The GE Healthcare anesthesia machines are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

Device Description

The GE Healthcare anesthesia systems supply set flows of medical gases to the breathing system. Gas flows are selected by the user and displayed on the display unit or through pneumatic flow meters. A large selection of options may be available to configure the system, including frames, brake style, gases, and anesthetic agents.

The GE anesthesia machines include a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure, and inhaled and exhaled volume. Flow, gas, and pressure sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).

AI/ML Overview

This is a 510(k) premarket notification for a medical device family (GE Healthcare anesthesia machines) and not a study describing a new algorithm or AI. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.

However, based on the provided text, I can infer the acceptance criteria for substantial equivalence and summarize the study that proves the device meets those criteria.

The primary purpose of this 510(k) submission is to demonstrate that the modified GE Healthcare anesthesia machines, incorporating two alternate flow sensors, are substantially equivalent to their previously cleared predicate devices. The "study" here refers to the non-clinical testing performed to establish this substantial equivalence.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly tied to the performance requirements of the predicate devices. The goal is to show that the modified devices perform equivalently and raise no new questions of safety or effectiveness.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary of Non-Clinical Tests)
Equivalent Intended Use/Indications for Use: No change to the intended use or indications for use compared to the predicate devices.	"There is no change to the intended use or indications for use of the GE anesthesia machines as a result of the introduction of the proposed alternative flow sensors. Each anesthesia machine retains its intended use as previously cleared and legally marketed." (Page 12)
Equivalent Technical Characteristics: The modified device employs the same fundamental scientific technology and does not introduce new technology.	"The GE Healthcare anesthesia machines employ the same fundamental scientific technology as their predicate devices. This 510(k) does not introduce new technology to the anesthesia machine or the two alternate flow sensors." (Page 14)"The GE Healthcare anesthesia machines are identical to the predicate GE Healthcare anesthesia machines, except for the introduction of two alternate flow sensors." (Page 14)
Biocompatibility: New materials in the patient gas path must not introduce new biomaterials risks and must be substantially equivalent to the predicate.	"Material composition: There are some new materials which are introduced to the patient gas path. Biocompatibility testing has been completed to demonstrate that the proposed materials do not introduce any new biomaterials risk, and are substantially equivalent to the predicate." (Page 14)Specific tests mentioned: "Biocompatibility – Cytotoxicity testing per ISO 10993-5, Sensitization testing per ISO 10993-10, Extractable testing" (Page 14)
Performance Equivalence: The performance of the anesthesia machine and the changed components must be identical or equivalent to the predicate, with minor changes delivering equivalent performance.	"Performance: The performance requirements of the anesthesia machine and the changed components are identical. Minor changes were made to the proposed alternative flow sensors to deliver equivalent performance. There is no change to the performance of the anesthesia machine or the alternate flow sensors." (Page 14)"As described below, the performance of the GE Healthcare anesthesia machines has been fully verified and validated with the changes described in this 510(k)." (Page 14)Testing performed included verification of specifications related to: Mating parts and interface, Accuracy, sensitivity and pressure drop, Leak, Over range flow, Breath cycle life, Shipping, Agent exposure, Connector performance, MRI compatibility and MR safety, Power, communications and data, System pressure drop, System electrical safety, EMC and EMI, Operational temperature and humidity, Storage environment, System ventilation accuracy, System water management, System communication, Agent compatibility. (Page 14)
Reprocessing Effectiveness: Updated reprocessing instructions for new components must be verified and validated.	"Reprocessing instructions: the proposed components are reprocessed differently from the predicate version, and the updated reprocessing instructions are included with the device and the spare parts. The updated reprocessing instructions have been verified and validated." (Page 14)Validation of design inputs including "Reprocessing" was performed. (Page 14)
Overall Safety and Effectiveness: The modified devices must perform in a manner that is substantially equivalent to the predicate devices without raising new safety or effectiveness concerns.	All testing passed, demonstrating that all design outputs meet the intended design inputs, and all product specifications continue to be met and the GE anesthesia machines perform in a manner which is substantially equivalent to the predicate products. (Page 14)

Study Details (Non-AI Specific)

Sample size used for the test set and the data provenance:
- The document describes a series of non-clinical tests (component-level and system-level testing, biocompatibility testing, reprocessing validation). It does not specify a "test set" in the context of patient data or algorithm performance. Instead, it refers to tests on the device's components and the complete system.
- Data provenance: Not explicitly stated as country of origin, but the submission is from GE Healthcare, Datex-Ohmeda, Inc., located in Madison, Wisconsin, USA. The testing is described as occurring prior to the submission date (September 2017). This is a retrospective analysis of engineering, functional, and safety tests performed on the device.
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. This submission does not involve clinical data that would require expert ground truth labeling in the context of an AI/algorithm study. The "ground truth" for these tests are engineering specifications, validated test methods, and compliance with industry standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image review), not for objective engineering tests on a physical device.
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 is not an AI/software device that assists human readers. It is a modification to an anesthesia gas machine.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/algorithm. Performance tests were conducted on the modified physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these tests are established engineering specifications, validated test methods, and compliance with relevant voluntary industry standards (e.g., ISO 10993 for biocompatibility) that define the expected performance and safety characteristics of an anesthesia gas machine.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning model that undergoes training with a dataset.
How the ground truth for the training set was established:
- Not applicable. See #7.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 3, 2017

Datex-Ohmeda, Inc. Trishia Mercier Regulatory Affairs Leader 3030 Ohmeda Drive, PO Box 7550 Madison, Wisconsin 53707-7550

Re: K172045

Trade/Device Name: Aestiva 7900, Aestiva MRI, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: Class II Product Code: BSZ Dated: September 26, 2017 Received: September 27, 2017

Dear Trishia Mercier:

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.

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K172045

Device Name Aespire 7100, Aespire 100

Indications for Use (Describe)

The Aespire Anesthesia Gas System with 7100 Ventilator is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers give full control of the system configuration. It is available with up to three gases, two vaporizer positions and up to three cylinder connections. All models are available with 02/Air, 02/N20, or 02/Air/N20. All Aespire systems accept Tec series vaporizers. Safety features and devices within the Aespire with 7100 decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures.

The 7100 Ventilator is a microprocessor based, electronically driven ventilator with a built in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices.

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)
-----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

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510(k) Number (if known)

K172045

Device Name Aespire 7900

Indications for Use (Describe)

The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for volume or pressure control ventilation.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

510(k) Number (if known)

K172045

Device Name Aespire View

Indications for Use (Describe)

The Aespire View anesthesia system is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation.

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.

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

510(k) Number (if known)

K172045

Device Name Aestiva 7100, Aestiva 7100 Compact

Indications for Use (Describe)

The Aestiva/5 Anesthesia Gas System with 7100 Ventilator is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers give full control of the system configuration. The Aestiva/5 with 7100 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N2O. The Aestiva/5 with 7100 comes with up to two optional gases (air, CO2, heliox). All Aestiva systems accept Tec series vaporizers. Safety features and devices within the Aestiva/5 with 7100 decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.

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

510(k) Number (if known)

K172045

Device Name Aestiva 7900

Indications for Use (Describe)

This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well measure inspired oxygen concentration. This allows for the compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices. Ventilatory modes for the device, include Volume Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation. (optional).

This device is to be used only by trained and qualified medical professionals.

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.

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

510(k) Number (if known)

K172045

Device Name Aestiva MRI

Indications for Use (Describe)

The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.

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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

510(k) Number (if known)

K172045

Device Name Aisys

Indications for Use (Describe)

The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.

Type of Use (Select one or both, as applicable)

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

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

510(k) Number (if known)

K172045

Device Name Aisys CS2

Indications for Use (Describe)

The GE Datex-Ohmeda Aisys CS2 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (nediatric, adult). The device is intended for volume or pressure control ventilation.

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)

| X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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

510(k) Number (if known)

K172045

Device Name Avance

Indications for Use (Describe)

The GE Datex-Ohmeda Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (nediatric, adult). The device is intended for volume or pressure control ventilation.

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)

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

510(k) Number (if known)

K172045

Device Name Avance CS2

Indications for Use (Describe)

The GE Datex-Ohmeda Avance CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

510(k) Summary

Date:	July 5, 2017	Product Code:	BSZ
Submitter:	GE HealthcareDatex-Ohmeda, Inc.3030 Ohmeda DrivePO Box 7550Madison, WI 53707-7550	PredicateDevices:	Aestiva 7900Aestiva MRIAestiva 7100 CompactAestiva 7100Aespire 100Aespire 7100Aespire 7900Aespire ViewAvanceAvance CS2
PrimaryContactPerson:	Trishia MercierRegulatory Affairs LeaderDatex-Ohmeda, Inc., a GE Healthcare companyTelephone: +1 (608) 695-8319Fax: +1 (608) 646-6488Email: Trishia.Mercier@ge.com	DeviceDescription:	The GE Healthcare anesthesia machines are intended to provide generalinhalation anesthesia and ventilatory support to a wide range of patients(neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to beused only by medical professionals trained and qualified in the administration ofgeneral anesthesia.The GE Healthcare anesthesia systems supply set flows of medical gases to thebreathing system. Gas flows are selected by the user and displayed on thedisplay unit or through pneumatic flow meters. A large selection of options maybe available to configure the system, including frames, brake style, gases, andanesthetic agents.The GE anesthesia machines include a microprocessor based, electronicallycontrolled, pneumatically driven ventilator that provides patient ventilationduring surgical procedures. The ventilator is equipped with a built-in monitoringsystem for inspired oxygen, airway pressure, and inhaled and exhaled volume.Flow, gas, and pressure sensors in the breathing circuit are used to control andmonitor patient ventilation as well as measure inspired oxygen concentration.This allows for the compensation of compression losses, fresh gas contribution
SecondaryContactPerson:	Monica MorrisonRegulatory Affairs DirectorDatex-Ohmeda, Inc., a GE Healthcare companyTelephone: +1 (608) 515-3077Fax: +1 (608) 646-7464Email: Monica.Morrison@ge.com	Intended Use:	There is no change to the intended use or indications for use of the GEanesthesia machines as a result of the introduction of the proposed alternativeflow sensors. Each anesthesia machine retains its intended use as previouslycleared and legally marketed.
Device TradeName:	Aestiva 7900Aestiva MRIAestiva 7100 CompactAestiva 7100Aespire 100Aespire 7100Aespire 7900Aespire ViewAvanceAvance CS2AisysAisys CS2	Indications for	Aestiva 7900	This version of the Datex-Ohmeda 7900 Ventilator is used inDatex-Ohmeda Aestiva Anesthesia Systems. It is a
Common/Usual Name:	Gas Machine, Anesthesia
ClassificationName:	Gas Machine, Anesthesia
RegulationNumber:	21 CFR 868.5160

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

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Use:	microprocessor based, electronically controlled, pneumaticallydriven ventilator that provides patient ventilation duringsurgical procedures. The 7900 ventilator is equipped with abuilt-in monitoring system for inspired oxygen, airwaypressure and exhaled volume. Sensors in the breathing circuitare used to control and monitor patient ventilation as wellmeasure inspired oxygen concentration. This allows for thecompensation of compression losses, fresh gas contributionand small leakage in the breathing absorber, bellows and system.User setting and microprocessor calculations controlbreathing patterns. User interface keeps settings in memory. Theuser may change settings with a simple and securesetting sequence. A bellows contains breathing gasses to bedelivered to the patient. Positive End Expiratory Pressure(PEEP) is regulated electronically. Positive pressure ismaintained in the breathing system so that any leakage thatoccurs is outward. An RS-232 serial digital communicationsport connects to and communicates with external devices.Ventilatory modes for the device, include Volume Mode,Pressure Control Mode, Synchronous Intermittent MandatoryVentilation (optional), Pressure Support with Apnea BackupVentilation (optional).This device is to be used only by trained and qualified medicalprofessionals.
Aestiva MRI	The Aestiva/5 MRI Anesthesia System provides the functionalfeature set offered by the conventional Aestiva/5 to the clinicianwith the added ability to be used in the MR environment.Among those standard Aestiva/5 features is the Datex-Ohmedauser interface, all the ventilation parameters of the SmartVentalong with the Aestiva breathing circuit. The Aestiva/5 MRIAnesthesia System performed to specifications when testeddirectly next to 1.5 and 3.0 Tesla shielded MRI devices in a fieldstrength that did not exceed 300 gauss.
Aestiva 7100CompactAestiva 7100	The Aestiva/5 Anesthesia Gas System with 7100 Ventilator is agas machine that supplies set flows of medical gases tothe breathing system. A large selection of frames, gases, andvaporizers give full control of the system configuration. TheAestiva/5 with 7100 is available in wide or narrow trolley andpendant models. The narrow trolley and pendant come withtwo or three gases, two vaporizer positions and up to fourcylinder connections. The wide trolley comes with two, three orfour gases, three vaporizer positions and up to five cylinderconnections. All models have O2 and N2O. The Aestiva/5with 7100 comes with up to two optional gases (air, CO2,heliox). All Aestiva systems accept Tec series vaporizers.Safety features and devices within the Aestiva/5 with 7100decrease the risk of hypoxic mixtures, agent mixtures andcomplete power or sudden gas supply failures.
	The 7100 Ventilator is a microprocessor based, electronicallycontrolled, pneumatically driven ventilator with a built inmonitoring system for inspired oxygen, airway pressure andexhaled volume. Sensors in the breathing circuit are used tocontrol and monitor patient ventilation as well as measureinspired oxygen concentration. This allows for thecompensation of compression losses, fresh gas contribution andsmall leakage in the breathing absorber, bellows andsystem. User setting and microprocessor calculations controlbreathing patterns. User interface keeps settings in memory.The user may change settings with a simple and secure settingsequence. A bellows contains breathing gasses to bedelivered to the patient. Positive End Expiratory Pressure(PEEP) is regulated electronically. Positive pressure ismaintained in the breathing system so that any leakage thatoccurs is outward. An RS-232 serial digital communicationsport connects to and communicates with external devices.
Aespire 100Aespire 7100	The Aespire Anesthesia Gas System with 7100 Ventilator is agas machine that supplies set flows of medical gases to thebreathing system. A large selection of frames, gases, andvaporizers give full control of the system configuration. It isavailable with up to three gases, two vaporizer positions and upto three cylinder connections. All models are available withO2/Air, O2/N2O, or O2/Air/N2O. All Aespire systems acceptTec series vaporizers. Safety features and devices within theAespire with 7100 decrease the risk of hypoxic mixtures, agentmixtures and complete power or sudden gas supply failures.The 7100 Ventilator is a microprocessor based, electronicallycontrolled, pneumatically driven ventilator with a built inmonitoring system for inspired oxygen, airway pressure andexhaled volume. Sensors in the breathing circuit are used tocontrol and monitor patient ventilation as well as measureinspired oxygen concentration. This allows for the compensationof compression losses, fresh gas contribution and small leakagein the breathing absorber, bellows and system. User setting andmicroprocessor calculations control breathing patterns. Userinterface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellowscontains breathing gasses to be delivered to the patient. PositiveEnd Expiratory Pressure (PEEP) is regulated electronically.Positive pressure is maintained in the breathing system so thatany leakage that occurs is outward. An RS-232 serial digitalcommunications port connects to and communicates withexternal devices.
Aespire 7900	The family of GE Datex-Ohmeda Aespire anesthesia systemswith 7900 ventilator (Aespire 7900 and Aespire View) isintended to provide general inhalation anesthesia and ventilatorysupport to a wide range of patients. The devices are intended for
		volume or pressure control ventilation.
AespireView		The Aespire View anesthesia system is intended to providegeneral inhalation anesthesia and ventilatory support to a widerange of patients. The device is intended for volume or pressurecontrol ventilation.
Avance		The GE Datex-Ohmeda Avance Anesthesia System is intendedto provide general inhalation anesthesia and ventilatory supportto a wide range of patients (neonatal, pediatric, adult). Thedevice is intended for volume or pressure control ventilation.
Avance CS2		The GE Datex-Ohmeda Avance CS2 is intended to providegeneral inhalation anesthesia and ventilatory support to a widerange of patients (neonatal, pediatric, adult). The device isintended for volume or pressure control ventilation.
Aisys		The GE Datex-Ohmeda Aisys Anesthesia System is intended toprovide general inhalation anesthesia and ventilatorysupport to a wide range of patients (neonatal, pediatric, adult).The device is intended for volume or pressure controlventilation. The Aisys is not suitable for use in a MRIenvironment.
Aisys CS2		The GE Datex-Ohmeda Aisys CS2 Anesthesia System isintended to provide general inhalation anesthesia and ventilatorysupport to a wide range of patients (neonatal, pediatric, adult).The device is intended for volume or pressure controlventilation.
Technology:	The GE Healthcare anesthesia machines employ the same fundamental scientifictechnology as their predicate devices. This 510(k) does not introduce newtechnology to the anesthesia machine or the two alternate flow sensors.The GE Healthcare anesthesia machines are identical to the predicate GEHealthcare anesthesia machines, except for the introduction of two alternateflow sensors The changed components can be used with all of the Aestiva,Aespire, Avance and Aisys models of anesthesia machine offered from GEHealthcare, and they differ from the predicate version in the following ways:• Material composition: There are some new materials which are introducedto the patient gas path. Biocompatibility testing has been completed todemonstrate that the proposed materials do not introduce any newbiomaterials risk, and are substantially equivalent to the predicate.• Performance: The performance requirements of the anesthesia machine andthe changed components are identical. Minor changes were made to theproposed alternative flow sensors to deliver equivalent performance. Thereis no change to the performance of the anesthesia machine or the alternateflow sensors. As described below, the performance of the GE Healthcareanesthesia machines has been fully verified and validated with the changesdescribed in this 510(k).
	Reprocessing instructions: the proposed components are reprocesseddifferently from the predicate version, and the updated reprocessinginstructions are included with the device and the spare parts. The updatedreprocessing instructions have been verified and validated. There are no other changes to the GE Healthcare anesthesia machines beingintroduced in this 510(k). Testing has demonstrated that the proposed GEHealthcare anesthesia machines perform in a substantially equivalent manner tothe predicate devices.
Determinationof SubstantialEquivalence:	Summary of Non-Clinical Tests:The GE anesthesia machines comply with voluntary standards. The changesdescribed in this 510(k) have been fully verified and validated to demonstratethat the GE anesthesia machines are substantially equivalent to the predicateanesthesia machines currently on the market. The following is a summary of thetesting performed to demonstrate substantial equivalence: Component-level testing verifying specifications related to: Mating parts and interface Accuracy, sensitivity and pressure drop Leak Over range flow Breath cycle life Shipping Agent exposure Connector performance MRI compatibility and MR safety Power, communications and data Biocompatibility – Cytotoxicity testing per ISO 10993-5, Sensitizationtesting per ISO 10993-10, Extractable testing System-level testing verifying specifications related to Internal pressure System pressure drop System electrical safety, EMC and EMI Operational temperature and humidity Storage environment System interface Material regulation System ventilation accuracy
	System water management
	Shipping
	System communication
	Agent compatibility
	Validation of design inputs, including the following:
	Reprocessing
	User needs
	The changes to the GE anesthesia machines described in this 510(k) did not require clinical studies to support substantial equivalence.All testing passed, demonstrating that all design outputs meet the intended design inputs, and all product specifications continue to be met and the GE anesthesia machines perform in a manner which is substantially equivalent to the predicate products.
Conclusion:	GE Healthcare considers the GE anesthesia machines described in this 510(k) with the alternate flow sensors to be substantially equivalent to the predicate devices.

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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).