(24 days)
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No
The document describes a conventional anesthesia system adapted for use in an MRI environment, focusing on material composition and performance near MRI fields. There is no mention of AI or ML capabilities.
No.
The device is an anesthesia system providing ventilation parameters, which supports a medical procedure (anesthesia and ventilation) but does not directly treat or cure a disease or condition.
No
This device is an anesthesia system, providing ventilation and anesthetic agent delivery, and does not perform diagnostic functions.
No
The device description explicitly mentions hardware components like the Aestiva breathing circuit and construction from primarily non-ferrous materials, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an "Anesthesia System" used in the "MR environment." It focuses on providing ventilation parameters and a breathing circuit to a patient during an MRI procedure. This is a life support and monitoring function performed on a living patient, not a test performed on a sample taken from a patient.
- Device Description: The description reinforces its function as an "Anesthesia System" and highlights its construction for use in an MRI environment. It mentions safety features related to gas mixtures and power failures, all relevant to patient care during anesthesia.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Aestiva/5 MRI Anesthesia System is a medical device used for patient care during MRI procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
Product codes (comma separated list FDA assigned to the subject device)
BSZ
Device Description
The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device:
- Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160
The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Datex-Ohmeda MRI has been walidated through rigorous testing that, in part, support the comp Aestivation 12 the above mentioned standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
December 28th, 2004
Subject: 510(k) Summary of Safety and Effectiveness Information for the GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System Datex-Ohmeda Aestiva/5 MRI Anesthesia System Proprietary: Common: Gas Machine, Anesthesia Anesthesiology, 73CBK, 21CFR868.5160 Classification:
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Aestiva SmartVent MRI Anesthesia System is substantially equivalent to the following currently marketed device:
- Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System - Class II -21CFR868.5160
The Aestiva/5 MRI provides the functional feature set offered by the conventional Aestiva 3000 (K973896) to the clinician with the added ability to be used in the MR environment (as cleared in K993410). Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent (Including those cleared in K023366) along with the Aestiva breathing circuit. The Aestiva/5 MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva/5 MRI performed to specifications when tested directly next to an MRI device of the field strength listed in the product labeling. Safety features and devices within the Aestiva/5 MRI decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures.
The Aestiva SmartVent MRI was designed to comply with the applicable portions of the following voluntary standards:
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- EN 740 Anesthetic Work Stations
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- EN 60601-1, IEC 601-1: 1988 Medical Electrical Equipment
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- EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment -Electromagnetic Compatibility
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- ISO 5358 Anesthetic Gas Machines
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- ASTM F1208-94 Anesthesia Breathing Circuit Standard
In addition, the FDA Document, A Primer on Medical Device Interactions wi part of the Resonance Imaging Systems, was used to help determine testing and labeling requirements.
The Datex-Ohmeda Aestiva/5 MRI and the currently marketed devices are subst equivalent in design concepts, technologies and materials. The Datex-Ohmeda MRI has been walidated through rigorous testing that, in part, support the comp Aestivation 12 the above mentioned standards.
Datex-Ohmeda, Inc.
P.O. Box 7550
Madison, WI 53707-7550
Now
GE family
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing protection and service. The image is in black and white.
Public Health Service
FEB - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Kosednar Manager, Regulatory Planning and Submissions, CARE Datex-Ohmeda, Incorporated P.O Box 7550 Madison, Wisconsin 53707-7550
Re: K050055
Trade/Device Name: GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: January 10, 2005 Received: January 11, 2005
Dear Mr. Kosednar:
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.
2
Page 2 - Mr. Kosednar
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 Office of Compliance at (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CluLs
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
3
Indications for Use
KOSOOSS 510(k) Number (if known):
Device Name: GE Datex-Ohmeda Aestiva/5 MRI Anesthesia System
Indications For Use:
The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
Prescription Use XXX (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division Sign-Off
Division of Anesthaslology. General F Intection Control, Dental Devi 510(k) Number: