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.

Device Description

The GE Datex-Ohmeda Aisys 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, 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 svstem display unit. The Aisvs 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 02. 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 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 cleared via K001814) and E-Gas Module (E-CAiOVX software revision 4.5 and above cleared via K051092) which can be physically integrated into the Aisys, receive electronic power from the Aisys and communicate 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 Aisvs 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 on to 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 requlated 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 Control Ventilation (VCV), Pressure Control Ventilation (PCV) (optional), Synchronized Intermittent Mandatory Ventilation/Pressure Support (SIMV/PSV) (optional), Pressure Support Ventilation (PSVPro) (optional), Synchronized Intermittent Mandatory Ventilation-Pressure Control (SIMV-PC) (optional), Pressure Control Ventilation-Volume Guaranteed (PCV-VG) (optional) and Constant Positive Airway Pressure/Pressure Support Ventilation (CPAP/PSV). Ventilator parameters and measurements are displayed on the system display unit.

AI/ML Overview

The provided text describes a premarket notification (510(k)) for the GE Datex-Ohmeda Aisys Anesthesia System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as would be found for a novel device.

The submission states that the modifications made did not require clinical testing, and the functionality was evaluated through nonclinical tests of design verification and validation testing. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for a new clinical claim is not present in this document.

However, I can extract information about the type of testing performed and the conclusion regarding substantial equivalence.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present:

1. A table of acceptance criteria and the reported device performance

Not explicitly provided in the document. The document states "The GE Datex-Ohmeda Aisys has been thoroughly tested through verification of specifications and validation, including software validation," but it does not list specific, quantitative acceptance criteria or corresponding reported performance metrics for clinical efficacy or diagnostic accuracy.
The overall "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to predicate devices. The conclusion states: "The performance data demonstrates the device is substantially equivalent to the predicates."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. No clinical test set or patient data is mentioned as the basis for the 510(k) in this document. The testing was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No clinical ground truth was established as no clinical testing was performed for this 510(k). Non-clinical testing would involve engineering and quality assurance experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical test set or adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an anesthesia system, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an anesthesia system. The software updates relate to user interface, control of gas delivery, and ventilator modes, not standalone algorithmic performance in a diagnostic context. "Standalone" performance testing would be more relevant to the device's functional operation (e.g., accuracy of gas delivery, ventilator parameters) which was covered by non-clinical verification and validation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided in a clinical sense. For the non-clinical testing, the "ground truth" would be the device's technical specifications and established engineering standards, against which its performance was verified and validated.

8. The sample size for the training set

Not applicable/Not provided. This document is not describing a machine learning or AI model that requires a training set in the conventional sense. The "software updates" are likely improvements to existing control algorithms and user interface logic.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, no training set for a machine learning model is mentioned.

Summary of what is present regarding testing:

The document states:

Reason for 510(k): Updates to the software for the GE Datex-Ohmeda Aisys Anesthesia System, introducing several new features (e.g., pediatric improvements, new ventilation mode CPAP/PSV with backup breaths, lung mechanics procedure options, UI enhancements).
Basis for Substantial Equivalence: Comparison to legally marketed predicate devices (GE Datex-Ohmeda Aisys (K090233) and GE Datex-Ohmeda Engstrom ventilator (K093886)). No changes to intended use or fundamental scientific technology.
Testing Performed:
- Nonclinical Testing: "thoroughly tested through verification of specifications and validation, including software validation."
- Quality Assurance Measures applied:
  - 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)
- Clinical Testing: "The modifications made to the GE Datex-Ohmeda Aisys did not require clinical testing. The functionality of the modified software features were completely evaluated by performing nonclinical tests of design verification and validation testing."
Conclusion: The performance data (nonclinical) demonstrates the device is substantially equivalent to the predicates, with no new questions of safety and effectiveness.

In essence, this 510(k) leverages the predicate devices' established safety and effectiveness, and for the software updates, relies on rigorous non-clinical engineering verification and validation testing rather than new clinical trials or performance studies against specific acceptance criteria for a novel claim.

Summary

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JUL 20 2011

Premarket Notification 510(k) Summary As required by section 807.92 GE Datex-Ohmeda Aisys

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda, Inc. PO Box 7550 Madison, WI 53707 USA Tel: 608-221-1551 Fax: 608-299-2132

NAME OF CONTACT:

Mr. James P. Raskob Ms. Monica Morrison (alternate)

DATE:

June 6, 2011

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

GE Datex-Ohmeda Aisys 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 required by 807.92(a)(3)

The GE Datex-Ohmeda Aisys is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Aisys (K090233) and GE Datex-Ohmeda Engstrom ventilator (K093886).

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DEVICE DESCRIPTION as required by 807.92(a)(4)

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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 GE Monitors (most recently cleared Carescape B850 via K092027 and Carescape B650 via 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 frame. An additional option allows the monitor to be linked to the power supply of the Aisys such that when the Aisys 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.

INTENDED USE as required by 807.92(a)(5)

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 (K090233). There have been no changes to the intended use or fundamental scientific technology.

The software for the Aisys has been updated to introduce several new features. A summary of the changes to the software and display monitor include:

. Pediatric Improvements: 02 concentration range improvement at low flows, reduction of spurious alarms when patient is adequately ventilated, improved control of the agent quick key, gas monitor ventilator Tidal Volume compensation, Breathing Tube Compliance On/Off option
Highlight the border of the menu button for increased visibility .
Checkout improvement: Remove "Leak < 250" question .
Temporary gas flow suspension capability .
Improved "unconfirmed" setting notification .
Remind clinician to set the agent .
. Ventilator defaults for each individual vent mode
New ventilation mode: CPAP/PSV with backup breaths .
Lung mechanics procedure options of Vital Capacity and Cycling .
Procedures button added to the existing display monitor. Quick Keys .

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SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The GE Datex-Ohmeda Aisys 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 .
Desian 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 did not require clinical testing. The functionality of the modified software features were completely evaluated by performing nonclinical tests of design verification and validation testing.

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the GE Datex-Ohmeda Aisys as compared to the predicate devices. The performance data demonstrates the device is substantially equivalent to the predicates.

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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 stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Datex-Ohmeda, Incorporated Mr. Jim Raskob Care Business Area PO Box 7550 3030 Ohmeda Drive Madison, Wisconsin 53707-7550

JUL 20 2011

Re: K110213

Trade/Device Name: GE Datex -- Ohmeda Aisys Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: July 13, 2011 Received: July 14, 2011

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 provice 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, rits s r, uns ooo to over in the Federal Register.

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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 gencies. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Antnong, D. Watson

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K

Device Name: GE Datex-Ohmeda Aisys Anesthesia System

Indications For Use:

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

E. Shultten

Division Sign-Off) **vision of Anesthesiology, General Hospital ·ection Control, Dental Devices

K110213 . 10(k) Number:

Regulation Number and Section

§ 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).