GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) by DATEX-OHMEDA, INC.

The GE Datex-Ohmeda Anesthesia Delivery Unit 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, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.

Device Description

The GE Datex-Ohmeda ADU supplies set flows of medical gases to the breathing system using mechanical gas mixing. Gas flows are selected by the user using the rotary controller on the frame and then displayed as electronic flow indicators on the system display unit. The ADU is equipped with a traditional flow tube, as well. The ADU 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 ADU comes with up to two optional gases (air, N2O). Safety features and devices within the ADU are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.

The anesthetic agent delivery for the ADU is controlled via an anesthesia computer through user input from that computer. An Aladin cassette 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 ADU is designed to allow only one active cassette at a time. Per the user input, valves within the active cassette bay will oney one allow agent to be delivered. The agent is mixed with gas within the FGC unit. After open and the wagent to of gases and agent is delivered to the breathing system and then onto the patient.

The ADU Anesthesia Ventilator is a microprocessor based, electronically controlled, The ADO Ancomesia "Pentilator that provides patient ventilation during surgical procedures. Sensors in the breathing circuit are used to control and monitor patient ventilation. This allows Schools in the oreating of compression losses, fresh gas contribution and small leakage in the for the compensation of our spression. 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 with a sitiple and becare othir pratory Pressure (PEEP) is regulated electronically. Positive ter the paintained in the breathing system so that any leakage that occurs is outward. Pressure is names for the device include Volume Mode, Pressure Control Mode, Pressure Support vith Apnea Backup Mode (Optional) and Synchronized Intermittent Mandatory Ventilation with Aplica Dackap Mode (Optional) and measurements are displayed on the system display unit.

The ADU must be used with additional monitoring that include at least inspired 02, expired volume, expired CO2 and Anesthetic Agent.

An RS-232 serial digital communications port connects to and communicates with external devices such a Datex-Ohmeda S/5 Anesthesia Monitor.

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). Additional or the Dations allow for the mounting of various patient monitors on the top shelf of the ADU.

AI/ML Overview

This document is a 510(k) summary for the GE Datex-Ohmeda S/5 ADU, an anesthesia delivery unit. It focuses on demonstrating substantial equivalence to previously cleared devices (GE Datex-Ohmeda ADU Carestation and Datex-Ohmeda AS/3 Anesthesia Delivery Unit) rather than detailing specific acceptance criteria and performance studies in the way one might expect for a new AI or diagnostic device.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC study, separate AI performance, training set details) are not applicable or not found within this submission document for a medical device of this type.

Here's the information that can be extracted and a clear statement about what is not included in the provided text:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Deemed Substantially Equivalent (K042154, K973985)
Adherence to Applicable Voluntary Standards (Safety & Performance)	Designed to comply with UL 2601, EN 740, EN/IEC 60601-1, etc.
Intended Use (General inhalation anesthesia & ventilatory support)	Provides general inhalation anesthesia and ventilatory support to a wide range of patients.
Functionality (Gas mixing, agent delivery, ventilation modes)	Supplies set flows of medical gases, uses Aladin cassette for agent delivery, offers Volume Mode, Pressure Control, Pressure Support, and SIMV with Apnea backup.
Safety Features (Hypoxic mixtures, power failures)	Designed to decrease the risk of hypoxic mixtures, agent mixtures, and complete power/gas supply failures.
Monitoring Capability (02, CO2, etc.)	Must be used with additional monitoring (inspired O2, expired volume, expired CO2, Anesthetic Agent).
Compatibility (External devices)	RS-232 serial digital communications port connects to external devices (e.g., Datex-Ohmeda S/5 Anesthesia Monitor).

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

This information is not provided in the document. This type of submission for an anesthesia machine typically relies on engineering specifications, adherence to standards, and possibly internal testing data, rather than clinical trials with patient-specific test sets in the context of AI or diagnostic algorithms.

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)

This information is not provided in the document. Ground truth establishment with experts is generally associated with diagnostic or AI algorithm testing, not with the clearance of an anesthesia delivery unit based on substantial equivalence to existing devices and adherence to performance standards.

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

This information is not provided in the document. As with the previous points, adjudication methods are typically relevant for human interpretation or AI performance assessment, which is not the primary focus of this 510(k) submission.

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

This information is not provided in the document. MRMC studies are used for evaluating diagnostic devices and AI systems where human interpretation is part of the workflow. This device is an anesthesia delivery unit, not a diagnostic imaging or AI-assisted interpretation tool.

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

This information is not provided in the document. This device is a complex electromechanical system, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

The concept of "ground truth" in the context of this 510(k) appears to be based on compliance with established safety and performance standards (e.g., UL, EN, ISO, ASTM) and the functional specifications meeting the intended use. This is demonstrated through engineering design, internal testing, and comparison to predicate devices, rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not provided in the document. The device is not learning from a "training set" in the machine learning sense. Its design and functionality are predetermined based on engineering principles and established medical device standards.

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

This information is not provided in the document, as there is no "training set" in the machine learning sense for this device.

Summary

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APR 1 2 2005

K050676

March 14, 2005 Date:

510(k) Summary of Safety and Effectiveness Information Subject: for the GE Datcx-Ohmeda S/5 ADU

GE Datex-Ohmeda S/5 Anesthesia Delivery Unit Proprietary:

Gas Machine, Anesthesia Common:

Anesthesiology, 73 BSZ, 21 CFR 868.5160 Classification:

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 ADU is substantially equivalent to the following currently marketed device:

GE Datex-Ohmeda ADU Carestation - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K042154

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 ADU is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. It is to be used only by trained and qualified medical professionals.

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The ADU must be used with additional monitoring that include at least inspired 02, expired volume, expired CO2 and Anesthetic Agent.

An RS-232 serial digital communications port connects to and communicates with external devices such a Datex-Ohmeda S/5 Anesthesia Monitor.

The GE Datex-Ohmeda ADU 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: 2001 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

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, with three curved lines representing its wings or feathers.

Public Health Service

APR 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Datex Ohmeda, AB c/o Mr. Dan Kosednar Manager, Regulatory Submissions Datex-Ohmeda, Incorporated Life Support Solutions P.O. Box 7550 Madison, Wisconsin 53707-7550

Re: K050676

Trade/Device Name: GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: March 15, 2005 Received: March 16, 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 mendments, 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 oonerols provisions of 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 (1 wr ), it har obe of Federal Regulations, Title 21, Parts 800 to 898. In Jour device of may publish further announcements concerning your device in the Federal Register.

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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. or the Free of any 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 and roting ( - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - required.le, 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), nlease contact the Office of Compliance 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 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 vours,

Charles

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

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Indications for Use

510(k) Number (if known): Kesow 7le Device Name: GE Datex-Ohmeda Anesthesia Delivery Unit (ADU)

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)

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Chris

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infaction Control, Dental Devices

510(k) Number K056626

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).