(120 days)
Aestiva 7900, Aestiva MRI, Aestiva 7100 Compact, Aestiva 7100, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2
Not Found
No
The description mentions "microprocessor calculations" and "electronically controlled," which are standard for modern medical devices, but does not include any terms or descriptions indicative of AI or ML, such as "learning," "adaptive," "predictive," or analysis of complex datasets beyond basic sensor inputs for control.
Yes
The device is described as an "anesthesia gas system with ventilator" intended to "provide general inhalation anesthesia and ventilatory support to a wide range of patients." Both anesthesia and ventilatory support are direct medical treatments, making the device a therapeutic one.
No
This device is an anesthesia gas system and ventilator, intended to provide general inhalation anesthesia and ventilatory support to patients. While it has a built-in monitoring system for various parameters, its primary function is therapeutic (delivering gases and ventilation), not diagnostic (identifying or characterizing a disease or condition). The monitoring is for controlling and ensuring the proper delivery of ventilation, not for diagnostic purposes.
No
The device description clearly outlines a physical anesthesia gas system with hardware components such as frames, gases, vaporizers, ventilators, sensors, bellows, and an RS-232 serial digital communications port. While it includes microprocessor-based control and a user interface, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary intended use is to "provide general inhalation anesthesia and ventilatory support to a wide range of patients." This involves delivering gases and controlling breathing within the patient's body, not analyzing samples taken from the body.
- Device Description: The description focuses on the mechanical and electronic functions of delivering gases, controlling ventilation, and monitoring physiological parameters like oxygen concentration, airway pressure, and exhaled volume. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
The device is clearly an anesthesia gas system and ventilator, which are considered medical devices used for patient support and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 O2/Air, O2/N20, or O2/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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal, pediatric, adult
Intended User / Care Setting
medical professionals trained and qualified in the administration of general anesthesia.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The GE anesthesia machines comply with voluntary standards. The changes described in this 510(k) have been fully verified and validated to demonstrate that the GE anesthesia machines are substantially equivalent to the predicate anesthesia machines currently on the market. The following is a summary of the 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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Aestiva 7900, Aestiva MRI, Aestiva 7100 Compact, Aestiva 7100, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 (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
2
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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
3
510(k) Number (if known)
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.
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
4
510(k) Number (if known)
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.
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
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 PRAStaff@fda.hhs.gov
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.
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
7
510(k) Number (if known)
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) |
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
8
510(k) Number (if known)
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) |
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
9
510(k) Number (if known)
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)
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
10
510(k) Number (if known)
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) |
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
11
510(k) Number (if known)
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.
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:
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12
510(k) Summary
| Date: | July 5, 2017 | Product Code: | BSZ | |
|---|---|---|---|---|
| Submitter: | GE Healthcare | |||
| Datex-Ohmeda, Inc. | ||||
| 3030 Ohmeda Drive | ||||
| PO Box 7550 | ||||
| Madison, WI 53707-7550 | Predicate | |||
| Devices: | Aestiva 7900 | |||
| Aestiva MRI | ||||
| Aestiva 7100 Compact | ||||
| Aestiva 7100 | ||||
| Aespire 100 | ||||
| Aespire 7100 | ||||
| Aespire 7900 | ||||
| Aespire View | ||||
| Avance | ||||
| Avance CS2 |
| |
| Primary
Contact
Person: | Trishia Mercier
Regulatory Affairs Leader
Datex-Ohmeda, Inc., a GE Healthcare company
Telephone: +1 (608) 695-8319
Fax: +1 (608) 646-6488
Email: Trishia.Mercier@ge.com | Device
Description: | 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.
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
| |
| Secondary
Contact
Person: | Monica Morrison
Regulatory Affairs Director
Datex-Ohmeda, Inc., a GE Healthcare company
Telephone: +1 (608) 515-3077
Fax: +1 (608) 646-7464
Email: Monica.Morrison@ge.com | Intended Use: | 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. | |
| Device Trade
Name: | Aestiva 7900
Aestiva MRI
Aestiva 7100 Compact
Aestiva 7100
Aespire 100
Aespire 7100
Aespire 7900
Aespire View
Avance
Avance CS2
Aisys
Aisys CS2 | Indications for | Aestiva 7900 | This version of the Datex-Ohmeda 7900 Ventilator is used in
Datex-Ohmeda Aestiva Anesthesia Systems. It is a |
| Common/
Usual Name: | Gas Machine, Anesthesia | | | |
| Classification
Name: | Gas Machine, Anesthesia | | | |
| Regulation
Number: | 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, 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
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).
This device is to be used only by trained and qualified medical
professionals. | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aestiva MRI | 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. | |
| Aestiva 7100
Compact
Aestiva 7100 | 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, agent mixtures and
complete power or sudden gas supply failures. | |
| | The 7100 Ventilator is a microprocessor based, electronically
controlled, pneumatically 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. | |
| Aespire 100
Aespire 7100 | 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
O2/Air, O2/N2O, or O2/Air/N2O. All Aespire systems accept
Tec series vaporizers. Safety features and devices within the
Aespire with 7100 decrease the risk of hypoxic mixtures, agent
mixtures and complete power or sudden gas supply failures.
The 7100 Ventilator is a microprocessor based, electronically
controlled, pneumatically 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. | |
| Aespire 7900 | The family of GE Datex-Ohmeda Aespire anesthesia systems
with 7900 ventilator (Aespire 7900 and 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. |
| Aespire
View | | 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. |
| Avance | | The GE Datex-Ohmeda Avance 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. |
| Avance CS2 | | 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. |
| Aisys | | 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. |
| Aisys CS2 | | The GE Datex-Ohmeda Aisys CS2 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. |
| 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.
The GE Healthcare anesthesia machines are identical to the predicate GE
Healthcare anesthesia machines, except for the introduction of two alternate
flow sensors The changed components can be used with all of the Aestiva,
Aespire, Avance and Aisys models of anesthesia machine offered from GE
Healthcare, and they differ from the predicate version in the following ways:
• 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.
• 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. 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). | |
| | 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. There are no other changes to the GE Healthcare anesthesia machines being
introduced in this 510(k). Testing has demonstrated that the proposed GE
Healthcare anesthesia machines perform in a substantially equivalent manner to
the predicate devices. | |
| Determination
of Substantial
Equivalence: | Summary of Non-Clinical Tests:
The GE anesthesia machines comply with voluntary standards. The changes
described in this 510(k) have been fully verified and validated to demonstrate
that the GE anesthesia machines are substantially equivalent to the predicate
anesthesia machines currently on the market. The following is a summary of the
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
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 | |
| | 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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