MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM by DATEX-OHMEDA, INC.

The Datex-Ohmeda S/5 Avance Anesthesia System 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 S/5 Avance is not suitable for use in a MRI environment.

Device Description

The Datex-Ohmeda S/5 Avance Anesthesia System 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 meters on the system display unit. The Avance 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 S/5 Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The S/5 Avance comes with up to two optional gases (air, N2O). The S/5 Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the S/5 Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance 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 Avance, receives electronic power from the Avance and communicates measured values to the Avance for Cisplay on the system display unit.

The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the S/5 Avance 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 Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results or acceptance criteria in the way a clinical trial report would.

Based on the provided text, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome or diagnostic task. Instead, the "acceptance criteria" appear to be compliance with relevant medical device standards and the demonstration of substantial equivalence to predicate devices.

Acceptance Criteria (Inferred from Document)	Reported Device Performance (Summary)
Compliance with Voluntary Standards	The Datex-Ohmeda S/5 Avance Anesthesia System 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: 1998 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
Substantial Equivalence to Predicate Devices	The Datex-Ohmeda S/5 Avance Anesthesia System is stated to be substantially equivalent to the Datex-Ohmeda S/5 Avance Anesthesia System (K032803) and Datex-Ohmeda 7900 Ventilator Enhancements (K023366). The document explicitly states: "The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are substantially equivalent in design concepts, technologies and materials." The FDA's letter confirms: "We have determined the device is substantially equivalent... to legally marketed predicate devices."
Safety Features	The S/5 Avance includes "Safety features and devices...designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures." (This is a design intent, not a quantified performance measure in this document).
Integrated Monitoring Performance	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 Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit." (Performance of this module is referenced by its own 510(k) and software revision, not detailed here.)
Ventilator Monitoring Performance	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." (Statements of functionality, not quantified performance here).

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a specific clinical "test set" in the context of an algorithm or diagnostic device. The "rigorous testing" mentioned is referred to as demonstrating compliance with standards and supporting substantial equivalence, which typically involves bench testing, engineering verification, and validation (V&V) activities. There is no mention of patient data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable/provided as the document describes a hardware anesthesia system and ventilator, not a diagnostic algorithm requiring ground truth established by experts for a test set. The validation focuses on engineering and regulatory standards compliance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable/provided for the same reasons as point 3.

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 applicable/provided. The device is an anesthesia system, not an AI-assisted diagnostic or decision-support tool that would involve human readers interpreting cases.

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

This information is not applicable/provided. The device is an integrated anesthesia system, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided as the validation is based on engineering and performance specifications against established standards and equivalence to predicate devices, not on a ground truth related to clinical outcomes or diagnostic accuracy in the context of an AI/diagnostic algorithm.

8. The Sample Size for the Training Set

This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device in the context of diagnostic algorithms.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided for the same reasons as point 8.

In summary:

This 510(k) summary focuses on demonstrating that the Datex-Ohmeda S/5 Avance Anesthesia System is substantially equivalent to legally marketed predicate devices and complies with relevant safety and performance standards. It achieves this through rigorous engineering and validation testing against those standards and by comparing its design and technology to existing cleared devices. The document does not describe clinical studies involving patient data or the performance of a diagnostic algorithm in the way the questions are framed.

Summary

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APR 2 2 2004

Date:	March 16th, 2004
Subject:	510(k) Summary of Safety and Effectiveness Informationfor the Datex-Ohmeda S/5 Avance Anesthesia System
Proprietary:	Datex-Ohmeda S/5 Avance Anesthesia System
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 Datex-Ohmeda S/5 Avance Anesthesia System 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 K032803

Datex-Ohmeda 7900 Ventilator Enhancements Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K023366

The Datex-Ohmeda S/5 Avance Anesthesia System 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 and Aespire Anesthesia Systems. It is to be used only by trained and qualified medical professionals.

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The Datex-Ohmeda S/5 Avance Anesthesia System 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 Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are substantially equivalent in design concepts, technologies and materials. The Datex-Ohmeda S/5 A vance Anesthesia System has been validated through rigorous testing that, in part, supports the compliance of S/5 Avance Anesthesia System to the standards listed above.

Dan Kosednar, RAC Contact: Manager, Regulatory Planning and Submissions

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2004

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

Rc: K040743

Trade/Device Name: Datex-Ohmeda S/5 Avance Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: March 22, 2004 Received: March 24, 2004

Dear Mr. Kosednar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatment date of the Medical Device Amendments, or to conimered province 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 rou may, dicrerer, mans 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 If your device is exactives (too at controls. Existing major regulations affecting your device can may be subject to back as back as Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advisou that I Drivisean that your device complies with other requirements of the Act that I Dri has made a aowd regulations administered by other Federal agencies. You must

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Page 2 – Mr. Dan Kosednar

comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Ace 3 requirements)01); good manufacturing practice requirements as set CI It rut 0077, adoning (2 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This product fashion vou to begin marketing your device as described in your Section 510(k) ; icaler will and wyou ve othe FDA finding of substantial equivalence of your device to a legally prematics notication " 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 11 you dobile of Compliance 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 Division of Small other general 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Hcalth

Enclosure

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Indications for Use

510(k) Number (if known): K040743

Device Name: Datex-Ohmeda S/5 Avance Anesthesia System

Indications For Use:

The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general I in Datex-Onnicatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The S/5 Avance 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

Jowhahn

on of Anesthesiology. General Hospital.

510(k) Number: K040743

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).