DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM

K032803 · Datex-Ohmeda · BSZ · Mar 10, 2004 · Anesthesiology

Device Facts

• Record ID: K032803
• Device Name: DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
• Applicant: Datex-Ohmeda
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The Datex-Ohmeda S/5 Avance Anesthesia System is an anesthesia delivery unit providing general inhalation anesthesia and ventilatory support. It supports both volume and pressure control ventilation modes. The system is designed for use in clinical settings by healthcare professionals; it is not MRI-compatible. The device integrates gas delivery and ventilation control to manage patient respiration during surgical procedures. It utilizes standard anesthesia breathing circuits and alarm systems to monitor and maintain patient safety. The system is intended to provide clinicians with precise control over anesthetic gas delivery and mechanical ventilation parameters, facilitating patient stability during anesthesia.

Clinical Evidence

Bench testing only. The device was validated through rigorous testing to demonstrate compliance with applicable voluntary standards (UL 2601, EN 740, IEC 60601-1, IEC 60601-1-2, EN 475, ASTM F1463-93, ASTM F1208-94, ASTM F1101-90, and ISO 5358).

Technological Characteristics

Anesthesia delivery system featuring volume and pressure control ventilation. Complies with UL 2601, EN 740, IEC 60601-1, IEC 60601-1-2, EN 475, ASTM F1463-93, ASTM F1208-94, ASTM F1101-90, and ISO 5358. Includes integrated alarm systems and breathing circuit interfaces. Not MRI compatible.

Indications for Use

Indicated for general inhalation anesthesia and ventilatory support for a wide range of patients requiring volume or pressure control ventilation. Contraindicated for use in an MRI environment.

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 Aestiva/5, with 7100 Ventilator (K000706)
• Datex-Ohmeda Excel 3000 (Aestiva), with 7900 Ventilator (K973896)
• Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU) (K973985)

Submission Summary (Full Text)

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K032803

MAR 1 0 2004

| Date: | January 7th, 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 Aestiva/5, with 7100 Ventilator, Anesthesia System - Class II -21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K000706

Datex-Ohmeda Excel 3000 (Aestiva), with 7900 Ventilator, Anesthesia System -Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973896

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

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.

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

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- 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 The Datest of Interious in design concepts, technologies and materials. The Datex-Ohmeda S/5 Substance Anesthesia System has been validated through rigorous testing that, in part, supports the I 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2994

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

Rc: K032803

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: January 8, 2004 Received: January 9, 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 for ass stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered provision 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 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 rr your de rice to such additional controls. Existing major regulations affecting your device can may of subject to one, when was and 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 r that FDA has made a determination that your device complies with other requirements of the Act that i Dri has made a and 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 compry with an the Act 31equirements, with and 01); good manufacturing practice requirements as set CITY art 6077, adomig (21 CFR Part 820); and if applicable, the electronic 101111 the quality systems (20) regarations 531-542 of the Act); 21 CFR 1000-1050. This production comes pro rasketing your device as described in your Section 510(k) icutification. The FDA finding of substantial equivalence of your device to a legally premailted notification: "The First mailing 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 If you desire specific at 100 101 594-4646. Also, please note the regulation entitled, Connact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html.

Sincerely vours,

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): K032803 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 he Datex-Olinieda Sr 7 Availed Anosulesand Joteswide range of patients. The device is
inhalation anesthesia and ventilatory support to a wide range of patiently for for intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment. Over-The-Counter Use AND/OR Prescription Use _XXX (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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_

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nesthesi Seneral Hospital.

510(k) Number: K03280