FABIUS MRI

K072884 · Draeger Medical AG & Co. KG · BSZ · Jul 30, 2008 · Anesthesiology

Device Facts

• Record ID: K072884
• Device Name: FABIUS MRI
• Applicant: Draeger Medical AG & Co. KG
• Product Code: BSZ · Anesthesiology
• Decision Date: Jul 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume. The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less. Federal law restricts this device to sale by, or on the order of a physician.

Device Story

Continuous flow anesthesia system for MRI environments; utilizes O2, N2O, and AIR from pipelines or cylinders. Electrically driven, electronically controlled ventilator provides volume-controlled, pressure-controlled, pressure-support, SIMV/PS, manual, and spontaneous ventilation. Monitors airway pressure, volume, and FiO2; requires external CO2 and anesthetic agent monitoring per IEC 60601-2-13. Operated by clinicians in ORs, induction/recovery rooms, and MRI suites. Features MRI-specific modifications including reduced ferromagnetic materials, tesla sensor, and integral gauss alarm for safety within 400 gauss limit. Benefits patient by enabling safe anesthesia delivery during MRI procedures.

Clinical Evidence

Bench testing only. Evidence includes risk management reports, system-level qualification, and verification testing according to applicable standards, including testing in an MRI environment.

Technological Characteristics

Continuous flow anesthesia system; electrically driven/electronically controlled ventilator. Materials modified for MRI compatibility (reduced ferromagnetic content). Connectivity includes medical gas pipeline/cylinder inputs. Monitors: airway pressure, volume, FiO2. Standards: IEC 60601-2-13. Safety features: integral gauss alarm for 400 gauss limit.

Indications for Use

Indicated for patients requiring anesthesia delivery and ventilation support in MRI environments (1.5T or 3.0T magnets, <400 gauss). Used for spontaneous, manual, or automatic ventilation, gas/anesthetic delivery, and monitoring of O2, pressure, and 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 (K042419)
• GE Datex Ohmeda Aestiva /5 MRI Anesthesia System (K050055)

Submission Summary (Full Text)

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510(k) Summary Fabius MRI

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# 510(k) Summary
21 CFR part 807.92

JUL 3 0 2008

| Applicants Name and Address: | Dräger Medical AG & Co. KG<br>Moislinger Allee 53-55<br>23542 Lübeck<br>Germany |
|----------------------------------|----------------------------------------------------------------------------------|
| Manufacturer Name and Address: | Dräger Medical AG & Co. KG<br>Moislinger Allee 53-55<br>23542 Lübeck<br>Germany |
| Establishment Regulation Number: | 9611500 |
| Contact Person: | Dr. Karin Luebbers<br>Senior Manager Regulatory Affairs |
| | Phone: + 49 [phone]<br>Fax: + 49 [phone] |
| Applicants US Contact Person: | Joyce Kilroy<br>Vice President, PQR<br>(Processes, Quality & Regulatory) |
| | Phone: [phone]<br>Fax: [phone] |
| Date submission was prepared: | 2007-10-05 |
| Device Name: | Fabius MRI |
| Common Name: | Gas-machine, anesthesia (73 BSZ) |
| Classification Name: | 21 CRF 868.5160 |
| Regulation Number: | II |
| Class: | |
| Predicate Device Identification: | Fabius GS K042419<br>GE Datex Ohmeda Aestiva /5 MRI Anesthesia<br>System K050055 |

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Section 3 - Page 1 of 3

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### Device Description:

The Fabius MRI is a continuous flow anesthesia system usable in an MRI environment.

#### Intended Use:

Fabius MRI is an inhalation anesthesia machine for use in MRI environments and standard ORs, induction and recovery rooms. It can be used in MR/ environments with 1.5 and 3 tesla magnets at a location of < 40 millitesta (400 gauss).

It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders.

Fabius MRI is equipped with a compact breathing system, providing fresh gas decoupling, PEEP, and pressure limitation.

The following ventilation options are available:

- Volume Controlled Ventilation �
- ◆ Pressure Controlled Ventilation
- . Pressure Support (Optional)
- SIMV/PS (Optional) ◆
- Manual Ventilation ◆
- . Spontaneous Breathing

Fabius MRI is equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2),

As per IEC 60601-2-13 (Anesthetic Workstations and their Modules - Particular Reguirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use.

#### Predicate Devices:

| 510(k) Number | Device Name | Manufacturer |
|---------------|--------------------------------|-----------------------------|
| K042419 | Fabius GS | Draeger Medical AG & Co. KG |
| K050055 | GE Datex Ohmeda Aestiva /5 MRI | GE Healthcare |

#### Substantial Equivalence:

The Fabius MRI is substantially equivalent to the Fabius GS (K042419) and the GE Datex Ohmeda Aestiva /5 MRI (K050055).

The Fabius GS was modified into the Fabius MRI. The two devices are identical with exception of modifications for the MRI environment (e.g. testa sensor, alarm indicators, MRI specific labeling reduction of ferromagnetic materials) and a few other minor differences, (e.g. auxiliary outlet standard, 2 vapors instead of 3).

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# 510(k) Summary Fabius MRI

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A Dräger and Siemens Company

The Fabius MRI is similar to the Aestival5MRI in that both devices can be used in MRI environments with shielded magnets of 1.5 and 3.0 Tesla. Both devices have limitations to the location of use. The Fabius MRI may be used at a location of <400 gauss, while the Aestival5MRI may be used at locations of 300 gauss. Both devices have integral gauss alarms that notify the user when the device in excess of their operating parameters (> 400 gauss, 300 gauss).

Qualification of the Fabius MRI includes a risk management report, system level qualification and verification testing according to applicable standards and testing in an MRI environment.

Section 3 - Page 3 of 3

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 2008

Draeger Medical AG & CO. KG Ms. Joyce Kilroy Vice President of Processes, Quality, and Regulatory Draeger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K072884

Trade/Device Name: Fabius MRI Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: July 22, 2008 Received: July 25, 2008

Dear Ms. Kilroy:

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 - Ms. Kilroy

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (QSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

TK Armele-Lund, m/frell

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): K

Device Name: Fabius MRI

# Indications For Use:

The Fabius MRI is indicated as a continuous flow anaesthesia system. The Fabius MRI may be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anaesthetic vapor, and monitoring of oxygen concentration, breathing pressure and respiratory volume.

The Fabius MRI is indicated for use in MRI scanner rooms with 1.5 and 3.0 tesla magnets at a location of 40 m tesla (400 gauss) or less.

Federal law restricts this device to sale by, or on the order of a physician.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

shl

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

510(k) Number: Ko 72884

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