(43 days)
No
The document describes a microprocessor-based, electronically controlled, pneumatically driven ventilator with user-defined settings and basic monitoring. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as an "Anesthesia System" intended to "provide general inhalation anesthesia and ventilatory support," which are therapeutic interventions.
Yes
The device integrates an optional respiratory gas monitoring system and a ventilator with a built-in monitoring system for inspired oxygen, airway pressure, and exhaled volume, which are diagnostic functions.
No
The device description clearly outlines numerous hardware components, including gas mixing systems, flow meters, a pneumatic back-up system, vaporizers, a ventilator, sensors, and a bellows. While it mentions software control and communication, it is fundamentally a hardware-based anesthesia system.
Based on the provided text, the GE Datex-Ohmeda Avance Anesthesia System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide general inhalation anesthesia and ventilatory support to a wide range of patients." This describes a device used directly on a patient for medical treatment and support, not for testing samples taken from the body.
- Device Description: The description details a system for delivering gases, controlling ventilation, and monitoring physiological parameters of the patient. It mentions components like gas mixers, ventilators, breathing circuits, and patient monitors. These are all characteristic of devices used in patient care, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are fundamental to IVD devices.
Therefore, the GE Datex-Ohmeda Avance Anesthesia System is a medical device used for patient care, specifically anesthesia and ventilation, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Datex-Ohmeda Avance 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 Avance is not suitable for use in a MRI environment.
Product codes
BSZ
Device Description
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The GE Datex-Ohmeda Avance is substantially equivalent to the following currently marketed devices:
Datex-Ohmeda S/5 Avance - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K040743
Datex-Ohmeda Aisys - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K061609
The GE Datex-Ohmeda Avance is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Aisys Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The Datex-Ohmeda Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The Avance comes with up to two optional gases (air, N2O).
The Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia System. 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 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. The 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. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional), Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional), Pressure Controlled Ventilation with Volume Guarantee (PCV-VG), and Volume Control Ventilation Mode for Cardiac Bypass Mode, Ventilator parameters and measurements are displayed on the system display unit.
Several options enable the mounting of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). An additional option allows the S/5 AM to be linked to the power supply of the Avance such that when the Avance is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.
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
Not Found
Intended User / Care Setting
used only by trained and qualified medical professionals.
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 Datex-Ohmeda Avance and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The logo is presented in black and white, with the letters and the inner part of the circle filled in black, while the border and the background are white. The design is stylized and recognizable, representing the brand identity of General Electric.
JUN -6 2007
PO Box 7550 Madison, WI 53707-7550 USA
GE Healthcare
T 608 221 1551 F 608 223 2476
May 23, 2007 Date:
510(k) Summary of Safety and Effectiveness Information Subject: for the GE Datex-Ohmeda Avance
Proprietary: GE Datex-Ohmeda Avance
Gas Machine, Anesthesia Common:
Classification: Anesthesiology, 73 BSZ, 21 CFR 868.5160
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The GE Datex-Ohmeda Avance is substantially equivalent to the following currently marketed devices:
Datex-Ohmeda S/5 Avance - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K040743
Datex-Ohmeda Aisys - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K061609
The GE Datex-Ohmeda Avance is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, and Aisys Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The Datex-Ohmeda Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have 02. The Avance comes with up to two optional gases (air, N2O).
Image /page/0/Picture/16 description: The image shows the handwritten text "1 of 3". The number 1 is on the left side of the image. The words "of" are in the middle of the image, and the number 3 is on the right side of the image.
General Electric Company
Datex-Ohmeda, Inc.
1
Image /page/1/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '0', '7', '1', '1', '4', and '2'. The numbers are written in a simple, slightly slanted style, and the image has a clear, legible quality.
The Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Avance Anesthesia System. 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 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. The 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. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Mode (Optional), Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional), Pressure Controlled Ventilation with Volume Guarantee (PCV-VG), and Volume Control Ventilation Mode for Cardiac Bypass Mode, Ventilator parameters and measurements are displayed on the system display unit.
Several options enable the mounting of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). An additional option allows the S/5 AM to be linked to the power supply of the Avance such that when the Avance is turned on, the S/5 AM is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Avance.
2 of 3
2
The GE Datex-Ohmeda Avance was designed to comply with the applicable portions of the following voluntary standards:
| Standard | Title |
|---|---|
| EN 740 : 1998 | Anesthesia Workstations and their components |
| EN 60601-1:1990 | Medical Electrical Equipment Part 1: General |
| Requirements for Safety Incorporates Corrigendum | |
| July 1994; Includes Amendments A1:1993, A11:1993, | |
| A12:1993, A2:1995, A13:1996, IEC 601-1:1998 + | |
| A2:1995 + Corrigendum 1995, Modified | |
| EN 60601-1-1:2000 | Medical Electrical Equipment - Medical Electrical |
| Systems | |
| EN 60601-1-2:2001 | Medical Electrical Equipment - Electromagnetic |
| Compatibility | |
| IEC 60601-1: | |
| 4:2000 | Safety of Programmable Electronic Medical Systems |
| EN 475:1995 | Electrically Generated Alarm Signals |
| EN 850:1997 | Small Medical Gas Cylinders - Pin Indexed |
| EN 980:1997 | Graphical Symbols |
| EN 1041:1998 | Information to be supplied with medical devices |
| EN 1089-3:1997 | Color coding for medical gases |
| ISO5356-1:1996 | Conical Connectors |
| EN 1820:1997 | Reservoir Bags |
The GE Datex-Ohmeda Avance and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Avance has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Avance to the standards listed above.
- Contact: Dan Kosednar Manager, Regulatory Affairs Phone: 608-221-1551 x 3581 Fax: 608-223-2496
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN -6 2007
Mr. Dan Kosednar Manager, Regulatory Affairs Datex-Ohmeda, Incorporated Life Support Solutions PO Box 7550 Madison, Wisconsin 53707
Re: K071142
Trade/Device Name: GE Datex-Ohmeda Avance Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: May 23, 2007 Received: May 24, 2007
Dear Mr. Kosednar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Kosednar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylitta Y. Micheltons.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KO7 | VY A
Device Name: GE Datex-Ohmeda Avance Anesthesia System
Indications For Use:
The GE Datex-Ohmeda Avance 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 Avance is not suitable for use in a MRI environment.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
O. R. L.
ിvision Sign-Off) ിഴിടിഠന വിട്ടീസ്
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
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