Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2

K172045 · Datex-Ohmeda, Inc. · BSZ · Nov 3, 2017 · Anesthesiology

Device Facts

• Record ID: K172045
• Device Name: Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
• Applicant: Datex-Ohmeda, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Nov 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Anesthesia gas systems supply medical gases to breathing circuits; user-selected flows displayed on unit or pneumatic meters. Microprocessor-based, electronically controlled, pneumatically driven ventilators provide patient ventilation. Sensors in breathing circuit monitor inspired oxygen, airway pressure, and exhaled volume; data used to control ventilation and compensate for compression losses, fresh gas contribution, and system leaks. Bellows deliver breathing gases to patient; PEEP regulated electronically. Systems include safety features to prevent hypoxic mixtures and power/gas failures. Used in clinical settings by trained medical professionals. RS-232 port enables communication with external devices. Subject device introduces alternate flow sensors with updated reprocessing instructions; otherwise identical to predicate systems.

Clinical Evidence

Bench testing only. No clinical data. Testing included component-level verification (mating, accuracy, sensitivity, pressure drop, leak, flow, breath cycle life, connector performance, MRI compatibility, electrical safety, EMC/EMI) and system-level verification (pressure, electrical safety, environmental, interface, ventilation accuracy, water management, agent compatibility, reprocessing, and user needs).

Technological Characteristics

Microprocessor-based, electronically controlled, pneumatically driven anesthesia gas systems. Materials in patient gas path verified for biocompatibility. Features include RS-232 serial digital communications, electronic PEEP regulation, and integrated monitoring for O2, pressure, and volume. Systems support volume or pressure control ventilation. Sterilization/reprocessing instructions updated for new components.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring general inhalation anesthesia and ventilatory support during surgical procedures.

Regulatory Classification

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. 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).

Predicate Devices

• Aestiva 7900 (K172045)
• Aestiva MRI (K172045)
• Aestiva 7100 Compact (K172045)
• Aestiva 7100 (K172045)
• Aespire 100 (K172045)
• Aespire 7100 (K172045)
• Aespire 7900 (K172045)
• Aespire View (K172045)
• Avance (K172045)
• Avance CS2 (K172045)

Submission Summary (Full Text)

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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.

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

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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *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:

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

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)

| <div> <span style="font-size:10pt"> <span style="font-family:Wingdings">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:10pt"> <span style="font-family:Wingdings">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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 [e-mail]

{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) | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### 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 [e-mail]

{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.

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) | |
|-------------------------------------------------|---------------------------------------------|
| 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.

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 [e-mail]

{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) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> 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 [e-mail]

{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) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *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 [e-mail]

{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)

| <span style="font-size: 10pt;"> <b> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <b> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> |

### 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 [e-mail]

{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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

| 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.

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 [e-mail]

{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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

## 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 [e-mail]

{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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#### *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 [e-mail]

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

# 510(k) Summary

| Date: | July 5, 2017 | Product Code: | BSZ | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare<br>Datex-Ohmeda, Inc.<br>3030 Ohmeda Drive<br>PO Box 7550<br>Madison, WI 53707-7550 | Predicate<br>Devices: | Aestiva 7900<br>Aestiva MRI<br>Aestiva 7100 Compact<br>Aestiva 7100<br>Aespire 100<br>Aespire 7100<br>Aespire 7900<br>Aespire View<br>Avance<br>Avance CS2<br> | |
| Primary<br>Contact<br>Person: | Trishia Mercier<br>Regulatory Affairs Leader<br>Datex-Ohmeda, Inc., a GE Healthcare company<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | Device<br>Description: | The GE Healthcare anesthesia machines are intended to provide general<br>inhalation anesthesia and ventilatory support to a wide range of patients<br>(neonatal, pediatric, adult). The GE Healthcare anesthesia machines are to be<br>used only by medical professionals trained and qualified in the administration of<br>general anesthesia.<br><br>The GE Healthcare anesthesia systems supply set flows of medical gases to the<br>breathing system. Gas flows are selected by the user and displayed on the<br>display unit or through pneumatic flow meters. A large selection of options may<br>be available to configure the system, including frames, brake style, gases, and<br>anesthetic agents.<br><br>The GE anesthesia machines include a microprocessor based, electronically<br>controlled, pneumatically driven ventilator that provides patient ventilation<br>during surgical procedures. The ventilator is equipped with a built-in monitoring<br>system for inspired oxygen, airway pressure, and inhaled and exhaled volume.<br>Flow, gas, and pressure sensors in the breathing circuit are used to control and<br>monitor patient ventilation as well as measure inspired oxygen concentration.<br>This allows for the compensation of compression losses, fresh gas contribution<br> | |
| Secondary<br>Contact<br>Person: | Monica Morrison<br>Regulatory Affairs Director<br>Datex-Ohmeda, Inc., a GE Healthcare company<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | Intended Use: | There is no change to the intended use or indications for use of the GE<br>anesthesia machines as a result of the introduction of the proposed alternative<br>flow sensors. Each anesthesia machine retains its intended use as previously<br>cleared and legally marketed. | |
| Device Trade<br>Name: | Aestiva 7900<br>Aestiva MRI<br>Aestiva 7100 Compact<br>Aestiva 7100<br>Aespire 100<br>Aespire 7100<br>Aespire 7900<br>Aespire View<br>Avance<br>Avance CS2<br>Aisys<br>Aisys CS2 | Indications for | Aestiva 7900 | This version of the Datex-Ohmeda 7900 Ventilator is used in<br>Datex-Ohmeda Aestiva Anesthesia Systems. It is a |
| Common/<br>Usual Name: | Gas Machine, Anesthesia | | | |
| Classification<br>Name: | Gas Machine, Anesthesia | | | |
| Regulation<br>Number: | 21 CFR 868.5160 | | | |

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

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

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

| Use: | microprocessor based, electronically controlled, pneumatically<br>driven ventilator that provides patient ventilation during<br>surgical procedures. The 7900 ventilator is equipped with a<br>built-in monitoring system for inspired oxygen, airway<br>pressure and exhaled volume. Sensors in the breathing circuit<br>are used to control and monitor patient ventilation as well<br>measure inspired oxygen concentration. This allows for the<br>compensation of compression losses, fresh gas contribution<br>and small leakage in the breathing absorber, bellows and system.<br>User setting and microprocessor calculations control<br>breathing patterns. User interface keeps settings in memory. The<br>user may change settings with a simple and secure<br>setting sequence. A bellows contains breathing gasses to be<br>delivered to the patient. Positive End Expiratory Pressure<br>(PEEP) is regulated electronically. Positive pressure is<br>maintained in the breathing system so that any leakage that<br>occurs is outward. An RS-232 serial digital communications<br>port connects to and communicates with external devices.<br>Ventilatory modes for the device, include Volume Mode,<br>Pressure Control Mode, Synchronous Intermittent Mandatory<br>Ventilation (optional), Pressure Support with Apnea Backup<br>Ventilation (optional).<br><br>This device is to be used only by trained and qualified medical<br>professionals. | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aestiva MRI | The Aestiva/5 MRI Anesthesia System provides the functional<br>feature set offered by the conventional Aestiva/5 to the clinician<br>with the added ability to be used in the MR environment.<br>Among those standard Aestiva/5 features is the Datex-Ohmeda<br>user interface, all the ventilation parameters of the SmartVent<br>along with the Aestiva breathing circuit. The Aestiva/5 MRI<br>Anesthesia System performed to specifications when tested<br>directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field<br>strength that did not exceed 300 gauss. | |
| Aestiva 7100<br>Compact<br>Aestiva 7100 | The Aestiva/5 Anesthesia Gas System with 7100 Ventilator is a<br>gas machine that supplies set flows of medical gases to<br>the breathing system. A large selection of frames, gases, and<br>vaporizers give full control of the system configuration. The<br>Aestiva/5 with 7100 is available in wide or narrow trolley and<br>pendant models. The narrow trolley and pendant come with<br>two or three gases, two vaporizer positions and up to four<br>cylinder connections. The wide trolley comes with two, three or<br>four gases, three vaporizer positions and up to five cylinder<br>connections. All models have O2 and N2O. The Aestiva/5<br>with 7100 comes with up to two optional gases (air, CO2,<br>heliox). All Aestiva systems accept Tec series vaporizers.<br>Safety features and devices within the Aestiva/5 with 7100<br>decrease the risk of hypoxic mixtures, agent mixtures and<br>complete power or sudden gas supply failures. | |
| | The 7100 Ventilator is a microprocessor based, electronically<br>controlled, pneumatically driven ventilator with a built in<br>monitoring system for inspired oxygen, airway pressure and<br>exhaled volume. Sensors in the breathing circuit are used to<br>control and monitor patient ventilation as well as measure<br>inspired oxygen concentration. This allows for the<br>compensation of compression losses, fresh gas contribution and<br>small leakage in the breathing absorber, bellows and<br>system. User setting and microprocessor calculations control<br>breathing patterns. User interface keeps settings in memory.<br>The user may change settings with a simple and secure setting<br>sequence. A bellows contains breathing gasses to be<br>delivered to the patient. Positive End Expiratory Pressure<br>(PEEP) is regulated electronically. Positive pressure is<br>maintained in the breathing system so that any leakage that<br>occurs is outward. An RS-232 serial digital communications<br>port connects to and communicates with external devices. | |
| Aespire 100<br>Aespire 7100 | The Aespire Anesthesia Gas System with 7100 Ventilator is a<br>gas machine that supplies set flows of medical gases to the<br>breathing system. A large selection of frames, gases, and<br>vaporizers give full control of the system configuration. It is<br>available with up to three gases, two vaporizer positions and up<br>to three cylinder connections. All models are available with<br>O2/Air, O2/N2O, or O2/Air/N2O. All Aespire systems accept<br>Tec series vaporizers. Safety features and devices within the<br>Aespire with 7100 decrease the risk of hypoxic mixtures, agent<br>mixtures and complete power or sudden gas supply failures.<br>The 7100 Ventilator is a microprocessor based, electronically<br>controlled, pneumatically driven ventilator with a built in<br>monitoring system for inspired oxygen, airway pressure and<br>exhaled volume. Sensors in the breathing circuit are used to<br>control and monitor patient ventilation as well as measure<br>inspired oxygen concentration. This allows for the compensation<br>of compression losses, fresh gas contribution and small leakage<br>in the breathing absorber, bellows and system. User setting and<br>microprocessor calculations control breathing patterns. User<br>interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows<br>contains breathing gasses to be delivered to the patient. Positive<br>End Expiratory Pressure (PEEP) is regulated electronically.<br>Positive pressure is maintained in the breathing system so that<br>any leakage that occurs is outward. An RS-232 serial digital<br>communications port connects to and communicates with<br>external devices. | |
| Aespire 7900 | The family of GE Datex-Ohmeda Aespire anesthesia systems<br>with 7900 ventilator (Aespire 7900 and Aespire View) is<br>intended to provide general inhalation anesthesia and ventilatory<br>support to a wide range of patients. The devices are intended for | |
| | | volume or pressure control ventilation. |
| Aespire<br>View | | The Aespire View anesthesia system is intended to provide<br>general inhalation anesthesia and ventilatory support to a wide<br>range of patients. The device is intended for volume or pressure<br>control ventilation. |
| Avance | | The GE Datex-Ohmeda Avance Anesthesia System is intended<br>to provide general inhalation anesthesia and ventilatory support<br>to a wide range of patients (neonatal, pediatric, adult). The<br>device is intended for volume or pressure control ventilation. |
| Avance CS2 | | The GE Datex-Ohmeda Avance CS2 is intended to provide<br>general inhalation anesthesia and ventilatory support to a wide<br>range of patients (neonatal, pediatric, adult). The device is<br>intended for volume or pressure control ventilation. |
| Aisys | | The GE Datex-Ohmeda Aisys Anesthesia System is intended to<br>provide general inhalation anesthesia and ventilatory<br>support to a wide range of patients (neonatal, pediatric, adult).<br>The device is intended for volume or pressure control<br>ventilation. The Aisys is not suitable for use in a MRI<br>environment. |
| Aisys CS2 | | The GE Datex-Ohmeda Aisys CS2 Anesthesia System is<br>intended to provide general inhalation anesthesia and ventilatory<br>support to a wide range of patients (neonatal, pediatric, adult).<br>The device is intended for volume or pressure control<br>ventilation. |
| Technology: | The GE Healthcare anesthesia machines employ the same fundamental scientific<br>technology as their predicate devices. This 510(k) does not introduce new<br>technology to the anesthesia machine or the two alternate flow sensors.<br><br>The GE Healthcare anesthesia machines are identical to the predicate GE<br>Healthcare anesthesia machines, except for the introduction of two alternate<br>flow sensors The changed components can be used with all of the Aestiva,<br>Aespire, Avance and Aisys models of anesthesia machine offered from GE<br>Healthcare, and they differ from the predicate version in the following ways:<br>• Material composition: There are some new materials which are introduced<br>to the patient gas path. Biocompatibility testing has been completed to<br>demonstrate that the proposed materials do not introduce any new<br>biomaterials risk, and are substantially equivalent to the predicate.<br><br>• Performance: The performance requirements of the anesthesia machine and<br>the changed components are identical. Minor changes were made to the<br>proposed alternative flow sensors to deliver equivalent performance. There<br>is no change to the performance of the anesthesia machine or the alternate<br>flow sensors. As described below, the performance of the GE Healthcare<br>anesthesia machines has been fully verified and validated with the changes<br>described in this 510(k). | |
| | Reprocessing instructions: the proposed components are reprocessed<br>differently from the predicate version, and the updated reprocessing<br>instructions are included with the device and the spare parts. The updated<br>reprocessing instructions have been verified and validated. There are no other changes to the GE Healthcare anesthesia machines being<br>introduced in this 510(k). Testing has demonstrated that the proposed GE<br>Healthcare anesthesia machines perform in a substantially equivalent manner to<br>the predicate devices. | |
| Determination<br>of Substantial<br>Equivalence: | Summary of Non-Clinical Tests:<br>The GE anesthesia machines comply with voluntary standards. The changes<br>described in this 510(k) have been fully verified and validated to demonstrate<br>that the GE anesthesia machines are substantially equivalent to the predicate<br>anesthesia machines currently on the market. The following is a summary of the<br>testing 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, Sensitization<br>testing 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…