FABIUS MRI

{0}------------------------------------------------ 510(k) Summary Fabius MRI Image /page/0/Picture/1 description: The image shows the logo for Dräger medical, which is a company that specializes in medical technology. Above the logo is the number 1072884. Below the logo, it states that Dräger is a Dräger and Siemens Company. The logo is in black and white. # 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 (451) 882-5367<br>Fax: + 49 (451) 882-4351 | | Applicants US Contact Person: | Joyce Kilroy<br>Vice President, PQR<br>(Processes, Quality & Regulatory) | | | Phone: +1 (215) 660-2626<br>Fax: +1 (215) 721-5424 | | 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 | 、 Section 3 - Page 1 of 3 : {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for Dräger Medical. The logo is in black and white, with the word "Dräger" in a bold, sans-serif font. Below the logo is the text "A Dräger and Siemens Company" in a smaller font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products. ### 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). {2}------------------------------------------------ # 510(k) Summary Fabius MRI Image /page/2/Picture/1 description: The image shows the word "Drägermedical". The word is written in a sans-serif font. The first letter "D" is capitalized, and the rest of the letters are in lowercase. The word is written in black color. 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 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. 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. {4}------------------------------------------------ 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 {5}------------------------------------------------ # 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 Page 1 of 1