Who is the manufacturer of Carescape One?

GE Healthcare filed the 510(k) submission for Carescape One (K190008).

What is the FDA product code for Carescape One?

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

What is the regulatory pathway for Carescape One?

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

What are the predicate devices for Carescape One?

Patient Data Module (PDM) (K071073); CARESCAPE Monitor B450 (K132533).

Who can help prepare an FDA 510(k) submission like Carescape One?

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

K190008 · GE Healthcare · MHX · Dec 20, 2019 · Cardiovascular

Device Facts

Record ID	K190008
Device Name	Carescape One
Applicant	GE Healthcare
Product Code	MHX · Cardiovascular
Decision Date	Dec 20, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital 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.

Device Story

CARESCAPE ONE is a compact, multi-parameter patient monitor for bedside use and intrahospital transport. It acquires physiological data (ECG, ST segment, arrhythmia, invasive/non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, CO2) via plug-and-play Active Cable Modules (ACMs) connected to custom USB ports; NIBP is integrated into the monitor. The device processes signals using a Common Software Platform (CSP) and displays waveforms, numerics, and alarms on a 7-inch touchscreen. Operated by trained healthcare practitioners, it provides real-time monitoring to support clinical decision-making. It functions as a standalone unit, eliminating the need for a separate host monitor. The device runs on internal battery or AC power via a docking station. It incorporates the EK-Pro V14 arrhythmia detection algorithm. Clinical benefits include continuous patient surveillance and portability during transport.

Clinical Evidence

No clinical studies were required. Evidence consists of bench testing, including hardware performance, electromagnetic compatibility, electrical safety, and usability testing. Algorithm performance for EK-Pro V14 was validated against the predicate EK-Pro V13 using ANSI/AAMI EC57:1998 (R)2012 standards. SpO2 accuracy was validated in a controlled desaturation study per ISO 80601-2-61:2011.

Technological Characteristics

Multi-parameter monitor with 7-inch TFT LCD touchscreen. Uses Active Cable Modules (ACMs) for parameter-specific signal conditioning and USB communication. Powered by Lithium-ion battery or AC. Software platform: Linux-based. Connectivity: Ethernet for service only (non-networked). Alarms: IEC 60601-1-8:2012 compliant. Biocompatibility testing performed on patient-contacting cables.

Indications for Use

Indicated for hemodynamic and respiratory monitoring of adult, pediatric, and neonatal patients in professional healthcare facilities during bedside care or intrahospital transport. Contraindicated 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

Patient Data Module (PDM) (K071073)
CARESCAPE Monitor B450 (K132533)

Reference Devices

Pro1000 (K022834)
APEXPRO TELEMETRY SYSTEM (K080251)
TRAM module (K011000)
DASH 3000/4000/5000 monitoring systems (K051367)
TRAMSCOPE SYSTEM (K900598)
B105/B125 monitor (K171580)
Monitor B40 (K151063)
MASIMO RADICAL Y PULSE CO-OXIMETER (K110028)
Nellcor pulse oximetry monitor interface cable (K172482)
LOFLO C5 CO2 SENSOR (K053174)
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM (K083750)

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
K213181 — CARESCAPE B650, E-musb · GE Healthcare Finland Oy · Apr 13, 2022
K132533 — CARESCAPE MONITOR B450 · GE Healthcare Finland Oy · Dec 4, 2013
K200494 — CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES · GE Healthcare · Mar 29, 2020
K131223 — CARESCAPE MONITOR B650 · GE Healthcare Finland Oy · Aug 28, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION". December 20, 2019 GE Healthcare Joel Kent Senior Regulatory Affairs Manager 8200 West Tower Avenue Milwaukee, Wisconsin 53223 # Re: K190008 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. MLD. DSI. BZO. DXN. DOA. DPZ. DRT. DSJ. DSK. FLL. CCK Dated: November 15, 2019 Received: November 18, 2019 # 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190008 Device Name CARESCAPE ONE ### Indications for Use (Describe) The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital 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. 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) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:flex; align-items:center;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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 background is black, and the logo is white, creating a strong contrast. The design is simple, yet recognizable. 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: | December 20, 2019 | |---------------------------|--------------------------------------------------------------------------------------------------------------------------| | 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 analyzer, gas, carbon-dioxide, gaseous-phase 21 CFR 870.2340 electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 computer, diagnostic, programmable 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 computer, blood-pressure 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 870.2910 thermometer, electronic, clinical 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 The primary predicate for this submission is K071073, Patient Predicate Device(s) (807.92(a)(3)): Data Module (PDM) > Additional predicates/reference devices: K132533 CARESCAPE Monitor B450 K022834 Pro1000 K080251 APEXPRO TELEMETRY SYSTEM K011000 TRAM module K051367 DASH 3000/4000/5000 monitoring systems K900598 TRAMSCOPE SYSTEM K171580 B105/B125 monitor K151063 Monitor B40 K110028 MASIMO RADICAL Y PULSE CO-OXIMETER K172482 The Nellcor pulse oximetry monitor interface cable. K053174 LOFLO C5 CO2 SENSOR K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM {5}------------------------------------------------ Device Description (807.92(a)(4)): CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533). CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including 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. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k). 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. {6}------------------------------------------------ Intended Use: (807.92(a)(5)): #### Indications (from labeling) The CARESCAPE ONE is a multi-parameter physiological patient monitor intended for use in multiple areas and intrahospital 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. # Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment The CARESCAPE ONE is a new multi-parameter monitor, Technology (807.92(a)(6)): introducing equivalent features and enhancements to existing features from two predicate devices. The primary predicate device is the PDM (K071073), and the main additional predicate used in this comparison is the CARESCAPE Monitor B450 with ESP V2 software (K132533). > The CARESCAPE ONE can be used as a full-standalone multiparameter monitor [equivalent to the CARESCAPE Monitor B450 (K132533) using the PDM (K071073)], providing the users the acquired display values, waveforms and alarms without the necessity of requiring a separate host monitor. The CARESCAPE ONE monitor's size is small and compact to support use in intra-hospital transport as well. {7}------------------------------------------------ Some key features of the device are summarized below: · The CARESCAPE ONE includes a touch screen display allowing the user to control the monitor's functions and display. · CARESCAPE ONE can be used as a stand-alone monitor This is equivalent to the functionality to the predicate CARESCAPE Monitor B450 using the PDM module. · The CARESCAPE ONE uses Active Cable Modules (also called Parameters) where the specific parameter electronics are encapsulated into the respective patient cables, allowing the monitor to be as compact as possible. In the PDM, the electronics related to a specific parameter, such as ECG, were contained within the PDM itself. In this case, the Active Cables Modules (ACMs) provide patient isolation, parameter data acquisition with signal conditioning, some signal processing, and USB communication back to the CARESCAPE ONE. The same technology to process and analyze the signals is maintained as compared to the predicate, and the equivalent functionality is maintained. However, the electronics are contained within the active cables themselves rather than inside the monitor. · Incorporates an alarm system that complies with IEC 60601-1-8:2012. Also adds additional flexibility for clinicians to tailor the alarms to their particular patient needs such as the ability to select/adjust the alarm priority levels for certain alarms and adjust time delays/alarm trigger delays. Alarms are displayed and alerted with visual alerts and audio directly on the CARESCAPE ONE Monitor. · Uses a Common Software Platform (CSP) that is used for the user interface, service interface, operating system, parameter data processing, alarms, trends, security, power management, and battery control. The operating system and display use a similar lavout and look/feel as the CARESCAPE bedside monitors. This gives the user a similar experience across the various products. · The CARESCAPE ONE incorporates the EK-Pro V14 arrhythmia detection algorithm into the monitor software. This is a slightly newer version of the EK-Pro algorithm that was utilized with the CARESCAPE Monitor B450 (EK-Pro v13), however it serves the same function and retains equivalent performance. · The CARESCAPE ONE measures LoFlo Sidestream CO2. PDM did not measure CO2 on its own. The B450 does include the display of CO2 through associated parameter modules. The CARESCAPE ONE CO2 measurement technology has been {8}------------------------------------------------ used by GE Healthcare in other existing bedside devices. The technology for this measurement has been cleared by its OEM developer, Respironics Novametrix LLC, with 510(k) K053174. This same technology was incorporated into GE Healthcare Solar and Dash bedside monitors with our Capnostat/Capnoflex CO2 System 510(k) K083750. • The CARESCAPE ONE and the PDM can measure SpO2 with technology supplied by OEM manufacturers Masimo and Nellcor. The CARESCAPE ONE can also measure SpO2 with the GE Trusignal technology. This technology is used in multiple FDA cleared GE devices including the B105/B125 monitor (K171580) and the Monitor B40 (K151063). A summary of the main changes compared to the predicate are listed below in the comparison table. | Specification | CARESCAPE B450 monitor with ESP V2 (K132533) | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates | |--------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------| | Patient type | Adult, pediatric & neonatal | 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) | Within a professional healthcare facility (Not intended for MRI) | Identical | | Intrahospital transport within a professional healthcare facility. | Yes | Yes | Yes | Identical | Product Comparison versus Predicate Main features {9}------------------------------------------------ | Specification | CARESCAPE B450 monitor with ESP V2 (K132533) | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Monitored Parameters | Parameters monitored by B450 with ESP V2 include: - hemodynamic (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), - respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange) - neurophysiological status (electroencephalog raphy, Entropy, Bispectral Index (BIS), and neuromuscular transmission) | Parameters monitored by PDM include: - hemodynamic (ECG, ST segment, arrhythmia detection, invasive pressures, NIBP, temperature, and pulse oximetry) - respiratory (impedance respiration) | Parameters monitored by CARESCAPE ONE include: - hemodynamic (ECG, ST segment, arrhythmia detection, invasive pressures, NIBP, temperature, and pulse oximetry) - respiratory (impedance respiration, CO2) | Equivalent. The CARESCAPE ONE monitors a subset of the parameters included for display on the B450. CARESCAPE ONE includes the same parameters for measurement acquisition as the PDM, with the addition of the LoFLo CO2 measurement. PDM does not include the CO2 parameter. The B450 does include the display of CO2 through associated parameter modules. The CARESCAPE ONE CO2 measurement technology has been used by GE Healthcare in other existing bedside devices. The technology for this measurement has been cleared by its OEM developer, Respironics Novametrix LLC, with 510(k) K053174. This same technology was incorporated into GE Healthcare Solar and Dash bedside monitors with our Capnostat/Capnoflex CO2 System 510(k) K083750. The additional parameters included in B450 which are not included in CARESCAPE ONE, such as anesthetic agents, N2O, and BIS, are not necessary for the function and use of the CARESCAPE ONE monitor. These changes do not affect the determination of substantial equivalence. | | Specification | CARESCAPE B450 monitor with ESP | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates | | | V2 (K132533) | | | | | Parameters Acquisition Method | B450 connects to multiple parameter acquisition modules, including PDM (Masimo and Nellcor), E-sCO. E-sCOV, E- sCAiO, E- sCAiOV, E-miniC, E-PSM, E-EEG, E- BIS, E-COP, E- ENTROPY, E- MASIMO, E- NMT, E-NSATX, E-P, E-PP, and E- PT for acquisition of measured parameters that are displayed on the B450. | The PDM is a parameter acquisition module, which includes the parameter acquisition electronics within the frame of the PDM. | 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 | Equivalent The same parameter acquisition technology is utilized in the CARESCAPE ONE as in the predicate PDM, however, some of the specific parameter electronics are encapsulated into the respective patient cables, allowing the monitor to be as compact as possible. In the PDM, the electronics related to a specific parameter, such as ECG, were contained within the PDM itself. In this case, the Active Cables Modules (ACMs) provide patient isolation, parameter data acquisition with signal conditioning, some signal processing, and USB communication back to the CARESCAPE ONE. The same technology to process and analyze the signals is maintained as compared to the predicate, and the equivalent functionality is maintained. However, the electronics are contained within the active cables themselves rather than inside the monitor. The additional measured parameter compared to PDM is CO2 as summarized in the line item above. The measurement technology and functionality remain equivalent to the predicate. | | EK-Pro arrhythmia detection algorithm | EK-Pro V13 | EK-Pro v11 | EK-Pro V14 | The CARESCAPE ONE incorporates the EK-Pro V14 arrhythmia detection algorithm into the monitor software. This is a slightly newer version of the EK- Pro algorithm that was utilized with the CARESCAPE Monitor B450 (EK-Pro v13), however it serves the same function and retains equivalent performance. | | Specification | CARESCAPE B450 monitor with ESP V2 (K132533) | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates | | Size (H x W x D) | 290 mm x 310 mm x 160 mm (11.4 in x 12.1 in x 6.2 in) | Height 6.4 cm (2.5 in.) maximum Width 14.0 cm (5.5 in.) maximum Depth 21.6 cm (8.5 in.) maximum | 155 mm x 270 mm x 65 mm (6.1 in x 10.6 in x 2.6 in) Note: Excludes dock | Equivalent. The CARESCAPE ONE is a patient monitor and performs the function of both CARESCAPE PDM and CARESCAPE B450 combined. As a patient monitor, the CARESCAPE ONE has reduced size making it easier to transport and mount. This improvement does not impact the determination of substantial equivalence since it is only a change in the physical size of the device. | | Weight | 4.7 kg (10.4 lbs) with two batteries but without modules | 1.0 kg (2.2 lbs.) without optional battery 1.2 kg (2.6 lbs.) with optional battery | 1.85 kg (4.1 lbs) with battery | Equivalent. The CARESCAPE ONE is a patient monitor and performs the function of both CARESCAPE PDM and CARESCAPE B450 combined. As a patient monitor, the CARESCAPE ONE has reduced weight making it easier to transport and mount. This improvement does not affect the determination of substantial equivalence since it is only a change in the weight of the of the device making it lighter than the predicate combination that performed similar functions. | | Battery Type | Lithium-Ion | Lithium-ion | Lithium-ion | Identical | | Display size | 12.1 in | Not Applicable | 7 inch | Equivalent. The smaller form factor of the CARESCAPE ONE required a smaller screen compared to the B450. The PDM does not have a display screen as it was used as a parameter acquisition module to communicate data to a patient monitor, like B450. The smaller screen is intended to make the device more transportable. The parameter data, waveforms, and alarms adequately fit on the display. This smaller screen does not affect the determination of substantial equivalence since it is only a change in the screen size of the device with specific design to display numerics and waveforms as the predicate. | | Specification | CARESCAPE B450 monitor with ESP V2 (K132533) | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates | | Display type | Active matrix color TFT LCD | Not Applicable | Active matrix color TFT LCD | Identical to B450. | | Number of traces (waveforms) | Up to 6, or up to 12 if optional dual display is used. | Not Applicable | Up to 8 with 4 available on 2nd waveform page. | Equivalent. The lower number of waveforms shown at one time, 4 verses 6, and 8 verses 12, is due to having a smaller screen and smaller set of available parameters. These technical differences are intentional to make the CARESCAPE ONE more transportable. The CARESCAPE B450 patient monitor also supports some specialized parameters which includes more waveforms, and these specialized parameters are not available with the CARESCAPE ONE. The CARESCAPE ONE can show 8 waveforms with swiping to a second page/screen while the CARESCAPE B450 requires a second physical display. Waveforms for all parameters supported by the CARESCAPE ONE can be displayed at the same time using the second waveform page. The lower number of waveforms shown does not affect the determination of substantial equivalence since the device displays waveforms for the parameters it specifies. | | Operating System | Linux Operating System | Linux operating system | Linux operating system | Identical | | Software packages | 5 software packages: Emergency Care (ED), Critical Care (ICU), Operating Room (OR), Post- Anesthesia Care (PACU), Neonatal Care (NICU) | Not Applicable | 5 software packages: Emergency Care (ED), Critical Care (ICU), Operating Room (OR), Post- Anesthesia Care (PACU), Neonatal Care (NICU) | Identical. | | Specification | CARESCAPE B450 monitor with ESP V2 (K132533) | PDM (K071073) | CARESCAPE ONE | Discussion of Differences CARESCAPE ONE and Predicates | | Patient Network functionality | WLAN, LAN | Not Applicable | Not Applicable | CARESCAPE ONE is not a networked monitor. Patient monitors do not require connection to a clinical network for safe and effective use. Therefore, this change does not affect the determination of substantial equivalence since it has been designed not to be directly connected to the network. | | Patient Network | Yes | Yes | No | Equivalent. | | Ethernet port connector (RJ45-8-pin) | Three Ethernet ports: Network MC, Network IX, Unity Network ID. | Powered Ethernet TCP/IP and USB | One Ethernet port for service tools. | The Ethernet port on the CARESCAPE ONE is intended for access to service functions when connected to the F0 Dock. This port is not intended for nor will it communicate on a clinical network. CARESCAPE ONE is not a networked monitor. Patient monitors do not require connection to a clinical network for safe and effective use. Therefore, this change does not affect the determination of substantial equivalence since it is only a change in the use of the network connection for service use since this device does not connect to the patient network. | | Defaults available | User selectable arrhythmia alarm levels, Parameter settings and alarm levels, default alarm limits, display layout, parameter priority, catheters, drugs and common events defaults. Up to 8 different pre- configured or custom defaults available. Not all parameters have configurable alarm priorities. | Not Applicable | User selectable arrhythmia alarm levels, Parameter settings and alarm levels, default alarm limits, display layout, parameter priority defaults. Up to 8 different pre- configured or custom defaults available. Not all parameters have configurable alarm priorities. | Equivalent. The CARESCAPE ONE does not support catheters, drugs and common events. Other defaults available are equivalent. Support for these are features and not essential to the use of the device, and therefore this change does not affect the determination of substantial equivalence since it is only a change due to the fact that the device supports different parameters compared to the predicate.…