FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM

K042086 · Draeger Medical, Inc. · BSZ · Aug 31, 2004 · Anesthesiology

Device Facts

• Record ID: K042086
• Device Name: FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Aug 31, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fabius GS and Fabius Tiro may be used for spontaneous, manually assisted, automatic, or pressure support ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius GS and Fabius Tiro can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.

Device Story

Fabius GS and Fabius Tiro are continuous flow anesthesia systems; provide spontaneous, manually assisted, automatic, or pressure support ventilation; deliver anesthetic gases/vapors; monitor inspired oxygen, breathing pressure, and respiratory volume. Modification adds Apnea Ventilation feature to Pressure Support mode; software-only change. Apnea Ventilation acts as short-term backup; if spontaneous breathing rate falls below set frequency, system automatically delivers Pressure Support breath at pre-set settings. Used in clinical anesthesia settings by healthcare professionals. Benefits patient by preventing apnea during pressure support ventilation.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, system-level qualification, and verification/validation tests.

Technological Characteristics

Continuous flow anesthesia system. Software-based Apnea Ventilation feature added to existing Pressure Support mode. Infrastructure, operating principles, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies remain unchanged from predicate.

Indications for Use

Indicated for patients requiring spontaneous, manually assisted, automatic, or pressure support ventilation during anesthesia, including delivery of gases and anesthetic vapor and monitoring of oxygen concentration, breathing pressure, and respiratory volume. For use under the order of a physician.

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 (K041622)
• Fabius Tiro Anesthesia System (K041622)
• Evita 4 Continuous Ventilator (K961687)
• 7900 Ventilator (K023366)

Submission Summary (Full Text)

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K042086

## SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE

| Proprietary Name: | Fabius GS Anesthesia System<br>Fabius Tiro 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 - K041622<br>Fabius Tiro Anesthesia System - K041622<br>Evita 4 Continuous Ventilator - K961687<br>7900 Ventilator - K023366 |

### Device Description:

AUG 3 1 2004

The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.

#### Intended Use:

The Fabius GS and Fabius Tiro may be used for spontaneous, manually assisted, automatic, or pressure support ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius GS and Fabius Tiro can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.

#### Substantial Equivalence:

The current Fabius GS/Tiro Anesthesia Systems (K041622) are being modified to incorporate an Apnea Ventilation feature into the Pressure Support ventilation mode. The addition of Apnea Ventilation is a software change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged.

The Apnea Ventilation feature is intended as a short term backup to prevent an apnea condition should a patient's spontaneous effort fail to trigger Pressure Support ventilation or cease entirely. It is not intended as a long term substitute for patient triggered pressure support ventilation. When Apnea Ventilation is enabled, if the patient spontaneous breathing rate falls below the minimum ventilation frequency (Freq Min) setting, the ventilator automatically delivers a Pressure Support breath at the pre-set Pressure Support settings.

> 510(k) Summary Page 1 of 2

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The Apnea Ventilation feature in the Fabius GS/Tiro is substantially equivalent to the Apnea Ventilation feature in the Evita 4 (K961687) and the Apnea Backup Mode feature in the 7900 Ventilator (K023366). All three are triggered if a user selected time elapses without a spontaneous breath during pressure support ventilation and all three can be disabled by the user. As stated earlier, when Apnea Ventilation is triggered in the Fabius GS, a pressure support breath is delivered at the pre-set Pressure Support settings. The Fabius GS/Tiro stays in Pressure Support mode. In the Evita 4, when Apnea Ventilation is triggered, the ventilator switches to Volume Controlled ventilation at a pre-set tidal volume and breath rate. The Evita 4 then stays in Volume Controlled mode unless the user switches back to Pressure Support mode. In the 7900 Ventilator, when Apnea Backup Mode is triggered, the ventilator switches to Synchronized Intermittent Mandatory Ventilation - Pressure Controlled (SIMV - PC) mode at a pre-set inspired pressure, breath rate and inspiratory time. The 7900 Ventilator stays in SIMV-PC mode unless the user switches back to Pressure Support mode. From a safety and efficacy standpoint, all three devices prevent an apnea condition and alert the user to the condition.

Oualification included hazard analysis, system level qualification, and verification/ validation tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or stripes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2004

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

Re: K042086

Trade/Device Name: Fabius GS and Fabius Tiro Anesthesia Systems Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: August 2, 2004 Received: August 3, 2004

Dear Mr. Kelhart:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave refrenced your becatermined 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 Interstate conmisered proves that have been reclassified in accordance with the provisions of Amendinens, or to arress and Cosmetic Act (Act) that do not require approval of a premarket the Fouch I vou, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of in 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 If your device is olabilition (see as additional controls. Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kelhart

Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast that FDA has made a determination that your device complies with other requirements moan that i Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally 1 oderal bake and successed including, but not limited to: registration r out must comply with as 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), arelity systems (QS) regulation (21 CFR Part 820); and if requirents us sectionic 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) This letter will anow you the bogan finding of substantial equivalence of your device to a premarket notified.com - 11.0 - 21.0 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), If you desire specific at 750 to: Joins 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 may ovean of Small Manufacturers, 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,

Cure

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): _Koy Zo &b

Device Name: __Fabius GS and Fabius Tiro Anesthesia Systems

Indications for Use:

The Fabius GS and Fabius Tiro are indicated as a continuous flow anesthesia systems. The Fabius GS and Fabius The are meleated for spontaneous, manually assisted, The Fablus OS and I abrus Tre Call of about station, delivery of gases and anesthetic was of paties automatic or pressure support venthanon; don't st gases or and respiratory volume of patients
monitoring oxygen concentration, breathing pressure and respiratory of a momiloring oxygen concentration, orcating pressure in the order of a physician.

X Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042086

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