MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM

K041622 · Draeger Medical, Inc. · BSZ · Jul 8, 2004 · Anesthesiology

Device Facts

• Record ID: K041622
• Device Name: MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Jul 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Fabius GS and Fabius Tiro are continuous flow anesthesia systems for clinical use by physicians. Systems deliver anesthetic gases/vapors and provide ventilation (spontaneous, manual, automatic, pressure support) while monitoring oxygen, pressure, and volume. Modification adds a heater plate to the compact breathing system (COSY) to minimize moisture accumulation during low-flow anesthesia or low ambient temperatures. Heater consists of foil, metal plate, and insulator mounted between absorber canister and COSY block; powered by external supply. Heater activation is manual (independent of anesthesia system power). Heat transfers via conduction to breathing system components. Benefit: reduced moisture buildup in breathing circuit.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, system-level qualification, and verification/validation tests to confirm the heater plate modification does not impact system safety or performance.

Technological Characteristics

Continuous flow anesthesia system. Modification: heater plate (heater foil, metal plate, insulator) added to COSY block. Powered by external supply. Operates via thermal conduction to warm breathing system components. No changes to basic infrastructure, alarm strategies, or pneumatic subassemblies.

Indications for Use

Indicated for patients requiring anesthesia via continuous flow anesthesia system; supports spontaneous, manually assisted, automatic, or pressure support ventilation; provides gas/anesthetic vapor delivery and monitoring of oxygen concentration, breathing pressure, and respiratory volume. 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 (K030624)
• Fabius Tiro Anesthesia System (K031400)
• Narkomed 6400 Anesthesia System (K033498)

Submission Summary (Full Text)

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K041622

## JUL = 8 2004

### 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 - K030624<br>Fabius Tiro Anesthesia System - K031400<br>Narkomed 6400 Anesthesia System - K033498 |

### Device Description:

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

#### Intended Use:

The Fabius GS 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 can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.

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

#### Substantial Equivalence:

The compact breathing system (COSY) used with the Fabius GS (K030624) and Fabius Tiro (K031400) anesthesia systems is being modified to incorporate a heater plate. The addition of a heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged.

The heater consists of a heater foil, metal plate and insulator plate that are mounted between the absorber canister and COSY block. The heater subassembly is connected via a power cable to a separate power supply mounted externally to a Fabius GS/Tiro Anesthesia System.

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Like the heater plate utilized in the NM6400's (K033498) Divan ventilator, the heater incorporated into the COSY is intended to warm the breathing system to minimize moisture accumulation in the breathing system components, especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures. It is not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. Once activated, the heating plate in the COSY, like the NM6400, heats up to a constant temperature. This heat is then transferred, through conduction, to the components of the breathing system above it. In the NM6400, the heater plate is activated when the NM6400 System Power switch is turned to the "On" position and is de-activated when the NM6400 is switched to "Standby." With the COSY, heater activation is independent of the Fabius GS/Tiro. To activate the heater, the user is required to switch the heater power supply to the "On" position. To deactivate, the user is required to switch the power supply to the "Off" position.

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

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# Indications for Use

510(k) Number (if known):

Device Name: Fabius GS Anesthesia System

Indications for 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, delivery of gases and anesthetic vapor, 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.

Prescription Use _ x (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)

Page 1 of 1

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2004

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

Re: K041622

Trade/Device Name: Fabius Tiro Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: June 15, 2004 Received: June 16, 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 be found in 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.

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#### Page 2 - Mr. Kelhart

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office 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 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,

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): Koylle 22

Device Name: Fabius Tiro Anesthesia System

Indications for Use:

The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, 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.

Prescription Use X (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)

Page 1 of 1

Auy Sylbom

Division Sign Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K041622