The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash3000/4000/5000 patient monitor is designed as a bedside, portable, and intrahospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK™ indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

The Solar 8000M/i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000M/i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000M/i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000M/i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000M/i patient monitoring system also provides physiological data over the UNITY NETWORK™

Device Description

The Capnostat / CapnoFlex CO2 System provides end-tidal CO2 monitoring which is continuous, noninvasive technique for determining the concentration of CO2 (carbon dioxide) in respiratory gas by measuring the adsorption of infrared light of specific wavelengths. The light generated in the analyzer bench is passed through respiratory gas samples. The amount of adsorption by CO2 in the sample is measured and digitized by the photodetector. The module processes the electronic signal and displays the waveform (labeled CO2) and digital values for expired CO2 (EXP), inspired CO2 (INSP) and respiratory rate (RR). The Capnostat / CapnoFlex CO2 System consists of a Capnostat Mainstream CO2 module used for intubated patients and a CapnoFlex LF CO2 module used for intubated or nonintubated patients. The Capnostat / CapnoFlex CO2 System uses specially designed sampling cannulas and on-airway adaptor kits. The CapnoFlex LF CO2 module uses a CapnoFlex LF Adapter that connects the CapnoFlex LF CO2 module to the Capnostat Mainstream CO2 module.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Healthcare Capnostat / CapnoFlex CO2 System. This type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials that set acceptance criteria.

Therefore, the document explicitly states that clinical studies were not required to support substantial equivalence. This means there are no acceptance criteria, no study proving the device meets those criteria, and consequently, no information on sample sizes, ground truth, expert qualifications, or comparative effectiveness studies for either training or test sets.

Here is a breakdown of the requested information based on the provided text:

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

Acceptance Criteria: Not applicable. The submission states, "The subject of this premarket submission, Capnostat / CapnoFlex CO2 System, did not require clinical studies to support substantial equivalence." Therefore, no specific acceptance criteria for device performance are mentioned as part of a clinical trial.
Reported Device Performance: The document generally states that the device "employs the same fundamental scientific technology as its predicate device" and that GE Healthcare "considers the Capnostat / CapnoFlex CO2 System to be as safe, as effective, and its performance is substantially equivalent to the predicate device." No specific performance metrics (e.g., accuracy, sensitivity, specificity) are reported in this summary.

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

Not applicable as no clinical studies were required or conducted as part of this submission for substantial equivalence.

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)

Not applicable as no clinical studies were required or conducted.

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

Not applicable as no clinical studies were required or conducted.

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

Not applicable. This device is a physiological monitoring system, not an AI-assisted diagnostic tool for human readers. Furthermore, no clinical studies were required or conducted.

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

The document describes the device as a "Capnostat / CapnoFlex CO2 System" for "end-tidal CO2 monitoring" which processes electronic signals and displays waveforms and digital values. While it operates "standalone" in the sense of continuously monitoring CO2, the submission does not present performance data from a standalone study. The focus is on demonstrating equivalence to an existing predicate device rather than de novo performance evaluation.

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

Not applicable as no clinical studies were required or conducted. Substantial equivalence was demonstrated based on fundamental scientific technology and adherence to voluntary standards.

8. The sample size for the training set

Not applicable as no clinical studies were required or conducted.

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

Not applicable as no clinical studies were required or conducted.

Summary of Non-Clinical Tests (from the document):

The submission highlights the following quality assurance measures and non-clinical tests 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)

These activities are standard for device development to ensure functionality and safety, but they are not presented as "clinical studies" with corresponding acceptance criteria or specific performance data compared to a ground truth in a clinical setting for this 510(k) summary. The device's "acceptance" for market clearance is based on its substantial equivalence to predicate devices and compliance with voluntary standards, rather than direct evidence from a clinical study.

Summary

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GE Healthcare 510(K) Premarket Notification Submission

510(k) Summary

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

Date:	March 20, 2009
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, Wisconsin 53223
Primary Contact Person:	Robert L CasarsaRegulatory Affairs LeaderGE HealthcarePhone: 1-414-362-3063Fax: 1-414-362-2585
Device Trade Name:	Capnostat / CapnoFlex CO2 System For Solar 8000M/i, Dash3000/4000/5000
Common/Usual Name:	Monitor, Physiological, Patient (With Arrhythmia Detection OrAlarms)
Classification Names:	21 CFR 870.1025
Product Code (Primary):	MHX
Product Code (Secondary) /Classification / Name:	CCK - Analyzer, Gas, Carbon Dioxide, Gaseous PhaseDSI - Detector and Alarm, ArrhythmiaDXN - System, Measurement, Blood Pressure, NoninvasiveDQK - Programmable Diagnostic ComputerDPS - ElectrocardiographDRT - Monitor, Cardiac (Incl. Cardiotachometer & rate alarm)DQA - OximeterDSB - Plethysmograph, ImpedanceGWQ - Electroencephalograph
Predicate Device(s):	K073462 - Dash 3000/4000/5000 Patient MonitorK071073 - Solar 8000M/iK030431 - Dash 3000/4000/5000 Patient Monitor
Device Description:	The Capnostat / CapnoFlex CO2 System provides end-tidal CO2monitoring which is continuous, noninvasive technique fordetermining the concentration of CO2 (carbon dioxide) inrespiratory gas by measuring the adsorption of infrared light ofspecific wavelengths. The light generated in the analyzer bench

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g

GE Healthcare 510(K) Premarket Notification Submission

is passed through respiratory gas samples. The amount of adsorption by CO2 in the sample is measured and digitized by the photodetector. The module processes the electronic signal and displays the waveform (labeled CO2) and digital values for expired CO2 (EXP), inspired CO2 (INSP) and respiratory rate (RR). The Capnostat / CapnoFlex CO2 System consists of a Capnostat Mainstream CO2 module used for intubated patients and a CapnoFlex LF CO2 module used for intubated or nonintubated patients. The Capnostat / CapnoFlex CO2 System uses specially designed sampling cannulas and on-airway adaptor kits. The CapnoFlex LF CO2 module uses a CapnoFlex LF Adapter that connects the CapnoFlex LF CO2 module to the Capnostat Mainstream CO2 module.

Dash 3000/4000/5000:

The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operator's manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK™ indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs.

Intended Use:

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9 GE Healthcare 510(K) Premarket Notification Submission

Solar 8000M/i:

The Solar 8000M/i patient monitoring system is a multiparameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000M/i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000M/i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000M/i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000M/i patient monitoring system also provides physiological data over the UNITY NETWORK™.

Technology:

Determination of

Substantial Equivalence:

The Capnostat / CapnoFlex CO2 System employs the same fundamental scientific technology as its predicate device.

Summary of Non-Clinical Tests:

The Capnostat / CapnoFlex CO2 System and its applications comply with voluntary standards as detailed in Section 9 and 17 of 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) t

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GE Healthcare 510(K) Premarket Notification Submission

Summary of Clinical Tests:

The subject of this premarket submission, Capnostat / CapnoFlex CO2 System, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the Capnostat / CapnoFlex CO2 System to be as safe, as effective, and its performance is substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAR 2 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Casarsa Regulatory Affairs Leader GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, Wisconsin 53223

Re: K083750

Trade/Device Name: Capnostat/CapnoFlex CO2 System for the Dash 3000/4000/5000 And Solar 8000M/i Monitors

Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia Detector and Alarm (Including ST-segment

Measurement and Alarm)

Regulatory Class: II

Product Code: MHX, CCK, DSI, DXN, DQK, DPS, DRT, DQA, DSB, GWQ Dated: February 23, 2009 Received: February 25, 2009

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Casarsa

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Satte K. Michie Davis

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GE Healthcare 510(K) Premarket Notification Submission

Page 1 of 2

510(k) Number (if known): K083750

Device Name: Capnostat / CapnoFlex CO2 System for the Dash 3000/4000/5000 and Solar 8000M/i Monitors

Indications for Use:

Dash 3000/4000/5000:

Solar 8000M/i:

K083750 - revised Jan-30-2009

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GE Healthcare 510(K) Premarket Notification Submission

Page 2 of 2

pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous p02 and pCO2, CO2 and respiratory mechanics. The Solar 8000M/i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000M/i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000M/i patient monitoring system also provides physiological data over the UNITY NETWORK™

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Puma

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: kof 3750

K083750 - revised Mar-20-2009

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.