What is the regulatory pathway for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES

Q: Who is the manufacturer of CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

GE Healthcare filed the 510(k) submission for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (K200494).

Q: What is the FDA product code for CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES?

MHX. It is classified under 21 CFR 870.1025 as a Class 2 device in the Cardiovascular panel.

K200494 · GE Healthcare · MHX · Mar 29, 2020 · Cardiovascular

Device Facts

Record ID	K200494
Device Name	CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
Applicant	GE Healthcare
Product Code	MHX · Cardiovascular
Decision Date	Mar 29, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters. The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode. The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.

Device Story

Multi-parameter physiological patient monitor; used in professional healthcare facilities and intra-hospital transport. Operates as standalone monitor or acquisition module for compatible CARESCAPE host monitors. Inputs: ECG, invasive/non-invasive pressure, SpO2, temperature, impedance respiration, CO2 via plug-and-play Active Cable Modules (ACM). Transforms inputs into waveforms, vital sign values, and alarms. Standalone mode: provides display, alarms, and user interface. Accessory mode: transmits data to host monitor; local UI/alarms disabled. Operated by licensed healthcare practitioners or trained personnel. Benefits: flexible bedside/transport monitoring; enables continuous patient data acquisition across care settings.

Clinical Evidence

No clinical studies required for substantial equivalence. Bench testing confirmed design specifications, software, hardware, and electromagnetic compatibility. Clinical report provided for GE TruSignal SpO2 sensors in neonates to support existing performance data; no changes to pulse oximetry algorithm or hardware compared to predicate.

Technological Characteristics

Multi-parameter monitor with 7-inch TFT LCD. Uses Active Cable Modules (ACM) for parameter acquisition via custom USB-style connectors. Internal battery and AC power. Linux OS. Complies with IEC 60601-1, IEC 60601-2-27, IEC 80601-2-30:2018, IEC 80601-2-49:2018, ISO 80601-2-55:2018, ISO 80601-2-56:2017+A1:2018, ISO 80601-2-61:2017, and IEC 62133-2:2017. IP44 water ingress rating.

Indications for Use

Indicated for monitoring hemodynamic (ECG, ST segment, arrhythmia, invasive/non-invasive BP, SpO2, pulse rate, temperature) and respiratory (impedance respiration, CO2) parameters in adult, pediatric, and neonatal patients. Not for use in controlled MR environments.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

CARESCAPE ONE (K190008)

Reference Devices

Patient Data Module (PDM) (K071073)
CARESCAPE B450 (K191249)
CARESCAPE B650 (K191149)
CARESCAPE B850 (K191323)

Related Devices

K213234 — CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 · Ge Medical Systems Information Technologies, Inc. · Apr 12, 2022
K053193 — PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 18, 2006
K102004 — ENDEAVOUR MONITORING SYSTEM · Mindray DS USA, Inc. · Sep 10, 2010
K151512 — Star 60 · Skanray Technologies Private Limited · Feb 14, 2016
K122253 — PROCARE MONITOR B20 · Ge Medical Systems China Co., Ltd. · Mar 22, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. March 29, 2020 GE Healthcare Joel Kent Senior Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, Wisconsin 53223 Re: K200494 Trade/Device Name: CARESCAPE ONE Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, BZQ, CCK, DPS, DPZ, DQA, DQK, DRT, DSI, DSI, DSK, DXN, FLL, MLD Dated: February 25, 2020 Received: February 28, 2020 Dear Joel Kent: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jennifer Shih Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200494 Device Name CARESCAPE ONE #### Indications for Use (Describe) The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters. The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arthythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode. The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The border has decorative flourishes resembling water droplets or stylized leaves at the top, bottom, and sides of the circle. GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, Wisconsin 53223 ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: ### Owner/Contact/Date (807.92(a)(1): | Date: | March 10, 2020 | |---------------------------|------------------------------------------------------------------------------------------------------------------| | Owner/Submitter: | GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, Wisconsin 53223 | | Primary Contact Person: | Joel Kent Senior Regulatory Affairs Manager GE Healthcare Phone: 617-851-0943 E-mail: joel.kent@ge.com | | Secondary Contact Person: | Monica Morrison Regulatory Affairs Director GE Healthcare Phone: 608-515-3077 E-mail: monica.morrison@ge.com | Device names (807.92(a)(2)): Trade Name: CARESCAPE ONE Common/Usual Name: Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms) {4}------------------------------------------------ Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including ST- segment measurement and alarm) 21 CFR 868.2375 monitor, breathing frequency 21 CFR 868.1400 Carbon dioxide gas analyzer 21 CFR 870.2340 Electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 Programmable diagnostic computer 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) 21 CFR 870.1025 detector and alarm, arrhythmia 21 CFR 870.1100 alarm, blood-pressure 21 CFR 870.1110 computers, blood-pressure 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 880.2910 Clinical electronic thermometer 21 CFR 870.1025 monitor, St Segment with alarm Product Code: MHX | Subsequent Product Codes: | |---------------------------| | BZQ | | CCK | | DPS | | DPZ | | DQA | | DQK | | DRT | | DSI | | DSJ | | DSK | | DXN | | FLL | | MLD | {5}------------------------------------------------ | Predicate Device(s) (807.92(a)(3)): | The primary predicate for this submission is K190008, CARESCAPE ONE Additional predicates/reference devices: K071073, Patient Data Module (PDM) K191249, CARESCAPE B450 K191149, CARESCAPE B650 K191323, CARESCAPE B850 | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description (807.92(a)(4)): | CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only th parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular vital sign, currently we have ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station. When connected to a compatible host monitor, CARESCAPE ONE operates as an acquisition device. In this mode, the CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received from the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages. | CARESCAPE ONE is compatible with the following 510(k) cleared host monitors: - CARESCAPE B450 (K191249) • - CARESCAPE B650 (K191149) - CARESCAPE B850 (K191323) {6}------------------------------------------------ Intended Use: (807.92(a)(5)): ## Indications The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters. The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, noninvasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode. The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment. {7}------------------------------------------------ The CARESCAPE ONE that is the subject of this submission is Technology (807.92(a)(6)): based on the primary predicate CARESCAPE ONE (K190008). > The main differences with respect to the predicate discussed throughout the submission are summarized below: - Add the capability for CARESCAPE ONE to be utilized as an acquisition device when connected with host monitors (CARECSAPE Monitors). CARESCAPE ONE can be used as an acquisition module for compatible host devices, in addition to use as a stand-alone monitor. There are no changes to the device itself specifically to enable compatibility with the host monitors, as it was already built into the device design. The labeling and instructions have been updated to reflect the use with compatible host devices. Compatibility with CARESCAPE ONE was already cleared in the additional predicate devices CARESCAPE B650 K191149, CARESCAPE B450 K191249 and CARESCAPE B850 K191323. The acquisition module functionality in CARESCAPE ONE, as discussed in K190008, is substantially equivalent to the Patient Data Module (K071073). - Minor software updates for maintenance/bug fixes only. No changes to function, operation, parameters monitored, or algorithms. - Compliance demonstrated with newer versions of FDA recognized standards. No actual changes to the device were required to meet the updated standards, other than one update to the labeling for the water ingress protection level (IP44). - Minor updates to the compatible accessories list. The CARESCAPE ONE remains substantially equivalent to the predicates and the device itself (software and hardware) remains nearly identical to the version cleared under K190008. There are no changes to the monitored parameters or algorithms. A summary of the main changes compared to the predicate are listed below in the comparison table. {8}------------------------------------------------ | Product Comparison versus Predicate Main features | | | | |---------------------------------------------------|--|--|--| | | | | | | Specification | PREDICATE CARESCAPE ONE (K190008) | CARESCAPE ONE | Discussion of Differences | |--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters. The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. | The CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters. The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode. | Equivalent. The predicate device is standalone Patient Monitor, which includes patient signal acquisition and processing, patient data display, alarm signal generation, and user input functions. The new device includes the standalone functionality and behavior, plus includes the ability to delegate alarm signal generation, patient data display, and user input functions to a connected "host" CARESCAPE Patient Monitor. The Patient Data Module (K071073) is a reference device which is similar to the CARESCAPE ONE used as an acquisition module since it connects to a CARESCAPE Monitor host and can also be used in patient transport and then reconnected to a host. The changes have been made to clarify that the CARESCAPE ONE can be used both as a standalone monitor and a compatible module/accessory for a host CARESCAPE Monitor. Verification of interoperability/ compatibility was completed. Compatibility of CARESCAPE ONE with the host monitors was also cleared in the following submissions: CARESCAPE B650 K191149, CARESCAPE B450 K191249 and CARESCAPE B850 K191323. This change is substantially equivalent to the predicate device. | | Contraindications for using CARESCAPE ONE: | The CARESCAPE ONE is not intended for use within a controlled MR environment. | The CARESCAPE ONE is | | | Specification | PREDICATE CARESCAPE ONE (K190008) | CARESCAPE ONE | Discussion of Differences | | | | The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment. | | | Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical | | Use environments | Within a professional healthcare facility (Not intended for MRI) | Within a professional healthcare facility (Not intended for MRI) | Identical | | Intrahospital transport within a professional healthcare facility. | Yes | Yes | Identical | | Acquisition Mode (accessory to a compatible host monitor) | N/A | Connects to a compatible "host" CARESCAPE Patient Monitor. The CARESCAPE ONE provides parameter acquisition for the host patient Monitor. Visual and audible alarms, user controls, and user interface functions are not active on the CARESCAPE ONE and instead those functions are provided by the host CARESCAPE Patient Monitor. | Equivalent. The predicate device is standalone Patient Monitor, which includes patient signal acquisition and processing, patient data display, alarm signal generation, and user input functions. The new device includes the standalone functionality and behavior, plus includes the ability to act as an acquisition device to a host monitor. This is equivalent to the reference device Patient Data Module (K071073) which acts as an acquisition module to a host device and was a predicate to K190008. This acquisition mode allows it to delegate alarm signal generation, patient data display, and user input functions to a connected "host" CARESCAPE Patient Monitor. The CARESCAPE ONE can be used both as a standalone and a compatible module for a host CARESCAPE Monitor. Verification of interoperability/compatibility was completed. Compatibility of CARESCAPE ONE with the host monitors was also cleared in the following submissions: CARESCAPE B650 K191149, CARESCAPE B450 K191249 and CARESCAPE B850 K191323. This change is substantially equivalent to the predicate device. | | Specification | PREDICATE CARESCAPE ONE (K190008) | CARESCAPE ONE | Discussion of Differences | | Monitored Parameters | Parameters monitored by CARESCAPE ONE include: - hemodynamic (ECG, ST segment, arrhythmia detection, invasive pressures, NIBP, temperature, and pulse oximetry) - respiratory (impedance respiration, CO2) | Parameters monitored by CARESCAPE ONE include: - hemodynamic (ECG, ST segment, arrhythmia detection, invasive pressures, NIBP, temperature, and pulse oximetry) - respiratory (impedance respiration, CO2) | Identical | | Medical Standards | IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 IEC 60601-1-2:2007 IEC 60601-1-2:2014-02 / EN 60601-1-2:2015 IEC 60601-1-6:2010 + A1:2013 IEC 60601-1-8:2006 + A1:2012 IEC 60601-2-27:2011 IEC 80601-2-30:2013 IEC 60601-2-34:2011 IEC 60601-2-49:2011 ISO 80601-2-55:2011 ISO 80601-2-56:2009 ISO 80601-2-61:2011 IEC 62304:2006 + A1:2015 IEC 62366:2017 + A1:2014 ISO 10993-1:2009 IEC 62133:2012 | IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 IEC 60601-1-2:2007 IEC 60601-1-2:2014-02 / EN 60601-1-2:2015 IEC 60601-1-6:2010 + A1:2013 IEC 60601-1-8:2006 + A1:2012 IEC 60601-2-27:2011 IEC 80601-2-30:2018 IEC 60601-2-34:2011 IEC 80601-2-49:2018 ISO 80601-2-55:2018 ISO 80601-2-56:2017 + A1:2018 ISO 80601-2-61:2017 IEC 62304:2006 + A1:2015 IEC 62366:2017 + A1:2014 ISO 10993-1:2009 IEC 62133-2:2017 | Equivalent. Both the predicate and the new device comply with the same standards, except the new device complies with the more recent edition of the particulars for the following standards: IEC 80601-2-30:2018 IEC 80601-2-49:2018 ISO 80601-2-55:2018 ISO 80601-2-56:2017+A1 2018 ISO 80601-2-61:2017 The battery is identical to the predicate, but we now comply with the most recent battery standard IEC 62133-2:2017. Verification testing to show compliance with the updated standards are included in the submission. In order to meet the new standard requirements we did not require any software or hardware changes compared to the predicate CARESCAPE ONE (K190008). We have only changed our manuals to list the new standards and our IP41 water ingress specification and label has changed to a higher rating to comply with IEC 60601-2-61:2017. The new pulse oximetry standard requires IPx2 instead of IPX1, but we tested to IP44 | | Specification | PREDICATE CARESCAPE ONE (K190008) | CARESCAPE ONE | Discussion of Differences | | Parameters Acquisition Method | The CARESCAPE ONE utilizes the Active Cable Modules (ACMs) or PARAMETERS, in which the parameter electronics are encapsulated into the respective patient cables, rather than inside the main frame of the monitor. Only the NIBP parameter is integrated into the CARESCAPE ONE monitor. Parameter/Active Cable Modules: CARESCAPE TEMP - Temperature CARESCAPE PRES – Invasive Pressure CARESCAPE ECG - ECG CARESCAPE SPO2 - Trusignal SPO2 CARESCAPE SPO2 Nellcor - Nellcor SPO2 CARESCAPE SPO2 Masimo - Masimo SPO2 CARESCAPE CO2 - LoFlo | The CARESCAPE ONE utilizes the Active Cable Modules (ACMs) or PARAMETERS, in which the parameter electronics are encapsulated into the respective patient cables, rather than inside the main frame of the monitor. Only the NIBP parameter is integrated into the CARESCAPE ONE monitor. Parameter/Active Cable Modules: CARESCAPE TEMP - Temperature CARESCAPE PRES – Invasive Pressure CARESCAPE ECG - ECG CARESCAPE SPO2 - Trusignal SPO2 CARESCAPE SPO2 Nellcor - Nellcor SPO2 CARESCAPE SPO2 Masimo - Masimo SPO2 CARESCAPE CO2 - LoFlo | Identical | | EK-Pro arrhythmia detection algorithm | EK-Pro V14 | EK-Pro V14 | Identical | | Size (H x W x D) | 155 mm x 270 mm x 65 mm (6.1 in x 10.6 in x 2.6 in) Note: Excludes dock | 155 mm x 270 mm x 65 mm (6.1 in x 10.6 in x 2.6 in) Note: Excludes dock | Identical…