(196 days)
Not Found
Not Found
No
The summary focuses on the device's functionality in an MRI environment and its equivalence to existing anesthesia systems, with no mention of AI or ML features.
No
{"explanation": "The device is described as an "Anesthesia System" and provides "ventilation parameters" and a "breathing circuit". Anesthesia systems are used during surgery to maintain physiological functions and are not primarily used for treating a disease or condition."}
No
The device is an anesthesia system (Aestiva SmartVent MRI Anesthesia System), which is used to deliver anesthesia and ventilate patients. It provides functional features related to ventilation parameters and a breathing circuit. It is not described as being used to diagnose conditions or diseases.
No
The device description explicitly mentions physical components like the "Aestiva breathing circuit" and being "constructed of primarily non-ferrous materials," indicating it is a hardware 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 focuses on providing ventilation and anesthesia in an MR environment. This is a therapeutic and life-support function, not a diagnostic test performed on samples from the body.
- Device Description: The description details the system's components related to ventilation and anesthesia delivery, and its construction for use in an MRI environment. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Keywords: The text does not contain any keywords typically associated with IVD devices, such as "sample," "assay," "reagent," "analyte," "diagnosis," "in vitro," etc.
The device is clearly described as an Anesthesia System designed for use in an MR environment. This falls under the category of medical devices used for patient care and treatment, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI performed to specifications when tested directly next to a 1.5 Tesla shielded MRI device in a field strength that did not exceed 300 gauss.
Product codes (comma separated list FDA assigned to the subject device)
73CBK, 73 BSZ
Device Description
The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva SmartVent 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 SmartVent MRI decrease the risk of hypoxic mixtures and complete power or sudden gas supply failures.
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
clinician
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)
The Datex-Ohmeda Aestiva SmartVent MRI and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The Datex-Ohmeda Aestiva SmartVent MRI has been validated through rigorous testing that, in part, support the compliance of Aestiva SmartVent MRI to 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.
Not Found
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.
Not Found
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).
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
APR 2 5 2000
October 8m, 1999
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Datex-Ohmeda
Aestiva SmartVent MRI Anesthesia System |
|-----------------|------------------------------------------------------------------------------------------------------------------------|
| Proprietary: | Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System |
| Common: | Gas Machine, Anesthesia |
| Classification: | Anesthesiology, 73CBK, 21CFR868.5160 |
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 3000 Anesthesia System Class II 21CFR868.5160 1.
- Ohmeda Excel MRI Anesthesia System Class II CFR868.5160 2.
The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI is constructed of primarily non-ferrous materials to help prevent attraction to the cryogenic magnets in the MRI systems. The Aestiva SmartVent 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 SmartVent MRI decrease the risk of hypoxic 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:
-
- EN 740 Anesthetic Work Stations
-
- EN 60601-1. IEC 601-1: 1988 Medical Electrical Equipment
-
- EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability
-
- ISO 5358 Anesthetic Gas Machines
-
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
In addition, the FDA Document, A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, was used to help determine testing a labeling requirements.
The Datex-Ohmeda Aestiva SmartVent MRI and the currently marketed devices are substantially equivalent in design concepts, technologies and materials. The Datex-Ohmeda Aestiva SmartVent MRI has been validated through rigorous testing that, in part, support the compliance of Aestiva SmartVent MRI to the above mentioned standards.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2000
Mr. Daniel Kosednar Datex-Ohmeda, Inc. Ohmeda Drive P.O. Box 7550 53707-7550 Madison, WI
K993410 Re: Aestiva SmartVent MRI Anesthesia System Requlatory Class: II (two) Product Code: 73 BSZ Dated: February 14, 2000 February 15, 2000 Received:
Dear Mr. Kosednar:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Daniel Kosednar
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
foA Wiozshena for,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K993410
Device Name: Datex-Ohmeda Aestiva SmartVent MRI Anesthesia Gas System
Indications For Use:
The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI performed to specifications when tested directly next to a 1.5 Tesla shielded MRI device in a field strength that did not exceed 300 gauss.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
K493410 510(k) Number:
Prescription Use (Per 21CFR801.109)
OR
le Huthon
ision of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Over-The-Counter Use-(Optional Format 1-2-96)