(130 days)
No
The document describes a traditional anesthesia delivery and ventilation system controlled by a microprocessor and user input, with no mention of AI or ML capabilities.
Yes
The device is intended to provide general inhalation anesthesia and ventilatory support to patients, which are therapeutic interventions.
No
The device is an anesthesia system designed for delivering general inhalation anesthesia and ventilatory support, not for diagnosing medical conditions. While it includes monitoring capabilities (e.g., inspired oxygen, airway pressure, exhaled volume), these are for managing the anesthesia and ventilation process, not for diagnostic purposes.
No
The device description clearly outlines numerous hardware components, including gas mixing systems, pneumatic backup, flow tubes, frames, cylinder connections, vaporizer cassettes, a ventilator, sensors, a display unit with an arm, and options for integrating patient monitors. While software is mentioned as controlling aspects of the device, it is an integral part of a larger hardware system.
Based on the provided text, the GE Datex-Ohmeda Aisys CS2 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 medical treatment and support, not for testing samples taken from the body.
- Device Description: The description details a system for delivering gases and anesthetic agents to a patient, controlling ventilation, and monitoring physiological parameters in vivo (within the living body). It mentions components like gas mixing, breathing systems, ventilators, and sensors in the breathing circuit.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing samples of blood, urine, tissue, or other bodily fluids in vitro (outside the living body).
Therefore, the GE Datex-Ohmeda Aisys CS2 Anesthesia System is a medical device used for patient care and support, not an IVD.
N/A
Intended Use / Indications for Use
The GE Datex-Ohmeda Aisys 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
BSZ
Device Description
The GE Datex-Ohmeda Aisys CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, Aisys, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The Aisys CS2 supplies set flows of medical gases to the breathing system using electronic gas mixing. Interfaces to control the system include the touch screen, keypad and rotary controller on the main display unit. Selected gas flows are 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 vaporizer cassettes are available to give the user control of the system configuration. The Aisys CS systems are also available in pendant models. The system shall support a maximum of two-cylinder supply connections mounted inboard on the machine and supported by cylinder yokes. All models have O2. The Aisys CS 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 and complete power or sudden gas supply failures. The Aisys CS 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 cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092). CARESCAPE Modules are also available for Aisys CS' (EsCAiO, E-sCAiOV cleared via K123195).
The above modules can be physically integrated into the Anesthesia device, receive electronic power from the said device and communicate measured values to the said device for display on the system display unit.
The anesthetic agent delivery for the Aisys CS2 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, 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) and Continuous Positive Airway Pressure / Pressure Support Ventilation (CPAP/PSV) Mode (Optional).
Aisys CS2 also supports optional Pressure Control Ventilation - Volume Guarantee mode with spontaneous breath pressure support (SIMV PCV-VG) 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 CS. 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 CS2 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 GE Monitors (cleared Carescape B850 via K092027 and B650 cleared on K102239). 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 CS frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS.
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
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 CS2 has been thoroughly tested through verification of specifications and validation, including software validation. Verification of compliance with applicable voluntary standards has also been made to support safe use of the device in its intended environment. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
The modifications made to the GE Datex-Ohmeda Aisys to create the GE Datex-Ohmeda Aisys CS2 did not require clinical testing, The functionality of the modified features was completely evaluated by performing nonclinical tests of design verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K001814, K051092, K123195, K973985, K973895, K092027, K102239
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
K132530
Page 1 of 4
DEC 2 0 2013
Premarket Notification 510(k) Summary As required by section 807.92 GE Datex-Ohmeda Aisys CS2
GENERAL COMPANY INFORMATION as required by 807.92(a)(1)
COMPANY NAME/ADDRESS/PHONE/FAX:
Datex-Ohmeda Inc. 3030 Ohmeda Drive PO Box 7550 Madison, WI 53707 USA Tel: 608-221-1551 Fax: 608-299-2132
NAME OF CONTACT:
Mr. Jim Raskob Mr. Monica Morrison (alternate)
DATE:
August 7, 2013
DEVICE NAME as required by 807.92(a){2)
TRADE NAME:
GE Datex-Ohmeda Aisys CS2 Anesthesia System
COMMON NAME:
Gas Machine, Anesthesia
CLASSIFICATION NAME:
Anesthesiology, 73 BSZ, 21 CFR 868.5160 Gas Machine, Anesthesia
NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as reguired by 807.92(a)(3)
The GE Datex-Ohmeda Aisys CS2 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Aisys (K110213).
1
DEVICE DESCRIPTION as required by 807.92(a)(4)
The GE Datex-Ohmeda Aisys CS2 is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). It represents one of the systems in a long line of products based on the Datex-Ohmeda Excel, Aestiva, Aespire, Aisys, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.
The Aisys CS2 supplies set flows of medical gases to the breathing system using electronic gas mixing. Interfaces to control the system include the touch screen, keypad and rotary controller on the main display unit. Selected gas flows are 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 vaporizer cassettes are available to give the user control of the system configuration. The Aisys CS systems are also available in pendant models. The system shall support a maximum of two-cylinder supply connections mounted inboard on the machine and supported by cylinder yokes. All models have O2. The Aisys CS 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 and complete power or sudden gas supply failures. The Aisys CS 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 cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092). CARESCAPE Modules are also available for Aisys CS' (EsCAiO, E-sCAiOV cleared via K123195).
The above modules can be physically integrated into the Anesthesia device, receive electronic power from the said device and communicate measured values to the said device for display on the system display unit.
The anesthetic agent delivery for the Aisys CS2 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, 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) and Continuous Positive Airway Pressure / Pressure Support Ventilation (CPAP/PSV) Mode (Optional).
25
2
Aisys CS2 also supports optional Pressure Control Ventilation - Volume Guarantee mode with spontaneous breath pressure support (SIMV PCV-VG) 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 CS. 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 CS2 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 GE Monitors (cleared Carescape B850 via K092027 and B650 cleared on K102239). 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 CS frame. An additional option allows the monitor to be linked to the power supply of the Aisys CS2 such that when the Aisys CS2 is turned on, the monitor is also turned on. Additional configurations allow for the mounting of various patient monitors on the top shelf of the Aisys CS .
INTENDED USE as required by 807.92(a)(5)
The GE Datex-Ohmeda Aisys 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.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a){6)
The GE Datex-Ohmeda Aisys has been updated from the predicate version (K110213) to create the GE Datex-Ohmeda Aisys CS2. There has been no change to the indications for use or the fundamental scientific technology.
The Aisys CS2 is nearly identical to the Aisys system, with the addition of the updates and features described in this submission. The Aisys CS introduces several new features. A summary of the changes include:
Display Unit
- 15" Display with integrated touchscreen .
- Revised user interface with flattened menu structure and touchscreen support .
- Supports VGA output of the display image .
Software Features
- "ecoFLOW" display option .
- Quick Picks, for settings adjustments .
- Additional Ventilation mode PCV-VG mode with pressure support (SIMV PCV-VG) .
- Improvements in screen configurability / customization .
- Auto Limits option, for quick setting of some alarm limits .
- Support of the CARESCAPE Respiratory Gas Module .
Hardware Features
- Revised color scheme .
- . Central brake for locking casters
3
- Arm design that enhances display movement .
- Improved work surface lighting with variable settings .
- Support for CARESCAPE Respiratory Gas Module .
SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)
The GE Datex-Ohmeda Aisys CS2 has been thoroughly tested through verification of specifications and validation, including software validation. Verification of compliance with applicable voluntary standards has also been made to support safe use of the device in its intended environment. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Performance testing (Verification) .
- . Safety testing (Verification)
- Simulated use testing (Validation) .
SUMMARY OF CLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(2)
The modifications made to the GE Datex-Ohmeda Aisys to create the GE Datex-Ohmeda Aisys CS2 did not require clinical testing, The functionality of the modified features was completely evaluated by performing nonclinical tests of design verification and validation testing.
CONCLUSION:
GE Healthcare considers the GE Datex-Ohmeda Aisys CS2 to be as safe, as effective, and have performance substantially equivalent to the predicate device.
. . . .
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Datex-Ohmeda Incorporated GE Healthcare Division Mr. James Raskob Regulatory Affairs Leader 3030 Ohmeda Drive P.O. Box 7550 MADISON WI 53707
Re: K132530
Trade/Device Name: GE Datex-Ohmeda Aisys CS2 Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas machine for anesthesia or analgesia Regulatory Class: II Product Code: BSZ Dated: November 22, 2013 Received: November 26, 2013
Dear Mr. Raskob:
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.
5
Page 2 - Mr. Raskob
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53) -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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Image /page/5/Picture/6 description: The image shows a signature and some text. The text reads "Sincerely yours, Tejashri Purohit-Sheth, M.D., Clinical. Deputy Director, DAGRID, FOR". The signature is illegible but appears to be a stylized version of a name.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: GE Datex-Ohmeda Aisys CS2 Anesthesia System
Indications For Use:
..............................................................................................................................................................................
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.
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)
Navan J. Patel . 2013.12.19 15:21:12 -05'00'
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