(295 days)
Not Found
No
The document describes a standard anesthesia system with various ventilation modes and monitoring capabilities, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an anesthesia system, used for ventilation and delivery of gases and anesthetic vapor, which are therapeutic interventions.
No
The device is an anesthesia system used for continuous flow anesthesia, ventilation, and monitoring of physiological parameters like oxygen concentration, breathing pressure, and respiratory volume. While it monitors some physiological parameters, its primary function is therapeutic (delivering anesthesia and ventilation) rather than diagnostic (identifying diseases or conditions).
No
The device description clearly outlines hardware components such as a continuous flow anesthesia system, breathing system, electrically driven and electronically controlled ventilator, and monitors for pressure, volume, and oxygen concentration.
Based on the provided information, the Fabius MRI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's an "anaesthesia system" used for delivering gases, anesthetic vapor, and monitoring physiological parameters like oxygen concentration, breathing pressure, and respiratory volume. This is a life support and monitoring system used directly on a patient.
- Device Description: The description reinforces its function as an anesthesia system with ventilation options and monitoring capabilities.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Fabius MRI does not interact with or analyze such specimens.
Therefore, the Fabius MRI falls under the category of a medical device used for patient care and monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BSZ
Device Description
The Fabius MRI is a continuous flow anesthesia system usable in an MRI environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MRI environments and standard ORs, induction and recovery rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)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.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. 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).(2)
Classification. Class II (performance standards).
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
Moislinger Allee 53-55
23542 Lübeck
Germany |
|----------------------------------|----------------------------------------------------------------------------------|
| Manufacturer Name and Address: | Dräger Medical AG & Co. KG
Moislinger Allee 53-55
23542 Lübeck
Germany |
| Establishment Regulation Number: | 9611500 |
| Contact Person: | Dr. Karin Luebbers
Senior Manager Regulatory Affairs |
| | Phone: + 49 (451) 882-5367
Fax: + 49 (451) 882-4351 |
| Applicants US Contact Person: | Joyce Kilroy
Vice President, PQR
(Processes, Quality & Regulatory) |
| | Phone: +1 (215) 660-2626
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
GE Datex Ohmeda Aestiva /5 MRI Anesthesia
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 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