K Number

Device Name

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)

Manufacturer

Date Cleared

2023-04-06

(134 days)

Product Code

MHX,BZK,BZL,BZQ,CAP,CBQ,CBR,CBS,CCK,CCL,DPS,DPZ,DQA,DQK,DRT,DSI,DSJ,DSK,DXG,DXN,FLL,GWJ,GWQ,KOI,KRB,MLD,MUD,NHO,NHP,NHQ,OLT,OLW,OMC,ORT,QEM

Regulation Number

870.1025

Type

Traditional

Panel

Cardiovascular

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

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.

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.

AI/ML Overview

Please note that the provided text is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and adherence to various standards. It explicitly states that clinical studies were not required to support substantial equivalence. Therefore, some of the requested information regarding clinical studies, human expert involvement, and ground truth establishment from patient data will likely not be present.

Based on the provided text, here's the information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific, quantifiable acceptance criteria alongside reported performance data. Instead, it states that various tests were conducted to demonstrate that the design meets specifications and complies with consensus standards. The performance is generally reported as "meets the specifications," "meets the EMC requirements," "meets the electrical safety requirements," and "fulfilled through compliance."

However, we can infer some "acceptance criteria" based on the standards and tests mentioned:

Category	Inferred Acceptance Criteria (Based on Compliance)	Reported Device Performance
General Performance	Device design meets specifications relevant to its intended use (multi-parameter patient monitoring, ECG, ST segment, arrhythmia detection, various physiological measurements).	"demonstrating the design meets the specifications"
Hardware	Hardware functions as intended and meets safety/performance standards.	"Hardware Bench Testing conducted"
Alarms	Alarm system (classification, notification, adjustment, critical limits, On/Off, audio silencing) functions correctly and meets relevant standards (IEC 60601-1-8).	"Alarms Bench Testing conducted." "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 (to predicate)." "meets the specifications listed in the requirements." "Additional data is provided for compliance to: IEC 60601-1-8: 2020..."
EMC	Meets Electromagnetic Compatibility (EMC) requirements as per IEC 60601-1-2 Edition 4.1 2020 and FDA guidance.	"meet the EMC requirements described in IEC 60601-1-2 Edition 4.1 2020." "evaluated for electromagnetic compatibility and potential risks from common emitters."
Electrical Safety	Meets electrical safety requirements as per IEC 60601-1:2020 "Edition 3.2" and 21 CFR Part 898, § 898.12 (electrode lead wires and cables).	"meet the electrical safety requirements of IEC 60601-1:2020 'Edition 3.2'." "performed by a recognized independent and Certified Body Testing Laboratory (CBTL)." "fulfilled through compliance with IEC 60601-1:2020... clause 8.5.2.3."
Specific Parameters	Meets performance standards for various physiological measurements (ECG, ST segment, NIBP, SpO2, temp, etc.) as detailed by specific IEC/ISO standards (e.g., IEC 60601-2-25, IEC 60601-2-27, IEC 80601-2-30, ISO 80601-2-55, etc.). Includes the EK-Pro arrhythmia detection algorithm performing equivalently to the predicate.	"Additional data is provided for compliance to: IEC 60601-2-25:2011, IEC 60601-2-27:2011, IEC 80601-2-30: 2018, IEC 60601-2-34: 2011, IEC 80601-2-49: 2018, ISO 80601-2-55: 2018, ISO 80601-2-56: 2017+AMD1:2018, ISO 80601-2-61: 2017, IEC 80601-2-26:2019, IEC 60601-2-40: 2016, ANSI/AAMI EC57:2012." "EK-Pro arrhythmia detection algorithm: EK-Pro V14 - Identical (to predicate)."
Environmental	Operates and stores safely within specified temperature, humidity, and pressure ranges. Withstands mechanical stress, fluid ingress, and packaging requirements.	"confirmed to meet the specifications listed in the requirements." "Environmental (Mechanical, and Thermal Safety) testing" conducted. "Fluid ingress." "Packaging Bench Testing."
Reprocessing	Reprocessing efficacy validation meets acceptance criteria based on documented instructions and worst-case devices/components, following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."	"Reprocessing efficacy validation has been conducted." "The reprocessing efficacy validation met the acceptance criteria for the reprocessing efficacy validation tests."
Human Factors/Usability	Meets usability requirements as per IEC 60601-1-6: 2020 and IEC 62366-1: 2020, and complies with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."	"Summative Usability testing has been concluded with 16 US Clinical, 16 US Technical and 15 US Cleaning users." "follows the FDA Guidance for Industry and Food and Drug Administration Staff 'Applying Human Factors and Usability Engineering to Medical Devices'."
Software	Complies with FDA software guidance documents (e.g., Content of Premarket Submissions for Software, General Principles of Software Validation, Off-The-Shelf Software Use) and software standards IEC 62304: 2015 and ISO 14971:2019, addressing patient safety, security, and privacy risks.	"follows the FDA software guidance documents as outlined in this submission." "Software testing was conducted." "Software for this device is considered as a 'Major' level of concern." "Software standards IEC 62304: 2015 ... and risk management standard ISO 14971:2019 ... were also applied." "patient safety, security, and privacy risks have been addressed."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document implies that the "test set" for performance evaluation was the device itself and its components as described ("CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19 and F2 Frame (F2-01)").
- For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" were involved.
Data Provenance: The testing described is non-clinical bench testing.
- For usability testing, the users were located in the US.
- No direct patient data or retrospective/prospective study data is mentioned beyond the device's inherent functional characteristics being tested according to standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable in the context of establishing "ground truth" for patient data, as no clinical studies with patient data requiring expert adjudication were conducted or reported to establish substantial equivalence.
For usability testing, "16 US Clinical, 16 US Technical and 15 US Cleaning users" participated. Their specific qualifications (e.g., years of experience, types of healthcare professionals) are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with patient data requiring adjudication were conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done, as the document explicitly states: "The subjects of this premarket submission... did not require clinical studies to support substantial equivalence." The device is a patient monitor, not an AI-assisted diagnostic tool for image interpretation or similar.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance evaluations mentioned (e.g., for general device functionality, electrical safety, EMC, specific parameter measurements like ECG/arrhythmia detection) represent the device's standalone performance in a bench setting, demonstrating its adherence to established standards and specifications. There is no separate "algorithm only" performance study reported distinctly from integrated device testing. The EK-Pro V14 algorithm, which is part of the device, is noted as "identical" to the predicate, implying its performance characteristics are maintained.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" was established by conformance to internationally recognized performance and safety standards (e.g., IEC, ISO, AAMI/ANSI) and the engineering specifications of the device/predicate. These standards define the acceptable range of performance for various parameters.
For usability testing, the "ground truth" was the successful completion of tasks and overall user feedback/satisfaction as assessed by human factors evaluation methods.
No ground truth from expert consensus on patient data, pathology, or outcomes data was used, as clinical studies were not required.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission for a patient monitor, not a machine learning or AI model trained on a dataset. The device contains "Platform Software that has been updated from version 3.2 to version 3.3," but this refers to traditional software development and not a machine learning model requiring a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a "training set" in the context of machine learning. The software development likely followed conventional software engineering practices, with ground truth established through design specifications, requirements, and verification/validation testing.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 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.

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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)

K223531

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:

· 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 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 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)

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CARESCAPE Canvas Smart Display is not intended for use in an MRI environment.

Indications for Use for CARESCAPE Canvas D19:

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.

Indications for Use for F2 Frame; F2-01:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular border. The logo is black and white, with the letters and border in black and the background in white.

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 200510 HelsinkiFINLANDPhone: +358 10 39411
Primary Contact Person:	Joel KentDirector, Regulatory Affairs StrategyGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com
Secondary Contact Person:	Päivi RoihaRegulatory Affairs ManagerGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 40 768 4664E-mail: paivi.roiha@ge.com
License names (807.92(a)(2)):
Trade Name:	CARESCAPE Canvas 1000, CARESCAPE Canvas Smart DisplayCARESCAPE 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 B125PK211171 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).

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:

· 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 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:

· 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.

Indications for Use for CARESCAPE Canvas D19

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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Indications for Use for F2 Frame; F2-01

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)	ProposedCARESCAPE Canvas1000, CARESCAPECanvas Smart DisplayCARESCAPE CanvasD19, and F2 Frame(F2-01)	Differences
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
Size (H x W xD) & Weight	91 mm x 401 mm x 340mm(3.6 in x 15.8 in x 13.4 in) and weight 7.5 kg (16.5lbs)	388 mm x 440 mm x 126mm(15.3 x 17.3 x 5.0 in) and weightCanvas 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 andF7 Frames. One slidemount for acquisitionmodule	Canvas 1000 V3.3:Two/Five/Seven optionalE-module slots inF2/F5/F7 Frame. Oneslide mount foracquisition module.	Equivalent
Display/screen	19" Active matrix colorTFT LCD	19" Active matrix colorTFT LCD	Identical
Waveforms andparameterwindows	Standard view: Up to 8individual waveforms andup to 20, if horizontalparameter area turned on.	Standard view: Up to 8individual waveforms andup to 20, if horizontalparameter area turned on.	Identical
Modules	PDM, CARESCAPEONE,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, CARESCAPEONECanvas 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 andE-sCAiOVE	Equivalent
Specification	CARESCAPE B850(K213336)	ProposedCARESCAPE Canvas1000, CARESCAPECanvas Smart DisplayCARESCAPE CanvasD19, and F2 Frame(F2-01)	Differences

Subiect Device and Predicate Device Comparis n

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Optional systemcomponents		Canvas 1000 V3.3. &Canvas Smart V3.3.:	Equivalent
	-Remote Control-CARESCAPE D19KTVER01 display-CARESCAPE RAD,Remote Alarm Device-Keyboard-Mouse-Barcode scanner-Laser Printer	-Remote Control-Keyboard-Mouse-Barcode scannerCARESCAPE RAD,Remote Alarm Device-Laser PrinterCanvas 1000 V3.3:E-musb Interface moduleCARESCAPE CanvasD19 display
Availablemeasurementparameters		Canvas 1000 V3.3:	Equivalent
	ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, cardiacoutput (thermodilutionand pulse contour),temperature, mixedvenous oxygen saturation,and central venousoxygen saturation,impedance respiration,airway gases (CO2, O2,N2O, and anestheticagents), spirometry, gasexchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission.	ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, regionaloxygen saturation, totalhemoglobinconcentration, cardiacoutput (thermodilutionand pulse contour),temperature, mixedvenous oxygen saturation,and central venousoxygen saturation,impedance respiration,airway gases (CO2, O2,N2O, and anestheticagents), spirometry, gasexchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission.Canvas Smart V3.3:ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, regionaloxygen saturation, totalhemoglobinconcentration, cardiacoutput (thermodilution),temperature, impedancerespiration, airway gases(CO2)
Specification	(K213336)	CARESCAPE B850	CARESCAPE Canvas 1000, CARESCAPECanvas Smart DisplayCARESCAPE CanvasD19, and F2 Frame(F2-01)	Proposed	Differences

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EK-Proarrhythmiadetectionalgorithm	EK-Pro V14	EK-Pro V14	Identical
Printing	Local recorder/printer andnetworked 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 trendsCanvas 1000 V3.3:Local recorder/localprinter	Equivalent
Mountingoptions	Multiple GCX mountingsystems	Multiple GCX mountingsystems	Identical
Alarms	Alarm management corefunctionalities:Classification andnotification of alarmsAdjustment of alarmsettingsPossibility to set criticalalarm limitsAlarm On/Offfunctionality and audiosilencing	Alarm management corefunctionalities:Classification andnotification of alarmsAdjustment of alarmsettingsPossibility to set criticalalarm limitsAlarm On/Offfunctionality and audiosilencing	Identical
Networkingcapability	CARESCAPE NetworkLAN/VLAN	CARESCAPE NetworkLAN/VLAN	Identical
Networkinterface	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

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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

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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:

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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.

Regulation Number and Section

§ 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.