DATES-OHMEDA AESTIVA SMARTVENT MRI

K993410 · Datex-Ohmeda, Inc. · BSZ · Apr 25, 2000 · Anesthesiology

Device Facts

• Record ID: K993410
• Device Name: DATES-OHMEDA AESTIVA SMARTVENT MRI
• Applicant: Datex-Ohmeda, Inc.
• Product Code: BSZ · Anesthesiology
• Decision Date: Apr 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Anesthesia gas machine designed for use in MR environments; provides ventilation and anesthesia delivery. Input: gas supply; Output: controlled anesthetic gas mixture to patient. Operation: utilizes Datex-Ohmeda user interface and Aestiva breathing circuit; constructed of non-ferrous materials to minimize interaction with MRI cryogenic magnets. Used by clinicians in clinical settings near MRI scanners. Benefits: enables anesthesia delivery during MRI procedures while maintaining safety features against hypoxic mixtures and power/gas supply failures.

Clinical Evidence

Bench testing only. Device validated for performance and safety when operated in proximity to a 1.5 Tesla shielded MRI device (field strength not exceeding 300 gauss). Compliance with EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, and ASTM F1208-94 standards documented.

Technological Characteristics

Non-ferrous materials construction; anesthesia breathing circuit; Datex-Ohmeda user interface. Complies with EN 740, EN 60601-1, EN 60601-1-2, ISO 5358, and ASTM F1208-94. Designed for MR compatibility (1.5 Tesla, <300 gauss).

Indications for Use

Indicated for use by clinicians as an anesthesia gas machine in the MR environment. Patient population not explicitly defined by age or disease state; intended for use in clinical settings requiring anesthesia delivery near MRI equipment.

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

• Datex-Ohmeda Aestiva 3000 Anesthesia System
• Ohmeda Excel MRI Anesthesia System

Submission Summary (Full Text)

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## APR 2 5 2000

K993410

October 8m, 1999

| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Datex-Ohmeda<br>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:

- 1. EN 740 Anesthetic Work Stations
- 2. EN 60601-1. IEC 601-1: 1988 Medical Electrical Equipment
- 4. EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability
- 5. ISO 5358 Anesthetic Gas Machines
- 6. 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.

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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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.

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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)