FABIUS TIRO ANESTHESIA SYSTEM

K031400 · Draeger Medical, Inc. · BSZ · Jul 15, 2003 · Anesthesiology

Device Facts

• Record ID: K031400
• Device Name: FABIUS TIRO ANESTHESIA SYSTEM
• Applicant: Draeger Medical, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Jul 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fabius Tiro may be used for spontaneous, manually assisted, or automatic 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. Federal law restricts this device to sale by or on the order of a physician.

Device Story

Continuous flow anesthesia system; provides spontaneous, manually assisted, or automatic ventilation; delivers anesthetic gases/vapors; monitors inspired oxygen, breathing pressure, and respiratory volume. Used in clinical settings by physicians/anesthesia providers. Core components include control module, gas flow control, ventilator, and breathing system. Available in trolley-mount or wall-mount configurations. Features integrated vaporizer mounting and medical gas pipeline connections. Secondary gas source support via pin-index hanger yokes and internal regulators. Output displayed on graphics screen for clinician monitoring of patient respiratory status during anesthesia. Device modifications from predicate include reduced vaporizer capacity (one vs. two), relocated gas pipeline connections, and updated yoke assembly configurations. Software remains functionally identical to predicate, with only display name updated.

Clinical Evidence

Bench testing only. Qualification included hazard analysis, system-level qualification, and verification tests. No clinical data provided.

Technological Characteristics

Continuous flow anesthesia system. Components: control module, gas flow control, ventilator, breathing system. Configurations: trolley-mount or wall-mount. Gas supply: medical gas pipeline and pin-index hanger yokes for O2/N2O/Air cylinders. Internal regulators. Software: embedded firmware for system control and graphics display. No functional software changes from predicate.

Indications for Use

Indicated for patients requiring spontaneous, manually assisted, or automatic ventilation during anesthesia, including delivery of gases and anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume.

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)
• OBA-1 Anesthesia Unit (K000859)

Submission Summary (Full Text)

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K031400

# JUL 15 2003

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

| Proprietary Name: | 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 – K011404<br>OBA-1 Anesthesia Unit – K000859 |

### Device Description:

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

#### Intended Use:

The Fabius Tiro may be used for spontaneous, manually assisted, or automatic 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 Fabius Tiro is a modification to the current Fabius GS Anesthesia System (K011404). The Fabius Tiro incorporates the same control module, gas flow control module, ventilator and breathing system subassemblies of the Fabius GS into a basic core module. Two versions of the Fabius Tiro are available; one that is designed to be mounted on a trolley and one that is designed to interface with other manufacturers' wall mounting solutions. The differences between the Fabius Tiro and Fabius GS are:

- Vaporizer mounting system: The Fabius GS can accommodate the mounting of up to two vaporizers and incorporates a mechanical exclusion system to ensure that only one vaporizer can be activated at one time. The Fabius Tiro can accommodate the mounting of only one vaporizer.
- Medical Gas Pipeline connections: On the Fabius GS, the medical gas pipeline connections are located on the back. On the Fabius Tiro, the medical gas pipeline connections are located on the right side (when viewed from the front).

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- Pin-index hanger yokes: The Fabius GS has three pin-index hanger yokes mounted on the back of the machine to accommodate the mounting of two Oxygen and either a Nitrous Oxide or Air cylinder as secondary gas sources. Cylinder regulators are mounted internally and cylinder contents gauges are on the front of the machine. The Fabius Tiro wall mount version has one external tethered pin-index yoke, regulator and cylinder contents gauge assembly, which can be mounted to an Oxygen cylinder as a secondary gas source. The tethered yoke assembly is similar to the oxygen manifold for one e-cylinder and pipeline supply offered by OBAMED Inc. for the OBA-1 Anesthesia Unit (K000859) in that both contain a yoke assembly, regulator, cylinder contents gauge, and a connecting hose. The manifold and check valve are internally mounted on the Fabius Tiro while the manifold and check valve are external (part of the yoke assembly) on the OBA-1. The yoke assembly is standard equipment on the Fabius Tiro and is permanently connected to the right side of the machine while the assembly is optional for the OBA-1 and is connected to the machine via a DISS connector. The Fabius Tiro trolley mount version has one pin index hanger yoke mounted on the back of the machine to accommodate the mounting of an Oxygen cylinder as a secondary gas source and an optional second pin-index hanger yoke is available to accommodate a Nitrous Oxide cylinder. As with the Fabius GS, cylinder regulators are mounted internally and cylinder contents gauges are on the front of the machine.
- -Software: There are no functional or operational changes to the software version from previously qualified software. The only software change was to change "Fabius GS" to "Fabius Tiro" as the name shown on the graphics display.

Qualification of the Fabius Tiro included a hazard analysis, system level qualification, and verification tests.

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Public Health Service

JUL 15 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031400

Trade/Device Name: Fabius Tiro Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas machine, Anesthesia Regulatory Class: II Product Code: 73 BSZ Dated: June 13, 2003 Received: June 16, 2003

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 deyice 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.

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.

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Page 2 - Mr. Michael A. Kelhart

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 your 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 vours.

Susan Runne

Susan Runner, DDS, MA Interim 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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Page

510(k) Number (if known): _ K631400

Fabius Tiro Anesthesia System -----------Device Name:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

.

OR

Over-The-Counter-Use __

Hine M. Ruto

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

K031400 510(k) Number:

(Optional Format 1-2-96)