The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment.

The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (O2), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed.

The CARESCAPE Central Station supports the ability to access information from GE products and hospital intranet in a web browser format. Additionally, CARESCAPE Central Station supports the ability to access patient information collected from the CARESCAPE network and stored on a network server.

Device Description

The CARESCAPE Central Station (CSCS) is based on a PC technology platform and is user friendly for easy operation using a simple logical screen menu. The interactive controls include the use of a computer mouse, keyboard and touch screen. Optional writers for the purpose of graphing waveforms and printing patient information include a 2-inch Direct Digital Writer and/or a laser printer. Internal speakers provide alarm audio indication.
The CSCS provides centralized monitoring of patients connected to GE Medical Systems Information Technologies, Inc.'s monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients and up to 9 waveforms for a single selected patient. Waveforms include ECG, SPO2, respiration ventilation flow and pressure, invasive blood pressure and CO2.
The device acts as a (1) viewing station, (2) reviewing station and (3) live monitoring station by obtaining its information from acquisition devices off the CARESCAPE network.
Patients may be admitted to and discharged from monitors and telemetry devices from the central location. The central station is also the control and display device for telemetry monitoring.
The CSCS provides secondary annunciation of alarms from primary bedside monitoring devices and primary annunciation of alarms from wireless telemetry devices.
The display window for each patient shows waveforms and vital information including: patient name, bed number, arrhythmia and alarm visual indicators, system messages, audio pause indicator, audio alarm indicator, alarm message line, heart rate, PVC count, transmitter number, ECG lead label, pacemaker status, ST measurement, and graph status. Physiological parameter values and waveforms from the GE Medical Systems Information Technologies, Inc.s' monitors can be displayed and printed from the CSCS.
Non-real time patient information available for reviewing and printing includes: Graphic Trends, Tabular Numeric Vital SignsTrends, Event HistoryReview, Full Disclosure, Calipers, and ST Review. Data can be printed to a networked laser printer. In the case of Event Review, data can also be printed to a PDF file.
The CARESCAPE Central Station also provides remote control of patient monitor and telemetry device configuration settings that includes:

Admitted patient demographics like name and medical record number;
Alarm Settings like high/low limit values and alarm priority levels:
Printing settings like selection of which waveforms to print on graphs and the printed output destinations;
ECG settings like primary lead selection, ST analysis on/off and pace maker detection on/off;
Initiate and terminate combination monitoring where a bedside patient monitor accepts ECG data from a telemetry transmitter:
Non-ECG parameter settings like respiration lead selection and NBP cuff size selection.
The Full Disclosure option provides up to 144 hours of beat-tobeat patient information from the bedside or telemetry system for parameters and waveforms. Full Disclosure also stores resting ECGs from 16 patients once per minute for 144 hours and up to 2000 alarm histories with waveform snippets for each patient. This information can be displayed at the CSCS in detailed and summary mode formats.

AI/ML Overview

The provided document (K162012) describes the CARESCAPE Central Station v2, a medical device intended for collecting, displaying, and printing patient data. However, the document does not contain specific acceptance criteria, study data, or performance metrics for the device's functionality in a format that would allow the completion of the requested table and detailed study information.

This document is a 510(k) premarket notification letter from the FDA, confirming substantial equivalence based on a review of submitted information. It primarily focuses on the device's intended use, classification, and a high-level comparison to predicate devices, along with a summary of non-clinical testing. It explicitly states: "The subject of this premarket submission, CARESCAPE Central Station, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information. The document does not include data like precision, recall, or other performance metrics, nor does it detail how ground truth was established for a testing or training set, or mention any MRMC studies.

However, I can extract the information that is present in the document:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document. The document lists general testing activities but no specific performance metrics or acceptance criteria in a quantitative format.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the document. The document mentions "Testing on unit level," "Integration testing," "Performance testing," "Safety testing," and "Simulated use testing," but does not provide details on sample sizes, data provenance, or the nature of the test sets used.

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)

This information is not present in the document. As no clinical studies were deemed necessary, there is no mention of expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the document.

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

This information is not present in the document. The device description does not indicate the presence of AI, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not present in the document. The device is described as a "central station," a viewing, reviewing, and live monitoring station with human-in-the-loop interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not present in the document.

8. The sample size for the training set

This information is not present in the document. The device is a "software driven device running on a PC platform" and primarily serves to display and manage data from other medical devices; it is not described as involving machine learning or AI models developed through training sets.

9. How the ground truth for the training set was established

This information is not present in the document.

Summary of what can be found regarding testing:

The document states:

Non-Clinical Tests: "The CARESCAPE Central Station and its applications were tested to, and comply with, applicable voluntary standards. The CARESCAPE Central Station was tested to assure that the device meets its design specifications."
Quality Assurance Measures applied to development and testing:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
Clinical Studies: "The subject of this premarket submission, CARESCAPE Central Station, did not require clinical studies to support substantial equivalence."

Based on the nature of the device (a central monitoring station for physiological data) and the fact that no clinical studies were required, the testing likely focused on functional verification, system integration, software validation, and adherence to safety and performance standards for displaying and managing data, rather than on diagnostic accuracy or AI-driven interpretations.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

GE Healthcare Mr. Robert Casarsa Regulatory Affairs Leader 8200 West Tower Ave. Milwaukee, Wisconsin 53223

Re: K162012

Trade/Device Name: CARESCAPE Central Station V2 Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: July 20, 2016 Received: July 21, 2016

Dear Mr. Robert Casarsa,

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Manda Jellison
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162012

Device Name CARESCAPE Central Station v2 (CSCS)

Indications for Use (Describe)

The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (O2), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS), Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed.

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.

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

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."

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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are in a stylized font, and there are decorative swirls around the circle. The logo is simple and recognizable, and it is associated with a well-known company.

K162012 PAGE 1 OF 6

510(K) SUMMARY

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: July 20, 2016 Submitter: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue Milwaukee, WI 53223 Contact Person: Robert Casarsa Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Email: robert.casarsa@ge.com Ph: (414) 362-3063 Cell: (262) 358-1082 Device Trade Name: CARESCAPE Central Station v2 (CSCS) Common/Usual Central Station Name Classification: 21 CFR 870.2450 Product Code: DXJ BZO 21 CFR 868.2375 monitor, breathing frequency Secondary Codes: 21 CFR 868.1700 analyzer, gas, nitrous-oxide, gaseous CBR phase (anesthetic conc.) CBS 21 CFR 868.1620 analyzer, gas, halothane, gaseousphase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, enflurane, gaseous-CBQ phase (anesthetic concentration) CCK 21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-phase

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GE Healthcare

510(k) Premarket Notification Submission

CCL	21 CFR 868.1720	analyzer, gas, oxygen, gaseous-phase
DXN	21 CFR 870.1130	system, measurement, blood-pressure, noninvasive
DOA	21 CFR 870.2700	oximeter
DPT	21 CFR 870.2300	monitor, cardiac (incl. cardiotachometer & rate alarm)
DSB	21 CFR 870.2770	plethysmograph, impedance
DSK	21 CFR 870.1110	computer, blood-pressure
GWQ	21 CFR 882.1400	full-montage standard electroencephalograph
FLL	21 CFR 880.2910	thermometer, electronic, clinical
NHO	21 CFR 868.1500	analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
NHP	21 CFR 868.1500	analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
NHQ	21 CFR 868.1500	analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)
BSE	21 CFR 868.1640	Helium gas analyzer
JEG	21 CFR 868.1075	Argon gas analyzer
CCI	21 CFR 868.1690	Nitrogen gas analyzer
Predicate Device(s):	CARESCAPE Central Station (K133882)MUSE ST Guard (K842308)12SL V22 – ACS (K092369)MUSE CV (K110132)
Device Description:	The CARESCAPE Central Station (CSCS) is based on a PC technology platform and is user friendly for easy operation using a simple logical screen menu. The interactive controls include the use of a computer mouse, keyboard and touch screen. Optional writers for the purpose of graphing waveforms and printing patient information include a 2-inch Direct Digital Writer and/or a laser printer. Internal speakers provide alarm audio indication.The CSCS provides centralized monitoring of patients connected to GE Medical Systems Information Technologies, Inc.'s monitors and telemetry transmitters. It may be configured to display up to four real-time waveforms per patient for up to 16 patients and up to 9 waveforms for a single selected patient. Waveforms include ECG, SPO2, respiration ventilation flow and pressure, invasive blood pressure and CO2.

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a blue circle with a decorative, swirling border. The logo is simple, recognizable, and represents the General Electric brand.

The device acts as a (1) viewing station, (2) reviewing station and (3) live monitoring station by obtaining its information from acquisition devices off the CARESCAPE network.

Patients may be admitted to and discharged from monitors and telemetry devices from the central location. The central station is also the control and display device for telemetry monitoring.

The CSCS provides secondary annunciation of alarms from primary bedside monitoring devices and primary annunciation of alarms from wireless telemetry devices.

The display window for each patient shows waveforms and vital information including: patient name, bed number, arrhythmia and alarm visual indicators, system messages, audio pause indicator, audio alarm indicator, alarm message line, heart rate, PVC count, transmitter number, ECG lead label, pacemaker status, ST measurement, and graph status. Physiological parameter values and waveforms from the GE Medical Systems Information Technologies, Inc.s' monitors can be displayed and printed from the CSCS.

Non-real time patient information available for reviewing and printing includes: Graphic Trends, Tabular Numeric Vital SignsTrends, Event HistoryReview, Full Disclosure, Calipers, and ST Review. Data can be printed to a networked laser printer. In the case of Event Review, data can also be printed to a PDF file.

The CARESCAPE Central Station also provides remote control of patient monitor and telemetry device configuration settings that includes:

Admitted patient demographics like name and medical record number;
Alarm Settings like high/low limit values and alarm priority levels:
Printing settings like selection of which waveforms to print on graphs and the printed output destinations;
ECG settings like primary lead selection, ST analysis on/off and pace maker detection on/off;

Initiate and terminate combination monitoring where a bedside patient monitor accepts ECG data from a telemetry transmitter:

Non-ECG parameter settings like respiration lead selection

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Image /page/6/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 blue circle. The circle is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.

and NBP cuff size selection.

The Full Disclosure option provides up to 144 hours of beat-tobeat patient information from the bedside or telemetry system for parameters and waveforms. Full Disclosure also stores resting ECGs from 16 patients once per minute for 144 hours and up to 2000 alarm histories with waveform snippets for each patient. This information can be displayed at the CSCS in detailed and summary mode formats.

The CARESCAPE Central Station is intended for use under the Intended Use: direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment.

The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (O2), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed.

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a wavy or swirling pattern around the letters, giving it a dynamic and recognizable appearance.

The CARESCAPE Central Station employs the same functional Technology: scientific technology as its predicate devices. The device is a software driven device running on a PC platform. The

CARESCAPE Central Station V2 utilizes new hardware platforms and embedded operating system.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The CARESCAPE Central Station and its applications were tested to, and comply with, applicable voluntary standards. The CARESCAPE Central Station was tested to assure that the device meets its design specifications. Testing included all new or modified features.

The following quality assurance measures were applied to the development and testing of the of the system:

Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) Summary of Clinical Tests:

The subject of this premarket submission, CARESCAPE Central Station, did not require clinical studies to support substantial equivalence.

Comparison: The following contains the differences of the CARESCAPE Central Station V2 when compared to the predicate CARESCAPE Central Station V1:

Hardware

Upgraded Platform; faster processor, increased RAM, increased SSD Flash Media, removed external RS-232 Serial port, removed DVI and VGA interfaces, removed unused network port, and increased MC support to 1000Mbps.

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font. The letters are enclosed within a circular frame that has decorative, swirling elements around the perimeter. The color of the logo is a light blue.

GE Healthcare

510(k) Premarket Notification Submission

2 configurations available, Desktop and Integrated hardware options
Supports widescreen displays

Eliminated cooling fan for low power CPU

Software

Upgraded platform from XP based OS to Windows 7 based.

Historical Trending

Added ability for additional trends where the bedside is already monitoring the now supported additional parameters

Alarming

Settings are password protected

Alarm levels now conform to IEC 60601-2-27:2011 Clause 208.6.6.2.105, Clause 208.6.1.2, and Clause 208.6.11.2.2

Printing

. Compatible with PCL 6 Compatible HP Universal Printers to support additional printers.
GE Healthcare considers the CARESCAPE Central Station to Conclusion: be as safe and as effective, and its performance substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).