(18 days)
No
The document describes a traditional anesthesia delivery system and ventilator with microprocessor control, but no mention of AI or ML is made.
Yes
The device is intended to provide general inhalation anesthesia and ventilatory support, which are therapeutic modalities.
Yes
Explanation: The device description states that the GE Datex-Ohmeda Aisys system can be equipped with "optional integrated respiratory gas monitoring" provided by the M-Gas Module and that the 7900 Anesthesia Ventilator used in the Aisys is equipped with a "built-in monitoring system for inspired oxygen, airway pressure and exhaled volume." It also mentions "Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration." These features indicate its capability to collect and display patient health data, which is a diagnostic function.
No
The device description clearly outlines numerous hardware components, including electronic gas mixing, pneumatic backup systems, flow tubes, vaporizers, cassettes, a ventilator, sensors, a display unit, and a physical frame. While software is involved in controlling these components, the device is fundamentally a hardware system with integrated software.
Based on the provided text, the GE Datex-Ohmeda Aisys is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "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 how the device delivers gases and anesthetic agents to a patient's breathing system and provides ventilation. It describes a system for patient care, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or other biological samples. There is no mention of reagents, assays, or diagnostic measurements performed on samples.
- Optional Integrated Monitoring: While the device can have optional integrated respiratory gas monitoring (via the M-Gas Module), this monitoring is of gases within the breathing circuit and exhaled by the patient, not analysis of biological samples for diagnostic purposes.
In summary, the GE Datex-Ohmeda Aisys is an anesthesia delivery and ventilation system used for patient treatment and support, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GE Datex-Ohmeda Aisys 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 Aisys is not suitable for use in a MRI environment.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
The GE Datex-Ohmeda Aisys Carestation 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, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The GE Datex-Ohmeda Aisys Carestation 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 indicators on the system display unit. The Aisys 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 Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys 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 Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit.
The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin 2 is inserted into the active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys 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) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit.
The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors.
Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional option allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys 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 Aisys.
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
a wide range of patients.
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 Aisys Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisys Carestation to the standards listed above.
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.
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.
K# 001814, K973985, K973895, K030812
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
JUN 27 2006
K061609
| Date: | June 8th, 2006 |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information |
| for the GE Datex-Ohmeda Aisys Carestation | |
| Proprietary: | GE Datex-Ohmeda Aisys Carestation |
| 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 Aisys Carestation is substantially equivalent to the following currently marketed device:
Datex-Ohmeda Aisys - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K042154
The GE Datex-Ohmeda Aisys Carestation 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, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The GE Datex-Ohmeda Aisys Carestation 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 indicators on the system display unit. The Aisys 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 Aisys is also available in a pendant model. It is available with two or three gases, and up to three cylinder connections. All models have O2. The Aisys comes with up to two optional gases (air, N2O). Safety features and devices within the Aisys are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aisys 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 Aisys, receives electronic power from the Aisys and communicates measured values to the Aisys for display on the system display unit.
The anesthetic agent delivery for the Aisys is controlled via an anesthesia computer through user input from the central display. The vaporization technology is based upon the electronic vaporizer cleared as part of the Datex-Ohmeda Anesthesia Delivery Unit (ADU) cleared via K973985. An Aladin cassette (also cleared as part of K973895) or Aladin 2 is inserted into the
1
active cassette bay. The cassette holds the agent to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow only one active cassette at a time. Per the user input into the main display, valves within the active cassette bay will open and allow agent to be delivered. The agent is mixed with gas from the FGC unit. After mixing, the combination of gases and agent is delivered to the breathing system and then onto the patient.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aisys 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) and Synchronized Intermittent Mandatory Ventilation (SIMV) Mode (Optional). Ventilator parameters and measurements are displayed on the system display unit.
The system display unit is mounted to an arm on the top shelf of the Aisys. The arm is counter balanced and capable of moving vertically and/or horizontally, and also tilting the display, enabling the user to position the display to the most advantageous viewing position. The arm length is limited such that the display position is always within the footprint of the Aisys frame. The arm also supports the mounting of additional display units for a variety of patient monitors.
Several frame configurations are available, including one that allows for the physical integration of the Datex-Ohmeda S/5 Anesthesia Monitor (most recently cleared via K030812). This configuration also provides cable management solutions such that the necessary connections from the monitor display unit to the monitor are hidden within the Aisys frame. An additional option allows the S/5 AM to be linked to the power supply of the Aisys such that when the Aisys 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 Aisys.
2
The GE Datex-Ohmeda Aisys Carestation 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: Medical Electrical Equipment Electromagnetic Compatibility
-
- EN 475 Electrically Generated Alarm Signals
-
- ASTM F1463-93 Standard Specification for Alarm Signals
-
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
-
- ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
-
- ISO 5358 Anesthetic Gas Machines
The GE Datex-Ohmeda Aisys Carestation and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Aisys Carestation has been validated through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisys Carestation to the standards listed above.
Contact: Dan Kosednar, RAC
Manager, Regulatory Planning and Submissions, CARE
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JUN 27 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Datex-Ohmeda, Incorporated Dan Kosednar Manager, Regulatory Affairs Planning and Submission Life Support Solutions P.O. Box 7550 Madison, Wisconsin 53707-7550
Re: K061609
Trade/Device Name: GE Datex-Ohmeda Aisys Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: June 8, 2006 Received: June 9, 2006
Dear Mr. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.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
5
Indications for Use
510(k) Number (if known): K
Device Name: GE Datex-Ohmeda Aisys
Indications For Use:
The GE Datex-Ohmeda Aisys 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 Aisys 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)
Page 1 of 1_______________________________________________________________________________________________________________________________________________________________
Sign-Off)
on of Anesthesiology, General Hospital,
on Control, Dental Devices