(194 days)
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.
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.
The provided text is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc.'s CARESCAPE ONE device. It outlines the device's characteristics, intended use, and a comparison to a predicate device (K200494). However, it explicitly states that clinical studies were not required to establish substantial equivalence for this submission.
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, specifically in the context of human reader performance or ground truth established by experts beyond what is implied by general device performance testing. The focus of this 510(k) submission is on demonstrating substantial equivalence to a previously cleared device through non-clinical bench testing, not through a clinical study involving human readers and a robust ground truth determination process.
Here's what can be extracted from the document regarding "acceptance criteria" and "device performance" in a general sense, based on the non-clinical tests performed:
Summary of Non-Clinical Tests and Implied Acceptance Criteria:
The non-clinical tests performed demonstrate that the device meets its own specifications and relevant consensus standards. The "acceptance criteria" implicitly refer to compliance with these standards and the device's design specifications.
Implied Acceptance Criteria and Reported Device Performance (based on Non-Clinical Tests):
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to Predicate | The CARESCAPE ONE utilizes the same fundamental technology and functionality as the predicate CARESCAPE ONE (K200494). There are no significant changes to the CARESCAPE ONE monitored parameters, and all measurement algorithms are identical to those in K200494. |
| Compatibility with OEM Modules/Host Monitors | Compatibility with new OEM CARESCAPE Parameter Modules and extended support for Masimo parameters were verified. Compatibility with CARESCAPE Bx50 host monitors running the latest software version was ensured. |
| Electrical Safety | CARESCAPE ONE was tested and meets the electrical safety requirements of IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1". Updated CB reports demonstrating compliance with FDA recognized standards were provided. |
| Electromagnetic Compatibility (EMC) | CARESCAPE ONE was tested and meets the EMC requirements described in IEC 60601-1-2 Edition 4.0 2014-02 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests". Compliance with FDA guidance on EMC was also demonstrated. |
| Software Performance & Safety | Bench testing related to software was conducted, demonstrating the design meets specifications. There are no changes to algorithms within CARESCAPE ONE or GE-created CARESCAPE Parameters, other than minor anomaly corrections in the ECG parameter device. The software is considered a "Major" level of concern. Patient safety, security, and privacy risks have been addressed, including Security Risk Assessment, Threat model, and Penetration testing (system integrity, access, audit, network, and remote service controls). |
| Usability (Human Factors) | The usability testing of the CARESCAPE ONE patient monitor is in compliance with the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016). |
| Environmental Requirements | The hardware design and environmental requirements have not changed since the predicate (K200494), and no new environmental testing was required. (Implies meeting previous environmental standards). |
Here's why the other requested information cannot be provided from this document:
-
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document focuses on non-clinical bench testing and compliance with standards. It does not mention clinical test sets, patient data, country of origin, or retrospective/prospective study design.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- No clinical user studies are mentioned that would require ground truth established by experts.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as there are no clinical test sets or expert reviews mentioned for adjudication.
-
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." Therefore, no MRMC study or AI assistance effect size is discussed.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- While the device has algorithms (e.g., EK-Pro arrhythmia algorithm), the document focuses on the device's performance in meeting safety and compatibility standards, not on a standalone algorithm's performance where "human-in-the-loop" is a distinct variable to be tested. The algorithms themselves are "identical" to the predicate, implying their performance was previously accepted.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not relevant to the non-clinical bench testing described. Ground truth is not established in the context of clinical accuracy for this submission.
-
8. The sample size for the training set
- The document does not describe the development or training of any AI/ML components or algorithms. It states that the measurement algorithms are "identical" to the predicate, suggesting they were already developed and validated.
-
9. How the ground truth for the training set was established
- Not applicable as there is no mention of a training set or its associated ground truth.
In summary, this 510(k) submission for the CARESCAPE ONE device relies on demonstrating "substantial equivalence" to a previously cleared predicate device (K200494) through non-clinical bench testing and adherence to recognized standards, rather than new clinical studies involving human performance or ground truth established by experts.
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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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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.9900 Innovation DriveWauwatosa, WI 53226, USA |
| Primary Contact Person: | Joel KentDirector, Regulatory Affairs StrategyGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com |
| Secondary Contact Person: | Monica MorrisonRegulatory Affairs ExecutiveGE HealthcarePhone: 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 CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
|---|---|---|---|
| Indications forUse | The CARESCAPE ONE isboth a multi-parameterphysiological patient monitorand an accessory to a multi-parameter patient monitorintended for use in multipleareas and intra-hospitaltransport within a professionalhealthcare facility. | CARESCAPE ONE is both amulti-parameter physiologicalpatient monitor and anaccessory to a multi-parameterpatient monitor intended foruse in multiple areas andintra-hospital transport withina professional healthcarefacility. | EquivalentAdded functionality to pass totalhemoglobin concentration [SpHb]from CARESCAPE SpO2 – Masimo(previously cleared K110028) andregional oxygen saturation (rSO2)from CARESCAPE rSO2 – INVOS |
| The CARESCAPE ONE isindicated for the monitoring ofhemodynamic (includingECG, ST segment, arrhythmiadetection, invasive pressure,non-invasive blood pressure, | CARESCAPE ONE isindicated for the monitoringof hemodynamic andrespiratory physiologicalparameters. | (previously cleared K182868) throughto a host monitor. These parametersare not displayed on the CARESCAPEONE. | |
| SpO2, pulse rate, andtemperature), and respiratory(impedance respiration andCO2 airway gas) physiologicalparameters. | When the CARESCAPEONE is operated as astandalone multi-parameterphysiological patientmonitor, it provides the | There were some minor text editsmade to improve clarity.This change is substantially equivalent | |
| The CARESCAPE ONE canbe used as a standalonemonitor. In this mode of | following physiologicalparameters: | to the predicate device. | |
| operation, the CARESCAPEONE provides ECG, STsegment, arrhythmia detection, | • ECG (heart rate, STsegment, and arrhythmiadetection) | ||
| invasive pressure, non-invasive blood pressure, SpO2,pulse rate, temperature,impedance respiration, andCO2 airway gas parameter | • Pulse oximetry (pulse rate,functional oxygen saturation[SpO2]) | ||
| acquisition and monitoring.The CARESCAPE ONE can | •Non-invasive bloodpressure (systolic, diastolic,and mean arterial | ||
| be connected as an accessoryto a compatible CARESCAPE | pressures) | ||
| monitor. In this mode ofoperation, the CARESCAPEONE provides ECG, ST | • Invasive pressure (pulserate and systolic, diastolic,and mean pressures) | ||
| segment, arrhythmia detection,invasive pressure, non- | •Temperature | ||
| invasive blood pressure, SpO2,pulse rate, temperature,impedance respiration, andCO2 airway gas parameteracquisition. | •Respiratory carbon dioxide(EtCO2, FiCO2, andrespiration rate)•Impedance respiration | ||
| Visual and audible alarms,user controls, and userinterface on the CARESCAPEONE are not active in thismode. | When the CARESCAPEONE is connected as anaccessory to a compatiblehost monitor, it provides the | ||
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| The CARESCAPE ONE isindicated for use on adult,pediatric, and neonatal patientsand on one patient at a time.The CARESCAPE ONE isindicated for use under thedirect supervision of a licensedhealthcare practitioner, or bypersonnel trained in the properuse of the equipment in aprofessional healthcarefacility.Contraindications for using | following physiologicalparameters to the hostmonitor:•ECG (heart rate, STsegment, and arrhythmiadetection)•Pulse oximetry (pulse rate,functional oxygen saturation[SpO2], and totalhemoglobin concentration[SpHb])•Non-invasive blood | ||
| CARESCAPE ONE:The CARESCAPE ONE is notintended for use within acontrolled MR environment. | pressure (systolic, diastolic,and mean arterialpressures) | ||
| •Invasive pressure (pulserate and systolic, diastolic,and mean pressures) | |||
| •Regional oxygen saturation(rSO2) | |||
| •Temperature | |||
| •Respiratory carbon dioxide(EtCO2, FiCO2, andrespiration rate) | |||
| •Impedance respiration | |||
| When the CARESCAPEONE is connected as anaccessory to a compatiblehost monitor, visual andaudible alarms, usercontrols, and user interfaceare provided on thecompatible host monitorand not on CARESCAPEONE. | |||
| CARESCAPE ONE isindicated for use on adult,pediatric, and neonatalpatients and on one patient ata time. | |||
| Regional oxygen saturation(rSO2) is an adjunctparameter for noninvasivemonitoring ofcerebral/somatic regionaloximetry of blood in thebrain or other tissuebeneath the sensor. It is | |||
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| intended to be used onpatients greater than 40 kg(88 lbs) at risk for reduced-flow or no-flow ischemicstates. | |||
| CARESCAPE ONE isintended for use under thedirect supervision of alicensed healthcarepractitioner, or by personneltrained in the proper use of theequipment in a professionalhealthcare facility. | |||
| Contraindications for usingCARESCAPE ONE: | |||
| The CARESCAPE ONE isnot intended for use within acontrolled MR environment. | |||
| Patient type | Adult, pediatric & neonatal | Adult, pediatric & neonatal | Identical |
| Useenvironments | Within a professionalhealthcare facility (Notintended for MRI) | Within a professionalhealthcare facility (Notintended for MRI) | Identical |
| Intrahospitaltransport withina professionalhealthcarefacility. | Yes | Yes | Identical |
| AcquisitionMode(accessory to acompatible hostmonitor) | Connects to a compatible"host" CARESCAPE PatientMonitor.The CARESCAPE ONEprovides parameter acquisitionfor the host patient Monitor.Visual and audible alarms,user controls, and userinterface functions are notactive on the CARESCAPEONE and instead thosefunctions are provided by thehost CARESCAPE PatientMonitor. | Connects to a compatible"host" CARESCAPE PatientMonitor.The CARESCAPE ONEprovides parameteracquisition for the host patientMonitor. Visual and audiblealarms, user controls, and userinterface functions are notactive on the CARESCAPEONE and instead thosefunctions are provided by thehost CARESCAPE PatientMonitor.CARESCAPE ONE iscompatible with host monitorsrunning the latest softwareversions. | EquivalentThe basic functionality, data transfermechanisms, and physical connectionmechanism between the CARESCAPEONE and compatible host monitors isidentical to the predicateCARESCAPE ONE (K200494).However, due to enhancements infunctionality (i.e., compatibility withnew CARESCAPE Parameters) thatare not available in older versions ofhost monitors, CARESCAPE ONE iscompatible with host monitors runningthe latest software versions.This change is substantially equivalentto the predicate device. |
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| MonitoredParameters | Parameters monitored byCARESCAPE ONE include:- hemodynamic (ECG, STsegment, arrhythmia detection,invasive pressures, NIBP,temperature, and pulseoximetry)- respiratory (impedancerespiration, CO2) | Parameters monitored byCARESCAPE ONE include:- hemodynamic (ECG, STsegment, arrhythmiadetection, invasive pressures,NIBP, temperature, and pulseoximetry)- respiratory (impedancerespiration, CO2) | Identical |
| MedicalStandards | IEC 60601-1:2005 + C1:2006+ C2:2007 + A1:2012IEC 60601-1-2:2007IEC 60601-1-2:2014-02 / EN60601-1-2:2015IEC 60601-1-6:2010 +A1:2013IEC 60601-1-8:2006 +A1:2012IEC 60601-2-27:2011IEC 80601-2-30:2018IEC 60601-2-34:2011IEC 80601-2-49:2018ISO 80601-2-55:2018ISO 80601-2-56:2017 +A1:2018ISO 80601-2-61:2017IEC 62304:2006 + A1:2015IEC 62366:2007+ A1:2014IEC 62366-1:2015ISO 10993-1:2009IEC 62133-2:2017UL 2054:2004UL 1642:2012AIM 7351731:2017 | IEC 60601-1:2005 + C1:2006+ C2:2007 + A1:2012IEC 60601-1-2:2014-02 / EN60601-1-2:2015IEC 60601-1-6:2010+A1:2013IEC 60601-1-8:2006 +A1:2012IEC 60601-2-27:2011IEC 80601-2-30:2018IEC 60601-2-34:2011IEC 80601-2-49:2018ISO 80601-2-55:2018ISO 80601-2-56:2017 +A1:2018ISO 80601-2-61:2017IEC 62304:2006 + A1:2015IEC 62366:2007+ A1:2014IEC 62366-1:2015ISO 10993-1:2009IEC 62133-2:2017UL 2054:2004UL 1642:2012AIM 7351731:2017 | EquivalentCARESCAPE ONE no longer claimscompliance to IEC 60601-1-2:2007because it has been superseded by IEC60601-1-2:2014-02 / EN 60601-1-2:2015. CARESCAPE ONE complieswith the FDA recognized standards inscope of the device and its intendeduse. This change is substantiallyequivalent to the predicate device. |
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| ParametersAcquisitionMethod | The CARESCAPE ONEutilizes the Active CableModules (ACMs) orPARAMETERS, in which theparameter electronics areencapsulated into therespective patient cables,rather than inside the mainframe of the monitor. Only theNIBP parameter is integratedinto the CARESCAPE ONEmonitor.Parameter/Active CableModules:CARESCAPE TemperatureCARESCAPE PressureCARESCAPE ECG (Includesimpedance respiration)CARESCAPE SPO2(TruSignal)OEM CARESCAPE SPO2 -Nellcor SPO2OEM CARESCAPE SPO2 -Masimo SPO2OEM CARESCAPE CO2 -LoFlo (Philips RespironicsLoFlo CO2) | The CARESCAPE ONEutilizes the Active CableModules (ACMs) orPARAMETERS, in which theparameter electronics areencapsulated into therespective patient cables,rather than inside the mainframe of the monitor. Only theNIBP parameter is integratedinto the CARESCAPE ONEmonitor.Parameter/Active CableModules:CARESCAPE TemperatureCARESCAPE PressureCARESCAPE ECG (Includesimpedance respiration)CARESCAPE SPO2(TruSignal)OEM CARESCAPE SPO2 -Nellcor SPO2OEM CARESCAPE SPO2 -Masimo SPO2OEM CARESCAPE CO2 -LoFlo (Philips RespironicsLoFlo CO2)OEM CARESCAPE CO2 –Microstream (Medtronic)OEM CARESCAPE rSO2 -INVOS (Medtronic) | EquivalentAdded OEM CARESCAPE CO2 –Microstream and OEM CARESCAPErSO2 - INVOS parameters.These two parameter cables can beplugged into any of the eight parameteracquisition ports on the CARESCAPEONE.This change is substantially equivalentto the predicate device. |
| EK-Proarrhythmiadetectionalgorithm | EK-Pro V14 | EK-Pro V14 | Identical |
| Size (H x W xD) | 155 mm x 270 mm x 65 mm(6.1 in x 10.6 in x 2.6 in)excluding dock and excludingany host CARESCAPE Patientmonitor. | 155 mm x 270 mm x 65 mm(6.1 in x 10.6 in x 2.6 in)excluding dock and excludingany host CARESCAPEPatient monitor. | Identical |
| Weight | 1.85 kg (4.1 lbs.) with batteryand excluding dock andexcluding any hostCARESCAPE Patient monitor. | 1.85 kg (4.1 lbs.) with batteryand excluding dock andexcluding any hostCARESCAPE Patientmonitor. | Identical |
| Battery Type | Lithium-Ion | Lithium-ion | Identical |
| Display size | 7 inch | 7 inch | Identical |
| Specification | PREDICATE CARESCAPEONE (K190008) | CARESCAPE ONE | Discussion of Differences |
| Display type | Active matrix color TFT LCD | Active matrix color TFT LCD | Identical |
| Number oftraces(waveforms) | Up to 8 with 4 available on2nd waveform page. | Up to 12 total with 4 availableon 1st page, 4 available on 2ndpage, and 4 available on 3rdpage. | EquivalentSupport for a third page with fouradditional parameter windows andwaveforms was added in this release.The third page is used to display anyparameter windows and waveformsthat are available but haven't beenconfigured to be shown on either thefirst or second page. This functionalityguarantees that all possible parameterwindows and waveforms can bedisplayed on the screen. Thisfunctionality was expanded from twopages to three pages, due to the twoadditional invasive pressure channelsthat can now be monitored in thisrelease.This change is substantiallyequivalent to the predicate device. |
| OperatingSystem | Linux Operating System | Linux operating system | Identical |
| Softwarepackages | 5 software packages:Emergency Care (ED), CriticalCare (ICU), Operating Room(OR), Post-Anesthesia Care(PACU), Neonatal Care(NICU) | 5 software packages:Emergency Care (ED),Critical Care (ICU), OperatingRoom (OR), Post-AnesthesiaCare (PACU), Neonatal Care(NICU) | Identical. |
| Patient Network | No | No | Identical |
| Ethernet portconnector(RJ45-8-pin) | One Ethernet port for servicetools. | One Ethernet port for servicetools. | Identical |
| Defaultsavailable | User selectable arrhythmiaalarm levels, Parametersettings and alarm levels,default alarm limits, displaylayout, parameter prioritydefaults. Up to 8 different pre-configured or custom defaultsavailable. Not all parametershave configurable alarmpriorities. | User selectable arrhythmiaalarm levels, Parametersettings and alarm levels,default alarm limits, displaylayout, parameter prioritydefaults. Up to 8 different pre-configured or custom defaultsavailable. Not all parametershave configurable alarmpriorities. | Identical |
| AlarmClassification(IEC) | Four levels - High, Medium,Low and Informational | Four levels - High, Medium,Low and Informational | Identical |
| AlarmNotification | Audible and visual | Audible and visual | Identical |
| Technicalalarms | System generated alarms tonotify the user of specialconditions. | System generated alarms tonotify the user of specialconditions. | Identical |
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Summary of Non-Clinical Tests:
Determination of Substantial Equivalence (807.92(b)(1)):
Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE ONE, demonstrating the design meets the specifications.
This section addresses the Non-Clinical testing for CARESAPE ONE modifications with respect to the predicate CARESCAPE ONE (K200494) that are the subject of this 510(k) submission.
Per the FDA guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff, Document issued on December 20, 2019", the following was verified:
- o Compatibility with new OEM CARESCAPE Parameter Modules
- o Extended support for Masimo parameters
- Updates to the list of accessories ●
- Updates to the user documentation
The CARESCAPE ONE hardware design and environmental requirements have not changed since CARESCAPE ONE (K200494) and none of the other design changes required any new environmental testing.
CARESCAPE ONE was tested and meets the EMC requirements described in IEC 60601-1-2 Edition 4.0 2014-02 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests".
Compliance according to the "Guidance for Industry and Food and Drug Administration Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Issued July 11, 2016" and "Electromagnetic Compatibility (EMC) of Medical Devices, issued on November 17,2020"
CARESCAPE ONE was tested and meets the electrical safety requirements of IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1".
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Due to the software changes and addition of compatibility with new OEM CARESCAPE Parameters and accessories that is included in this submission. CARESCAPE ONE received updated CB reports demonstrating compliance with the FDA recognized standards in scope for the product.
The usability testing of the CARESCAPE ONE patient monitor is in compliance with the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).
The main differences with respect to the predicate (related to software) are listed 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
·Continuous improvements in Cybersecurity
· Workflow enhancements in the clinical software
· Workflow enhancements in the monitor service and installation features
There are no changes to algorithms within CARESCAPE ONE, or any changes to any of the software within the CARESCAPE Parameters created by GE other than correction of minor anomalies in the CARESCAPE ECG parameter device. Testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "Major" level of concern.
Patient safety, security, and privacy risks have been addressed in the design and development of CARESCAPE ONE including a Security Risk Assessment, Threat model and Penetration testing. This includes system integrity controls, access controls, audit controls, network controls, and remote service controls which address the General Principles and Security Capabilities outlined in the FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for
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Industry and Food and Drug Administration Staff Document issued on October 2, 2014 (and is in-line with the draft Guidance issue October 2018).
| Clinical (807.92(b)(2)): | Summary of Clinical Tests:Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence. |
|---|---|
| Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE ONE to be substantially equivalent to the predicate device. |
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.