GE DATEX-OHMEDA AISYS CARESTATION by DATEX-OHMEDA, INC.

The GE Datex-Ohmeda Aisys Carestation 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 Carestation is not suitable for use in a MRI environment.

Device Description

The GE Datex-Ohmeda Aisyis 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 system comg crecurence gain 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 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, 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 I ho unesthetie central display. The vaporization technology is based upon the electronic itiput from the collinar display. The x-Ohmeda Anesthesia Delivery Unit (ADU) cleared via Vaportzer etcared as part of the Bacer as part of K973895) is inserted into the active cassette 15715765. An Indin bassette (as to be delivered - Halothane, Enflurane, Isoflurane, Desflurane or Sevoflurane. Agent is delivered as a percent volume/volume. The Aisys is designed to allow of be ronature. I rigent to a time. Per the user input into the main display, valves within the only one actry cassette bay will opent to be delivered. The agent is mixed with gas from athe 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 The Dates Onlined 1900 tronically controlled, pneumatically driven ventilator that provides microprocessor based, erections of ocedures. The 7900 ventilator is equipped with a built-in monitoring system for inspired oxygen, airway pressure and exhaled volume. Sensors in the montoning 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 on for concentration "Prakage in the breathing absorber, bellows and system. User setting and microprocessor calculations control breathing patterns. The user interface keeps settings in merory. 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 feature obeats is ournaler vees. 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 I he system display and 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 from the monitor S/5 AM to be linked to the power supply of the Aisys such that when the Aisyis 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.

AI/ML Overview

This document pertains to the 510(k) summary for the GE Datex-Ohmeda Aisys Carestation, a type of Anesthesia Gas Machine. As such, it describes a medical device, not an AI/ML-driven solution or a diagnostic tool that would typically undergo the types of studies you've inquired about (e.g., those involving performance metrics like sensitivity/specificity, reader studies, or ground truth establishment by experts).

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types. These aspects are specific to the validation of diagnostic or AI-powered devices, which the Aisys Carestation is not.

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant voluntary standards for medical electrical equipment and anesthesia workstations. The "acceptance criteria" in this context refer to compliance with these standards and established regulatory pathways for anesthesia machines.

Here's what can be inferred from the provided text regarding the closest equivalents to your request:

Acceptance Criteria (in the context of a medical device 510(k) application):
- Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices.
- Compliance with Voluntary Standards: The device was designed to comply with applicable portions of specific voluntary standards. This compliance serves as an "acceptance criterion" for safety, performance, and functionality.
Study/Evidence that Proves the Device Meets Acceptance Criteria:
- The document states: "The GE Datex-Ohmeda Aisyis Carestation in accept vehicled through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisyis Carestation to the standards listed above."
- While specific study details (like sample sizes or statistical results) are not provided in this 510(k) summary, the "rigorous testing" mentioned typically includes:
  - Bench testing: To verify technical specifications, safety features, and functional performance against engineering requirements and the chosen voluntary standards (e.g., verifying gas flow accuracy, ventilator performance, alarm functionality, electromagnetic compatibility).
  - Software validation: Given the electronic controls and microprocessor-based components, software validation would have been performed.
  - Biocompatibility testing: For patient-contacting materials, though not explicitly mentioned here.
  - Electrical safety testing: To meet standards like UL 2601 and EN/IEC 60601-1.
  - Electromagnetic compatibility (EMC) testing: To meet EN/IEC 60601-1-2.

Summary of available information as per your requested format (with caveats):

Information Point	GE Datex-Ohmeda Aisys Carestation (K042154)
1. Table of Acceptance Criteria & Reported Device Performance	Acceptance Criteria (Compliance with Standards):- Substantial Equivalence to K040743, K032803, K973985- UL 2601- EN 740- EN/IEC 60601-1- EN/IEC 60601-1-2- EN 475- ASTM F1463-93- ASTM F1208-94- ASTM F1101-90- ISO 5358Reported Device Performance:The document states that compliance to these standards was supported by "rigorous testing." No specific performance metrics (e.g., statistical results, accuracy values) are provided in this summary.
2. Sample size and Data Provenance (Test Set)	Not applicable. This is a medical device approval, not a diagnostic algorithm study. Testing involved engineering and regulatory compliance, not typically "test sets" in the AI/ML sense.
3. Number of experts and Qualifications (Ground Truth)	Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on imaging) is not relevant for this device. Safety and performance were assessed against engineering specifications and voluntary standards.
4. Adjudication Method (Test Set)	Not applicable for this type of device and submission.
5. MRMC Comparative Effectiveness Study Effect Size	Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone performance (algorithm only)	Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used	Not applicable in the context of diagnostic/AI ground truth. Device performance verified against technical specifications, engineering requirements, and voluntary standards.
8. Sample Size for Training Set	Not applicable. This is a hardware/software medical device, not an AI/ML model that undergoes "training."
9. How Ground Truth for Training Set was Established	Not applicable.

The 510(k) summary focuses on demonstrating that the Aisys Carestation is safe and effective for its intended use, based on substantial equivalence to existing devices and compliance with recognized standards, rather than proving diagnostic accuracy via clinical trials or AI performance studies.

Summary

{0}------------------------------------------------

AUG 3 1 2004	K042154
Date:	August 6, 2004
Subject:	510(k) Summary of Safety and Effectiveness Informationfor 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 S/5 Avance Anesthesia System - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K040743 and K032803

Datex-Ohmeda AS/3 Anesthesia Delivery Unit - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973985

The GE Datex-Ohmeda Aisyis 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 and volunately support to a Marreda Excel, Aestiva, Aespire, and Avance Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

{1}------------------------------------------------

{2}------------------------------------------------

The GE Datex-Ohmeda Aisyis Carestation was designed to comply with the applicable portions of the following voluntary standards;

1. UL 2601 General requirements for Medical Electrical Equipment
1. EN 740 Anesthetic Work Stations
1. EN/IEC 60601-1: General requirements for Medical Electrical Equipment
1. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
1. EN 475 Electrically Generated Alarm Signals
1. ASTM F1463-93 Standard Specification for Alarm Signals
1. ASTM F1208-94 Anesthesia Breathing Circuit Standard
1. ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
1. ISO 5358 Anesthetic Gas Machines

The GE Datex-Ohmeda Aisyis Carestation and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The GE Datex-Ohmeda Aisyis equiration in accept vehicled through rigorous testing that, in part, supports the compliance of GE Datex-Ohmeda Aisyis Carestation to the standards listed above.

Dan Kosednar, RAC Contact:

Manager, Regulatory Planning and Submissions, CARE

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

Mr. Daniel Kosednar, RAC Manager, Regulatory Planning and Submissions, CARE Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, Wisconsin 53707

Re: K042154

Trade/Device Name: GE Datex-Ohmeda Aisys Carestation Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: August 9, 2004 Received: August 10, 2004

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 microlie commerce prives that have been reclassified in accordance with the provisions of Amenditorial of to do roomsond Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided of are ristration, 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 (1 Nr.), it hay be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device car or round in ther 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 I least that FDA has made a determination that your device complies with other requirements moun that 1 Dr may Federal statutes and regulations administered by other Federal agencies. of the Act of all) - each all the Act's requirements, including, but not limited to: registration r out indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF reful 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirence as bet form in the qualify ion 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) I mis letter will and n your e FDA finding of substantial equivalence of your device to a premaired notified bevice 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 at not to your as at (301) 594-4646. 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 overn 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/dsma/dsmamain.html

Sincerely yours,

Carl

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): K042154

Device Name: GE Datex-Ohmeda Aisys Carestation

Indications For Use:

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________________________________________________________________________________________________________________________________________________________________

Aue Syloun

(Division Sign-Off (Division Sign-Olix)
Division of Anesthestology, General Hospital, Infection Control, Denta

510(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).