The CARESCAPE™ Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time

The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et CO2, O2, N2O and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status.

The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network.

The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel.

The CARESCAPE Monitor B850 is not intended for use during MRI.

Device Description

The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options.

The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure.

AI/ML Overview

The provided text is a 510(k) summary for the GE CARESCAPE™ Monitor B850. It explicitly states that no clinical studies were required or performed to support substantial equivalence for this device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment does not exist within this document for the CARESCAPE Monitor B850 itself.

The substantial equivalence determination was based on non-clinical tests and a comparison to predicate devices, asserting that the device is as safe and effective due to its fundamental technology being the same as the predicates.

Here's a breakdown of why each requested point cannot be addressed by the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document outlines general "quality assurance measures" (e.g., Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) but no specific performance acceptance criteria or results are given.
Sample sized used for the test set and the data provenance: Not provided, as no clinical test set was used for substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external test set requiring expert ground truth was mentioned for the substantial equivalence determination.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool, and no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "multi-parameter patient monitor," implying continuous operation with human oversight, not a standalone algorithm. Performance metrics in an "algorithm only" context are not discussed.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth data for the device was used in its pathway to substantial equivalence.
The sample size for the training set: Not applicable, as this is a patient monitor, not an AI software/algorithm requiring a training set in the conventional sense for a 510(k) submission focused on substantial equivalence to existing predicate hardware/software.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document states: "The subject of this premarket submission, CARESCAPE™ Monitor B850 did not require clinical studies to support substantial equivalence." Therefore, the detailed information about acceptance criteria and clinical study results that you requested is not available in this document. The submission relied on non-clinical testing and comparison to predicate devices.

Summary

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510(k) Summarv

AUG 2 8 2009

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

Date: July 2, 2009

Submitter: GE Medical Systems Information Technologies

8200 West Tower Avenue Milwaukee, Wisconsin 53223 USA

Primary Contact Person:

Joel Kent Manager, Quality and regulatory Affairs GE Healthcare phone 781-449-8685 fax 781-433-1344

Secondary Contact Person: David Wahlig Director, Regulatory Affairs GE Healthcare phone 414-362-3242

fax 414 918-8112

CARESCAPE™ Monitor B850 Device: Trade Name: multi-parameter patient monitor Common/Usual Name:

Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm)

MHX Product Code:

Predicate Device(s):

K071073: Solar 8000 and Transport Pro with Patient Data Module

K.051400: Datex Ohmeda S/5 Anesthesia Monitor with L-ANE05 and L-ANE05A software

The CARESCAPE Monitor B850 includes both new and existing Device Description: subsystems interconnected to form a high acuity, multi-parameter patient monitoring system. A typical configuration would be a CARESCAPE Monitor B850 host processing unit running the CARESCAPE Monitoring platform software, a display with integrated keyboard and a frame for the insertion of parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader), additional modules and frames and software options.

The new subsystems include a host processing unit (CPU), a 15 inch LCD display with an integrated keypad, 19 inch LCD display with an integrated keypad and touch panel interface, a five slot parameter module frame, a seven slot parameter module frame, a cabled remote control, a cabled remote keypad, and the

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K092027
p2/3

CARESCAPE Monitoring platform software. Some of these new major subsystems include non-patient contact accessory items (e.g. cables and mounting hardware). The CARESCAPE Monitor B850 interfaces to a variety of existing physiological parameter measurement modules. In addition, the CARESCAPE Monitor B850 interfaces to a variety of existing OEM medical devices via the existing network infrastructure.

Intended Use:

The CARESCAPE™ Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time

The CARESCAPE Monitor B850 is not intended for use during MRI.

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K092027
p3/3

Technology: The CARESCAPE Monitor B850 is a new monitor that essentially is a combination of the features and parameters of two existing predicate monitor platforms. The predicate Solar 8000i V5 Patient Monitoring System (K071073) and the S/5 Anesthesia Monitor system (K051400). The fundamental technology of the CARESCAPE Monitor B850 is the same as the predicate devices. The CARESCAPE Monitor B850 device is as safe and effective the predicate devices.

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence:

The CARESCAPE™ Monitor B850 and its applications comply with voluntary standards as detailed in this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirements Reviews �
Design Reviews .
Testing on unit level (Module verification) .
Integration testing (System verification) ●
Final acceptance testing (Validation)
Performance testing (Verification)
Safety testing (Verification)

Summary of Clinical Tests:

The subject of this premarket submission, CARESCAPE™ Monitor B850 did not require clinical studies to support substantial equivalence.

GE Healthcare considers the CARESCAPE™ Monitor B850 to Conclusion: be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 2 8 2009

GE Medical Systems Information Technogoies c/o Mr. Joel Kent Manager, Qaulity and Regulatory Affairs 8200 West Tower Avenue Milwaukee, WI 53223

Re: K092027

CARESCAPE™ Monitor B850 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm)

Regulatory Class: Class II (two) Product Code: MHX Dated: July 2, 2009 Received: July 6, 2009

Dear Mr. 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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kittray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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Page 2 -- Mr. Joel Kent

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

i R. lochner

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): Ko92027 Device Name: CARESCAPETM Monitor B850

Indications for use:

The CARESCAPE Th4 Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time

The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et CO2, O2, N2O and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (V02), C02 production (VC02), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status.

The CARESCAPE Monitor B850 is not intended for use during MRI.

Prescription Use (Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Page ___ of ___
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Division of Cardiovascular Devices
510(k) Number	K092027

Regulation Number and Section

§ 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.