring systems. In addition, the new devices CARESCAPE Canvas D19 and F2 Frame (F2-01) are a new secondary display and new module frame respectively.
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display patient monitors incorporates a 19-inch display with a capacitive touch screen and the screen content is user-configurable. They have an integrated alarm light and USB connectivity for other user input devices. The user interface is touchscreen-based and can be used also with a mouse and a keyboard or a remote controller. The system also includes the medical application software (CARESCAPE Software version 3.3). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display include features and subsystems that are optional or configurable.
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are compatible with the CARESCAPE Patient Data Module and CARESCAPE ONE acquisition device via F0 docking station (cleared separately).
For the CARESCAPE Canvas 1000 patient monitor, the other type of acquisition modules, E-modules (cleared separately) can be chosen based on care requirements and patient needs. Interfacing subsystems that can be used to connect the E-modules to the CARESCAPE Canvas 1000 include a new two-slot parameter module F2 frame (F2-01), a five-slot parameter module F5 frame (F5-01), and a seven-slot parameter module F7 frame (F7-01).
The CARESCAPE Canvas 1000 can also be used together with the new secondary CARESCAPE Canvas D19 display. The CARESCAPE Canvas D19 display provides a capacitive touch screen, and the screen content is user configurable. The CARESCAPE Canvas D19 display integrates audible and visual alarms and provides USB connectivity for other user input devices.
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 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 Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01) demonstrating the design meets the specifications. This section addresses the non-Clinical testing for CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01) relied on for a determination of substantial equivalence to the predicate K213336 CARESCAPE B850.
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:
- Hardware Bench Testing
- Alarms Bench Testing
- IEC 60601-2-25:2011
- IEC 60601-2-27:2011
- IEC 80601-2-30: 2018
- IEC 60601-2-34: 2011
- ISO 80601-2-55: 2018
- ISO 80601-2-56: 2017+AMD1:2018
- ISO 80601-2-61: 2017 (corrected 2018
- IEC 80601-2-26:2019
- IEC 60601-2-40: 2016
- AAMI/ANSI EC57:2012
- IEC 80601-2-49: 2018
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitoring systems meet the EMC requirements described in IEC 60601-1-2 Edition 4.1 2020 "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 "Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued on June 6, 2022" the CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitoring systems have been evaluated for electromagnetic compatibility and potential risks from common emitters in the CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display systems environment.
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitoring systems meet the electrical safety requirements of IEC 60601-1:2020 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.2". This testing was performed by a recognized independent and Certified Body Testing Laboratory (CBTL) under the IECEE CB Scheme.
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display systems were designed and tested for compliance to the FDA 21 CFR Part 898, § 898.12 (Performance standard for electrode lead wires and cables). The performance standard is fulfilled through compliance with IEC 60601-1:2020, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.2. clause 8.5.2.3 which is equivalent with clause 56.3 c in the IEC 60601-1:1988.
Additional data is provided for compliance to:
- IEC 60601-1-8: 2020 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-25:2011: Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- IEC 60601-2-27:2011: Medical electrical equipment Part 2-27: Particular Requirements for the Safety, Including Essential Performance of Electrocardiographic Monitoring Equipment
- IEC 80601-2-30: 2018: Medical electrical equipment Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 60601-2-34: 2011: Medical electrical equipment Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- IEC 80601-2-49: 2018: Medical electrical equipment Part 2-49: Particular requirements for the safety essential performance of multifunction patient monitoring equipment
- ISO 80601-2-55: 2018: Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- ISO 80601-2-56: 2017+AMD1:2018: Medical electrical equipment Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement
- ISO 80601-2-61: 2017 (corrected 2018): Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- IEC 80601-2-26:2019: Medical electrical equipment Part 2-26: Particular requirements for the safety and essential performance of electroencephalographs
- IEC 60601-2-40: 2016: Medical Electrical Equipment Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
- ANSI/AAMI EC57:2012: Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
Environmental (Mechanical, and Thermal Safety) testing, based on the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) proposed uses and locations, was confirmed to meet the specifications listed in the requirements. The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) specifications verification evidence is included for the following:
- Operating temperature
- Operating humidity
- Operating pressure
- Storage and transport temperature
- Storage and transport humidity
- Storage and transport pressure
- Mechanical stress
- Fluid ingress
- Packaging Bench Testing
The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follow the guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff. Document issued on: March 17, 2015". Reprocessing efficacy validation has been conducted in accordance with the documented reprocessing instructions using worst-case devices/components of the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01). The reprocessing efficacy validation met the acceptance criteria for the reprocessing efficacy validation tests.
The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follows the Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on: February 3, 2016 and the following standards:
- IEC 60601-1-6: 2020: Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1: 2020: Medical devices Part 1: Application of usability engineering to medical devices
Summative Usability testing has been concluded with 16 US Clinical, 16 US Technical and 15 US Cleaning users. The usability testing of the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follows the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).
The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follow the FDA software guidance documents as outlined in this submission.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on May 11, 2005
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on January 11, 2002
- Off-The-Shelf Software Use in Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on September 27, 2019
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff issued October 18, 2018
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Document issued on September 6, 2017
Software 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. Software standards IEC 62304: 2015 Medical device software - Software life cycle processes and risk management standard ISO 14971:2019 Medical devices - Application of risk management to medical devices were also applied to the design.
Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D10 and F2 Frame (F2-01) 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 "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff issued October 18, 2018".
Summary of Clinical Tests:
The subjects of this premarket submission, CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01) did not require clinical studies to support substantial equivalence.
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.
K213336 CARESCAPE B850 V3.2
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.
K213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P, K211171 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories
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.
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April 6, 2023
GE Healthcare Finland Oy Joel Kent Director Regulatory Affairs Strategy Kuortaneenkatu 2 Helsinki, FI-00510 Finland
Re: K223531
Trade/Device Name: CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) 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, DXG, DXN, FLL, KRB, MLD, MUD, QEM, BZK, BZL, CAP, CBQ, CBR, CBS, CCL, GWJ, GWQ, KOI, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Dated: November 23, 2022 Received: March 8, 2023
Dear Joel Kent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Shruti N. Mistry -S
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
CARESCAPE Canvas 1000; CARESCAPE Canvas Smart Display; CARESCAPE Canvas D19; F2 Frame (F2-01)
ndications for Use (Describe)
Indications for Use for CARESCAPE Canvas 1000:
CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas 1000 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.
CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
CARESCAPE Canvas 1000 is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas Smart Display:
CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas Smart Display is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and · respiratory (impedance respiration, airway gases (CO2)
3
CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.
CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events. CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas D19:
CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.
CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.
Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.
Indications for Use for F2 Frame; F2-01:
The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.
The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility.
The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Type of Use (Select one or both, as applicable)
otion Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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Device
GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki Finland T: +358 10 39411
510(k) Summary for K223531
In accordance with 21 CFR 807.92 the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1)):
| Date: | November 23, 2022 |
|---|---|
| Owner/Submitter: | GE Healthcare Finland Oy. |
| Kuortaneenkatu 2 | |
| 00510 Helsinki | |
| FINLAND | |
| Phone: +358 10 39411 | |
| Primary Contact Person: | Joel Kent |
| Director, Regulatory Affairs Strategy | |
| GE Healthcare | |
| Phone: 617-851-0943 | |
| E-mail: joel.kent@ge.com | |
| Secondary Contact Person: | Päivi Roiha |
| Regulatory Affairs Manager | |
| GE Healthcare Finland Oy | |
| Kuortaneenkatu 2 | |
| 00510 Helsinki | |
| Finland | |
| Phone: + 358 40 768 4664 | |
| E-mail: paivi.roiha@ge.com | |
| License names (807.92(a)(2)): | |
| Trade Name: | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display |
| CARESCAPE Canvas D19, and F2 Frame (F2-01) |
Multiparameter patient monitor (monitor, physiological, patient (with Common/Usual Name: arrhythmia detection or alarms)
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| Classification Names: | |
|---|---|
| MHX - 21 CFR 870.1025 | monitor, physiological, patient (with arrhythmia detection or alarms) |
| DSI - 21 CFR 870.1025 | detector and alarm, arrhythmia |
| MLD - 21 CFR 870.1025 | monitor, St Segment with alarm |
| DSJ - 21 CFR 870.1100 | alarm, blood-pressure |
| DSK - 21 CFR 870.1110 | computers, blood-pressure |
| DXN - 21 CFR 870.1130 | system, measurement, blood-pressure, non-invasive |
| DQK - 21 CFR 870.1425 | Programmable diagnostic computer |
| DXG - 21 CFR 870.1435 | computer, diagnostic, pre-programmed, single-function |
| KRB - 21 CFR 870.1915 | probe, thermodilution |
| DRT - 21 CFR 870.2300 | monitor, cardiac (incl. cardiotachometer & rate alarm) |
| DPS - 21 CFR 870.2340 | Electrocardiograph |
| DQA - 21 CFR 870.2700 | oximeter |
| MUD - 21 CFR 870.2700 | oximeter, tissue saturation |
| QEM - 21 CFR 870.2700 | cerebral oximeter |
| DPZ - 21 CFR 870.2710 | oximeter, ear |
| CCK - 21 CFR 868.1400 | Carbon dioxide gas analyzer |
| BZQ - 21 CFR 868.2375 | monitor, breathing frequency |
| FLL - 21 CFR 880.2910 | Clinical electronic thermometer |
| BZK - 21 CFR 868.1850 | spirometer, monitoring (w/wo alarm) |
| BZL - 21 CFR 868.1730 | computer, oxygen-uptake |
| CAP - 21 CFR 868.2600 | monitor, airway pressure (includes gauge and/or alarm) |
| CBQ - 21 CFR 868.1500 | analyzer, gas, enflurane, gaseous-phase (anesthetic concentration) |
| NHO - 21 CFR 868.1500 | analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| NHP - 21 CFR 868.1500 | analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| NHQ - 21 CFR 868.1500 | analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| CBS - 21 CFR 868.1620 | analyzer, gas, halothane, gaseous-phase (anesthetic conc.) |
| CBR - 21 CFR 868.1700 | analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) |
| CCL - 21 CFR 868.1720 | analyzer, gas, oxygen, gaseous-phase |
| GWQ - 21 CFR 882.1400 | full-montage standard electroencephalograph |
| OLT - 21 CFR 882.1400 | non-normalizing quantitative electroencephalograph software |
| OLW - 21 CFR 882.1400 | index-generating electroencephalograph software |
| OMC - 21 CFR 882.1400 | reduced- montage standard electroencephalograph |
| ORT - 21 CFR 882.1400 | burst suppression detection software for electroencephalograph |
| GWJ - 21 CFR 882.1900 | stimulator, auditory, evoked response |
| ΚΟΙ - 21 CFR 868.2775 | stimulator, nerve, peripheral, electric |
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| Product Code: | MHX |
|---|---|
| Subsequent Product Codes: | BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, KRB, MLD, MUD, QEM, BZK, BZL, CAP, CBQ, CBR, CBS, CCL, GWJ, GWQ, KOI, NHO, NHP, NHQ, OLT, OLW, OMC, ORT |
| Predicate Device(s) (807.92(a)(3)): | The primary predicate for this submission is K213336 CARESCAPE B850 V3.2 |
| Reference devices: | |
| K213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | |
| K211171 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories | |
| Device Description (807.92(a)(4)): | Hardware and software modifications carried out on the legally marketed predicate device CARESCAPE B850 V3.2, resulted in new products CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display, along with the CARESCAPE Canvas D19 and F2 Frame (F2-01) all of which are the subject of this submission. CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new modular multi-parameter patient monitoring systems. In addition, the new devices CARESCAPE Canvas D19 and F2 Frame (F2-01) are a new secondary display and new module frame respectively. The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display patient monitors incorporates a 19-inch display with a capacitive touch screen and the screen content is user-configurable. They have an integrated alarm light and USB connectivity for other user input devices. The user interface is touchscreen-based and can be used also with a mouse and a keyboard or a remote controller. The system also includes the medical application software (CARESCAPE Software version 3.3). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display include features and subsystems that are optional or configurable. The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are compatible with the CARESCAPE Patient Data Module and CARESCAPE ONE acquisition device via F0 docking station (cleared separately). For the CARESCAPE Canvas 1000 patient monitor, the other type of acquisition modules, E-modules (cleared separately) can be chosen based on care requirements and patient needs. Interfacing subsystems that can be used to connect the E-modules to the CARESCAPE Canvas 1000 include |
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a new two-slot parameter module F2 frame (F2-01), a five-slot parameter module F5 frame (F5-01), and a seven-slot parameter module F7 frame (F7-01).
The CARESCAPE Canvas 1000 can also be used together with the new secondary CARESCAPE Canvas D19 display. The CARESCAPE Canvas D19 display provides a capacitive touch screen, and the screen content is user configurable. The CARESCAPE Canvas D19 display integrates audible and visual alarms and provides USB connectivity for other user input devices.
Intended Use: (807.92(a)(5)): The indications for use of the CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display have been updated compared to the predicate CARESCAPE B850 (K213336). The updates are related to clarity of labeling, and CARESCAPE Canvas Smart Display for changes of modified functionality due to reduced support of interfaces. We also include explicit indications for CARESCAPE Canvas D19 and F2 Frame (F2-01) where previously the secondary display and frame functionality was included as part of the main CARESCAPE B850 indications.
Indications (from labeling)
CARESCAPE Canvas 1000
CARESCAPE Canvas 1000 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility. CARESCAPE Canvas 1000 is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas 1000 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
CARESCAPE Canvas 1000 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas 1000 also shows alarms from other ECG sources.
CARESCAPE Canvas 1000 also provides other alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
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CARESCAPE Canvas 1000 can interface to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas 1000 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
CARESCAPE Canvas 1000 is not intended for use in an MRI environment.
CARESCAPE Canvas Smart Display
CARESCAPE Canvas Smart Display is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.
CARESCAPE Canvas Smart Display is intended for use on adult, pediatric, and neonatal patients one patient at a time.
CARESCAPE Canvas Smart Display is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution), and temperature, and
· respiratory (impedance respiration, airway gases (CO2)
CARESCAPE Canvas Smart Display is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. CARESCAPE Canvas Smart Display also shows alarms from other ECG sources.
CARESCAPE Canvas Smart Display also provides other alarms, trends, snapshots and events.
CARESCAPE Canvas Smart Display can use CARESCAPE ONE or CARESCAPE Patient Data Module (PDM) as patient data acquisition devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
CARESCAPE Canvas Smart Display is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.
Indications for Use for CARESCAPE Canvas D19
CARESCAPE Canvas D19 is intended for use as a secondary display with a compatible host device. It is intended for displaying measurement and parametric data from the host device and providing visual and audible alarms generated by the host device.
CARESCAPE Canvas D19 enables controlling the host device, including starting and discharging a patient case, changing parametric measurement settings, changing alarm limits and disabling alarms.
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Using CARESCAPE Canvas D19 with a compatible host device enables real-time multi-parameter patient monitoring and continuous evaluation of the patient's ventilation, oxygenation, hemodynamic, circulation, temperature, and neurophysiological status.
Indications for Use for F2 Frame; F2-01
The F2 Frame, module frame with two slots, is intended to be used with compatible GE multiparameter patient monitors to interface with two single width parameter modules, CARESCAPE ONE with a slide mount, and recorder.
The F2 Frame is intended for use in multiple areas within a professional healthcare facility. The F2 Frame is intended for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility. The F2 Frame is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
Technology (807.92(a)(6)): The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display are new monitors where features and parameters are essentially same as in predicate monitor platform CARESCAPE B850 V3.2 (K213336). The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitors use the CARESCAPE Software Platform (also called CSP software) version 3.3 whereas the predicate monitor CARESCAPE B850 (K213336) has software version 3.2.
The CARESCAPE Canvas D19 is a new secondary display where the functionality is essentially same as in predicate D19KT Display of CARESCAPE B850 V3.2 (K213336).
The F2 Frame (F2-01) is a new parameter module frame for interfacing with acquisition devices with essentially same functionality as in predicate F5 Frame (F5-01) of CARESCAPE B850 V3.2 (K213336).
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display with CSP v3.3 software has following changes at high level.
The devices that are subject of this 510(k) submission are the proposed new patient monitors CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display with the software CARESCAPE Software version 3.3. The new patient monitors CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display incorporate new hardware with modified software from the legally marketed device CARESCAPE B850 V3.2 (K213336).
The CARESCAPE Canvas 1000 V3.3 and CARESCAPE Canvas Smart Display V3.3 monitors incorporate new common hardware platform.
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The CARESCAPE Canvas 1000 V3.3 and CARESCAPE Canvas Smart Display V3.3 monitors include Platform Software that has been updated from version 3.2 to version 3.3.
The CARESCAPE Canvas 1000 V3.3 and CARESCAPE Canvas Smart Display V3.3 monitors utilize the same type of measurement parameters as the predicate device.
The indications for use for CARESCAPE Canvas 1000 V3.3 and CARESCAPE Canvas Smart Display V3.3 are equivalent to the predicate device CARESCAPE B850 V3.2 (K213336) with changes mostly related to language clarity and text alignment with modified functionality.
The CARESCAPE Canvas 1000 V3.3 and CARESCAPE Canvas Smart Display V3.3 use the same fundamental technology, functions and operations as that of the predicate device CARESCAPE B850 V3.2 (K213336).
The detailed comparison between the proposed CARESCAPE Canvas 1000 V3.3, CARESCAPE Canvas Smart Display V3.3, CARESCAPE Canvas D19 and F2 Frame (F2-01) and the predicate is presented in Substantial Equivalence Comparison and a summary of the primary changes within this submission are listed below.
A summary of the main changes compared to the predicate are listed below in the comparison table.
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| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Specification | CARESCAPE B850 | ||
| (K213336) | Proposed | ||
| CARESCAPE Canvas | |||
| 1000, CARESCAPE | |||
| Canvas Smart Display | |||
| CARESCAPE Canvas | |||
| D19, and F2 Frame | |||
| (F2-01) | Differences | ||
| Patient type | Adult, pediatric & | ||
| neonatal | Adult, pediatric & | ||
| neonatal | Identical | ||
| Use | |||
| environments | Within a professional | ||
| healthcare facility (Not | |||
| intended for MRI) | Within a professional | ||
| healthcare facility (Not | |||
| intended for MRI) | Identical | ||
| Size (H x W x | |||
| D) & Weight | 91 mm x 401 mm x 340 | ||
| mm | |||
| (3.6 in x 15.8 in x 13.4 in) and weight 7.5 kg (16.5 | |||
| lbs) | 388 mm x 440 mm x 126 | ||
| mm | |||
| (15.3 x 17.3 x 5.0 in) and weight | |||
| Canvas 1000 V3.3: | |||
| 7.6 kg (16.6 lb) | |||
| Canvas Smart V3.3: | |||
| 7.4 kg (16.3 lb) | Equivalent | ||
| Module Housing | Up to 12 optional E- | ||
| module slots with F5 and | |||
| F7 Frames. One slide | |||
| mount for acquisition | |||
| module | Canvas 1000 V3.3: | ||
| Two/Five/Seven optional | |||
| E-module slots in | |||
| F2/F5/F7 Frame. One | |||
| slide mount for | |||
| acquisition module. | Equivalent | ||
| Display/screen | 19" Active matrix color | ||
| TFT LCD | 19" Active matrix color | ||
| TFT LCD | Identical | ||
| Waveforms and | |||
| parameter | |||
| windows | Standard view: Up to 8 | ||
| individual waveforms and | |||
| up to 20, if horizontal | |||
| parameter area turned on. | Standard view: Up to 8 | ||
| individual waveforms and | |||
| up to 20, if horizontal | |||
| parameter area turned on. | Identical | ||
| Modules | PDM, CARESCAPE | ||
| ONE, | |||
| E-BIS, E-COP, E- | |||
| COPSv, E-PiCCO, E- | |||
| EEGX, E-Entropy, E- | |||
| Masimo, E-miniC, E- | |||
| NMT, E-NSATX, E-PP, | |||
| E-PT, E-sCAiO , E- | |||
| sCAiOV, E-sCAiOVX, | |||
| E-sCO, E-sCOV, E- | |||
| sCOVX | Canvas 1000 V3.3. & | ||
| Canvas Smart V3.3 .: | |||
| PDM, CARESCAPE | |||
| ONE | |||
| Canvas 1000 V3.3: | |||
| E-BIS, E-COP, E- | |||
| COPSv, E-PiCCO, E- | |||
| EEGX, E-Entropy, E- | |||
| Masimo, E-miniC, E- | |||
| NMT, E-NSATX, E-PP, | |||
| E-PT, E-sCAiO , E- | |||
| sCAiOV, E-sCAiOVX, | |||
| E-sCO, E-sCOV, E- | |||
| E-sCOVX, E-sCAiOE and | |||
| E-sCAiOVE | Equivalent | ||
| Specification | CARESCAPE B850 | ||
| (K213336) | Proposed | ||
| CARESCAPE Canvas | |||
| 1000, CARESCAPE | |||
| Canvas Smart Display | |||
| CARESCAPE Canvas | |||
| D19, and F2 Frame | |||
| (F2-01) | Differences |
Subiect Device and Predicate Device Comparis n
13
| Optional system
components | | Canvas 1000 V3.3. &
Canvas Smart V3.3.: | Equivalent | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------|-------------|
| | -Remote Control
-CARESCAPE D19KT
VER01 display
-CARESCAPE RAD,
Remote Alarm Device
-Keyboard
-Mouse
-Barcode scanner
-Laser Printer | -Remote Control
-Keyboard
-Mouse
-Barcode scanner
CARESCAPE RAD,
Remote Alarm Device
-Laser Printer
Canvas 1000 V3.3:
E-musb Interface module
CARESCAPE Canvas
D19 display | | | |
| Available
measurement
parameters | | Canvas 1000 V3.3: | Equivalent | | |
| | ECG, ST segment,
arrhythmia detection,
ECG diagnostic analysis
and measurement,
invasive pressure, non-
invasive blood pressure,
pulse oximetry, cardiac
output (thermodilution
and pulse contour),
temperature, mixed
venous oxygen saturation,
and central venous
oxygen saturation,
impedance respiration,
airway gases (CO2, O2,
N2O, and anesthetic
agents), spirometry, gas
exchange,
electroencephalography,
Entropy, Bispectral Index
(BIS), neuromuscular
transmission. | ECG, ST segment,
arrhythmia detection,
ECG diagnostic analysis
and measurement,
invasive pressure, non-
invasive blood pressure,
pulse oximetry, regional
oxygen saturation, total
hemoglobin
concentration, cardiac
output (thermodilution
and pulse contour),
temperature, mixed
venous oxygen saturation,
and central venous
oxygen saturation,
impedance respiration,
airway gases (CO2, O2,
N2O, and anesthetic
agents), spirometry, gas
exchange,
electroencephalography,
Entropy, Bispectral Index
(BIS), neuromuscular
transmission.
Canvas Smart V3.3:
ECG, ST segment,
arrhythmia detection,
ECG diagnostic analysis
and measurement,
invasive pressure, non-
invasive blood pressure,
pulse oximetry, regional
oxygen saturation, total
hemoglobin
concentration, cardiac
output (thermodilution),
temperature, impedance
respiration, airway gases
(CO2) | | | |
| Specification | (K213336) | CARESCAPE B850 | CARESCAPE Canvas 1000, CARESCAPE
Canvas Smart Display
CARESCAPE Canvas
D19, and F2 Frame
(F2-01) | Proposed | Differences |
14
| EK-Pro
arrhythmia
detection
| algorithm | EK-Pro V14 | EK-Pro V14 | Identical |
|---|---|---|---|
| Printing | Local recorder/printer and | ||
| networked laser printer. | |||
| Printings for waveforms, | |||
| alarms waveforms, | |||
| numeric trends. | Canvas 1000 V3.3. & | ||
| Canvas Smart V3.3.: | |||
| Networked laser printer. | |||
| Printings for waveforms, | |||
| alarms waveforms, | |||
| numeric trends | |||
| Canvas 1000 V3.3: | |||
| Local recorder/local | |||
| printer | Equivalent | ||
| Mounting | |||
| options | Multiple GCX mounting | ||
| systems | Multiple GCX mounting | ||
| systems | Identical | ||
| Alarms | Alarm management core | ||
| functionalities: | |||
| Classification and | |||
| notification of alarms | |||
| Adjustment of alarm | |||
| settings | |||
| Possibility to set critical | |||
| alarm limits | |||
| Alarm On/Off | |||
| functionality and audio | |||
| silencing | Alarm management core | ||
| functionalities: | |||
| Classification and | |||
| notification of alarms | |||
| Adjustment of alarm | |||
| settings | |||
| Possibility to set critical | |||
| alarm limits | |||
| Alarm On/Off | |||
| functionality and audio | |||
| silencing | Identical | ||
| Networking | |||
| capability | CARESCAPE Network | ||
| LAN/VLAN | CARESCAPE Network | ||
| LAN/VLAN | Identical | ||
| Network | |||
| interface | 10baseT, 100baseT | 10baseT, 100baseT | 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 Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01) demonstrating the design meets the specifications. This section addresses the non-Clinical testing for CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01) relied on for a determination of substantial equivalence to the predicate K213336 CARESCAPE B850.
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:
- Hardware Bench Testing ●
- Alarms Bench Testing ●
- IEC 60601-2-25:2011 ●
- IEC 60601-2-27:2011
- IEC 80601-2-30: 2018
- IEC 60601-2-34: 2011 ●
- ISO 80601-2-55: 2018 ●
- ISO 80601-2-56: 2017+AMD1:2018
- ISO 80601-2-61: 2017 (corrected 2018 ●
- IEC 80601-2-26:2019
- IEC 60601-2-40: 2016 ●
- AAMI/ANSI EC57:2012
- IEC 80601-2-49: 2018
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitoring systems meet the EMC requirements described in IEC 60601-1-2 Edition 4.1 2020 "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 "Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued on June 6, 2022" the CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitoring systems have been evaluated for electromagnetic compatibility and potential risks from common emitters in the CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display systems environment.
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display monitoring systems meet the electrical safety requirements of IEC 60601-1:2020 "Medical electrical equipment
16
- Part 1: General requirements for basic safety and essential performance - Edition 3.2". This testing was performed by a recognized independent and Certified Body Testing Laboratory (CBTL) under the IECEE CB Scheme.
The CARESCAPE Canvas 1000 and CARESCAPE Canvas Smart Display systems were designed and tested for compliance to the FDA 21 CFR Part 898, § 898.12 (Performance standard for electrode lead wires and cables). The performance standard is fulfilled through compliance with IEC 60601-1:2020, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.2. clause 8.5.2.3 which is equivalent with clause 56.3 c in the IEC 60601-1:1988.
Additional data is provided for compliance to:
- . IEC 60601-1-8: 2020 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-25:2011: Medical electrical equipment Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
- IEC 60601-2-27:2011: Medical electrical equipment Part ● 2-27: Particular Requirements for the Safety, Including Essential Performance of Electrocardiographic Monitoring Equipment
- IEC 80601-2-30: 2018: Medical electrical equipment Part ● 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- IEC 60601-2-34: 2011: Medical electrical equipment Part . 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
- IEC 80601-2-49: 2018: Medical electrical equipment Part . 2-49: Particular requirements for the safety essential performance of multifunction patient monitoring equipment
- . ISO 80601-2-55: 2018: Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
- . ISO 80601-2-56: 2017+AMD1:2018: Medical electrical equipment Part 2-56: Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement
- ISO 80601-2-61: 2017 (corrected 2018): Medical ● electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
17
- IEC 80601-2-26:2019: Medical electrical equipment Part ● 2-26: Particular requirements for the safety and essential performance of electroencephalographs
- . IEC 60601-2-40: 2016: Medical Electrical Equipment Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
- ANSI/AAMI EC57:2012: Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms
Environmental (Mechanical, and Thermal Safety) testing, based on the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) proposed uses and locations, was confirmed to meet the specifications listed in the requirements. The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) specifications verification evidence is included for the following:
- Operating temperature
- Operating humidity
- Operating pressure ●
- Storage and transport temperature ●
- Storage and transport humidity
- Storage and transport pressure
- Mechanical stress
- Fluid ingress ●
- Packaging Bench Testing
The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follow the guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff. Document issued on: March 17, 2015". Reprocessing efficacy validation has been conducted in accordance with the documented reprocessing instructions using worst-case devices/components of the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01). The reprocessing efficacy validation met the acceptance criteria for the reprocessing efficacy validation tests.
The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follows the Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on: February 3, 2016 and the following standards:
18
- IEC 60601-1-6: 2020: Medical electrical equipment Part ● 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1: 2020: Medical devices Part 1: Application of usability engineering to medical devices
Summative Usability testing has been concluded with 16 US Clinical, 16 US Technical and 15 US Cleaning users. The usability testing of the CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follows the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).
The CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) follow the FDA software guidance documents as outlined in this submission.
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on May 11, 2005
- General Principles of Software Validation; Final ● Guidance for Industry and FDA Staff, Document issued on January 11, 2002
- . Off-The-Shelf Software Use in Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on September 27, 2019
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff issued October 18, 2018
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Document issued on September 6, 2017
Software 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. Software standards IEC 62304: 2015 Medical device software - Software life cycle processes and risk management standard ISO 14971:2019 Medical devices - Application of risk management to medical devices were also applied to the design.
Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D10 and F2 Frame (F2-01) including a Security Risk Assessment,
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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 "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff issued October 18, 2018".
Clinical (807.92(b)(2)): Summary of Clinical Tests:
The subjects of this premarket submission, CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01) did not require clinical studies to support substantial equivalence.
GE Healthcare considers the CARESCAPE Canvas 1000, Conclusion (807.92(b)(3)): CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, and F2 Frame (F2-01) to be substantially equivalent to the predicate device.