(14 days)
K0040743, K023366
Not Found
No
The description mentions a "microprocessor based, electronically controlled, pneumatically driven ventilator" and "microprocessor calculations control breathing patterns," but there is no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended to provide general inhalation anesthesia and ventilatory support, which are direct treatments for medical conditions or support vital bodily functions.
No
The device is an anesthesia system designed to provide general inhalation anesthesia and ventilatory support, not to diagnose a condition or disease.
No
The device description clearly details hardware components such as gas supply systems, vaporizers, a microprocessor-based ventilator, sensors, and a bellows, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the GE Datex-Ohmeda Aespire 7900 Anesthesia System is not an In Vitro Diagnostic (IVD) 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 life support and anesthesia delivery.
- Device Description: The description details a system that mixes and delivers gases, controls ventilation, and monitors physiological parameters within the patient's breathing circuit.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Aespire 7900 does not perform these functions. It interacts directly with the patient's respiratory system.
Therefore, the GE Datex-Ohmeda Aespire 7900 Anesthesia System is a medical device used for patient care, not an IVD.
N/A
Intended Use / Indications for Use
The GE Datex-Ohmeda Aespire 7900 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 modes. The Aespire 7900 is not suitable for use in a MRI environment.
Product codes
BSZ
Device Description
The GE Datex-Ohmeda Aespire 7900 Anesthesia System supplies set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Aespire 7900 is available in trolley and pendant models. It is available with two or three gases, one or two vaporizer positions and up to three cylinder connections. All models have O2. The Aespire 7900 comes with up to two optional gases (air, N2O). The Aespire 7900 systems accept Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Aespire 7900 are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire 7900 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 Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.
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
It is to be 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 Aespire 7900 Anesthesia System has been validated through rigorous testing that, in part, supports the compliance of Aespire 7900 Anesthesia System to the standards listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0040743, K023366
Reference Device(s)
Not Found
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
MAR 2 5 2005
| K | 050626 |
|---|---|
| --- | -------- |
| Date: | March 9th, 2005 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information |
| for the GE Datex-Ohmeda Aespire 7900 Anesthesia System | |
| Proprietary: | GE Datex-Ohmeda Aespire 7900 Anesthesia System |
| Common: | Gas Machine, Anesthesia |
| 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 Aespire 7900 Anesthesia System is substantially equivalent to the following currently marketed device:
GE Datex-Ohmeda S/5 Avance Anesthesia System - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K0040743
Datex-Ohmeda 7900 Ventilator Enhancements Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K023366
The GE Datex-Ohmeda Aespire 7900 Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It represents the next system in a long line of products based on the Datex-Ohmeda Excel, Aestiva and Aespire Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The GE Datex-Ohmeda Aespire 7900 Anesthesia System supplies set flows of medical gases to the breathing system. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The Aespire 7900 is available in trolley and pendant models. It is available with two or three gases, one or two vaporizer positions and up to three cylinder connections. All models have O2. The Aespire 7900 comes with up to two optional gases (air, N2O). The Aespire 7900 systems accept Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the Aespire 7900 are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire 7900 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
1
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 Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.
The GE Datex-Ohmeda Aespire 7900 Anesthesia System was designed to comply with the applicable portions of the following voluntary standards;
-
- UL 2601 General requirements for Medical Electrical Equipment
-
- EN 740 Anesthetic Work Stations
-
- EN/IEC 60601-1: General requirements for Medical Electrical Equipment
-
- EN/IEC 60601-1-2: 2001 Medical Electrical Equipment Electromagnetic Compatibility
-
- EN 475 Electrically Generated Alarm Signals
-
- ASTM F1463-93 Standard Specification for Alarm Signals
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- ASTM F1208-94 Anesthesia Breathing Circuit Standard
-
- ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia
The GE Datex-Ohmeda Aespire 7900 Anesthesia System and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Aespire 7900 Anesthesia System has been validated through rigorous testing that, in part, supports the compliance of Aespire 7900 Anesthesia System to the standards listed above.
Contact: Dan Kosednar, RAC
Manager, Regulatory Planning and Submissions
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes extending from its wing.
Public Health Service
MAR 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Kosednar Manager, Regulatory Planning and Submissions Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707
Re: K050626
Trade/Device Name: GE Datex-Ohmeda Aespire 7900 Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: March 8, 2005 Received: March 11, 2005
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 Eederal Register.
3
Page 2 – Mr. Kosednar
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTS isbaarse on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal stars requirements, including, but not limited to: registration You must comply with an the Fee e requirements (21 CFR Part 801); good manufacturing practice and ilsing (21 CFR Part 007), laboling (21 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 -1 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) This letter will anow you to begin mainer of your device 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), If you desire specific author for your ce at (240) 276-0102. 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sritte Michie O.D.
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
4
Indications for Use
510(k) Number (if known): KK050626 Device Name: GE Datex-Ohmeda Aespire 7900 Anesthesia System
Indications For Use:
The GE Datex-Ohmeda Aespire 7900 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 modes. The Aespire 7900 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)
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