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
Device Facts
| Record ID | K213234 |
|---|---|
| Device Name | 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 |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product Code | MHX · Cardiovascular |
| Decision Date | Apr 12, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
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. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters: - ECG (heart rate, ST segment, and arrhythmia detection) - Pulse oximetry (pulse rate, functional oxygen saturation [SpO2]) - Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - Temperature - Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor: - ECG (heart rate, ST segment, and arrhythmia detection) - Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]] - Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - Regional oxygen saturation (rSO2) - Temperature - Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE. CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended 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.
Device Story
CARESCAPE ONE is a multi-parameter physiological monitor for bedside use and intra-hospital transport. It functions as a standalone monitor or as an acquisition accessory to a compatible host monitor. Input data is acquired via plug-and-play Active Cable Modules (ACM) for ECG, SpO2, invasive pressure, temperature, CO2, and rSO2; non-invasive blood pressure (NIBP) is integrated into the main unit. The device processes these signals to provide waveforms, vital sign values, and alarms. When used as an accessory, the device transmits data to a host monitor, which manages the user interface and alarms. Operated by trained healthcare personnel, the device provides real-time physiological data to support clinical decision-making. Benefits include flexible, modular configuration for patient-specific monitoring needs and continuous data acquisition during transport.
Clinical Evidence
No clinical data required; substantial equivalence established through bench testing, including software verification, hardware performance, and compliance with recognized consensus standards (IEC 60601 series).
Technological Characteristics
Modular patient monitor with 7-inch TFT LCD; internal battery and AC power. Uses Active Cable Modules (ACM) for parameter acquisition. Connectivity via custom medical-grade USB ports and Ethernet. Software runs on Linux. Complies with IEC 60601-1, IEC 60601-1-2, and ISO 80601 series standards.
Indications for Use
Indicated for hemodynamic and respiratory monitoring of adult, pediatric, and neonatal patients in professional healthcare facilities and during intra-hospital transport. rSO2 monitoring indicated for patients >40 kg at risk for ischemic states. Contraindicated for use in 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 (K200494)
Reference Devices
- CARESCAPE B650 (K191149)
- CARESCAPE B850 (K191323)
- CARESCAPE B450 (K191249)
- INVOS PM7100 Patient Monitor (K182868)
- INVOS Adult rSO2 Sensor (K182868)
- MASIMO RADICAL Y PULSE CO-OXIMETER (K110028)
Submission Summary (Full Text)
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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 26, 2022
GE Medical Systems Information Technologies, Inc. Joel Kent Sr. Manager Regulatory Affairs 9900 Innovation Drive Wauwatosa, Wisconsin 53226
### Re: K213234
Trade/Device Name: 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 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, DXN, FLL, MLD, MUD, QEM
Dear Joel Kent:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 12, 2022. Specifically, FDA is updating this SE Letter to add a missing product code as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jennifer Shih, OHT2: Office of Cardiovascular Devices, Jennifer.Shih(@fda.hhs.gov.
Sincerely,
# Jennifer W. Shih -S
Jennifer Shih Assistant 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
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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2022
GE Medical Systems Information Technologies, Inc. Joel Kent Sr. Manager Regulatory Affairs 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K213234
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, DRT, DSI, DSK, DXN, FLL, MLD, MUD, OEM Dated: March 16, 2022 Received: March 17, 2022
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
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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 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,
Jennifer W.Shih -S
Jennifer Shih Assistant 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
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# Indications for Use
510(k) Number (if known) K213234
Device Name CARESCAPE ONE
#### Indications for Use (Describe)
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. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters:
- · ECG (heart rate, ST segment, and arrhythmia detection)
- · Pulse oximetry (pulse rate, functional oxygen saturation [SpO2])
- · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
- · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
- · Temperature
- · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
- · Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor:
- · ECG (heart rate, ST segment, and arrhythmia detection)
- · Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]]
- · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
- · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
- · Regional oxygen saturation (rSO2)
- · Temperature
- · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
- · Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE.
CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states.
CARESCAPE ONE is intended 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)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circle. The circle is surrounded by decorative swirls or flourishes. The logo is black and white.
GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226, USA
#### 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: April 7, 2022 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|
| Owner/Submitter: | GE Medical Systems Information Technologies, Inc.<br>9900 Innovation Drive<br>Wauwatosa, WI 53226, USA |
| Primary Contact Person: | Joel Kent<br>Director, Regulatory Affairs Strategy<br>GE Healthcare<br>Phone: 617-851-0943<br>E-mail: joel.kent@ge.com |
| Secondary Contact Person: | Monica Morrison<br>Regulatory Affairs Executive<br>GE Healthcare<br>Phone: 608-515-3077 |
Device names (807.92(a)(2)):
Trade Name: CARESCAPE ONE Common/Usual Name: Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms)
E-mail: monica.morrison(@ge.com
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Classification Names: 21 CFR 870.1025 monitor, physiological, patient (with
arrhythmia detection or alarms)
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
21 CFR 870.2700 Oximeter, Tissue Saturation
21 CFR 870.2700 Cerebral Oximeter
Product Code: MHX
| Subsequent Product Codes: | BZQ |
|---------------------------|-----|
| | CCK |
| | DPS |
| | DPZ |
| | DQA |
| | DQK |
| | DRT |
| | DSI |
| | DSJ |
| | DSK |
| | DXN |
| | FLL |
| | MLD |
| | MUD |
| | QEM |
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The primary predicate for this submission is K200494, Predicate Device(s) (807.92(a)(3)): CARESCAPE ONE
> Additional reference devices: K191149, CARESCAPE B650 K191323, CARESCAPE B850 K191249, CARESCAPE B450 K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor K110028, MASIMO RADICAL Y PULSE CO-OXIMETER
Device Description (807.92(a)(4)):
CARESCAPE ONE belongs to the CARESCAPE patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular vital sign, currently there are ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, CO2, and rSO2 (rSO2 monitoring is only supported when CARESCAPE ONE is operating as an acquisition device. rSO2 values are not displayed on CARESCAPE ONE). 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, CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received form the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.
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#### Intended Use: (807.92(a)(5)):
#### Indications
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.
CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters.
When the CARESCAPE ONE is operated as a standalone multiparameter physiological patient monitor, it provides the following physiological parameters:
·ECG (heart rate, ST segment, and arrhythmia detection)
·Pulse oximetry (pulse rate, functional oxygen saturation [SpO2])
·Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
·Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
·Temperature
•Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
·Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor:
·ECG (heart rate, ST segment, and arrhythmia detection)
•Pulse oximetry (pulse rate, functional oxygen saturation [SpO2], and total hemoglobin concentration [SpHb])
•Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures)
•Invasive pressure (pulse rate and systolic, diastolic, and mean pressures)
·Regional oxygen saturation (rSO2)
·Temperature
•Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate)
·Impedance respiration
When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE.
CARESCAPE ONE is intended for use on adult, pediatric, and
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neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for noninvasive monitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended 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. Technology (807.92(a)(6)): The CARESCAPE ONE uses the same fundamental technology and functionality as the predicate CARESCAPE ONE (K200494). The main differences with respect to the predicate discussed throughout the submission are summarized below: - Compatibility with CARESCAPE Bx50 host monitors running the latest version of software - Compatibility with new OEM CARESCAPE Parameter Modules - Extended support for Masimo parameters - Updates to the Indications for Use (We have revised the Indications for Use statement from the predicate to reflect the changes that have been made for clarity and to reflect the inclusion of the acquisition of OEM parameter rSO2 with the CARESCAPE rSO2 – INVOS™ Parameter module and extended functionality with CARESCAPE SpO2 - Masimo measurement device - Continuous improvements in Cybersecurity - Workflow enhancements in the clinical software - Workflow enhancements in the monitor service and installation features - Updates to the list of accessories - Updates to the user documentation The CARESCAPE ONE remains substantially equivalent to the predicates and the device itself (software and hardware) remains nearly identical to the version cleared under K200494. There are no significant changes to the CARESCAPE ONE monitored parameters, and all measurement algorithms are identical to those that were included in K200494.
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A summary of the main changes compared to the predicate are listed below in the comparison table.
# Product Comparison versus Predicate Main features
| Specification | PREDICATE CARESCAPE<br>ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The CARESCAPE ONE is<br>both a multi-parameter<br>physiological patient monitor<br>and an accessory to a multi-<br>parameter patient monitor<br>intended for use in multiple<br>areas and intra-hospital<br>transport within a professional<br>healthcare facility. | CARESCAPE ONE is both a<br>multi-parameter physiological<br>patient monitor and an<br>accessory to a multi-parameter<br>patient monitor intended for<br>use in multiple areas and<br>intra-hospital transport within<br>a professional healthcare<br>facility. | Equivalent<br>Added functionality to pass total<br>hemoglobin concentration [SpHb]<br>from CARESCAPE SpO2 – Masimo<br>(previously cleared K110028) and<br>regional oxygen saturation (rSO2)<br>from CARESCAPE rSO2 – INVOS |
| | The CARESCAPE ONE is<br>indicated for the monitoring of<br>hemodynamic (including<br>ECG, ST segment, arrhythmia<br>detection, invasive pressure,<br>non-invasive blood pressure, | CARESCAPE ONE is<br>indicated for the monitoring<br>of hemodynamic and<br>respiratory physiological<br>parameters. | (previously cleared K182868) through<br>to a host monitor. These parameters<br>are not displayed on the CARESCAPE<br>ONE. |
| | SpO2, pulse rate, and<br>temperature), and respiratory<br>(impedance respiration and<br>CO2 airway gas) physiological<br>parameters. | When the CARESCAPE<br>ONE is operated as a<br>standalone multi-parameter<br>physiological patient<br>monitor, it provides the | There were some minor text edits<br>made to improve clarity.<br>This change is substantially equivalent |
| | The CARESCAPE ONE can<br>be used as a standalone<br>monitor. In this mode of | following physiological<br>parameters: | to the predicate device. |
| | operation, the CARESCAPE<br>ONE provides ECG, ST<br>segment, arrhythmia detection, | • ECG (heart rate, ST<br>segment, and arrhythmia<br>detection) | |
| | invasive pressure, non-<br>invasive blood pressure, SpO2,<br>pulse rate, temperature,<br>impedance respiration, and<br>CO2 airway gas parameter | • Pulse oximetry (pulse rate,<br>functional oxygen saturation<br>[SpO2]) | |
| | acquisition and monitoring.<br>The CARESCAPE ONE can | •Non-invasive blood<br>pressure (systolic, diastolic,<br>and mean arterial | |
| | be connected as an accessory<br>to a compatible CARESCAPE | pressures) | |
| | monitor. In this mode of<br>operation, the CARESCAPE<br>ONE provides ECG, ST | • Invasive pressure (pulse<br>rate and systolic, diastolic,<br>and mean pressures) | |
| | segment, arrhythmia detection,<br>invasive pressure, non- | •Temperature | |
| | invasive blood pressure, SpO2,<br>pulse rate, temperature,<br>impedance respiration, and<br>CO2 airway gas parameter<br>acquisition. | •Respiratory carbon dioxide<br>(EtCO2, FiCO2, and<br>respiration rate)<br>•Impedance respiration | |
| | Visual and audible alarms,<br>user controls, and user<br>interface on the CARESCAPE<br>ONE are not active in this<br>mode. | When the CARESCAPE<br>ONE is connected as an<br>accessory to a compatible<br>host monitor, it provides the | |
| Specification | PREDICATE CARESCAPE<br>ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| | The CARESCAPE ONE is<br>indicated for use on adult,<br>pediatric, and neonatal patients<br>and on one patient at a time.<br><br>The CARESCAPE ONE is<br>indicated for use under the<br>direct supervision of a licensed<br>healthcare practitioner, or by<br>personnel trained in the proper<br>use of the equipment in a<br>professional healthcare<br>facility.<br><br>Contraindications for using | following physiological<br>parameters to the host<br>monitor:<br>•ECG (heart rate, ST<br>segment, and arrhythmia<br>detection)<br><br>•Pulse oximetry (pulse rate,<br>functional oxygen saturation<br>[SpO2], and total<br>hemoglobin concentration<br>[SpHb])<br><br>•Non-invasive blood | |
| | CARESCAPE ONE:<br>The CARESCAPE ONE is not<br>intended for use within a<br>controlled MR environment. | pressure (systolic, diastolic,<br>and mean arterial<br>pressures) | |
| | | •Invasive pressure (pulse<br>rate and systolic, diastolic,<br>and mean pressures) | |
| | | •Regional oxygen saturation<br>(rSO2) | |
| | | •Temperature | |
| | | •Respiratory carbon dioxide<br>(EtCO2, FiCO2, and<br>respiration rate) | |
| | | •Impedance respiration | |
| | | When the CARESCAPE<br>ONE is connected as an<br>accessory to a compatible<br>host monitor, visual and<br>audible alarms, user<br>controls, and user interface<br>are provided on the<br>compatible host monitor<br>and not on CARESCAPE<br>ONE. | |
| | | CARESCAPE ONE is<br>indicated for use on adult,<br>pediatric, and neonatal<br>patients and on one patient at<br>a time. | |
| | | Regional oxygen saturation<br>(rSO2) is an adjunct<br>parameter for noninvasive<br>monitoring of<br>cerebral/somatic regional<br>oximetry of blood in the<br>brain or other tissue<br>beneath the sensor. It is | |
| Specification | PREDICATE CARESCAPE<br>ONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| | | intended to be used on<br>patients greater than 40 kg<br>(88 lbs) at risk for reduced-<br>flow or no-flow ischemic<br>states. | |
| | | CARESCAPE ONE is<br>intended for use under the<br>direct supervision of a<br>licensed healthcare<br>practitioner, or by personnel<br>trained in the proper use of the<br>equipment in a professional<br>healthcare facility. | |
| | | Contraindications for using<br>CARESCAPE ONE:…
