MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM

K030624 · Draeger Medical, Inc. · BSZ · Mar 17, 2004 · Anesthesiology

Device Facts

• Record ID: K030624
• Device Name: MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Mar 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, and monitoring oxygen concentration, breathing pressure, and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.

Device Story

Fabius GS is a continuous flow anesthesia system used in clinical settings by physicians to deliver gases and provide respiratory support during anesthesia. The device monitors inspired oxygen concentration, breathing pressure, and respiratory volume. The modified system incorporates Pressure Support Ventilation (PSV), which is flow-triggered and flow-cycled, similar to the Evita 4 ventilator. The system provides clinicians with adjustable ventilation settings, including trigger level and support pressure, to assist patient breathing. Output is displayed on an operator control panel, allowing the physician to adjust ventilation parameters to manage patient respiratory status during anesthesia delivery.

Clinical Evidence

No clinical data provided. Evidence consists of hazard analysis, system-level qualification, and verification/validation testing.

Technological Characteristics

Continuous flow anesthesia system. Features include flow-triggered and flow-cycled Pressure Support Ventilation (PSV). Hardware includes an operator control panel with an added hard key for PSV. Monitors oxygen concentration, breathing pressure, and respiratory volume. Software includes ventilation control algorithms for spontaneous, manual, automatic, and pressure support modes.

Indications for Use

Indicated for patients requiring anesthesia during spontaneous, manually assisted, automatic, or pressure support ventilation. Prescription use only.

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

• Fabius GS Anesthesia System (K011404)
• Evita 4 Continuous Ventilator (K961687)

Submission Summary (Full Text)

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MAR 1 7 2004

# SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE

| Proprietary Name: | Fabius GS Anesthesia System |
|---------------------------------------------------------|------------------------------------------------------------------------------------|
| Classification Name: | Gas Machine, Anesthesia - 73 BSZ |
| Device Class: | Class II |
| Initial Distributor: | Draeger Medical, Inc.<br>3135 Quarry Road<br>Telford, Pennsylvania 18969 USA |
| Establishment Registration No.: | 2517967 |
| Devices to which substantial<br>equivalence is claimed: | Fabius GS Anesthesia System -- K011404<br>Evita 4 Continuous Ventilator -- K961687 |

### Device Description:

The modified Fabius GS is a continuous flow gas anesthesia system.

### Intended Use:

The modified Fabius CS may be used for spontaneous, manually assisted, automatic, or The modified i dolus of patients during anesthesia, and delivery of gases and pressure support venthanon of partins GS can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.

### Substantial Equivalence:

The current Fabius GS Anesthesia System (K011404) is being modified to include The current Paoras OS Incounted a Joional ventilation mode. The addition of Pressure Fressure Support Ventiation is an opportune change. The only hardware change was the Support Venthanon is essenzary hard key on the operator control panel. With the exception of minor incremental changes that did not require a 510(k) notification, the exception of inmor merentental sixtingle, alarm strategies, fault detection circuitry, and basic infrastration operating printesp within the Fabius GS remain unchanged from the initially released Fabius GS. Adjustable ventilation settings available in Pressure Support mittany released i ublis Sb. Frigger Level (sensitivity level at which a breath is mode at Support Pressure 2017) ----------------------------------------------------------------------------------------------------------------------------------------------uctected), Maximum mopiratevel are new settings. Maximum Inspiratory Flow and I Tessure Ecver and Trigger 2017 are ventilation settings already available to the user in the current automatic ventilation modes.

Like the Evita 4 Continuous Ventilator (K961687), Pressure Support Ventilation (PSV) in the Fabius GS is flow triggered and flow cycled.

Qualification of the modified Fabius GS included hazard analysis, system level qualification, and verification/validation tests.

K030624

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2004

Mr. Michael A. Kelhart Regulatory Affairs Project Manager Draeger Medical Incorporated 3135 Quarry Road Telford, PA 18969

Re: K030624

Trade/Device Name: Fabius GS Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: February 18, 2004 Received: February 19, 2004

Dear Mr. Kelhart:

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 Amendments, 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 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 may be subject to such additional controls. Existing major regulations affecting your device can may or dayer to our it of the Code of Federal 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 rease or as mode a determination that your device complies with other requirements of the Act than + Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Michael Kelhart

comply 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 requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This production control pro histor pro raise (ing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The PDF intellig of cation 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 100 100 100 100 [phone]. Also, please note the regulation entitled, Comation of Collied of Collier of Commarket notification" (21CFR Part 807.97). You may obtain Misoranums of reference to presence to promosibilities 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,

J.H. Wubben

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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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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K030624

Device Name: ______________Fabius GS Anesthesia System

Indications for Use:

The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can The I ablus OD is manually assisted, automatic or pressure support ventilation, be used for sponancous, manaary assemant and monitoring oxygen concentration, breathing denvory of gases and ancellers in potients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Per 21 CFR 801.109)

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrerice of CDRH, Office of Device Evaluation (ODE)


ivision Sian-Off rision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number