MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM

K040743 · Datex-Ohmeda, Inc. · BSZ · Apr 22, 2004 · Anesthesiology

Device Facts

• Record ID: K040743
• Device Name: MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
• Applicant: Datex-Ohmeda, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Anesthesia workstation providing inhalation anesthesia and ventilatory support; used in clinical settings by trained medical professionals. System inputs include medical gases (O2, air, N2O) and user-defined settings via keypad/rotary controller. Microprocessor-based 7900 ventilator controls breathing patterns, PEEP, and gas delivery; sensors monitor inspired O2, airway pressure, and exhaled volume. System compensates for compression losses, fresh gas contribution, and circuit leaks. Outputs include electronic flow metering, ventilation parameters, and optional respiratory gas monitoring (via integrated M-Gas Module). Safety features prevent hypoxic mixtures and agent delivery errors. RS-232 port enables external communication. Benefits include precise gas delivery, automated ventilation control, and integrated monitoring to support patient safety during surgical procedures.

Clinical Evidence

Bench testing only. Device validated through rigorous testing to demonstrate compliance with voluntary standards including UL 2601, EN 740, EN/IEC 60601-1, EN/IEC 60601-1-2, EN 475, ASTM F1463-93, ASTM F1208-94, ASTM F1101-90, and ISO 5358.

Technological Characteristics

Anesthesia workstation with electronic gas mixing and pneumatic back-up. Features 7900 microprocessor-controlled ventilator. Supports Tec 4, 5, 6, 7 vaporizers on Selectatec manifold. Connectivity via RS-232. Integrated respiratory gas monitoring via M-Gas Module (M-CAiO/M-CAiOV). Complies with UL 2601, EN 740, IEC 60601-1, ISO 5358, and ASTM standards for anesthesia breathing circuits and ventilators.

Indications for Use

Indicated for general inhalation anesthesia and ventilatory support (volume or pressure control) for a wide range of patients. Contraindicated for use in MRI environments.

Regulatory Classification

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. 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).

Predicate Devices

• Datex-Ohmeda S/5 Avance Anesthesia System (K032803)
• Datex-Ohmeda 7900 Ventilator Enhancements (K023366)

Submission Summary (Full Text)

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## APR 2 2 2004

| Date: | March 16th, 2004 |
|-----------------|-------------------------------------------------------------------------------------------------------------|
| Subject: | 510(k) Summary of Safety and Effectiveness Information<br>for 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.

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.

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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.

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
- 2. EN 740 Anesthetic Work Stations
- 3. EN/IEC 60601-1: General requirements for Medical Electrical Equipment
- 4. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
- 5. EN 475 Electrically Generated Alarm Signals
- 6. ASTM F1463-93 Standard Specification for Alarm Signals
- 7. ASTM F1208-94 Anesthesia Breathing Circuit Standard
- 8. ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
- 9. 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 [phone]. 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 [phone] or [phone] 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