DATES-OHMEDA AESTIVA SMARTVENT MRI by DATEX-OHMEDA, INC.

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.

AI/ML Overview

This document is a 510(k) summary for the Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System. It describes the device, its intended use, and its substantial equivalence to predicate devices, along with compliance with voluntary standards. However, it does not contain the detailed information necessary to complete the specific request regarding acceptance criteria and a study that proves the device meets those criteria.

Therefore, many sections of your request cannot be fulfilled using the provided text.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be created. The document states "The Aestiva SmartVent MRI performed to specifications when tested directly next to an MRI device..." and "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." However, it does not specify what those "specifications" or "performance" metrics were, nor does it provide a table of acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be determined. The document mentions "rigorous testing" but gives no details about sample size, data provenance, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be determined. This device is an anesthesia system, not an AI/diagnostic device that relies on expert interpretation for ground truth. The document does not describe any such expert involvement.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be determined. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/diagnostic imaging device where human readers would typically be involved in interpreting output for a comparative effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device (anesthesia system), not an algorithm or AI. Performance is evaluated based on its functional specifications and safety in the intended environment.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated in the context of ground truth as typically understood for diagnostic AI. For this type of device, "ground truth" would likely refer to engineering specifications, safety standards, and physiological measurements to ensure the device performs as intended (e.g., delivers precise gas mixtures, ventilates according to parameters) and functions correctly in the MR environment. The document implicitly suggests compliance with voluntary standards (EN 740, EN 60601-1, etc.) as the "ground truth" for its design and performance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of available information:

Device Name: Datex-Ohmeda Aestiva SmartVent MRI Anesthesia System
Intended Use/Key Performance Aspect: Provides functions of conventional Aestiva 3000 but with added ability to be used in the MR environment. Specifically states it "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."
Compliance Relied Upon (Implicit Acceptance Criteria):
- 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 Comparability
- ISO 5358 Anesthetic Gas Machines
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
- Guidance from "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems"

This document serves as a regulatory submission demonstrating substantial equivalence and compliance with relevant standards for a medical device, rather than a detailed scientific study report with explicit acceptance criteria and performance metrics for an AI-enabled diagnostic tool.

Summary

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APR 2 5 2000

K993410

October 8m, 1999

Subject:	510(k) Summary of Safety and Effectiveness Information for the Datex-OhmedaAestiva 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
1. EN 60601-1. IEC 601-1: 1988 Medical Electrical Equipment
1. EN 60601-1-2, IEC 601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatability
1. ISO 5358 Anesthetic Gas Machines
1. 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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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.

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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 (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

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510(k) Number (if known): K993410

Device Name: Datex-Ohmeda Aestiva SmartVent MRI Anesthesia Gas System

Indications For Use:

(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)

le Huthon

ision of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Over-The-Counter Use-(Optional Format 1-2-96)

Regulation Number and Section

§ 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).