The Carestation750/750c anesthesia systems are intended to provide monitored anesthesia care, general inhalation anesthesia and/ or ventilatory support to a wide range of patients (neonatal, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

Device Description

The GE Carestation 750/750c anesthesia machines (Carestation 750 series) are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonate, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment such as hospitals, surgical centers, or clinics. They represent one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), Aespire View (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), Carestation 620/650/650c (Carestation 600 series) (K151570) Anesthesia Systems. The Carestation 750 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

The Carestation™ 750/750c anesthesia systems combine advanced anesthesia delivery, patient monitoring. and care information management. The contemporary, compact design allows for easy mobility and addresses many ergonomic considerations including an effective cable management solution, aesthetic covers, and an expandable work surface area. Optional integrated features include auxiliary common gas outlet, auxiliary 02 outlet, auxiliary 02+Air outlet, suction control, and respiratory gas monitoring. The system provides integration of ventilation and gas delivery on a 15-inch color graphical touchscreen interface. This system also features electronic gas mixing of oxygen and a balance gas of either N2O or Air. The Carestation 750 series represents one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), AespireView (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), and Carestation 600 Series (K151570) Anesthesia Systems.

This anesthesia system is designed for mixing and delivering inhalation anesthetics (Isoflurane, Sevoflurane, or Desflurane), Air, O2, and N2O. This anesthesia system has Recruitment maneuvers, a feature to perform automated lung recruitment maneuver in a single step or in multi steps.

This anesthesia system uses electronic flow valve ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. This technology also features Pressure Control Ventilation, optional Pressure Support Ventilation with an Apnea Backup (PSVPro™) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV) modes, Pressure Control Ventilation-Volume Guarantee (PCVG), Continuous Positive Airway Pressure + Pressure Support Ventilation (CPAP + PSV), and VCV Cardiac Bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of a broad patient range. The device includes the following basic components:

The Carestation 750 series anesthesia systems supply set flows of medical gases to the breathing system using an electronic gas mixer (O2 with Air or O2 with N2O). Gas flows are adjusted by the user on the touchscreen, the flows are displayed on the system graphical user interface assembly as numerical digits and as electronic representations of flow meters. The system provides an option for auxiliary mixed Oxygen + Air flow delivery where 02 with Air are blended and delivered to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. An optional auxiliary O2 supply includes a separate O2 flow tube and needle valve flow control that delivers O2 flow to an auxiliary port used to support spontaneously breathing patients using a nasal cannula. The gas flow from the optional auxiliary O2 subsystem does not flow through the electronic gas mixer.

The Carestation 750 series models include up to 3 breathing gases with O2 and Air as standard, and N20 as an optional breathing gas. The systems include two vaporizer positions compatible with, Isoflurane, Sevotlurane, and Desflurane vaporizers. The Carestation 750 is available with up to three back-up gas cylinder connections. The Carestation 750 series systems are also available in pendant (Carestation 750c) models.

The system uses touchscreen technology, hard keys, and a Comwheel to access system functions, menus, and settings on a 15'' color graphical user interface assembly (aka display). The graphical user interface assembly is mounted on an arm on the left side of the machine. It can be rotated via the arm toward, or away from, the system to adjust the horizontal position. The arm is available allowing the display to be tilted up or down to adjust the vertical viewing angle or be tilted left or right to adjust the horizontal position of the display. An optional arm can be raised/lowered and rotated 360 degrees. A split screen field can be set to show gas trends, Spirometry loops, a Paw gauge, airway compliance, and optional ecoFlow information. If none is selected, the waveforms expand to fill the split screen area.

The Carestation 750 series systems accept Tec 7, and Tec 820/850 series vaporizers on a 2position Selectatec manifold. Safety features and devices within the systems are designed to decrease the risk of hypoxic mixtures, multiple anesthetic agent mixtures, complete power failure, or sudden gas supply The Carestation 750 series systems are available with optional integrated respiratory gas failures. monitoring which can be physically integrated into the system, receive electronic power from the Carestation 750/750c, and communicate measured values to the Carestation 750/750c for display on the system graphical user interface assembly. When supplied as an option, integrated respiratory gas monitoring is provided via the GE CARESCAPE series (EsCAiO or E-sCAiOV) respiratory airway modules (GE Healthcare Finland Oy, CE 0537) which is identical to the module used on Avance CS2.

The Anesthesia Ventilator used in the Carestation 750 series is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. This version of the GE 7900 ventilator is equipped with a built-in system for monitoring inspired oxygen (using an optional 02 cell or optional integrated gas module), patient airway pressure, and exhaled volume. Flow sensors in the breathing circuit are used to monitor and control patient ventilation.

This allows for the compensation of gas and tubing compression losses, fresh gas contribution, and small gas leakage from the breathing absorber, bellows, and pneumatic system connections. User settings and microprocessor calculations control breathing patterns. The user interface keeps ventilation settings in memory. The user may change settings with a simple ventilation parameter setting sequence. A bellows contains breathing gasses to be delivered to the patient and provides a barrier keeping patient gas separate from the ventilatory drive gas. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that occurs is outward from the patent breathing circuit.

This ventilator comes with a standard ventilation mode as well as optional ventilation modes.

Standard ventilation modes:

VCV (Time Cycled, Volume Controlled Ventilation) .
. PCV (Time Cycled, Pressure Control Ventilation)

Optional ventilation modes:

VCV-SIMV (Synchronized Intermittent Mandatory Ventilation Volume Control)
. PCV-SIMV (Synchronized Intermittent Mandatory Ventilation Pressure Control)
PSVPro (Pressure supported ventilation with apnea backup)
. PCV-VG (Pressure Controlled ventilation - Volume Guaranteed)
. PCV-VG-SIMV (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled ventilation - Volume Guaranteed)
. CPAP+PSV (Continuous Positive Airway Pressure/Pressure Support)

The system can include an internal, factory installed, suction regulator and control visible from the front of the machine. It can mount different monitors using an arm or shelf mounts. The mounting is achieved through a combination of GE Healthcare adapters and other third-party mounts, including one that allows for the physical integration of the GE Monitor Series B650 (K102239). The Carestation 750 system also includes an optional cable management solution, which can help user to manage the various cables attached to the system.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the Carestation 750/750c anesthesia system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Carestation 620/650/650c) through technological characteristic comparison and bench testing against recognized standards.

Therefore, the document does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria related to a specific performance metric or clinical outcome, especially for AI or algorithmic performance. There is no information about:

Specific acceptance criteria for device performance in terms of diagnostic accuracy or clinical effectiveness. The acceptance criteria mentioned are related to compliance with quality assurance measures and recognized safety standards.
A study that proves the device meets acceptance criteria in a clinical setting with patient data, experts, or specific performance metrics like sensitivity, specificity, or effect sizes.
Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
Ground truth types or sample sizes for training sets in the context of AI/algorithms.

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance, albeit in a different context than what might be expected for an AI-driven device:

1. Table of Acceptance Criteria and Reported Device Performance (based on compliance criteria):

Acceptance Criteria (Compliance with Standards/Testing)	Reported Device Performance (as stated in the document)
Risk Analysis	Performed
Requirements Reviews	Performed
Design Reviews	Performed
Testing on unit level (Module verification)	Performed
Integration testing (System verification)	Performed
Performance testing (including accuracy, environmental, tip, threshold testing)	Performed
Biocompatibility Testing (PM, VOC, leachables)	Performed (Classified as Limit exposure based on ISO18562-1:2017)
Safety testing (electrical safety, EMC)	Performed
Simulated use testing (Validation)	Performed
Compliance with ANSI AAMI ES60601-1:2005/(R)2012	Compliant
Compliance with IEC 60601-1-2:2014	Compliant
Compliance with IEC 60601-1-6 Edition 3.1 2013-10	Compliant
Compliance with IEC 60601-1-8 Edition 2.1 2012-11	Compliant
Compliance with ISO 80601-2-13:2011	Compliant
Compliance with IEC 62366-1 Edition 1.0 2015-02	Compliant
Compliance with IEC 62304 Edition 1.1 2015-06	Compliant
Compliance with ISO 18562 series (parts 1, 2, 3, 4) 2017	Compliant (e.g., "Classified as Limit exposure based on ISO18562-1:2017")
Compliance with AIM 7351731 Rev. 2.00 2017-02-23	Compliant
Compliance with ISO 17664:2017	Compliant

The study that proves the device meets the acceptance criteria is described as:

Bench testing: "Bench testing was performed to establish substantial equivalence of the Carestation 750/750c."
Verification and validation testing: "Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the Carestation 750/750c is substantially equivalent to the predicate Carestation 620/650/650c."
Non-clinical design verification and validation tests: "The Carestation 750/750c anesthesia machines incorporate modifications to the predicate Carestation 620/650/650c. These modifications did not require clinical testing. The changes made were completely evaluated by non-clinical design verification and validation tests to verify and validate the safety and functionality of the anesthesia machines."

Regarding the specific questions about AI/algorithmic studies, the document provides no relevant information:

Sample size used for the test set and the data provenance: Not applicable/Not provided. The testing focused on engineering validation and adherence to standards, not on a clinical test set with patient data for algorithmic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth in the context of clinical expert review is not mentioned.
Adjudication method: Not applicable/Not provided.
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 an anesthesia machine, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device itself is an anesthesia machine, not a standalone algorithm.
The type of ground truth used: For the engineering and standards compliance, the "ground truth" would be the specifications and requirements of the standards themselves, as well as validated engineering measurements against design specifications.
The sample size for the training set: Not applicable/Not provided. This is not an AI/ML submission that would typically involve training sets of data for model development.
How the ground truth for the training set was established: Not applicable/Not provided.

In summary, this document is a regulatory submission for an anesthesia machine, which relies on demonstrating equivalence to an existing device through rigorous engineering testing and compliance with established medical device standards. It does not describe an AI or algorithm evaluation study.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in a smaller font size.

March 28, 2023

Datex-Ohmeda, Inc. Kimberly Mangum Regulatory Affairs Director 3030 Ohmeda Drive, PO Box 7550 Madison, Wisconsin 53707-7550

Re: K213867

Trade/Device Name: Carestation 750/750c Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine For Anesthesia Or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: February 17, 2023 Received: February 22, 2023

Dear Kimberly Mangum:

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/ofdocs/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 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

{1}------------------------------------------------

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 mediation-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,

James J. Lee -S

James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K213867

Device Name Carestation 750/750c

Indications for Use (Describe)

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 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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram on the left and the words "GE HealthCare" on the right. The monogram is a stylized version of the letters "GE" inside of a circle. The text is in a simple, sans-serif font.

Premarket Notification 510(k) Summary

As required by section 807.92 Carestation 750/750c GENERAL COMPANY INFORMATION as required by 807.92(a)(1) K213867

I. Submitter

Company Name/Address/Phone/Fax:

Mailing Address: Datex-Ohmeda, Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707-7550 USA

Physical Address: Datex-Ohmeda, Inc. 3030 Ohmeda Drive Madison, WI 53718 USA Tel: 608-334-4281

Name of Contact:

Kimberly Mangum Regulatory Affairs Director - Anesthesia and Respiratory Care (ARC) Patient Care Solutions - GE HealthCare Kimberly.Mangum@ge.com Phone: 267-400-5180 www.gehealthcare.com

Date Prepared: March 24, 2023

II. DEVICE

Name of Device: Carestation 750/750c Common or Usual Name: Gas Machine, Anesthesia (21 CFR 868.5160) Regulatory Class: II Product Code: BSZ

III. PREDICATE DEVICE

Primary Predicate: Carestation 620/650/650c, K151570 Reference Device: Avance CS2, K131945

DEVICE DESCRIPTION IV.

{4}------------------------------------------------

anesthesia systems are suitable for use in a patient environment such as hospitals, surgical centers, or clinics. They represent one of the systems in a long line of products based on the Datex-Ohmeda Aestiva (K000706), Aespire View (K122445), Aisys CS2 (K170872), Avance CS2 (K131945), Carestation 620/650/650c (Carestation 600 series) (K151570) Anesthesia Systems. The Carestation 750 series anesthesia systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

Mandatory Ventilation (SIMV) modes, Pressure Control Ventilation-Volume Guarantee (PCVG), Continuous Positive Airway Pressure + Pressure Support Ventilation (CPAP + PSV), and VCV Cardiac Bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of a broad patient range. The device includes the following basic components:

{5}------------------------------------------------

assembly is mounted on an arm on the left side of the machine. It can be rotated via the arm toward, or away from, the system to adjust the horizontal position. The arm is available allowing the display to be tilted up or down to adjust the vertical viewing angle or be tilted left or right to adjust the horizontal position of the display. An optional arm can be raised/lowered and rotated 360 degrees. A split screen field can be set to show gas trends, Spirometry loops, a Paw gauge, airway compliance, and optional ecoFlow information. If none is selected, the waveforms expand to fill the split screen area.

This ventilator comes with a standard ventilation mode as well as optional ventilation modes.

Standard ventilation modes:

VCV (Time Cycled, Volume Controlled Ventilation) .
. PCV (Time Cycled, Pressure Control Ventilation)

Optional ventilation modes:

VCV-SIMV (Synchronized Intermittent Mandatory Ventilation Volume Control)
. PCV-SIMV (Synchronized Intermittent Mandatory Ventilation Pressure Control)
PSVPro (Pressure supported ventilation with apnea backup)
. PCV-VG (Pressure Controlled ventilation - Volume Guaranteed)
. PCV-VG-SIMV (Synchronized Intermittent Mandatory Ventilation, Pressure Controlled ventilation - Volume Guaranteed)
. CPAP+PSV (Continuous Positive Airway Pressure/Pressure Support)

{6}------------------------------------------------

for the physical integration of the GE Monitor Series B650 (K102239). The Carestation 750 system also includes an optional cable management solution, which can help user to manage the various cables attached to the system.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Carestation 750 series is primarily based on the predicate device Carestation 600 series feature set (K151570) and contains identical or comparable hardware and software components. A comparison of the CS750 and predicate device technological characteristics is provided as Table 1 below.

{7}------------------------------------------------

Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS2 (K131945)
Pneumatic System	Supplies set flows of medical gases to the breathingsystem using electronic controlled gas mixing of 2gasses (O2 with Air or O2 with N2O).	Supplies set flows of medical gases tothe breathing system using mechanicalcontrolled gas mixing of 2 gasses (O2with Air or O2 with N2O) or 3 gases(O2, Air, and N2O).	Supplies set flows of medicalgases to the breathing systemusing electronic controlledgas mixing of 2 gasses (O2with Air or O2 with N2O).
Gas Supply	The gas mixing subsystem is a two gas mixerproviding a mixture of O2 and Air or O2 and N2O(100% O2 or 100% Air (21% O2) can also beselected).	The gas mixing subsystem is a three gasmixer providing a mixture of O2 andAir or O2 and N2O or O2, Air and N2O(100% O2 or 100% Air (21% O2) canalso be selected).	The gas mixing subsystem isa two gas mixer providing amixture of O2 and Air or O2andN2O (100% O2 or 100% Air(21% O2) can also beselected).
O2 Flow	A pressurized gas source (pipeline, or regulatedcylinder), supplies O2 directly to the gas mixingsubsystem.	A secondary pressure regulator in thegas mixing subsystem regulatesconstant O2 gas pressure and supplies itto the O2 flow control valve.	A pressurized gas source(pipeline, or regulatedcylinder), supplies O2 directlyto the gas mixing subsystem.
Air and N2O flow	Air gas flows from a pressurized gas source(pipeline or regulated cylinder) to the Air/N2Oselector valve on the gas mixing subassembly.	Air gas flows from a pressurized gassource (pipeline or regulated cylinder)to the Air selector valve or a secondarypressure regulator (optional) on the gasmixing subassembly.	Air gas flows from apressurized gas source(pipeline or regulatedcylinder) to the Air/N2Oselector valve on the gasmixing subassembly.
Gas Mixer	Digital display and control of flows using anelectronic mass air flow sensor to provideelectronic mixing and proportioning of gases (O2and Air or N2O).	Digital display of flows with traditionalneedle valve flow control and flow headmixing and proportioning of gases (Air,O2, N2O).	Digital display and control offlows using an electronicmass air flow sensor toprovide electronic mixing andproportioning of gases (O2and Air or N2O).

Table 1: Carestation 750/750c Technological Characteristics Comparison
------------------------------------------------------------------------	--

{8}------------------------------------------------

Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS2 (K131945)
Aux O2 option	An auxiliary O2 gas supply to provide O2 gas tothe patient through internal connections andcontrol with an auxiliary O2 flowmeter.	An auxiliary O2 gas supply to provideO2 gas to the patient through internalconnections and control with anauxiliary O2 flowmeter.	Not a comparison point
Aux O2+Air gasdelivery option	The Aux O2+Air gas delivery option provides anauxiliary O2+Air gas mixture to the patientthrough internal connections and control with theO2 and Air fresh gas controls.	The Aux O2+Air gas delivery optionprovides an auxiliary O2+Air gasmixture to the patient through internalconnections and control with the O2 andAir fresh gas controls.	Not a comparison point
ACGO	Use the optional Auxiliary Common Gas Outlet(ACGO) switch to direct the fresh gas flow throughthe ACGO port on the front of the system.	Use the optional Auxiliary CommonGas Outlet (ACGO) switch to direct thefresh gas flow through the ACGO porton the front of the system.	Not a comparison point
O2 Flush	The O2 flush button supplies a high flow of O2 tothe breathing system.	The O2 flush button supplies a highflow of O2 to the breathing system.	Not a comparison point
ALT 02	The Alternate O2 control is not an auxiliarysource of O2. The Alternate O2 is intended to beused when in certain failures, such as theelectronic gas mixer is not available or the displayscreen has failed.	None	ALT O2 as the auxiliarysource of O2 for electronicgas mixer
VaporizersCompatibility	Carestation 750 series provide a two positionvaporizer manifold to support up to 2 activepositions for Tec series GE vaporizers.	Carestation 620/650/650c provides atwo position vaporizer manifold tosupport up to 2 active positions for Tecseries GE vaporizers.	Not a comparison point
Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS² (K131945)
RespiratoryGas MonitorsCompatibility	Airway Gas Option is:CARESCAPE series: E-sCAiO and E-sCAiOV.The CAiOV feature set of theCARESCAPE series E-sCAiOVX and EsCAiOVEAirway Modules	Airway Gas Option is :CARESCAPE series: E-sCAiO andE-sCAiOV.The CAiOV feature set of theCARESCAPE series E-sCAiOVXand E-sCAiOVE Airway ModulesN-CAiO (without Spirometryconnector)	Airway Gas Option is:CARESCAPE series:EsCAiO and E-sCAiOV.The CAiOV feature set of theCARESCAPE seriesEsCAiOVX and E-sCAiOVEAirway Modules
OptionalIntegratedSuctionRegulation	The vacuum suction regulator uses an externalvacuum supply. The venturi suction regulator usesthe system air supply source.	The vacuum suction regulator uses anexternal vacuum supply. The venturisuction regulator uses the system airsupply source.	Not a comparison point
Optional GasScavenging	Yes	Yes	Not a comparison point
Breathing System	The integrated circle breathing system can be usedfor both manual (bag) and mechanical (automatic)patient ventilation. The breathing system includesbellows assembly, APL valve, bag-to-vent switch,CO2 bypass assembly.	The integrated circle breathing systemcan be used for both manual (bag) andmechanical (automatic) patientventilation. The breathing systemincludes bellows assembly, APL valve,bag-to-vent switch, CO2 bypassassembly.	Not a comparison point
Flow Sensors	Variable orifice flow sensor (autoclavable) withpneumatic and electrical connections located in theinspiratory outlet and expiratory inlet inside thebreathing system. The outer chamber of the sensoris heated.	Variable orifice flow sensor(autoclavable) with pneumatic andelectrical connections located in theinspiratory outlet and expiratory inletinside the breathing system. The outerchamber of the sensor is heated.	Not a comparison point
CO2 AbsorberCanister	CO2 absorber canister absorbs CO2 in the gas pathfrom bellows.	CO2 absorber canister absorbs CO2 inthe gas path from bellows.	Not a comparison point
Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS² (K131945)
Ventilator Engine	The ventilator engine is located in the middle panof the system, under the user work surface. Aprecision flow servo system control gas flow tothe patient.	The ventilator engine is located in themiddle pan of the system, under theuser work surface. A precision flowservo system control gas flow to thepatient.	Not a comparison point
SystemMountings	Carestation 750 is a trolley mounted configurationwhile the Carestation 750c can be configured andinstalled with a pendant mounted version.	Carestation 650 and Carestation 620 area trolley mounted configuration whilethe Carestation 650c can be configuredand installed with either a pendant orwall mounted version.	Not a comparison point
CableManagement	Clip and cubby are to fix cables, rear cover couldshield hoses and cables.	Clips are to fix cables.	Not a comparison point
ElectricalSubsystem	The electrical system consists of two maincomputing units: the Graphical user interfaceassembly (previously known as the display unit)and the Anesthesia Computer Board (ACB).The other key electrical boards are PowerManagement Board, Sensor Interface Board, andMixer Interface Board.	The electrical system consists of twomain computing units: the Graphicaluser interface assembly (previouslyknown as the display unit) and theAnesthesia Computer Board (ACB).The other key electrical boards arePower Management Board, SensorInterface Board, and Frame InterfaceBoard.	Mixer Interface Board tosupport electronic mixer
Touch Screen	Projective Capacitive (P-Cap) touch screen detectstouch by measuring the capacitance at eachaddressable electrode.P-Cap touch screen software driver.	Surface acoustic wave (SAW) detectstouch by measuring SAW on the routeSAW P-Cap touch screen softwaredriver.	Not a comparison point
Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS2 (K131945)
SoftwareSubsystem	The software provides user interface, powermanagement, and controls the delivery oftherapy to patients. As the segregation strategy,the Carestation 750 series software is comprisedof below top-level Software Items/Units.Display Computer/Display Unit Power Supply Controller/PowerSubsystem Front Panel Controller Anesthesia Control Board/Anesthesia Computer Mixer Interface Board Subsystem Sensor Interface Board Subsystem Mixer	The software provides userinterface, power management, andcontrols the delivery of therapy topatients. As the segregationstrategy, the Carestation 600 seriessoftware is comprised of below top-level Software Items/Units. Display Computer/Display Unit Power Supply Controller/PowerSubsystem Front Panel Controller Anesthesia Control Board/Anesthesia Computer Frame Interface Board Subsystem Sensor Interface Board Subsystem	Not a comparison point
ecoFLOW	ecoFLOW option within the split screen thatshows a visual indicator reference for the total gasflows, agent usage, cost and approximateminimum O2 flow needed to maintain theclinician's desired inspired O2 concentration.Carestation 750 series flows are limited to only O2,Air or N2O.	ecoFLOW option within the split screenthat shows a visual indicator referencefor the total gas flows, agent usage, costand approximate minimum O2 flowneeded to maintain the clinician'sdesired inspired O2 concentration.Carestation 620/650/650c allows all 3gases to be present due to traditionalneedle valve flow control.	ecoFLOW option within thesplit screen that shows avisual indicator reference forthe total gas flows, agentusage, cost and approximateminimum O2 flow needed tomaintain the clinician'sdesired inspired O2concentration.Avance CS2 flows are limitedto only O2, Air or N2O.
User Interface	Color display with Com Wheel or touch activation.Quick keys provide quick activation access via thetouch screen user interface. Seven quick keysavailable for ventilation and three quick keysavailable for gas.	Color display with Com Wheel or touchactivation. Quick keys provide quickactivation access via the touch screenuser interface. Seven quick keysavailable for ventilation.	Not a comparison point
Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS2 (K131945)
Operating System	The graphical user interface operating system onCarestation 750 series is WEC 2013 (Windows).	The graphical user interface operatingsystem on Carestation 600 series is CE6(Windows).	Not a comparison point
Display Arm	User Interface is mounted on an arm on the leftside of the machine. It can be rotated left or rightvia the arm toward or away from the system toadjust the horizontal position. Both standard armand premium arm can be tilted up or down toadjust the vertical angle or be tilted left or right toadjust the horizontal angle of the User Interface.Premium arm can also be raised/lowered androtated 360 degrees.	User Interface is mounted on an arm onthe left side of the machine. It can berotated left or right via the arm towardor away from the system to adjust thehorizontal position. For the Carestation650 and 650c it can also be tilted up ordown to adjust the vertical angle or betilted left or right to adjust thehorizontal angle of the User Interface.The Carestation 620 uses a basic armthat allows the User Interface to moveleft and right but does not tilt.	Not a comparison point
HDX GUIStyle	Added Modern Interface Style (HDX), user canenable in Super User System Config menu.	Classic GUI Interface Style onCarestation 600.	Not a comparison point
Super user andservice modepasswords	User could change super user password and servicepassword. New Password Entry item will berestricted to a 6-22 digit password.User could set new password to protect the devicewith only authorized personnel entering the SuperUser mode and Service mode.	The different 5 digit passwords of Superuser and Service mode are fixed, usercould not change the passwords.	Not a comparison point
Specification	Proposed Device Carestation 750/750c	GE Datex-Ohmeda Predicate Device Carestation 620/650/650c	Reference Device Avance CS² (K131945)
RecruitmentManeuver	Use the Single Step recruitment maneuver todeliver a pressure breath for a set time.	Use the Vital Capacity procedure todeliver a pressure breath for a set time.	Not a comparison point
	Use the Multi Step recruitment maneuver to deliverpressure breaths through a series of ventilationsteps.	Use the Cycling procedure to deliverpressure breaths through a series ofventilation steps.	Not a comparison point
Direct access toimportant functions	A button bar is at the right side of the usergraphical interface to allow direct user access to 10important functions:Audio Pause, Alarm Setup, Auto Limits,System Setup, Next page, Trends, RecruitmentManeuver, Pause Gas Flow, Timer function , Endcase.	A button bar is at the right side of theuser graphical interface to allow directuser access to 10 important functions:Audio Pause, Alarm Setup, AutoLimits, System Setup, Next page,Trends, Spirometry, Procedures, Timerfunction, End case.	Not a comparison point
Recourse & Recovery	When Display Computer (DC) softwareerror occurs a processor reset will initiate the DCreboot. However, the Anesthesia Computer (AC)will keep working by using the current parameters,when the system reboot successfully it will go toTherapy mode directly by using setting valuesrecovered by AnesthesiaComputer software. DISPLAYCOMPUTER RESTARTED alarm will bedisplayed on screen.	None	Not a comparison point
Checkoutfailuretroubleshootingmessage panel	If checkout tests failed, it will display atroubleshooting message panel with problemstatement and step by step messages to instruct userto remove the failure.	The preoperative checkout andcalibration are digitally shown andguided according to the menu.	Not a comparison point
DatexOhmeda COMchanges	DatexOhmeda COM exists onCarestation 700 (updates made)	DatexOhmeda COM exists onCarestation 600.	Not a comparison point
Specification	Proposed Device Carestation750/750c	GE Datex-Ohmeda PredicateDeviceCarestation 620/650/650c	Reference Device AvanceCS2 (K131945)
New Mixer andAlternate O2checkout test	Electronic Mixer and Alternate O2 checkout	None	Electronic Mixer andAlternate O2 checkout
Gas Setup andPreset menu,Alt O2, Air Only andrelated Alarms	Electronic mixer, alternate O2, and Air only mode	None	Electronic mixer, alternateO2, and Air only mode
Remove latch alarm	The latched alarms could be removed becausealarm log history could be used instead.	Latched alarms exist as a feature inCarestation 600 series.	Not a comparison point
Principles ofOperation:Control andPhaseVariables	Anesthesia machine settings are separated into fivecategories:Gas Flow (Electronic gas mixer) and Breathing Circuit Controls Main Ventilation Parameters Breath Timing Patient Ventilation Synchrony Safety	Anesthesia machine settings areseparated into five categories:Gas Flow (Mechanical gas mixer) and Breathing Circuit Controls Main Ventilation Parameters Breath Timing Patient Ventilation Synchrony Safety	Gas Flow (Electronic gasmixer)
VentilationModes	VCV, PCV, VCV-SIMV,PCV-SIMV, PSVPro,PCV-VG, PCV-VG-SIMV,CPAP-PSV	VCV, PCV, VCV-SIMV,PCV-SIMV, PSVPro,PCV-VG, PCV-VG-SIMV, CPAP-PSV	Not a comparison point
SafetyStandards	Compliance with applicable FDA recognizedconsensus standards	Compliance with applicable FDArecognized consensus standards	Not a comparison point

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for GE HealthCare. The logo consists of the GE monogram on the left and the words "GE HealthCare" on the right. The monogram and the words are both in purple.

VII. PERFORMANCE DATA

The Carestation 750/750c has been thoroughly tested through verifications and validation, including software validation for a major level of concern software. Verification of compliance with applicable voluntary standards has also been made to support safe use of the device in its intended environment. 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)
. Performance testing (Verification) including but not limited to accuracy testing, environmental testing, tip testing and threshold testing
. Biocompatibility Testing including particulate matter (PM), Volatile Organic Compounds (VOC) and leachables in condensate (Classified as Limit exposure based on ISO18562-1:2017)
. Safety testing (Verification) including electrical safety and electromagnetic compatibility testing
. Simulated use testing (Validation)

The product was designed and tested for compliance to FDA recognized consensus standards including the following:

Standard	FDARecognitionNumber
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012, , Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance (IEC 60601-1:2005, MOD)	19-4
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests	19-8
IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance - Collateralstandard: Usability	5-89
IEC 60601-1-8 Edition 2.1 2012-11, Medical electrical equipment - Part 1-8:General requirements for basic safety and essential performance - CollateralStandard: General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems	5-76
ISO 80601-2-13:2011 and A1:2015 and A2:2018, Medical electrical equipment- Part 2-13: Particular requirements for basic safety and essential performanceof an anesthetic workstation	1-141
IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application ofusability engineering to medical devices [Including CORRIGENDUM 1 (2016)]	5-114

{16}------------------------------------------------

Standard	FDARecognitionNumber
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes	13-79
ISO 18562-1 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process	1-134
ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter	1-135
ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds	1-136
ISO 18562-4 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate	1-137
AIM 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard	19-30
ISO 17664:2017 Second edition 2017-10 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices	14-515

Bench testing was performed to establish substantial equivalence of the Carestation 750/750c. Verification and validation testing was performed according to predetermined acceptance criteria, which concluded that the Carestation 750/750c is substantially equivalent to the predicate Carestation 620/650/650c.

Clinical Testing

The Carestation 750/750c anesthesia machines incorporate modifications to the predicate Carestation 620/650/650c. These modifications did not require clinical testing. The changes made were completely evaluated by non-clinical design verification and validation tests to verify and validate the safety and functionality of the anesthesia machines.

Conclusion

The subject device and the predicate device have the same intended use, and the technological differences do not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).